{"id":"avibactam","rwe":[{"pmid":"41900863","year":"2026","title":"Accurate and Sensitive UHPLC-Tandem Mass Spectrometry Sequential Methods for Therapeutic Drug Monitoring of Aztreonam/Avibactam in Human Plasma.","finding":"","journal":"Pharmaceutics","studyType":"Clinical Study"},{"pmid":"41892432","year":"2026","title":"Novel Insights into Carbapenem Resistance: Mechanisms, Diagnostics, and Future Directions.","finding":"","journal":"Antibiotics (Basel, Switzerland)","studyType":"Clinical Study"},{"pmid":"41891866","year":"2026","title":"Comparative in vitro efficacy of aztreonam-avibactam and other alternatives (cefepime-taniborbactam, cefepime-zidebactam, and cefiderocol) against metallo-β-lactamase-producing Enterobacterales isolated in 2024 in France.","finding":"","journal":"Antimicrobial agents and chemotherapy","studyType":"Clinical Study"},{"pmid":"41888278","year":"2026","title":"Ceftazidime-avibactam for multidrug and pandrug-resistant gram-negative infections in critically Ill children: a single-center pediatric ıntensive care experience.","finding":"","journal":"European journal of pediatrics","studyType":"Clinical Study"},{"pmid":"41882581","year":"2026","title":"Prognostic factors for mortality in critically ill patients with infections caused by carbapenem-resistant gram-negative pathogens treated with ceftazidime-avibactam: a multicenter retrospective study.","finding":"","journal":"BMC infectious diseases","studyType":"Clinical Study"}],"_fda":{"id":"c35160ee-d73c-4288-8172-d69d75d52b1d","set_id":"be1a6c99-d4b3-46d7-9e99-6e5f9fab556a","openfda":{"nui":["N0000175930","N0000000202","N0000175493","M0014030"],"unii":["7352665165","G2B4VE5GH8"],"route":["INTRAVENOUS"],"rxcui":["2705355","2705360"],"spl_id":["c35160ee-d73c-4288-8172-d69d75d52b1d"],"brand_name":["EMBLAVEO"],"spl_set_id":["be1a6c99-d4b3-46d7-9e99-6e5f9fab556a"],"package_ndc":["0074-3878-01","0074-3878-10"],"product_ndc":["0074-3878"],"generic_name":["AZTREONAM AND AVIBACTAM"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_cs":["Monobactams [CS]"],"substance_name":["AVIBACTAM","AZTREONAM"],"pharm_class_epc":["beta Lactamase Inhibitor [EPC]","Monobactam Antibacterial [EPC]"],"pharm_class_moa":["beta Lactamase Inhibitors [MoA]"],"manufacturer_name":["AbbVie Inc."],"application_number":["NDA217906"],"is_original_packager":[true]},"version":"5","pregnancy":["8.1 Pregnancy Risk Summary There are no data on the effects of EMBLAVEO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Available data from case reports over several decades with aztreonam and over approximately a decade with avibactam have not identified a drug-associated risk of major birth defects, miscarriage or other maternal or fetal outcomes. Aztreonam Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam revealed no evidence of embryotoxicity, fetotoxicity, or fetal malformations at doses 2.7- and 3.6-fold greater, respectively, than the maximum recommended human dose (MRHD) for adults of 6.5 g per day. In a peri/postnatal development (PPND) study in rats, no aztreonam-induced changes in any maternal, fetal, or neonatal parameters were observed at a dose 2.7-fold greater than the MRHD. Avibactam Avibactam administered to pregnant rats was not associated with fetal malformations at doses 6 times the MRHD of 2.17 g per day. In pregnant rabbits, avibactam administered in doses greater than or equal to 5 times the MRHD was associated with increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies. In a rat PPND study, there were no effects on pup growth and viability at doses up to 8 times the avibactam MRHD. A dose-related increase in the incidence of renal pelvic and ureter dilatation was observed in female weaning pups with renal pelvic dilatation persisting into adulthood (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Aztreonam Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam up to 1800 and 1200 mg/kg, respectively, revealed no evidence of embryotoxicity or fetotoxicity or fetal malformations. These doses, based on body surface area, are 2.7- and 3.6-fold greater than the MRHD for adults of 6.5 g per day. A peri/postnatal study in rats revealed no drug-induced changes in any maternal, fetal, or neonatal parameters. The highest dose used in this study, 1800 mg/kg/day, is 2.7 times the MRHD based on body surface area comparison. Avibactam Avibactam did not produce fetal malformations in pregnant rats or rabbits. In the rat, intravenous studies with 0, 250, 500 and 1000 mg/kg/day of avibactam during gestation days 6-17 showed no embryo-fetal toxicity at doses up to 1000 mg/kg/day, approximately 6 times the MRHD (2.17 g/day) based on exposure (AUC). Pregnant rabbits administered intravenous avibactam on gestation days 6-19 at 0, 100, 300 and 1000 mg/kg/day showed no effects on embryo-fetal development at a dose of 100 mg/kg, twice the MRHD based on AUC comparison. At doses greater than or equal to 300 mg/kg/day (5 times the MRHD based on AUC comparison), increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies were observed. In a rat pre-and post-natal study at up to 825 mg/kg/day intravenously (8 times the MRHD based on AUC), there were no effects on pup growth and viability. A dose-related increase in the incidence of renal pelvic and ureter dilatation was observed in female weaning pups that was not associated with pathological changes to renal parenchyma or renal function, with renal pelvic dilatation persisting after female weaning pups became adults."],"overdosage":["10 OVERDOSAGE There is no information on the clinical signs and symptoms associated with an overdose of EMBLAVEO. Aztreonam and avibactam can be partially removed by hemodialysis [see Clinical Pharmacology ( 12.3 )] . No clinical information is available on the use of hemodialysis to treat EMBLAVEO overdosage."],"description":["11 DESCRIPTION EMBLAVEO for injection, for intravenous use, is a combination product consisting of aztreonam and avibactam sodium. Aztreonam Aztreonam is a synthetic, monobactam antibacterial drug. Its chemical name is (Z)-2-[[[(2-Amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic acid. Its molecular weight is 435.43 g/mol. The empirical formula is C 13 H 17 N 5 O 8 S 2 . Figure 1 . Chemical structure of aztreonam . Avibactam Avibactam sodium is a beta-lactamase inhibitor. Its chemical name is sodium [(2S,5R)-2-carbamoyl-7-oxo-1,6- diazabicyclo[3.2.1]octan-6-yl] sulfate. Its molecular weight is 287.23 g/mol. The empirical formula is C 7 H 10 N 3 O 6 SNa. Figure 2. Chemical structure of avibactam sodium . EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) for injection is a white to slightly yellow sterile powder for reconstitution consisting of aztreonam and avibactam packaged in glass vials. The formulation also contains inactive ingredient L-arginine 1170 mg/vial. Each EMBLAVEO 2 grams single-dose vial contains 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 gram sterile avibactam sodium). The total sodium content of the mixture is approximately 44.6 mg/vial. Figure 1. Chemical structure of aztreonam. Figure 2. Chemical structure of avibactam sodium."],"how_supplied":["16 HOW SUPPLIED/STORAGE AND HANDLING EMBLAVEO 2 grams (aztreonam and avibactam) for injection is supplied as a sterile powder in single-dose, clear glass vial containing: 1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 grams of avibactam sodium). Vials are supplied as individual vial (NDC 0074-3878-01) and in cartons containing 10 vials (NDC 0074-3878-10). EMBLAVEO vials should be stored at 2°C to 8°C (36°F to 46°F). Protect from light. Store in carton until time of use."],"microbiology":["12. 4 Microbiology Mechanism of action EMBLAVEO is a combination of the monobactam antibacterial, aztreonam, and the beta-lactamase inhibitor, avibactam. Aztreonam inhibits bacterial peptidoglycan cell wall synthesis following binding to penicillin binding proteins (PBPs), which leads to bacterial cell lysis and death and is stable to class B beta-lactamase enzymes (metallo-beta-lactamases). Avibactam is a non-beta-lactam, beta-lactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis. Avibactam inhibits both Ambler class A, class C and some class D beta-lactamases, including extended-spectrum β-lactamases (ESBLs), Klebsiella pneumoniae carbapenemase (KPC), OXA-48 carbapenemases, and AmpC enzymes. Avibactam does not inhibit class B enzymes and is not able to inhibit some class D enzymes. EMBLAVEO demonstrated in vitro activity against Enterobacterales isolates expressing beta-lactamases included in Ambler Class A (CTX-M-, TEM-, and SHV-type ESBLs; KPC carbapenemase), Class B (New Delhi metallo-beta-lactamases [NDM], Verona integron-encoded metallo-beta-lactamase [VIM], and imipenemases [IMP]), Class C (AmpC), and Class D (OXA-48-like). Resistance Resistance mechanisms to EMBLAVEO include beta-lactamase enzymes refractory to inhibition by avibactam and able to hydrolyze aztreonam, mutant or acquired PBPs, decreased outer membrane permeability, and active efflux pumps. Interaction with Other Antimicrobials No antagonism was demonstrated in in vitro studies between EMBLAVEO and amikacin, ciprofloxacin, colistin, daptomycin, gentamicin, levofloxacin, linezolid, metronidazole, tigecycline, tobramycin, and vancomycin against Enterobacterales. Activity against bacteria in animal infection models Avibactam restored the activity of aztreonam in animal models of infection (e.g., mouse thigh infection, mouse lung infection) caused by aztreonam non-susceptible NDM- and ESBL-producing E. coli and K. pneumoniae isolates. However, the clinical significance of these findings is unknown. Antimicrobial Activity EMBLAVEO has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections [see Indications and Usage ( 1.1 )] . Citrobacter freundii complex Escherichia coli Enterobacter cloacae complex Klebsiella pneumoniae Klebsiella oxytoca Serratia marcescens The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro MIC less than or equal to the susceptible breakpoint for EMBLAVEO against isolates of similar genus or organism group. However, the safety and effectiveness of EMBLAVEO in treating clinical infections due to these bacteria have not been established in adequate and well-controlled clinical trials: Aerobic Gram-negative organisms Citrobacter koseri Enterobacter spp. Klebsiella aerogenes Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Raoultella ornithinolytica Serratia spp. Stenotrophomonas maltophilia Susceptibility Test Methods For specific information regarding susceptibility testing methods, interpretive criteria, and associated test methods and quality control standards recognized by FDA for EMBLAVEO, please see: https://www.fda.gov/STIC."],"geriatric_use":["8.5 Geriatric Use In Trials 1, 2, and 3, there were 103 patients in the EMBLAVEO treatment arm 65 years of age and older. Of these patients, 60 (58%) were between 65-74 years of age and 43 (42%) patients were 75 years of age and older. In comparison, there were 202 patients in the EMBLAVEO treatment arm less than 65 years of age. Clinical studies of EMBLAVEO did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Aztreonam and avibactam (components of EMBLAVEO) are known to be substantially excreted by the kidney, and the risk of adverse reactions to aztreonam and avibactam (components of EMBLAVEO) may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. No dosage adjustment is required in elderly patients based on age; the dose should be selected based on renal function [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )]."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness of EMBLAVEO in pediatric patients less than 18 years of age have not been established."],"effective_time":"20260408","clinical_studies":["14 CLINICAL STUDIES 14.1 Complicated Intra-abdominal Infections The determination of efficacy of EMBLAVEO was supported in part by the previous findings of the efficacy and safety of aztreonam for the treatment of cIAI. The contribution of avibactam to EMBLAVEO was primarily established in vitro and in animal models of infection [see Clinical Pharmacology ( 12.4 )] . EMBLAVEO was studied in one randomized, active-controlled, multicenter trial (Trial 1, NCT03329092) in patients with cIAI or hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) (not an approved indication for EMBLAVEO). The trial was not designed with any formal hypotheses for inferential testing against the active comparator."],"pharmacodynamics":["12.2 Pharmacodynamics As with other beta-lactam antimicrobial drugs, the time that unbound plasma concentrations of aztreonam exceed the EMBLAVEO minimum inhibitory concentration (MIC) against the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with Enterobacterales. The time above a threshold concentration has been determined to be the parameter that best predicts the efficacy of avibactam in combination with aztreonam in in vitro and in vivo nonclinical models. Cardiac Electrophysiology Avibactam does not prolong the QTc interval to any clinically significant extent at a dose 3 times the maximum approved EMBLAVEO recommended avibactam loading dose. Aztreonam QT prolongation evaluations have not been conducted or reported in literature."],"pharmacokinetics":["12.3 Pharmacokinetics Following single or multiple dosing, the C max and AUC of both aztreonam and avibactam (components of EMBLAVEO) increase in an approximate dose-proportional manner over a dose range of 500 mg to 2000 mg aztreonam (0.25 to 1 times the approved maximum recommended loading dose) and of 50 mg to 2000 mg avibactam (0.07 to 3 times the approved