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Tygacil (TIGECYCLINE)
Tygacil works by binding to the 30S ribosomal subunit of bacteria, preventing the aminoacyl-tRNA from binding and thereby inhibiting protein synthesis.
At a glance
| Generic name | TIGECYCLINE |
|---|---|
| Sponsor | Fresenius Kabi |
| Drug class | Tetracycline-class Antibacterial [EPC] |
| Target | 30S ribosomal subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 2005 |
Mechanism of action
Tigecycline is tetracycline class antibacterial drug [see Microbiology (12.4)].
Approved indications
- Abdominal abscess
- Complicated Bacterial Peritonitis
- Complicated Skin and Skin Structure E. Coli Infection
- Complicated Skin and Skin Structure Enterococcus Faecalis Infection
- Complicated Skin and Skin Structure Infection
- Complicated Skin and Skin Structure Staphylococcus Aureus Infection
- Complicated Skin and Skin Structure Streptococcus Agalactiae Infection
- Complicated Skin and Skin Structure Streptococcus Pyogenes Infection
- Complicated appendicitis
- Haemophilus influenzae pneumonia
- Infectious disease of abdomen
- Legionella Pneumophila Pneumonia
- Pneumonia due to Streptococcus
Boxed warnings
- WARNING: ALL-CAUSE MORTALITY An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline for injection should be reserved for use in situations when alternative treatments are not suitable [see Indications and Usage ( 1.4 ), Warnings and Precautions (5.1, 5.2) and Adverse Reactions (6.1)]. WARNING: ALL-CAUSE MORTALITY See full prescribing information for complete boxed warning. All-cause mortality was higher in patients treated with tigecycline for injection than comparators in a meta-analysis of clinical trials. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established. Tigecycline for injection should be reserved for use in situations when alternative treatments are not suitable ( 1.4 , 5.1 , 5.2 , 6.1 ).
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Headache
- Increased SGPT
- Increased SGOT
- Phlebitis
- Dyspepsia
- Nervous System Dizziness
- Rash
- Pneumonia
Drug interactions
- Warfarin
- Calcineurin Inhibitors (e.g., tacrolimus, cyclosporine)
- Oral Contraceptives
Key clinical trials
- Intracalvariosseous Plus Intravenous Antibiotics for Moderate-to-Severe Bacterial Meningitis (NA)
- Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial (PHASE2)
- Efficacy of Taurolidine Containing Lock Solution for Prevention of Central Venous Catheter Infection in ICU Patients (NA)
- The Efficacy and Adverse Reactions of Neotetracycline in the Treatment of GNB Infections
- Clinical Effectiveness of a Once-daily Regimen of Tigecycline Compared to the Standard Regimen (PHASE4)
- Comparing Oral Versus Parenteral Antimicrobial Therapy (PHASE4)
- Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (PHASE2,PHASE3)
- Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tygacil CI brief — competitive landscape report
- Tygacil updates RSS · CI watch RSS
- Fresenius Kabi portfolio CI