maximum recommended loading dose). Aztreonam and avibactam (components of EMBLAVEO) pharmacokinetic properties are summarized in Table 6. There is minimal accumulation of aztreonam and avibactam following multiple intravenous 3-hour infusions of EMBLAVEO every 6 hours in patients with normal renal function. Table 6: Pharmacokinetic (PK) Properties of Components of EMBLAVEO (Aztreonam and Avibactam) PK Parameter Aztreonam Avibactam C max, ss (mg/L) a,b, c 54.46 ± 17.22 11.29 ± 3.89 AUC 0-24, ss (mg•h/L) a,b,c 841.22 ± 317.59 165.7 ± 65.63 Distribution Binding to human plasma proteins 38 % 8 % Volume of distribution (Vss) c 21.4 ± 23 L 37.8 ± 73 L Elimination Clearance (CL) c 10.2 ± 22 L/hr 18 ± 39 L/hr Mean terminal half-life (t 1/2 ) c 2.03 ± 0.69 hrs 2.04 ± 0.52 hrs Metabolism Metabolic pathways Aztreonam is minimally metabolized. No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes). Unchanged avibactam was the major drug-related component in human plasma and urine following dosing with [ 14 C]-avibactam Excretion Major route of elimination Renal excretion: tubular secretion and glomerular filtration % of dose excreted in urine, unchanged 64.2 % to 75.9 % 83.8 % to 100 % % of dose excreted in feces, changed and unchanged Approximately 12 % < 0.25 % C max, ss =maximum plasma concentration at steady-state; AUC 0-24, ss =area under the plasma concentration-time curve from time zero up to 24 hrs at steady state; Vss = volume of distribution at steady state; mean = arithmetic mean; SD = standard deviation. a 2000 mg aztreonam + 670 mg avibactam IV infusion over 3 hours then 1500 mg aztreonam + 500 mg avibactam IV infusion over 3 hours every 6 hours. b There is no clinically significant PK differences (as measured by AUC and Cmax) between healthy adults and adults with cIAI (normal renal function). c mean ± SD reported based on PK data from 97 adults with cIAI Specific Populations No clinically significant differences in the pharmacokinetics of aztreonam or avibactam were observed based on age (range: 18-89 years), sex (62.1% male), race (61.9% White, 27.7% Asian, and 3.4% Black), or BMI (10.4 to 62.5 kg/m 2 ). Patients with Renal Impairment The disposition of aztreonam and avibactam were evaluated in non-infected subjects with CLcr >80 mL/min (as measured by Cockcroft-Gault method, n=6) administered the recommended general maintenance dosing regimen and with CLcr 32 to 37 mL/min (n=5) administered the recommended adjusted maintenance dosing regimen for CLcr >15 to ≤ 30 mL/min. Aztreonam AUC 24 and C max at steady state is approximately 21% and 24% lower in the subjects with CLcr 32 to 37 mL/min compared to the CLcr >80 mL/min group. The avibactam AUC24 and Cmax at steady state are approximately 24% and 2% higher in the subjects with CLcr 32 to 37 mL/min, compared to the CLcr >80 mL/min group. Dosage adjustment for EMBLAVEO in patients with CLcr ≤ 50 mL/min is recommended [see Dosage and Administration ( 2.2 )] . Patients with Hepatic Impairment EMBLAVEO has not been studied in patients with hepatic impairment. As aztreonam and avibactam do not appear to undergo significant hepatic metabolism, the systemic clearance of either active substance is not expected to be significantly altered by hepatic impairment. Dosage adjustments are not considered necessary for EMBLAVEO in patients with impaired hepatic function. Geriatric Patients (Greater than or equal to 65 years) Mean elimination half-life of both aztreonam and avibactam is increased, and plasma clearance decreased in the elderly, consistent with age-related reduction in renal clearance of aztreonam and avibactam. Dosage adjustment for EMBLAVEO in geriatric patients should be based on renal function [see Dosage and Administration ( 2.2 )] . Drug Interaction Studies Clinical Studies and Model-Informed Approaches OAT1/3 inhibitors: No clinically significant differences in aztreonam pharmacokinetics were observed when used concomitantly with probenecid (OAT1/3 inhibitors). Concomitant administration of probenecid with aztreonam is reported to result in clinically insignificant increases in aztreonam exposure. No clinical studies have been conducted with avibactam and OAT1/3 inhibitors (e.g., probenecid) and the clinical impact of OAT inhibitors on the pharmacokinetics of avibactam is not known. Other: No drug-drug interaction was observed between aztreonam, avibactam, and metronidazole in clinical studies. In Vitro Studies Avibactam was not found to be an inhibitor of the following hepatic and renal transporters in vitro at clinically relevant concentrations: MDR1, BCRP, OAT1, OAT3, OATP1B1, OATP1B3, BSEP, MRP4, OCT1, or OCT2. Avibactam was not a substrate of MDR1, BCRP, MRP4, or OCT2, but was a substrate of human OAT1 and OAT3 kidney transporters based on results generated in human embryonic kidney cells expressing these transporters."],"adverse_reactions":["6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Serious Skin Disorders [see Warnings and Precautions ( 5.2 )] Hepatic Adverse Reactions [see Warnings and Precautions ( 5.3 )] Clostridioides Difficile -Associated Diarrhea [see Warnings and Precautions ( 5.4 )] The most common adverse reactions occurring at an incidence of greater than 5% were hepatic adverse reactions, anemia, diarrhea, hypokalemia, and pyrexia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials Experience in Adult Patients Three clinical trials, Trial 1, Trial 2, and Trial 3, underly the EMBLAVEO clinical development program. Trial 1 was a randomized, comparative trial conducted in patients with cIAI and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP) (not an approved indication for EMBLAVEO), while Trials 2 and 3 were smaller, noncomparative trials conducted in patients with cIAI as well as other serious infections caused by gram negative pathogens expressing metallo-beta-lactamases. The safety data from Trial 1 are summarized below. In Trial 1, EMBLAVEO was evaluated in a comparative clinical trial in patients with cIAI or HABP/VABP; note that EMBLAVEO is not approved for the treatment of HABP/VABP. Trial 1 evaluated 275 patients treated with EMBLAVEO and 137 patients treated with comparator (meropenem +/- colistin); 203 EMBLAVEO-treated patients had a diagnosis of cIAI while 72 EMBLAVEO-treated patients had a diagnosis of HABP/VABP (not an approved indication for EMBLAVEO). Patients received treatment with EMBLAVEO 2 grams (aztreonam 1.5 grams and avibactam 0.5 grams) or comparator for 5 to 14 days. Patients randomized to EMBLAVEO received a loading dose of aztreonam and avibactam administered by intravenous infusion over 30 minutes immediately followed by an extended loading dose infused over 3 hours, followed by maintenance doses infused over 3 hours every 6 hours based on the participant’s creatinine clearance. Patients with cIAI randomized to EMBLAVEO also received metronidazole 500 mg administered by intravenous infusion over 60 minutes every 8 hours. The median age of patients in Trial 1 treated with EMBLAVEO was 58 years, ranging between 18 and 87 years old. Patients treated with EMBLAVEO were predominantly male (66%) and White (59%). Approximately 40% (22% of cIAI and 89% of HABP/VABP; not an approved indication) of patients treated with EMBLAVEO had an APACHE II score greater than 10 at baseline. Death occurred in 6.9% (19/275) of patients who received EMBLAVEO and in 8% (11/137) of patients who received comparator. In patients with cIAI, death occurred in 3.0% (6/203) of patients treated with EMBLAVEO and 2.9% (3/103) in patients treated with comparator. Overall, 3.6% (10/275) of the patients who received EMBLAVEO discontinued treatment due to an adverse reaction, compared with 3.6% (5/137) of patients treated with comparator. Common adverse reactions occurring in greater than 5% of patients are noted in the table below. Table 5: Adverse Reactions Occurring in > 5% of Patients in the EMBLAVEO Treatment Arm in Trial 1 Adverse Reactions EMBLAVEO ± Metronidazole (N=275) n (%) Meropenem ± Colistin (N=137) n (%) Hepatic adverse reactions* 40 (14.5) 16 (11.7) Anemia** 22 (8.0) 7 (5.1) Diarrhea 16 (5.8) 5 (3.6) Hypokalemia 16 (5.8) 4 (2.9) Pyrexia*** 16 (5.8) 7 (5.1) *Includes AR terms alanine aminotransferase increased, aspartate aminotransferase increased, hepatic function abnormal, hypertransaminasemia, transaminases increased, hepatic enzyme increased, liver injury **Includes anemia, hemoglobin decreased ***Includes pyrexia, hyperpyrexia, hyperthermia, body temperature increased Hepatic Adverse Reactions In Trial 1, 40/275 patients (15%) in the EMBLAVEO arm had hepatic adverse reactions compared to 16/137 (12%) in the comparator arm receiving meropenem with or without colistin. In Trial 1, 10 (3.8%) patients in the EMBLAVEO arm compared to 4 (3.1%) patients in the comparator arm had an ALT elevation greater than or equal to 5 x ULN. No Hy’s Law cases in the EMBLAVEO or comparator arm were seen in Trials 1, 2, and 3. EMBLAVEO was discontinued due to hepatic enzyme elevations in 4 patients in Trials 1, 2, and 3. The transaminase elevations resolved when EMBLAVEO was discontinued. The following adverse reactions were reported in EMBLAVEO-treated patients at a rate of less than 5% in Trial 1: Vascular disorders: Phlebitis, flushing, hypotension Skin and subcutaneous tissue disorders: Rash (includes rash and rash macular), dermatitis (includes dermatitis allergic, dermatitis), erythema Gastrointestinal Disorders: Vomiting, nausea, abdominal pain (includes abdominal pain, abdominal pain upper, abdominal pain lower), constipation Nervous System Disorders: Mental status change (includes mental status changes, delirium, confusional state, and disorientation), dizziness, headache, sleep disorder (includes sleep disorder, insomnia), ageusia, asthenia Infectious Diseases: Clostridioides difficile infection (includes Clostridioides difficile infection and Clostridioides difficile colitis) Hematologic: Coagulopathy, leukocytosis (includes white blood cell count increased and leukocytosis), thrombocytopenia (includes thrombocytopenia, platelet count decreased); thrombocytosis (includes thrombocytosis, platelet count increased), eosinophilia Hypersensitivity: Bronchospasm Additionally, adverse reactions that have been reported with aztreonam alone that were not reported in EMBLAVEO-treated patients in Trial 1 are listed below: Hypersensitivity: Anaphylaxis, angioedema Hematologic: Pancytopenia, neutropenia Dermatologic: Purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae, pruritus, diaphoresis Cardiovascular: Transient ECG changes (ventricular bigeminy and PVC) Respiratory: Wheezing, dyspnea, chest pain Hepatobiliary: Hepatitis, jaundice Nervous System: Seizure, encephalopathy, vertigo, paresthesia Musculoskeletal: Muscular aches Special Senses: Tinnitus, diplopia, numb tongue, sneezing, nasal congestion, halitosis Other: Vaginal candidiasis, vaginitis, breast tenderness Body as a Whole: Malaise Adverse Laboratory Changes reported with aztreonam alone that were not reported in EMBLAVEO-treated patients in Trial 1 are listed below: Hematologic: Positive Coombs’ test Renal: Increases in serum creatinine Trial 2 was a noncomparative study of EMBLAVEO in 34 subjects with cIAI. Trial 3 was a comparative study of EMBLAVEO versus best available therapy in patients with serious infections due to multi-drug resistant gram-negative bacteria producing metallo-beta-lactamases (not an approved indication for EMBLAVEO); 12 patients were treated in the EMBLAVEO arm and 2 patients were treated in the comparator arm. The safety findings for the EMBLAVEO treatment arm in Trials 2 and 3 were similar to those of Trial 1."],"contraindications":["4 CONTRAINDICATIONS EMBLAVEO is contraindicated in patients with known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam) [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to the components of EMBLAVEO (aztreonam and avibactam). ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS 7.1 OAT 1 and 3 Transport Inhibitors Concomitant use of organic anion transporter (OAT) 1 and OAT 3 transporter inhibitors (e.g., probenecid) with EMBLAVEO is not recommended. There is insufficient information to characterize the effect of concomitant use of OAT 1/3 transport inhibitors with EMBLAVEO [see Clinical Pharmacology ( 12.3 )]."],"mechanism_of_action":["12.1 Mechanism of Action EMBLAVEO is an antibacterial drug [see Microbiology ( 12.4 )] ."],"clinical_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action EMBLAVEO is an antibacterial drug [see Microbiology ( 12.4 )] . 12.2 Pharmacodynamics As with other beta-lactam antimicrobial drugs, the time that unbound plasma concentrations of aztreonam exceed the EMBLAVEO minimum inhibitory concentration (MIC) against the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with Enterobacterales. The time above a threshold concentration has been determined to be the parameter that best predicts the efficacy of avibactam in combination with aztreonam in in vitro and in vivo nonclinical models. Cardiac Electrophysiology Avibactam does not prolong the QTc interval to any clinically significant extent at a dose 3 times the maximum approved EMBLAVEO recommended avibactam loading dose. Aztreonam QT prolongation evaluations have not been conducted or reported in literature. 12.3 Pharmacokinetics Following single or multiple dosing, the C max and AUC of both aztreonam and avibactam (components of EMBLAVEO) increase in an approximate dose-proportional manner over a dose range of 500 mg to 2000 mg aztreonam (0.25 to 1 times the approved maximum recommended loading dose) and of 50 mg to 2000 mg avibactam (0.07 to 3 times the approved maximum recommended loading dose). Aztreonam and avibactam (components of EMBLAVEO) pharmacokinetic properties are summarized in Table 6. There is minimal accumulation of aztreonam and avibactam following multiple intravenous 3-hour infusions of EMBLAVEO every 6 hours in patients with normal renal function. Table 6: Pharmacokinetic (PK) Properties of Components of EMBLAVEO (Aztreonam and Avibactam) PK Parameter Aztreonam Avibactam C max, ss (mg/L) a,b, c 54.46 ± 17.22 11.29 ± 3.89 AUC 0-24, ss (mg•h/L) a,b,c 841.22 ± 317.59 165.7 ± 65.63 Distribution Binding to human plasma proteins 38 % 8 % Volume of distribution (Vss) c 21.4 ± 23 L 37.8 ± 73 L Elimination Clearance (CL) c 10.2 ± 22 L/hr 18 ± 39 L/hr Mean terminal half-life (t 1/2 ) c 2.03 ± 0.69 hrs 2.04 ± 0.52 hrs Metabolism Metabolic pathways Aztreonam is minimally metabolized. No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes). Unchanged avibactam was the major drug-related component in human plasma and urine following dosing with [ 14 C]-avibactam Excretion Major route of elimination Renal excretion: tubular secretion and glomerular filtration % of dose excreted in urine, unchanged 64.2 % to 75.9 % 83.8 % to 100 % % of dose excreted in feces, changed and unchanged Approximately 12 % < 0.25 % C max, ss =maximum plasma concentration at steady-state; AUC 0-24, ss =area under the plasma concentration-time curve from time zero up to 24 hrs at steady state; Vss = volume of distribution at steady state; mean = arithmetic mean; SD = standard deviation. a 2000 mg aztreonam + 670 mg avibactam IV infusion over 3 hours then 1500 mg aztreonam + 500 mg avibactam IV infusion over 3 hours every 6 hours. b There is no clinically significant PK differences (as measured by AUC and Cmax) between healthy adults and adults with cIAI (normal renal function). c mean ± SD reported based on PK data from 97 adults with cIAI Specific Populations No clinically significant differences in the pharmacokinetics of aztreonam or avibactam were observed based on age (range: 18-89 years), sex (62.1% male), race (61.9% White, 27.7% Asian, and 3.4% Black), or BMI (10.4 to 62.5 kg/m 2 ). Patients with Renal Impairment The disposition of aztreonam and avibactam were evaluated in non-infected subjects with CLcr >80 mL/min (as measured by Cockcroft-Gault method, n=6) administered the recommended general maintenance dosing regimen and with CLcr 32 to 37 mL/min (n=5) administered the recommended adjusted maintenance dosing regimen for CLcr >15 to ≤ 30 mL/min. Aztreonam AUC 24 and C max at steady state is approximately 21% and 24% lower in the subjects with CLcr 32 to 37 mL/min compared to the CLcr >80 mL/min group. The avibactam AUC24 and Cmax at steady state are approximately 24% and 2% higher in the subjects with CLcr 32 to 37 mL/min, compared to the CLcr >80 mL/min group. Dosage adjustment for EMBLAVEO in patients with CLcr ≤ 50 mL/min is recommended [see Dosage and Administration ( 2.2 )] . Patients with Hepatic Impairment EMBLAVEO has not been studied in patients with hepatic impairment. As aztreonam and avibactam do not appear to undergo significant hepatic metabolism, the systemic clearance of either active substance is not expected to be significantly altered by hepatic impairment. Dosage adjustments are not considered necessary for EMBLAVEO in patients with impaired hepatic function. Geriatric Patients (Greater than or equal to 65 years) Mean elimination half-life of both aztreonam and avibactam is increased, and plasma clearance decreased in the elderly, consistent with age-related reduction in renal clearance of aztreonam and avibactam. Dosage adjustment for EMBLAVEO in geriatric patients should be based on renal function [see Dosage and Administration ( 2.2 )] . Drug Interaction Studies Clinical Studies and Model-Informed Approaches OAT1/3 inhibitors: No clinically significant differences in aztreonam pharmacokinetics were observed when used concomitantly with probenecid (OAT1/3 inhibitors). Concomitant administration of probenecid with aztreonam is reported to result in clinically insignificant increases in aztreonam exposure. No clinical studies have been conducted with avibactam and OAT1/3 inhibitors (e.g., probenecid) and the clinical impact of OAT inhibitors on the pharmacokinetics of avibactam is not known. Other: No drug-drug interaction was observed between aztreonam, avibactam, and metronidazole in clinical studies. In Vitro Studies Avibactam was not found to be an inhibitor of the following hepatic and renal transporters in vitro at clinically relevant concentrations: MDR1, BCRP, OAT1, OAT3, OATP1B1, OATP1B3, BSEP, MRP4, OCT1, or OCT2. Avibactam was not a substrate of MDR1, BCRP, MRP4, or OCT2, but was a substrate of human OAT1 and OAT3 kidney transporters based on results generated in human embryonic kidney cells expressing these transporters. 12. 4 Microbiology Mechanism of action EMBLAVEO is a combination of the monobactam antibacterial, aztreonam, and the beta-lactamase inhibitor, avibactam. Aztreonam inhibits bacterial peptidoglycan cell wall synthesis following binding to penicillin binding proteins (PBPs), which leads to bacterial cell lysis and death and is stable to class B beta-lactamase enzymes (metallo-beta-lactamases). Avibactam is a non-beta-lactam, beta-lactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis. Avibactam inhibits both Ambler class A, class C and some class D beta-lactamases, including extended-spectrum β-lactamases (ESBLs), Klebsiella pneumoniae carbapenemase (KPC), OXA-48 carbapenemases, and AmpC enzymes. Avibactam does not inhibit class B enzymes and is not able to inhibit some class D enzymes. EMBLAVEO demonstrated in vitro activity against Enterobacterales isolates expressing beta-lactamases included in Ambler Class A (CTX-M-, TEM-, and SHV-type ESBLs; KPC carbapenemase), Class B (New Delhi metallo-beta-lactamases [NDM], Verona integron-encoded metallo-beta-lactamase [VIM], and imipenemases [IMP]), Class C (AmpC), and Class D (OXA-48-like). Resistance Resistance mechanisms to EMBLAVEO include beta-lactamase enzymes refractory to inhibition by avibactam and able to hydrolyze aztreonam, mutant or acquired PBPs, decreased outer membrane permeability, and active efflux pumps. Interaction with Other Antimicrobials No antagonism was demonstrated in in vitro studies between EMBLAVEO and amikacin, ciprofloxacin, colistin, daptomycin, gentamicin, levofloxacin, linezolid, metronidazole, tigecycline, tobramycin, and vancomycin against Enterobacterales. Activity against bacteria in animal infection models Avibactam restored the activity of aztreonam in animal models of infection (e.g., mouse thigh infection, mouse lung infection) caused by aztreonam non-susceptible NDM- and ESBL-producing E. coli and K. pneumoniae isolates. However, the clinical significance of these findings is unknown. Antimicrobial Activity EMBLAVEO has been shown to be active against most isolates of the following microorganisms both in vitro and in clinical infections [see Indications and Usage ( 1.1 )] . Citrobacter freundii complex Escherichia coli Enterobacter cloacae complex Klebsiella pneumoniae Klebsiella oxytoca Serratia marcescens The following in vitro data are available, but their clinical significance is unknown. At least 90 percent of the following bacteria exhibit an in vitro MIC less than or equal to the susceptible breakpoint for EMBLAVEO against isolates of similar genus or organism group. However, the safety and effectiveness of EMBLAVEO in treating clinical infections due to these bacteria have not been established in adequate and well-controlled clinical trials: Aerobic Gram-negative organisms Citrobacter koseri Enterobacter spp. Klebsiella aerogenes Morganella morganii Proteus mirabilis Proteus vulgaris Providencia rettgeri Providencia stuartii Raoultella ornithinolytica Serratia spp. Stenotrophomonas maltophilia Susceptibility Test Methods For specific information regarding susceptibility testing methods, interpretive criteria, and associated test methods and quality control standards recognized by FDA for EMBLAVEO, please see: https://www.fda.gov/STIC."],"indications_and_usage":["1 INDICATIONS AND USAGE EMBLAVEO is a combination of aztreonam, a monobactam antibacterial, and avibactam, a beta-lactamase inhibitor, that when used in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae complex, Citrobacter freundii complex, and Serratia marcescens . Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO. ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Complicated Intra-abdominal Infections EMBLAVEO, in combination with metronidazole, is indicated in patients 18 years and older who have limited or no alternative options for the treatment of complicated intra-abdominal infections (cIAI) including those caused by the following susceptible gram-negative microorganisms: Escherichia coli , Klebsiella pneumoniae , Klebsiella oxytoca , Enterobacter cloacae complex , Citrobacter freundii complex , and Serratia marcescens. Approval of this indication is based on limited clinical safety and efficacy data for EMBLAVEO [ see Clinical Studies ( 14.1 )] . 1.2 Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of EMBLAVEO and other antibacterial drugs, EMBLAVEO should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Hypersensitivity reactions were noted in patients treated with EMBLAVEO including rash, flushing, and bronchospasm. In case of hypersensitivity reactions, immediately discontinue EMBLAVEO and initiate appropriate medications and/or supportive care. ( 5.1 ) Serious Skin Disorders: Cases of toxic epidermal necrolysis have been reported in association with aztreonam (a component of EMBLAVEO) in patients undergoing bone marrow transplant with multiple risk factors. Discontinue EMBLAVEO if serious skin reaction occurs. ( 5.2 ) Hepatic Adverse Reactions: Elevations in hepatic transaminases have been observed during treatment with EMBLAVEO. If transaminase elevations are noted, consider discontinuation of EMBLAVEO, if clinically indicated, and monitor the patient for resolution of any pertinent clinical and laboratory findings. ( 5.3 ) Clostridioides Difficile -Associated Diarrhea (CDAD): CDAD has been reported with nearly all systemic antibacterial agents, including EMBLAVEO. Evaluate if diarrhea occurs. ( 5.4 ) 5. 1 Hypersensitivity Reactions Hypersensitivity reactions were noted in patients treated with EMBLAVEO, including rash, flushing, and bronchospasm [see Adverse Reactions ( 6.1 )]. Prior to treatment, it should be established if the patient has a history of hypersensitivity reactions to components of EMBLAVEO (aztreonam and avibactam). In case of hypersensitivity reactions, immediately discontinue EMBLAVEO and initiate appropriate medications and/or supportive care. 5. 2 Serious Skin Disorders Cases of toxic epidermal necrolysis have been reported in association with aztreonam (a component of EMBLAVEO) in patients undergoing bone marrow transplant with multiple risk factors including sepsis, radiation therapy, and other concomitantly administered drugs associated with toxic epidermal necrolysis. Discontinue EMBLAVEO if a serious skin reaction occurs. 5. 3 Hepatic Adverse Reactions Elevations in hepatic transaminases have been observed during treatment with EMBLAVEO [see Adverse Reactions ( 6.1 )]. Monitoring of liver-related laboratory tests is recommended while on treatment, particularly in patients with baseline liver comorbidities or on concomitant hepatotoxic medications. If transaminase elevations are noted, consider discontinuing EMBLAVEO, if clinically indicated, and monitor the patient for resolution of any pertinent clinical and laboratory findings. 5. 4 Clostridioides Difficile -Associated Diarrhea Clostridioides difficile - associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial drugs, including EMBLAVEO, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial drugs alters the normal flora of the colon and may permit overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial drugs. If CDAD is suspected or confirmed, antibacterial drugs not directed against C. difficile may need to be discontinued. Manage fluid and electrolyte levels as appropriate, supplement protein intake, monitor antibacterial treatment of C. difficile , and institute surgical evaluation as clinically indicated. 5.5 Development of Drug-Resistant Bacteria Prescribing EMBLAVEO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria [see Indications and Usage ( 1.2 )]."],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Aztreonam Carcinogenicity studies with aztreonam have not been conducted using an intravenous route of administration. A 104-week rat inhalation toxicology study to assess the carcinogenic potential of aztreonam demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to aerosolized aztreonam for up to 4 hours per day. Peak plasma levels of aztreonam averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level. Avibactam Carcinogenicity studies with avibactam have not been conducted. Mutagenesis Aztreonam Genetic toxicology studies performed with aztreonam in vitro (Ames test, mouse lymphoma forward mutation assay, gene conversion assay, chromosome aberration assay in human lymphocytes) and in vivo (mouse bone marrow cytogenetic assay) did not reveal evidence of mutagenic or clastogenic potential. Avibactam Avibactam was negative for genotoxicity in the Ames assay, unscheduled DNA synthesis, chromosomal aberration assay, and a rat micronucleus study. Impairment of Fertility Aztreonam A two-generation reproduction study in rats at daily doses of 150, 600, or 2400 mg/kg/day given prior to and during gestation and lactation, revealed no evidence of impaired fertility. Based on body surface area, the high dose is 3.6-fold greater than the maximum recommended human dose (MRHD) for adults of 6.5 g per day. There was a slightly reduced survival rate during the lactation period in the offspring of rats that received the highest dose, but not in offspring of rats that received lower doses of aztreonam. Avibactam Avibactam had no adverse effects on fertility of male and female rats given up to 1g/kg/day (approximately 4.5-fold higher than the MRHD of 2.17 g/day on a body surface area basis). There was a dose-related increase in the percentage of pre-and post-implantation loss relative to controls, resulting in a lower mean litter size at doses of 0.5 g/kg/day (approximately 2 times the MRHD on a body surface area basis) and greater with intravenous administration to female rats beginning 2 weeks prior to mating."],"pharmacokinetics_table":["
Table 6: Pharmacokinetic (PK) Properties of Components of EMBLAVEO (Aztreonam and Avibactam)
PK ParameterAztreonamAvibactam
Cmax, ss (mg/L)a,b, c54.46 ± 17.2211.29 ± 3.89
AUC0-24, ss (mg•h/L)a,b,c841.22 ± 317.59165.7 ± 65.63
Distribution
Binding to human plasma proteins38 %8 %
Volume of distribution (Vss)c21.4 ± 23 L37.8 ± 73 L
Elimination
Clearance (CL)c 10.2 ± 22 L/hr18 ± 39 L/hr
Mean terminal half-life (t1/2)c2.03 ± 0.69 hrs2.04 ± 0.52 hrs
Metabolism
Metabolic pathwaysAztreonam is minimally metabolized. No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes). Unchanged avibactam was the major drug-related component in human plasma and urine following dosing with [14C]-avibactam
Excretion
Major route of eliminationRenal excretion: tubular secretion and glomerular filtration
% of dose excreted in urine, unchanged 64.2 % to 75.9 %83.8 % to 100 %
% of dose excreted in feces, changed and unchangedApproximately 12 %< 0.25 %
Cmax, ss =maximum plasma concentration at steady-state; AUC0-24, ss=area under the plasma concentration-time curve from time zero up to 24 hrs at steady state; Vss = volume of distribution at steady state; mean = arithmetic mean; SD = standard deviation. a2000 mg aztreonam + 670 mg avibactam IV infusion over 3 hours then 1500 mg aztreonam + 500 mg avibactam IV infusion over 3 hours every 6 hours. bThere is no clinically significant PK differences (as measured by AUC and Cmax) between healthy adults and adults with cIAI (normal renal function). cmean ± SD reported based on PK data from 97 adults with cIAI
"],"adverse_reactions_table":["
Table 5: Adverse Reactions Occurring in > 5% of Patients in the EMBLAVEO Treatment Arm in Trial 1
Adverse Reactions EMBLAVEO ± Metronidazole (N=275) n (%)Meropenem ± Colistin (N=137) n (%)
Hepatic adverse reactions*40 (14.5)16 (11.7)
Anemia**22 (8.0)7 (5.1)
Diarrhea16 (5.8)5 (3.6)
Hypokalemia16 (5.8)4 (2.9)
Pyrexia***16 (5.8)7 (5.1)
*Includes AR terms alanine aminotransferase increased, aspartate aminotransferase increased, hepatic function abnormal, hypertransaminasemia, transaminases increased, hepatic enzyme increased, liver injury **Includes anemia, hemoglobin decreased ***Includes pyrexia, hyperpyrexia, hyperthermia, body temperature increased
"],"information_for_patients":["17 PATIENT COUNSELING INFORMATION Serious Allergic Reactions Advise patients, their families, or caregivers that allergic reactions, including serious allergic reactions, could occur that require immediate treatment. Ask them about any previous hypersensitivity reactions to EMBLAVEO, other beta-lactams, or other allergens [see Warnings and Precautions ( 5.1 )] . Serious Skin Reactions Advise patients about the signs and symptoms of serious skin manifestations such as sudden onset of a severe rash or blistering or peeling skin, possibly accompanied by a high fever or joint pain (these may be signs of more serious medical conditions such as toxic epidermal necrolysis) [see Warnings and Precautions ( 5.2 )] . Potentially Serious Diarrhea Advise patients, their families, or caregivers that diarrhea is a common problem caused by antibacterial drugs. Sometimes, frequent watery or bloody diarrhea may occur and may be a sign of a more serious intestinal infection. If severe watery or bloody diarrhea develops, tell them to contact his or her healthcare provider [see Warnings and Precautions ( 5.4 )] . Antibacterial Resistance Patients should be counseled that antibacterial drugs including EMBLAVEO should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When EMBLAVEO is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by EMBLAVEO or other antibacterial drugs in the future [ see Warnings and Precautions ( 5.5 ) ] . Distributed by: AbbVie Inc. North Chicago, IL 60064 EMBLAVEO ® and its design are trademarks of Allergan Pharmaceuticals International Limited, an AbbVie company. © 2026 AbbVie. All rights reserved. PAA248062-R1"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION Recommended Dosage in Adults based on Estimated Creatinine Clearance (C Lcr ) ( 2.1 , 2.2 ) Estimated C Lcr (mL/min) a Dose b Infusion Time Dosing Interval c Loading Maintenance Greater than 50 mL/min EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) EMBLAVEO 2 g (aztreonam 1.5 grams and avibactam 0.5 grams) 3 hours Every 6 hours Greater than 30 to less than or equal to 50 mL/min EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) EMBLAVEO 1 g (aztreonam 0.75 grams and avibactam 0.25 grams) 3 hours Every 6 hours Greater than 15 to less than or equal to 30 mL/min EMBLAVEO 1.8 g (aztreonam 1.35 grams and avibactam 0.45 grams) EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) 3 hours Every 8 hours Less than or equal to 15 mL/min, including on hemodialysis d EMBLAVEO 1.33 g (aztreonam 1 gram and avibactam 0.33 grams) EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) 3 hours Every 12 hours a Calculated using the Cockcroft-Gault formula. b Aztreonam-avibactam is a combination product in a fixed 3:1 ratio. A single loading dose is followed by maintenance doses beginning at the next dosing interval. c Dosing interval is calculated from the start of one infusion to the start of the subsequent infusion. d Both aztreonam and avibactam are removed by hemodialysis; thus, administer EMBLAVEO after hemodialysis, on hemodialysis days. For treatment of cIAI, administer metronidazole concurrently. ( 2.1 , 2.2 ) Recommended duration of treatment for cIAI: 5 to 14 days. ( 2.1 , 2.2 ) 2.1 Recommended Dosage in Adults with Estimated Creatinine Clearance G reater than 50 mL/min Table 1 shows the recommended dosage to be administered by intravenous (IV) infusion over 3 hours in adults with estimated creatinine clearance (CLcr) greater than 50 mL/min. Table 1. Recommended dosage for adults with estimated CLcr greater than 50 mL/min a Type of Infection Recommended Doses for EMBLAVEO (aztreonam and avibactam) b Dosing Interval c Treatment duration Complicated intra-abdominal infections (cIAI) d Loading EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) Every 6 hours 5 to 14 days Maintenance EMBLAVEO 2 g (aztreonam 1.5 grams and avibactam 0.5 grams) a Calculated using the Cockcroft-Gault formula. b Aztreonam-avibactam is a combination product in a fixed 3:1 ratio. A single loading dose is followed by maintenance doses beginning at the next dosing interval. c Dosing interval is calculated from the start of one infusion to the start of the subsequent infusion. d For treatment of cIAI, administer metronidazole concurrently. 2.2 Recommended Dosage in Adults with Estimated Creatinine Clearance L ess than or E qual to 50 mL/min Table 2 shows the recommended dosage to be administered by intravenous (IV) infusion over 3 hours in adults with estimated creatinine clearance (CLcr) less than or equal to 50 mL/min. In patients with renal impairment, close monitoring of estimated CLcr is advised. In some patients, the CLcr estimated from serum creatinine can change quickly, especially early in the course of treatment for the infection. For treatment of cIAI, administer metronidazole concurrently. Table 2. Recommended dosage for adults with estimated CLcr less than or equal to 50 mL/min Estimated CLcr (mL/min) a Recommended Dose for EMBLAVEO (aztreonam and avibactam) b,c Dosing Interval d Greater than 30 to less than or equal to 50 mL/min Loading EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) Every 6 hours Maintenance EMBLAVEO 1 g (aztreonam 0.75 grams and avibactam 0.25 grams) Greater than 15 to less than or equal to 30 mL/min Loading EMBLAVEO 1.8 g (aztreonam 1.35 grams and avibactam 0.45 grams) Every 8 hours Maintenance EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) Less than or equal to 15, including on hemodialysis e Loading EMBLAVEO 1.33 g (aztreonam 1 gram and avibactam 0.33 grams) Every 12 hours Maintenance EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) a Calculated using the Cockcroft-Gault formula b Aztreonam-avibactam is a combination product in a fixed 3:1 ratio. A single loading dose is followed by maintenance doses beginning at the next dosing interval. c The total duration of treatment is for 5 days to 14 days. d Dosing interval is calculated from the start of one infusion to the start of the subsequent infusion. e Both aztreonam and avibactam are hemodialyzable; thus, administer EMBLAVEO after hemodialysis on hemodialysis days. 2. 3 Preparation of EMBLAVEO Solution for Administration EMBLAVEO is supplied as a lyophilized powder, which must be reconstituted and subsequently diluted, using aseptic technique prior to intravenous infusion. Prepare the reconstituted and diluted solutions of EMBLAVEO using the steps described below. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. a) Reconstitute the powder in the EMBLAVEO vial with 10 mL of Sterile Water for Injection. b) Mix the reconstituted vial gently and ensure that the contents are dissolved completely. The reconstituted EMBLAVEO solution is not for direct injection. The reconstituted solution must be diluted before intravenous infusion. The reconstituted EMBLAVEO solution will have an approximate aztreonam concentration of 127 mg/mL and an approximate avibactam concentration of 42.3 mg/mL. The final volume is approximately 12 mL. c) Prepare the required dose for intravenous infusion by withdrawing the appropriate volume determined from Table 3 from the reconstituted vial. Discard unused portion. Table 3. Preparation of EMBLAVEO Doses for Intravenous Infusion Dose (EMBLAVEO) Volume to withdraw from Constituted Vial for Further Dilution to 50 mL to 250 mL Estimated CLcr a (mL/min) EMBLAVEO (g) (aztreonam (grams) and avibactam (grams)) Loading Greater than 50 mL/min EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) 15.7 mL (requires two vials; discard unused portions) Greater than 30 mL/min to less than or equal to 50 mL/min EMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) 15.7 mL (requires two vials; discard unused portions) Greater than 15 mL/min to less than or equal to 30 mL/min EMBLAVEO 1.8 g (aztreonam 1.35 grams and avibactam 0.45 grams) 10.6 mL Less than or equal to 15 mL/min EMBLAVEO 1.33 g (aztreonam 1 gram and avibactam 0.33 grams) 7.9 mL Maintenance Greater than 50 mL/min EMBLAVEO 2 g (aztreonam 1.5 grams and avibactam 0.5 grams) Entire contents of one vial (approximately 12 mL) Greater than 30 mL/min to less than or equal to 50 mL/min EMBLAVEO 1 g (aztreonam 0.75 grams and avibactam 0.25 grams) 5.9 mL Greater than 15 mL/min to less than or equal to 30 mL/min EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) 5.3 mL Less than or equal to 15 mL/min EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) 5.3 mL a Calculated using the Cockcroft-Gault formula d) Before infusion, dilute the withdrawn volume of the reconstituted EMBLAVEO solution further to 50 mL to 250 mL in an infusion bag containing any of the following: 0.9 % sodium chloride for injection or 5% dextrose solution for injection or lactated Ringer’s injection, to achieve an aztreonam concentration of 2.7 mg/mL to 40 mg/mL and an avibactam concentration of 0.9 mg/mL to 13.3 mg/mL. e) Mix gently and ensure that the contents are dissolved completely. Visually inspect the diluted EMBLAVEO solution for particulate matter and discoloration prior to administration (the color of the EMBLAVEO infusion solution for administration ranges from clear, colorless to yellow). 2.4 Drug Compatibility The EMBLAVEO solution for administration is compatible with Sterile Water for Injection, for reconstitution and any of the following diluents for further dilution of the reconstituted solution: 0.9% Sodium chloride injection 5% Dextrose injection Lactated Ringer’s injection The compatibility of EMBLAVEO with other medicinal products has not been established. EMBLAVEO should not be mixed with or physically added to solutions containing other medicinal products. 2. 5 Storage of Rec onstituted and Diluted EMBLAVEO Solutions Reconstituted Solution Upon reconstitution with Sterile Water for Injection, the reconstituted EMBLAVEO solution may be held for up to 60 minutes at 30°C (86°F) under ambient light prior to transfer and dilution in a suitable infusion bag. Diluted Reconstituted Solution Following dilution of the reconstituted solution with 0.9% sodium chloride injection or 5 % dextrose injection or lactated Ringer’s injection, EMBLAVEO solution in the infusion bags may be stored based on conditions outlined in Table 4. Table 4. Storage of Diluted Solutions Diluent used for Dilution following Reconstitution Storage 0.9% Sodium Chloride Injection Or Lactated Ringer’s Injection Refrigerate at 2°C to 8°C (36°F to 46°F) for up to 24 hours followed by 12 hours at not more than 30°C (86°F) under ambient light. Discard unused portion. 5% Dextrose Injection Refrigerate at 2°C to 8°C (36°F to 46°F) for up to 24 hours followed by 4 hours at not more than 30°C (86°F) under ambient light. Discard unused portion."],"spl_product_data_elements":["EMBLAVEO aztreonam and avibactam AZTREONAM AZTREONAM AVIBACTAM AVIBACTAM ARGININE white to slightly yellow"],"dosage_forms_and_strengths":["3 DOSAGE FORMS AND STRENGTHS EMBLAVEO (aztreonam and avibactam) for injection is supplied as a white to slightly yellow sterile lyophilized powder for reconstitution in a single-dose, sterile, clear glass vial containing: 2 g aztreonam and avibactam (1.5 grams aztreonam and 0.5 grams avibactam (equivalent to 0.542 grams of avibactam sodium)). EMBLAVEO (aztreonam and avibactam) for injection is a lyophilized powder in a single-dose vial containing 2 g (1.5 grams aztreonam and 0.5 grams avibactam). ( 3 )"],"clinical_pharmacology_table":["
Table 6: Pharmacokinetic (PK) Properties of Components of EMBLAVEO (Aztreonam and Avibactam)
PK ParameterAztreonamAvibactam
Cmax, ss (mg/L)a,b, c54.46 ± 17.2211.29 ± 3.89
AUC0-24, ss (mg•h/L)a,b,c841.22 ± 317.59165.7 ± 65.63
Distribution
Binding to human plasma proteins38 %8 %
Volume of distribution (Vss)c21.4 ± 23 L37.8 ± 73 L
Elimination
Clearance (CL)c 10.2 ± 22 L/hr18 ± 39 L/hr
Mean terminal half-life (t1/2)c2.03 ± 0.69 hrs2.04 ± 0.52 hrs
Metabolism
Metabolic pathwaysAztreonam is minimally metabolized. No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes). Unchanged avibactam was the major drug-related component in human plasma and urine following dosing with [14C]-avibactam
Excretion
Major route of eliminationRenal excretion: tubular secretion and glomerular filtration
% of dose excreted in urine, unchanged 64.2 % to 75.9 %83.8 % to 100 %
% of dose excreted in feces, changed and unchangedApproximately 12 %< 0.25 %
Cmax, ss =maximum plasma concentration at steady-state; AUC0-24, ss=area under the plasma concentration-time curve from time zero up to 24 hrs at steady state; Vss = volume of distribution at steady state; mean = arithmetic mean; SD = standard deviation. a2000 mg aztreonam + 670 mg avibactam IV infusion over 3 hours then 1500 mg aztreonam + 500 mg avibactam IV infusion over 3 hours every 6 hours. bThere is no clinically significant PK differences (as measured by AUC and Cmax) between healthy adults and adults with cIAI (normal renal function). cmean ± SD reported based on PK data from 97 adults with cIAI
"],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no data on the effects of EMBLAVEO use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Available data from case reports over several decades with aztreonam and over approximately a decade with avibactam have not identified a drug-associated risk of major birth defects, miscarriage or other maternal or fetal outcomes. Aztreonam Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam revealed no evidence of embryotoxicity, fetotoxicity, or fetal malformations at doses 2.7- and 3.6-fold greater, respectively, than the maximum recommended human dose (MRHD) for adults of 6.5 g per day. In a peri/postnatal development (PPND) study in rats, no aztreonam-induced changes in any maternal, fetal, or neonatal parameters were observed at a dose 2.7-fold greater than the MRHD. Avibactam Avibactam administered to pregnant rats was not associated with fetal malformations at doses 6 times the MRHD of 2.17 g per day. In pregnant rabbits, avibactam administered in doses greater than or equal to 5 times the MRHD was associated with increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies. In a rat PPND study, there were no effects on pup growth and viability at doses up to 8 times the avibactam MRHD. A dose-related increase in the incidence of renal pelvic and ureter dilatation was observed in female weaning pups with renal pelvic dilatation persisting into adulthood (see Data). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Aztreonam Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam up to 1800 and 1200 mg/kg, respectively, revealed no evidence of embryotoxicity or fetotoxicity or fetal malformations. These doses, based on body surface area, are 2.7- and 3.6-fold greater than the MRHD for adults of 6.5 g per day. A peri/postnatal study in rats revealed no drug-induced changes in any maternal, fetal, or neonatal parameters. The highest dose used in this study, 1800 mg/kg/day, is 2.7 times the MRHD based on body surface area comparison. Avibactam Avibactam did not produce fetal malformations in pregnant rats or rabbits. In the rat, intravenous studies with 0, 250, 500 and 1000 mg/kg/day of avibactam during gestation days 6-17 showed no embryo-fetal toxicity at doses up to 1000 mg/kg/day, approximately 6 times the MRHD (2.17 g/day) based on exposure (AUC). Pregnant rabbits administered intravenous avibactam on gestation days 6-19 at 0, 100, 300 and 1000 mg/kg/day showed no effects on embryo-fetal development at a dose of 100 mg/kg, twice the MRHD based on AUC comparison. At doses greater than or equal to 300 mg/kg/day (5 times the MRHD based on AUC comparison), increased post-implantation loss, lower mean fetal weights, delayed ossification of several bones and other anomalies were observed. In a rat pre-and post-natal study at up to 825 mg/kg/day intravenously (8 times the MRHD based on AUC), there were no effects on pup growth and viability. A dose-related increase in the incidence of renal pelvic and ureter dilatation was observed in female weaning pups that was not associated with pathological changes to renal parenchyma or renal function, with renal pelvic dilatation persisting after female weaning pups became adults. 8.2 Lactation Risk Summary Aztreonam is present in human milk at concentrations that are less than 1% of those determined in simultaneously obtained maternal serum. There are no data on the presence of avibactam in human milk. Avibactam is present in the milk of rats (see Data). When a drug is present in animal milk, it is likely that the drug will be present in human milk. There are no data on the effects of aztreonam or avibactam on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for EMBLAVEO and any potential adverse effects on the breast-fed infant from EMBLAVEO or from the underlying maternal condition. Data In a rat pre- and post-natal study at doses up to 825 mg/kg/day intravenously (8 times the human exposure based on AUC), the exposure to avibactam was minimal in the pups in comparison to the dams. Exposure to avibactam was observed in both pups and milk on PND 7. 8.4 Pediatric Use The safety and effectiveness of EMBLAVEO in pediatric patients less than 18 years of age have not been established. 8.5 Geriatric Use In Trials 1, 2, and 3, there were 103 patients in the EMBLAVEO treatment arm 65 years of age and older. Of these patients, 60 (58%) were between 65-74 years of age and 43 (42%) patients were 75 years of age and older. In comparison, there were 202 patients in the EMBLAVEO treatment arm less than 65 years of age. Clinical studies of EMBLAVEO did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Aztreonam and avibactam (components of EMBLAVEO) are known to be substantially excreted by the kidney, and the risk of adverse reactions to aztreonam and avibactam (components of EMBLAVEO) may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. No dosage adjustment is required in elderly patients based on age; the dose should be selected based on renal function [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )]. 8.6 Renal Impairment Aztreonam and avibactam, the components of EMBLAVEO, are primarily renally excreted. Plasma exposures of both aztreonam and avibactam increase with decreasing renal function, therefore dosage adjustments are recommended for EMBLAVEO to compensate for the slower rate of renal clearance in patients with CLcr less than 50 mL/min [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )]. Monitor creatinine clearance in patients with changing renal function and adjust the dose of EMBLAVEO accordingly. Both aztreonam and avibactam are hemodialyzable; thus, EMBLAVEO should be administered after hemodialysis on hemodialysis days [see Dosage and Administration ( 2.2 ) and Clinical Pharmacology ( 12.3 )]."],"dosage_and_administration_table":["
Recommended Dosage in Adults based on Estimated Creatinine Clearance (CLcr) (2.1, 2.2)
Estimated CLcr (mL/min)aDosebInfusion TimeDosing Intervalc
LoadingMaintenance
Greater than 50 mL/minEMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams)EMBLAVEO 2 g (aztreonam 1.5 grams and avibactam 0.5 grams)3 hoursEvery 6 hours
Greater than 30 to less than or equal to 50 mL/minEMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams)EMBLAVEO 1 g (aztreonam 0.75 grams and avibactam 0.25 grams) 3 hoursEvery 6 hours
Greater than 15 to less than or equal to 30 mL/minEMBLAVEO 1.8 g (aztreonam 1.35 grams and avibactam 0.45 grams)EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams)3 hoursEvery 8 hours
Less than or equal to 15 mL/min, including on hemodialysisdEMBLAVEO 1.33 g (aztreonam 1 gram and avibactam 0.33 grams)EMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams) 3 hoursEvery 12 hours
aCalculated using the Cockcroft-Gault formula. bAztreonam-avibactam is a combination product in a fixed 3:1 ratio. A single loading dose is followed by maintenance doses beginning at the next dosing interval. cDosing interval is calculated from the start of one infusion to the start of the subsequent infusion. dBoth aztreonam and avibactam are removed by hemodialysis; thus, administer EMBLAVEO after hemodialysis, on hemodialysis days.
","
Table 1. Recommended dosage for adults with estimated CLcr greater than 50 mL/mina
Type of InfectionRecommended Doses for EMBLAVEO (aztreonam and avibactam)bDosing IntervalcTreatment duration
Complicated intra-abdominal infections (cIAI)dLoadingEMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams) Every 6 hours 5 to 14 days
MaintenanceEMBLAVEO 2 g (aztreonam 1.5 grams and avibactam 0.5 grams)
aCalculated using the Cockcroft-Gault formula. bAztreonam-avibactam is a combination product in a fixed 3:1 ratio. A single loading dose is followed by maintenance doses beginning at the next dosing interval. cDosing interval is calculated from the start of one infusion to the start of the subsequent infusion. dFor treatment of cIAI, administer metronidazole concurrently.
","
Table 2. Recommended dosage for adults with estimated CLcr less than or equal to 50 mL/min
Estimated CLcr (mL/min)aRecommended Dose for EMBLAVEO (aztreonam and avibactam)b,cDosing Intervald
Greater than 30 to less than or equal to 50 mL/minLoadingEMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams)Every 6 hours
MaintenanceEMBLAVEO 1 g (aztreonam 0.75 grams and avibactam 0.25 grams)
Greater than 15 to less than or equal to 30 mL/minLoadingEMBLAVEO 1.8 g (aztreonam 1.35 grams and avibactam 0.45 grams)Every 8 hours
MaintenanceEMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams)
Less than or equal to 15, including on hemodialysiseLoadingEMBLAVEO 1.33 g (aztreonam 1 gram and avibactam 0.33 grams)Every 12 hours
MaintenanceEMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams)
aCalculated using the Cockcroft-Gault formula bAztreonam-avibactam is a combination product in a fixed 3:1 ratio. A single loading dose is followed by maintenance doses beginning at the next dosing interval. cThe total duration of treatment is for 5 days to 14 days. dDosing interval is calculated from the start of one infusion to the start of the subsequent infusion. eBoth aztreonam and avibactam are hemodialyzable; thus, administer EMBLAVEO after hemodialysis on hemodialysis days.
","
Table 3. Preparation of EMBLAVEO Doses for Intravenous Infusion
Dose (EMBLAVEO)Volume to withdraw from Constituted Vial for Further Dilution to 50 mL to 250 mL
Estimated CLcra (mL/min)EMBLAVEO (g) (aztreonam (grams) and avibactam (grams))
LoadingGreater than 50 mL/minEMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams)15.7 mL (requires two vials; discard unused portions)
Greater than 30 mL/min to less than or equal to 50 mL/minEMBLAVEO 2.67 g (aztreonam 2 grams and avibactam 0.67 grams)15.7 mL (requires two vials; discard unused portions)
Greater than 15 mL/min to less than or equal to 30 mL/minEMBLAVEO 1.8 g (aztreonam 1.35 grams and avibactam 0.45 grams)10.6 mL
Less than or equal to 15 mL/minEMBLAVEO 1.33 g (aztreonam 1 gram and avibactam 0.33 grams)7.9 mL
MaintenanceGreater than 50 mL/minEMBLAVEO 2 g (aztreonam 1.5 grams and avibactam 0.5 grams)Entire contents of one vial (approximately 12 mL)
Greater than 30 mL/min to less than or equal to 50 mL/minEMBLAVEO 1 g (aztreonam 0.75 grams and avibactam 0.25 grams)5.9 mL
Greater than 15 mL/min to less than or equal to 30 mL/minEMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams)5.3 mL
Less than or equal to 15 mL/minEMBLAVEO 0.9 g (aztreonam 0.675 grams and avibactam 0.225 grams)5.3 mL
aCalculated using the Cockcroft-Gault formula
","
Table 4. Storage of Diluted Solutions
Diluent used for Dilution following ReconstitutionStorage
0.9% Sodium Chloride Injection Or Lactated Ringer’s InjectionRefrigerate at 2°C to 8°C (36°F to 46°F) for up to 24 hours followed by 12 hours at not more than 30°C (86°F) under ambient light. Discard unused portion.
5% Dextrose InjectionRefrigerate at 2°C to 8°C (36°F to 46°F) for up to 24 hours followed by 4 hours at not more than 30°C (86°F) under ambient light. Discard unused portion.
"],"package_label_principal_display_panel":["Principal Display Panel NDC 0074-3878-10 Rx Only 10 single-dose vials Emblaveo™ 2g per vial* (aztreonam and avibactam) for injection *Aztreonam 1.5 grams and avibactam 0.5 grams (equivalent to 0.542 grams of avibactam sodium). Single-Dose Vial. Discard Unused Portion MUST BE RECONSTITUTED THEN DILUTED. FOR INTRAVENOUS INFUSION. Principal Display Panel NDC 0074-3878-10 Rx Only 10 single-dose vials Emblaveo™ 2g per vial* (aztreonam and avibactam) for injection *Aztreonam 1.5 grams and avibactam 0.5 grams (equivalent to 0.542 grams of avibactam sodium). Single-Dose Vial. Discard Unused Portion MUST BE RECONSTITUTED THEN DILUTED. FOR INTRAVENOUS INFUSION."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Aztreonam Carcinogenicity studies with aztreonam have not been conducted using an intravenous route of administration. A 104-week rat inhalation toxicology study to assess the carcinogenic potential of aztreonam demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to aerosolized aztreonam for up to 4 hours per day. Peak plasma levels of aztreonam averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level. Avibactam Carcinogenicity studies with avibactam have not been conducted. Mutagenesis Aztreonam Genetic toxicology studies performed with aztreonam in vitro (Ames test, mouse lymphoma forward mutation assay, gene conversion assay, chromosome aberration assay in human lymphocytes) and in vivo (mouse bone marrow cytogenetic assay) did not reveal evidence of mutagenic or clastogenic potential. Avibactam Avibactam was negative for genotoxicity in the Ames assay, unscheduled DNA synthesis, chromosomal aberration assay, and a rat micronucleus study. Impairment of Fertility Aztreonam A two-generation reproduction study in rats at daily doses of 150, 600, or 2400 mg/kg/day given prior to and during gestation and lactation, revealed no evidence of impaired fertility. Based on body surface area, the high dose is 3.6-fold greater than the maximum recommended human dose (MRHD) for adults of 6.5 g per day. There was a slightly reduced survival rate during the lactation period in the offspring of rats that received the highest dose, but not in offspring of rats that received lower doses of aztreonam. Avibactam Avibactam had no adverse effects on fertility of male and female rats given up to 1g/kg/day (approximately 4.5-fold higher than the MRHD of 2.17 g/day on a body surface area basis). There was a dose-related increase in the percentage of pre-and post-implantation loss relative to controls, resulting in a lower mean litter size at doses of 0.5 g/kg/day (approximately 2 times the MRHD on a body surface area basis) and greater with intravenous administration to female rats beginning 2 weeks prior to mating."]},"tags":[{"label":"beta Lactamase Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Intravenous","category":"route"},{"label":"Powder","category":"form"},{"label":"Active","category":"status"},{"label":"Bacterial urinary infection","category":"indication"},{"label":"Infectious disease of abdomen","category":"indication"},{"label":"Pyelonephritis","category":"indication"},{"label":"Cerexa Inc","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Anti-Bacterial Agents","category":"pharmacology"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"beta-Lactamase Inhibitors","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"commonSideEffects":[{"effect":"Diarrhea","drugRate":"8%","severity":"common","_validated":true},{"effect":"Nausea","drugRate":"7%","severity":"common","_validated":true},{"effect":"Vomiting","drugRate":"5%","severity":"common","_validated":true},{"effect":"Headache","drugRate":"3%","severity":"mild","_validated":true},{"effect":"Dizziness","drugRate":"2%","severity":"mild","_validated":true},{"effect":"Infusion site phlebitis","drugRate":"reported","severity":"mild"},{"effect":"Rash","drugRate":"reported","severity":"mild"},{"effect":"Abdominal Pain","drugRate":"1%","severity":"mild","_validated":true},{"effect":"Death","drugRate":"","severity":"serious","_validated":false,"_confidence":0.3},{"effect":"Increased Mortality","drugRate":"1.5%","severity":"serious","_validated":true}],"specialPopulations":{"Pregnancy":"There are no adequate and well-controlled studies of AVYCAZ, ceftazidime, or avibactam in pregnant women. Neither ceftazidime nor avibactam were teratogenic in rats at doses 40 and times the recommended human clinical dose. In the rabbit, at twice the exposure as seen at the human clinical dose, there were no effects on embryofetal development with avibactam. The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies within the general population. Because animal reproduction studies are not always predictive of human response, this drug should be used in pregnancy only if clearly needed.","Geriatric use":"Of the 1809 patients treated with AVYCAZ in the Phase and Phase clinical trials 621 (34.5%) were 65 years of age and older, including 302 (16.7 %) patients 75 years of age and older. The incidence of adverse reactions in both treatment groups was higher in older patients (>= 65 years of age).","Paediatric use":"The safety and effectiveness of AVYCAZ in the treatment of cUTI and cIAI have been established in pediatric patients 3 months to less than 18 years. Use of AVYCAZ in these age groups is supported by evidence from adequate and well-controlled studies of AVYCAZ in adults with cUTI and cIAI and additional pharmacokinetic and safety data from pediatric trials."}},"trials":[],"aliases":[],"company":"Cerexa Inc","patents":[{"source":"FDA Orange Book via DrugCentral","expires":"2032-06-15","territory":"US","patentNumber":"8969566"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-06-15","territory":"US","patentNumber":"9284314"},{"source":"FDA Orange Book via DrugCentral","expires":"2032-06-15","territory":"US","patentNumber":"9695122"},{"source":"FDA Orange Book via DrugCentral","expires":"2031-08-12","territory":"US","patentNumber":"8471025"},{"source":"FDA Orange Book via DrugCentral","expires":"2030-10-08","territory":"US","patentNumber":"8835455"},{"source":"FDA Orange Book via DrugCentral","expires":"2026-11-12","territory":"US","patentNumber":"7612087"},{"source":"FDA Orange Book via DrugCentral","expires":"2026-01-07","territory":"US","patentNumber":"7112592"}],"pricing":[],"_fixedAt":"2026-03-30T16:45:13.570173","_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AVIBACTAM","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T02:05:03.417945+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T02:05:03.417830+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T02:05:08.672010+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AVIBACTAM","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T02:05:09.237486+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:05:01.816945+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:05:01.816984+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:05:01.816990+00:00"},"mechanism.oneSentence":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"12.1 Mechanism of Action EMBLAVEO is an antibacterial drug [see Microbiology ( 12.4 )] .","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:05:15.115951+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1689063/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T02:05:10.019850+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA217906","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T02:05:01.816995+00:00"}},"allNames":"avycaz","offLabel":[],"synonyms":["NXL-104","avibactam","NXL104","AVE1330A","avibactam sodium"],"timeline":[{"date":"2015-02-25","type":"positive","source":"DrugCentral","milestone":"FDA approval (Cerexa Inc)"}],"brandName":"Avycaz","ecosystem":[{"indication":"Bacterial urinary infection","otherDrugs":[{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amoxicillin","slug":"amoxicillin","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"},{"name":"aztreonam","slug":"aztreonam","company":"Bristol Myers Squibb"}],"globalPrevalence":null},{"indication":"Infectious disease of abdomen","otherDrugs":[{"name":"alatrofloxacin","slug":"alatrofloxacin","company":"Pfizer"},{"name":"amikacin","slug":"amikacin","company":"Apothecon"},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"ampicillin","slug":"ampicillin","company":"Wyeth Ayerst"}],"globalPrevalence":null},{"indication":"Pyelonephritis","otherDrugs":[{"name":"cefiderocol","slug":"cefiderocol","company":"Shionogi Inc"},{"name":"doripenem","slug":"doripenem","company":"Shionogi Inc"},{"name":"levofloxacin","slug":"levofloxacin","company":"Janssen Pharms"},{"name":"norfloxacin","slug":"norfloxacin","company":""}],"globalPrevalence":null}],"mechanism":{"novelty":"Follow-on","moaClass":"beta Lactamase Inhibitors","modality":"Small Molecule","drugClass":"beta Lactamase Inhibitor [EPC]","explanation":"AVYCAZ is an antibacterial drug see Clinical Pharmacology 12.4 ].","oneSentence":"EMBLAVEO is an antibacterial drug.","technicalDetail":"Avycaz inhibits serine beta-lactamases, including Class A, C, and D enzymes, through a reversible covalent binding mechanism, thereby preventing the hydrolysis of beta-lactam antibiotics and restoring their antibacterial activity."},"commercial":{"launchDate":"2015","_launchSource":"DrugCentral (FDA 2015-02-25, CEREXA INC)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4946","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=AVIBACTAM","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AVIBACTAM","fields":["publications"],"source":"PubMed/NCBI"}],"_enrichedAt":"2026-03-30T08:51:39.809396","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:05:16.782398+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"benzathine benzylpenicillin","drugSlug":"benzathine-benzylpenicillin","fdaApproval":"1952-06-27","relationship":"same-target"},{"drugName":"benzylpenicillin","drugSlug":"benzylpenicillin","fdaApproval":"1947-02-06","relationship":"same-target"},{"drugName":"clavulanic acid","drugSlug":"clavulanic-acid","fdaApproval":"1984-08-06","relationship":"same-target"},{"drugName":"cloxacillin","drugSlug":"cloxacillin","fdaApproval":"1974-09-17","genericCount":3,"patentStatus":"Off-patent — generic available","relationship":"same-target"},{"drugName":"fulvestrant","drugSlug":"fulvestrant","fdaApproval":"2002-04-25","patentExpiry":"May 17, 2034","patentStatus":"Patent protected","relationship":"same-target"},{"drugName":"sulbactam","drugSlug":"sulbactam","fdaApproval":"1986-12-31","relationship":"same-target"},{"drugName":"tazobactam","drugSlug":"tazobactam","fdaApproval":"1993-10-22","relationship":"same-target"}],"genericName":"avibactam","indications":{"approved":[{"name":"Bacterial urinary infection","source":"DrugCentral","snomedId":312124009,"regulator":"FDA"},{"name":"Infectious disease of abdomen","source":"DrugCentral","snomedId":128070006,"regulator":"FDA"},{"name":"Pyelonephritis","source":"DrugCentral","snomedId":45816000,"regulator":"FDA","eligibility":{"age":"2 months or older","stage":"complicated urinary tract infections (cUTI)","microorganisms":["Escherichia coli","Klebsiella pneumoniae","Enterobacter cloacae","Citrobacter freundii complex","Proteus mirabilis","Pseudomonas aeruginosa"]}}],"offLabel":[],"pipeline":[]},"_fixedFields":["pubmed(2981)"],"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"benzathine-benzylpenicillin","brandName":"benzathine benzylpenicillin","genericName":"benzathine benzylpenicillin","approvalYear":"1952","relationship":"same-target"},{"drugId":"benzylpenicillin","brandName":"benzylpenicillin","genericName":"benzylpenicillin","approvalYear":"1947","relationship":"same-target"},{"drugId":"clavulanic-acid","brandName":"clavulanic acid","genericName":"clavulanic acid","approvalYear":"1984","relationship":"same-target"},{"drugId":"cloxacillin","brandName":"cloxacillin","genericName":"cloxacillin","approvalYear":"1974","relationship":"same-target"},{"drugId":"fulvestrant","brandName":"fulvestrant","genericName":"fulvestrant","approvalYear":"2002","relationship":"same-target"},{"drugId":"sulbactam","brandName":"sulbactam","genericName":"sulbactam","approvalYear":"1986","relationship":"same-target"},{"drugId":"tazobactam","brandName":"tazobactam","genericName":"tazobactam","approvalYear":"1993","relationship":"same-target"}],"trialDetails":[{"nctId":"NCT07494981","phase":"","title":"Individualized Precision Therapy With Ceftazidime and Avibactam Guided by PK/PD in Geriatric Populations","status":"NOT_YET_RECRUITING","sponsor":"Chinese PLA General Hospital","startDate":"2026-03-25","conditions":["Ceftazidime-avibactam"],"enrollment":150,"completionDate":"2030-12-31"},{"nctId":"NCT05639647","phase":"PHASE2","title":"Study of 2 Medicines (Aztreonam and Avibactam) Compared to Best Available Therapy for Serious Gram-negative Infections","status":"RECRUITING","sponsor":"Pfizer","startDate":"2023-04-18","conditions":["Gram-negative Bacterial Infections"],"enrollment":48,"completionDate":"2026-08-17"},{"nctId":"NCT07268560","phase":"","title":"Real-World Effectiveness of Aztreonam-Avibactam Against MBL-Producing CRE","status":"RECRUITING","sponsor":"Sir Run Run Shaw Hospital","startDate":"2025-12-25","conditions":["Complicated Intra-Abdominal Infections, cIAIs","Hospital-acquired Pneumonia (HAP)","Ventilator-Associated Pneumonia (VAP)"],"enrollment":100,"completionDate":"2027-07-31"},{"nctId":"NCT06462235","phase":"PHASE2","title":"A Study to Learn About the Study Medicine Aztreonam-Avibactam (ATM-AVI) in Infants and Newborns Admitted in Hospitals With Bacterial Infection (CHERISH)","status":"RECRUITING","sponsor":"Pfizer","startDate":"2024-09-25","conditions":["Gram-negative Bacterial Infection"],"enrollment":48,"completionDate":"2027-12-02"},{"nctId":"NCT07478484","phase":"PHASE4","title":"Different Administration Regimens of CAZ-AVI in Combination With ATM for the Treatment of CR-GNB","status":"RECRUITING","sponsor":"Jing Zhou","startDate":"2026-03-31","conditions":["Ceftazidime-avibactam","Aztreonam","Gram-negative Bacterial Infection","Metallo-β-lactamase-producing","Carbapenem-resistant"],"enrollment":144,"completionDate":"2028-01-31"},{"nctId":"NCT07431307","phase":"PHASE2","title":"Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex","status":"NOT_YET_RECRUITING","sponsor":"BioVersys AG","startDate":"2026-07","conditions":["Ventilator Associated Bacterial Pneumonia (VABP)","Hospital Acquired Bacterial Pneumonia (HABP)","Blood Stream Infection","Meningitis, Bacterial","Ventriculitis, Infectious"],"enrollment":120,"completionDate":"2028-07"},{"nctId":"NCT07327619","phase":"PHASE3","title":"A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP","status":"RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2026-01-22","conditions":["Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia"],"enrollment":420,"completionDate":"2028-10"},{"nctId":"NCT07369518","phase":"","title":"Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae","status":"NOT_YET_RECRUITING","sponsor":"Sohag University","startDate":"2026-01","conditions":["ISOLATION OF KLEB. by Culture on macConkey Agar","Antibiotic Sensitivity Testing of Different Antibiotics According to Clsi 25","Effect of Ceftazidime-Avibactam on Carbapenemase-Producing Klebsiella Pneumoniae","Detection of Resistance Gene in Isolates Using Conventional Pcr","Detection of Some Virulence Genes Using Conventional Pcr"],"enrollment":100,"completionDate":"2026-12"},{"nctId":"NCT06672276","phase":"PHASE1","title":"To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency","status":"COMPLETED","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2024-11-20","conditions":["Resistant to Gram-positive, Gram-negative and Anaerobic Bacteria"],"enrollment":32,"completionDate":"2025-05-06"},{"nctId":"NCT06717594","phase":"","title":"PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE","status":"RECRUITING","sponsor":"IRCCS Azienda Ospedaliero-Universitaria di Bologna","startDate":"2023-12-01","conditions":["Gram Negative Infections","Antimicrobial Resistance (AMR)"],"enrollment":60,"completionDate":"2026-04-30"},{"nctId":"NCT06864585","phase":"","title":"A Study to Learn About the Study Medicine - Zavicefta in Patients With Sepsis or Loss of Kidney Function in Japan","status":"NOT_YET_RECRUITING","sponsor":"Pfizer","startDate":"2026-03-15","conditions":["Infectious Diseases"],"enrollment":59,"completionDate":"2029-03-30"},{"nctId":"NCT07204522","phase":"","title":"Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.","status":"RECRUITING","sponsor":"Shanxi Bethune Hospital","startDate":"2025-09-22","conditions":["Febrile Neutropenia"],"enrollment":20,"completionDate":"2027-09-22"},{"nctId":"NCT07063095","phase":"PHASE3","title":"A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infections","status":"RECRUITING","sponsor":"Angela HUTTNER","startDate":"2025-08-25","conditions":["Gram Negative Infections","Sepsis and Septic Shock"],"enrollment":100,"completionDate":"2026-12"},{"nctId":"NCT07176247","phase":"","title":"Real-world Multicentre Study of AZtreonam-AVIbactam Treatment With Infections or Suspected Infections Caused by Multidrug-resistant Gram-negative Bacteria","status":"ENROLLING_BY_INVITATION","sponsor":"French Society for Intensive Care","startDate":"2024-01-01","conditions":["Critical Care","Infection","Antibiotic Resistance","Infectious Diseases"],"enrollment":100,"completionDate":"2028-12-31"},{"nctId":"NCT07160569","phase":"","title":"Microbiological and Clinical Characteristics of Severe Infections Caused by Carbapenem-Resistant Enterobacterales","status":"NOT_YET_RECRUITING","sponsor":"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","startDate":"2025-09-01","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":100,"completionDate":"2026-08-31"},{"nctId":"NCT05487586","phase":"","title":"Real-World Study of Ceftazidime Avibactam in China","status":"TERMINATED","sponsor":"Pfizer","startDate":"2022-10-20","conditions":["Hospital Acquired Pneumonia","Ventilator Acquired Pneumonia","Complicated Intra Abdominal Infections"],"enrollment":220,"completionDate":"2024-07-11"},{"nctId":"NCT05733104","phase":"","title":"A Study to Learn About the Study Medicine Zavicefta After it is Released Into the Markets in Korea","status":"RECRUITING","sponsor":"Pfizer","startDate":"2024-02-19","conditions":["Complicated Intra-abdominal Infection","Complicated Urinary Tract Infection","Hospital-acquired Pneumonia"],"enrollment":600,"completionDate":"2029-09-28"},{"nctId":"NCT05977868","phase":"PHASE4","title":"Comparing Oral Versus Parenteral Antimicrobial Therapy","status":"TERMINATED","sponsor":"West Virginia University","startDate":"2023-08-04","conditions":["Endovascular Infection","Bone and Joint Infection","Skin and Soft Tissue Infection","Pulmonary Infection","Gastrointestinal Infection","Genitourinary Infection"],"enrollment":94,"completionDate":"2025-02-14"},{"nctId":"NCT05413343","phase":"","title":"Clinical Study on Monitoring the Plasma Concentration of Ceftazidime-Avibactam in Critically Ill Patients","status":"ACTIVE_NOT_RECRUITING","sponsor":"First Affiliated Hospital of Zhejiang University","startDate":"2021-06-01","conditions":["Severe Sepsis"],"enrollment":30,"completionDate":"2025-10-31"},{"nctId":"NCT07089186","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections","status":"RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2025-04-12","conditions":["Hospital-acquired Bacterial Pneumonia (HABP)","Ventilator-associated Bacterial Pneumonia (VABP)","Complicated Intra-abdominal Infection (cIAI)","Complicated Urinary Tract Infection (cUTI)","Bloodstream Infection (BSI)"],"enrollment":80,"completionDate":"2027-04"},{"nctId":"NCT07004049","phase":"PHASE4","title":"Optimising TREATment for Severe Gram-Negative Bacterial Infections","status":"RECRUITING","sponsor":"National University of Singapore","startDate":"2025-04-21","conditions":["Bloodstream Infection","Ventilator Associated Bacterial Pneumonia","Hospital Acquired Bacterial Pneumonia","Carbapenem Resistant Bacterial Infection","Multidrug Resistance"],"enrollment":600,"completionDate":"2028-12-31"},{"nctId":"NCT06593054","phase":"PHASE1","title":"To Learn How Different Forms of Study Medicine Are Taken up Into the Blood and the Effect of Food on Study Medicine in Healthy Adults","status":"COMPLETED","sponsor":"Pfizer","startDate":"2024-07-29","conditions":["Healthy"],"enrollment":13,"completionDate":"2024-10-11"},{"nctId":"NCT06051513","phase":"NA","title":"Efficacy and Safety of Colistimethate Sodium for Injection in The Treatment of Carbapenem-Resistant Enterobacteriaceae Infection","status":"RECRUITING","sponsor":"Southeast University, China","startDate":"2023-11-27","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":404,"completionDate":"2025-12-31"},{"nctId":"NCT06939829","phase":"PHASE4","title":"A Multicenter Clinical Study on the Continuous vs. Intermittent Infusion of Ceftazidime-Avibactam in Critically Ill Patients With Severe Infections","status":"NOT_YET_RECRUITING","sponsor":"Southeast University, China","startDate":"2025-05-01","conditions":["Patients With Critically Ill Infections"],"enrollment":1200,"completionDate":"2027-12-31"},{"nctId":"NCT06811727","phase":"PHASE4","title":"CONTinuous Infusion Versus Intermittent Dosing of ceftaZidime/AVIbactam in Critically Ill Patients","status":"NOT_YET_RECRUITING","sponsor":"Ivan Šitum, MD","startDate":"2025-05-01","conditions":["Severe Infection"],"enrollment":140,"completionDate":"2027-08-01"},{"nctId":"NCT06818565","phase":"NA","title":"Comparison of Efficacy and Safety of Ceftazidime Avibactam Versus Extended Infusions of High Dose Meropenem in Patients of ACLF With Nosocomial Infections.","status":"NOT_YET_RECRUITING","sponsor":"Institute of Liver and Biliary Sciences, India","startDate":"2025-02-10","conditions":["Acute-On-Chronic Liver Failure"],"enrollment":150,"completionDate":"2026-12-31"},{"nctId":"NCT03329092","phase":"PHASE3","title":"A Study to Determine the Efficacy, Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI) ± Metronidazole (MTZ) Versus Meropenem (MER) ± Colistin (COL) for the Treatment of Serious Infections Due to Gram Negative Bacteria.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2018-04-05","conditions":["Complicated Intra-abdominal Infection","Hosptial Acquired Pneumonia","Ventilator Associated Pneumonia"],"enrollment":422,"completionDate":"2023-02-23"},{"nctId":"NCT06419296","phase":"","title":"Mortality of MBL-producing Enterobacteriaceae Bacteremias with the Combined Use of Ceftazidime-avibactam and Aztreonam Vs. Other Active Antibiotics. a Multicenter Target Trial Emulation.","status":"COMPLETED","sponsor":"Hospital Italiano de Buenos Aires","startDate":"2024-06-01","conditions":["Bacteremia"],"enrollment":265,"completionDate":"2024-11-19"},{"nctId":"NCT04882085","phase":"PHASE4","title":"Efficacy and Safety of CAZ-AVI in the Treatment of Infections Due to Carbapenem-resistant G- Pathogens in Chinese Adults","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-08-26","conditions":["Urinary Tract Infection","Acute Pyelonephritis","Hospital Acquired Pneumonia","Ventilator-associated Pneumonia","Bacteremia","Intra-abdominal Infection"],"enrollment":60,"completionDate":"2023-08-31"},{"nctId":"NCT06651047","phase":"","title":"PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections","status":"RECRUITING","sponsor":"University of Bologna","startDate":"2024-07-09","conditions":["Gram Negative Infection","Antimicrobial Resistance (AMR)"],"enrollment":120,"completionDate":"2025-09-30"},{"nctId":"NCT06633718","phase":"PHASE3","title":"Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in CIAI","status":"NOT_YET_RECRUITING","sponsor":"Qilu Pharmaceutical Co., Ltd.","startDate":"2024-10-31","conditions":["Intra-abdominal Infections"],"enrollment":786,"completionDate":"2027-05-30"},{"nctId":"NCT04774094","phase":"PHASE4","title":"Efficacy and Safety of Ceftazidime-Avibactam (CAZ-AVI) in Chinese Participants With HAP (Including VAP)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-05-21","conditions":["Hospital-Acquired Pneumonia"],"enrollment":235,"completionDate":"2023-05-04"},{"nctId":"NCT04785924","phase":"PHASE4","title":"Imipenem/Cilastatin/Relebactam (IMI/REL) in Treatment of CRE Infections","status":"WITHDRAWN","sponsor":"Wake Forest University Health Sciences","startDate":"2021-06-07","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection","KPC","Gram-Negative Bacterial Infections","Antibiotic Resistant Infection"],"enrollment":0,"completionDate":"2023-01-12"},{"nctId":"NCT04628572","phase":"","title":"Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-01-29","conditions":["Gram Negative Infections"],"enrollment":189,"completionDate":"2022-03-11"},{"nctId":"NCT06528028","phase":"PHASE4","title":"Relationship Between Different Administration Regimens of Ceftazidime/Avibactam and Clinical Outcomes","status":"RECRUITING","sponsor":"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","startDate":"2024-07-01","conditions":["Anti-Infective Agent"],"enrollment":140,"completionDate":"2025-07-30"},{"nctId":"NCT05566665","phase":"","title":"Nosocomial Infections in ECMO Patients","status":"RECRUITING","sponsor":"Policlinico Hospital","startDate":"2023-01-01","conditions":["Acute Respiratory Distress Syndrome","Nosocomial Infection","Extracorporeal Membrane Oxygenation Complication"],"enrollment":200,"completionDate":"2026-12-31"},{"nctId":"NCT03923426","phase":"","title":"Real-World Observational Study Of Zavicefta to Characterize Use Patterns","status":"COMPLETED","sponsor":"Pfizer","startDate":"2018-11-27","conditions":["Infection"],"enrollment":572,"completionDate":"2022-03-28"},{"nctId":"NCT05048693","phase":"","title":"Use of New Antibiotics in Sweden","status":"COMPLETED","sponsor":"Uppsala University","startDate":"2021-11-01","conditions":["Multi-antibiotic Resistance"],"enrollment":41,"completionDate":"2023-12-30"},{"nctId":"NCT05258851","phase":"PHASE3","title":"Ceftazidime-Avibactam Use in Critically Ill Patients With Carbapenem-Resistant Enterobacteriaceae Infections","status":"TERMINATED","sponsor":"King Faisal Specialist Hospital & Research Center","startDate":"2022-06-01","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":29,"completionDate":"2024-01-28"},{"nctId":"NCT04126031","phase":"PHASE2","title":"Evaluation of Pharmacokinetics, Safety, and Tolerability of Ceftazidime-avibactam in Neonates and Infants.","status":"TERMINATED","sponsor":"Pfizer","startDate":"2020-01-14","conditions":["Gram-negative Bacterial Infection"],"enrollment":48,"completionDate":"2022-12-30"},{"nctId":"NCT04927312","phase":"PHASE3","title":"Study to Assess Efficacy and Safety of PF-06947386 in Japanese Adult Patients With Complicated Intra-abdominal Infection","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-10-01","conditions":["Complicated Intra-abdominal Infection"],"enrollment":60,"completionDate":"2022-09-15"},{"nctId":"NCT05979545","phase":"PHASE4","title":"EaRly impAct theraPy With Ceftazidime-avibactam Via rapID Diagnostics","status":"RECRUITING","sponsor":"National University of Singapore","startDate":"2023-12-12","conditions":["Blood Stream Infections","Ventilator Associated Pneumonia","Healthcare Associated Infection","Carbapenem-Resistant Enterobacteriaceae Infection","Hospital-acquired Pneumonia"],"enrollment":1900,"completionDate":"2026-12-31"},{"nctId":"NCT03580044","phase":"PHASE3","title":"Efficacy, Safety, and Tolerability of ATM-AVI in the Treatment of Serious Infection Due to MBL-producing Gram-negative Bacteria","status":"TERMINATED","sponsor":"Pfizer","startDate":"2020-12-25","conditions":["Serious Bacterial Infection"],"enrollment":15,"completionDate":"2023-01-23"},{"nctId":"NCT06210542","phase":"","title":"Precise Treatment of Ceftazidime-Avibactam in Patients With CRO Infections Under the Guidance of TDM and PPK Model","status":"NOT_YET_RECRUITING","sponsor":"Sichuan Provincial People's Hospital","startDate":"2024-01","conditions":["ECMO","Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":50,"completionDate":"2026-12"},{"nctId":"NCT04973826","phase":"PHASE1","title":"Study to Assess the Pharmacokinetics, Safety and Tolerability of Aztreonam-Avibactam in Healthy Chinese Participants.","status":"COMPLETED","sponsor":"Pfizer","startDate":"2021-08-20","conditions":["Healthy"],"enrollment":12,"completionDate":"2021-09-27"},{"nctId":"NCT04486625","phase":"PHASE1","title":"Pharmacokinetic Study of Aztreonam-Avibactam in Severe Renal Impairment","status":"COMPLETED","sponsor":"Pfizer","startDate":"2020-08-10","conditions":["Renal Insufficiency"],"enrollment":11,"completionDate":"2021-10-18"},{"nctId":"NCT05862402","phase":"PHASE4","title":"Dose Optimization by Pharmacokinetic/Pharmacodynamic of Antibiotics to Improve Clinical Outcome of Carbapenem Resistant Klebsiella Pneumoniae Bloodstream Infections in Critically Ill Patients at Phramongkutklao Hospital","status":"UNKNOWN","sponsor":"Phramongkutklao College of Medicine and Hospital","startDate":"2023-05-07","conditions":["Carbapenem Resistant Klebsiella Pneumoniae"],"enrollment":76,"completionDate":"2024-06-30"},{"nctId":"NCT05850871","phase":"NA","title":"Drug Resistance Mechanism of Enterobacteriaceae and Its Strategies","status":"UNKNOWN","sponsor":"Qianfoshan Hospital","startDate":"2023-01-06","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":427,"completionDate":"2025-01-31"},{"nctId":"NCT05588531","phase":"PHASE1","title":"Study on Tolerance, Pharmacokinetics and Drug Interaction of YK-1169 in Healthy Volunteers","status":"COMPLETED","sponsor":"Nanjing Yoko Biomedical Co., Ltd.","startDate":"2021-12-20","conditions":["Pharmacokinetics"],"enrollment":66,"completionDate":"2022-04-08"},{"nctId":"NCT04040621","phase":"PHASE1","title":"Single-dose PK Study of Ceftazidime-Avibactam In Hospitalized Children Receiving Systemic Antibiotics for Nosocomial Pneumonia","status":"TERMINATED","sponsor":"Pfizer","startDate":"2020-06-15","conditions":["Hospitalized Children With Suspected or Confirmed Nosocomial Pneumonia"],"enrollment":4,"completionDate":"2021-05-07"},{"nctId":"NCT03978091","phase":"PHASE1,PHASE2","title":"A Trial to Evaluate the Pharmacokinetics and Safety of AVYCAZ(R) in Combination With Aztreonam","status":"COMPLETED","sponsor":"National Institute of Allergy and Infectious Diseases (NIAID)","startDate":"2019-07-09","conditions":["Bacterial Infection"],"enrollment":48,"completionDate":"2020-11-23"},{"nctId":"NCT05340530","phase":"PHASE1","title":"To Evaluate the Pharmacokinetic Effects of TQD3606 for Injection in Healthy Adult Subjects","status":"UNKNOWN","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2022-04","conditions":["Infections"],"enrollment":56,"completionDate":"2023-12"},{"nctId":"NCT03790176","phase":"PHASE1","title":"ZAVI APD ELF Protocol v2.2","status":"UNKNOWN","sponsor":"Markus Zeitlinger","startDate":"2018-10-01","conditions":["Peritonitis","Pneumonia"],"enrollment":20,"completionDate":"2022-12"},{"nctId":"NCT04167228","phase":"","title":"Impact of Ceftazidime / Avibactam Treatment vs Better Available Therapy on Mortality of Patients With Infections Caused by Carbapenem-resistant Enterobacteria","status":"COMPLETED","sponsor":"Maimónides Biomedical Research Institute of Córdoba","startDate":"2019-10-01","conditions":["Carbapenem-Resistant Enterobacteriaceae Infection"],"enrollment":348,"completionDate":"2021-05-05"},{"nctId":"NCT04358991","phase":"","title":"Pharmacokinetics of Ceftazidime-avibactam Among Critically-ill Patients Receiving CVVHDF","status":"COMPLETED","sponsor":"University of Pittsburgh","startDate":"2017-01-01","conditions":["Bacterial Infections"],"enrollment":20,"completionDate":"2019-12-31"},{"nctId":"NCT04402359","phase":"","title":"Usage of Meropenem/Gentamicin Versus Ceftazidime/Avibactam in ARDS","status":"COMPLETED","sponsor":"King Abdul Aziz Specialist Hospital","startDate":"2018-07-05","conditions":["Ventilator Associated Pneumonia"],"enrollment":200,"completionDate":"2019-12-30"},{"nctId":"NCT03941951","phase":"NA","title":"Study to Optimize the Use of New Antibiotics","status":"UNKNOWN","sponsor":"Fundación Pública Andaluza para la gestión de la Investigación en Sevilla","startDate":"2019-07-09","conditions":["Bacterial Infections","Fungal Infection"],"enrollment":900,"completionDate":"2022-12-31"},{"nctId":"NCT02655419","phase":"PHASE2","title":"Determine the PK and Safety and Tolerability of ATM-AVI for the Treatment of cIAIs in Hospitalized Adults (REJUVENATE)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2016-05-19","conditions":["Complicated Intra-Abdominal Infections, cIAIs"],"enrollment":40,"completionDate":"2017-10-26"},{"nctId":"NCT03243864","phase":"","title":"Study of Ceftazidime-Avibactam Blood Concentrations in Intensive Care Unit Patients With Renal Failure Requiring Continuous Dialysis","status":"UNKNOWN","sponsor":"Temple University","startDate":"2017-03-13","conditions":["Renal Failure","Bacterial Infections","Critical Illness"],"enrollment":10,"completionDate":"2020-10-21"},{"nctId":"NCT02822950","phase":"PHASE1","title":"A Study of Avycaz (Ceftazidime/Avibactam) Pharmacokinetics/Pharmacodynamics (PK/PD) in Critically Ill Patients","status":"COMPLETED","sponsor":"Michigan State University","startDate":"2017-01","conditions":["Pharmacokinetics of Avycaz in ICU Patients"],"enrollment":10,"completionDate":"2017-12"},{"nctId":"NCT02504827","phase":"PHASE4","title":"Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis","status":"COMPLETED","sponsor":"University of Southern California","startDate":"2015-09","conditions":["Cystic Fibrosis"],"enrollment":12,"completionDate":"2016-10"},{"nctId":"NCT02475733","phase":"PHASE2","title":"Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).","status":"COMPLETED","sponsor":"Pfizer","startDate":"2015-08-01","conditions":["Complicated Intra-abdominal Infections"],"enrollment":83,"completionDate":"2017-06-01"},{"nctId":"NCT02497781","phase":"PHASE2","title":"Evaluation of Safety, Pharmacokinetics and Efficacy of Ceftazidime and Avibactam (CAZ-AVI ) Compared With Cefepime in Children From 3 Months to Less Than 18 Years of Age With Complicated Urinary Tract Infections (cUTIs)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2015-09-24","conditions":["Complicated Urinary Tract Infections"],"enrollment":97,"completionDate":"2017-09-15"},{"nctId":"NCT00752219","phase":"PHASE2","title":"Prospective Multicenter Doubleblind Randomized Study of NXL104/Ceftazidime + Metronidazole vs. Meropenem in Treatment of Complicated Intra-abdominal Infections","status":"COMPLETED","sponsor":"Pfizer","startDate":"2009-03-31","conditions":["Complicated Intra-abdominal Infections"],"enrollment":204,"completionDate":"2009-12-31"},{"nctId":"NCT00690378","phase":"PHASE2","title":"Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections","status":"COMPLETED","sponsor":"Pfizer","startDate":"2008-11","conditions":["Complicated Urinary Tract Infection"],"enrollment":137,"completionDate":"2010-07"},{"nctId":"NCT01644643","phase":"PHASE3","title":"Ceftazidime-Avibactam for the Treatment of Infections Due to Ceftazidime Resistant Pathogens","status":"COMPLETED","sponsor":"Pfizer","startDate":"2013-01","conditions":["Complicated Urinary Tract Infection","Complicated Intra-abdominal Infection"],"enrollment":345,"completionDate":"2014-09"},{"nctId":"NCT01599806","phase":"PHASE3","title":"Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-10","conditions":["Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis"],"enrollment":641,"completionDate":"2014-08"},{"nctId":"NCT01726023","phase":"PHASE3","title":"Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections","status":"COMPLETED","sponsor":"Pfizer","startDate":"2013-01","conditions":["Complicated Intra-abdominal Infection"],"enrollment":486,"completionDate":"2015-03"},{"nctId":"NCT01689207","phase":"PHASE1","title":"To Investigate the Safety and Tolerability of Aztreonam-Avibactam (ATM-AVI)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-09","conditions":["Complicated Infection","Bacterial Infections"],"enrollment":222,"completionDate":"2014-12"},{"nctId":"NCT01499290","phase":"PHASE3","title":"Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-03","conditions":["Complicated Intra-Abdominal Infection"],"enrollment":493,"completionDate":"2014-04"},{"nctId":"NCT01808092","phase":"PHASE3","title":"A Study Comparing Ceftazidime-Avibactam Versus Meropenem in Hospitalized Adults With Nosocomial Pneumonia","status":"COMPLETED","sponsor":"Pfizer","startDate":"2013-04","conditions":["Nosocomial Pneumonia (NP)","Ventilator-associated Pneumonia (VAP)"],"enrollment":969,"completionDate":"2016-01"},{"nctId":"NCT01595438","phase":"PHASE3","title":"Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-10","conditions":["Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis"],"enrollment":598,"completionDate":"2014-08"},{"nctId":"NCT01893346","phase":"PHASE1","title":"Safety and Tolerability of Ceftazidime-Avibactam for Pediatric Patients With Suspected or Confirmed Infections","status":"COMPLETED","sponsor":"Pfizer","startDate":"2013-07","conditions":["Systemic Infections"],"enrollment":35,"completionDate":"2014-10"},{"nctId":"NCT01920399","phase":"PHASE1","title":"A Phase I Study to Assess the Safety, Tolerability and PK of Ceftazidime-Avibactam in Healthy Chinese Subjects","status":"COMPLETED","sponsor":"Pfizer","startDate":"2013-10","conditions":["Healthy Volunteers"],"enrollment":42,"completionDate":"2013-11"},{"nctId":"NCT01789528","phase":"PHASE1","title":"A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers","status":"COMPLETED","sponsor":"Pfizer","startDate":"2013-08","conditions":["Pharmacokinetics","Open Label","CAZ-AVI","CXL","Effect on Intestinal Flora","Safety"],"enrollment":48,"completionDate":"2014-03"},{"nctId":"NCT01534247","phase":"PHASE1","title":"A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately","status":"COMPLETED","sponsor":"Pfizer","startDate":"2012-02","conditions":["Healthy"],"enrollment":28,"completionDate":"2012-07"},{"nctId":"NCT01291602","phase":"PHASE1","title":"A Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-02","conditions":["Healthy Male and Female Japanese Volunteers"],"enrollment":15,"completionDate":"2011-04"},{"nctId":"NCT01430910","phase":"PHASE1","title":"A Study to Assess the Levels of Two Antibiotics in the Blood When Given Together and Separately","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-09","conditions":["Healthy"],"enrollment":43,"completionDate":"2012-10"},{"nctId":"NCT01448395","phase":"PHASE1","title":"Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]NXL104","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-10","conditions":["Healthy"],"enrollment":6,"completionDate":"2011-11"},{"nctId":"NCT01395420","phase":"PHASE1","title":"Study to Assess the Concentration of Avibactam and Ceftazidime in Epithelial Lining Fluid and Plasma","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-08","conditions":["Healthy"],"enrollment":45,"completionDate":"2012-07"},{"nctId":"NCT01290900","phase":"PHASE1","title":"A Single-centre, Randomised, Double-blind, Placebo-controlled, Four Way Crossover Phase I Study to Investigate the Effect on QT/QTc Interval of Ceftazidime NXL104 or Ceftaroline Fosamil NXL104, Compared With Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers","status":"COMPLETED","sponsor":"Pfizer","startDate":"2011-02","conditions":["Healthy Male Volunteers"],"enrollment":54,"completionDate":"2011-05"},{"nctId":"NCT02732327","phase":"PHASE2","title":"Comparative Study of Ceftazidime-Avibactam Versus Standard of Care as Therapy in Febrile Neutropenic Adults With Cancer","status":"TERMINATED","sponsor":"Forest Laboratories","startDate":"2016-05-17","conditions":["Neoplasms","Febrile Neutropenia"],"enrollment":2,"completionDate":"2016-06-27"},{"nctId":"NCT01624246","phase":"PHASE1","title":"Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2012-05","conditions":["Augmented Renal Clearance (ARC)","Systemic Inflammatory Response Syndrome (SIRS)"],"enrollment":12,"completionDate":"2013-03"},{"nctId":"NCT01281462","phase":"PHASE2","title":"Comparative Study of Coadministered Ceftaroline Fosamil and NXL104 vs. Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infections","status":"COMPLETED","sponsor":"Forest Laboratories","startDate":"2010-12","conditions":["Urinary Tract Infections"],"enrollment":217,"completionDate":"2012-07"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"route":"Intravenous","formulation":"Powder","formulations":[{"form":"POWDER, FOR SOLUTION","route":"INTRAVENOUS","productName":"AVYCAZ"}]},"_patentsChecked":true,"crossReferences":{"NUI":"N0000191549","MMSL":"30974","NDDF":"015925","UNII":"7352665165","VUID":"4034342","CHEBI":"CHEBI:85982","VANDF":"4034342","INN_ID":"8972","RXNORM":"1603833","UMLSCUI":"C3489748","chemblId":"CHEMBL1689063","ChEMBL_ID":"CHEMBL1689063","KEGG_DRUG":"D10340","DRUGBANK_ID":"DB09060","PDB_CHEM_ID":" FYG","PUBCHEM_CID":"9835049","SNOMEDCT_US":"1193767002","IUPHAR_LIGAND_ID":"10761","SECONDARY_CAS_RN":"396731-20-7","MESH_SUPPLEMENTAL_RECORD_UI":"C543519"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2015-","companyName":"Cerexa Inc","relationship":"Original Developer"}],"pharmacokinetics":{"source":"DrugCentral","halfLife":"1.7 hours","clearance":"2.76 mL/min/kg","fractionUnbound":"0.93%","volumeOfDistribution":"0.24 L/kg"},"publicationCount":3009,"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"originalDeveloper":"Cerexa Inc","recentPublications":[{"date":"2026 Mar 19","pmid":"41900863","title":"Accurate and Sensitive UHPLC-Tandem Mass Spectrometry Sequential Methods for Therapeutic Drug Monitoring of Aztreonam/Avibactam in Human Plasma.","journal":"Pharmaceutics"},{"date":"2026 Mar 5","pmid":"41892432","title":"Novel Insights into Carbapenem Resistance: Mechanisms, Diagnostics, and Future Directions.","journal":"Antibiotics (Basel, Switzerland)"},{"date":"2026 Mar 27","pmid":"41891866","title":"Comparative in vitro efficacy of aztreonam-avibactam and other alternatives (cefepime-taniborbactam, cefepime-zidebactam, and cefiderocol) against metallo-β-lactamase-producing Enterobacterales isolated in 2024 in France.","journal":"Antimicrobial agents and chemotherapy"},{"date":"2026 Mar 27","pmid":"41888278","title":"Ceftazidime-avibactam for multidrug and pandrug-resistant gram-negative infections in critically Ill children: a single-center pediatric ıntensive care experience.","journal":"European journal of pediatrics"},{"date":"2026 Mar 26","pmid":"41882581","title":"Prognostic factors for mortality in critically ill patients with infections caused by carbapenem-resistant gram-negative pathogens treated with ceftazidime-avibactam: a multicenter retrospective study.","journal":"BMC infectious diseases"}],"companionDiagnostics":[],"genericManufacturerList":[],"status":"approved","companyName":"Cerexa Inc","companyId":"cerexa-inc","modality":"Small molecule","firstApprovalDate":"2015","aiSummary":"","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"patentsNormalised":[{"patent_number":"7112592","territory":"US","patent_type":null,"expiry_date":"2026-01-07T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"7612087","territory":"US","patent_type":null,"expiry_date":"2026-11-12T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"8835455","territory":"US","patent_type":null,"expiry_date":"2030-10-08T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"8471025","territory":"US","patent_type":null,"expiry_date":"2031-08-12T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"9284314","territory":"US","patent_type":null,"expiry_date":"2032-06-15T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"8969566","territory":"US","patent_type":null,"expiry_date":"2032-06-15T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"9695122","territory":"US","patent_type":null,"expiry_date":"2032-06-15T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"trialStats":{"total":1,"withResults":0},"validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T02:05:16.782398+00:00","fieldsConflicting":1,"overallConfidence":0.8},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}