{"id":"cytarabine","rwe":[{"pmid":"41904192","year":"2026","title":"Zanubrutinib-rituximab followed by shortened chemoimmunotherapy as frontline treatment for mantle cell lymphoma (CHESS): a phase II trial.","finding":"","journal":"Nature communications","studyType":"Clinical Study"},{"pmid":"41899441","year":"2026","title":"MSTN and TCF12 as Candidate Immunometabolic Signatures in Glioma-Associated Foam Cells: Insights from Integrated Multi-Omics Analysis.","finding":"","journal":"Current issues in molecular biology","studyType":"Clinical Study"},{"pmid":"41895776","year":"2026","title":"Tenofovir Alafenamide Promotes Differentiation and Induces Apoptosis of AML Cells by Inhibiting Telomerase Reverse Transcriptase.","finding":"","journal":"Anticancer research","studyType":"Clinical Study"},{"pmid":"41892363","year":"2026","title":"Epigenetic Activity of Cancer Therapy Drugs Revealed by HeLa TI Cell-Based Assay.","finding":"","journal":"Epigenomes","studyType":"Clinical Study"},{"pmid":"41890705","year":"2026","title":"Survival after intensive therapy or clofarabine in fit older adults with acute myeloid leukemia: E2906 phase 3 trial.","finding":"","journal":"Blood neoplasia","studyType":"Clinical Study"}],"_fda":{"id":"038a9b4b-a951-4c8c-be74-00a4a64eedd1","set_id":"1be2668b-d76f-4c65-aea9-86c5c40889a2","openfda":{"nui":["N0000000233","N0000175595"],"unii":["04079A1RDZ"],"route":["INTRAVENOUS","SUBCUTANEOUS"],"rxcui":["240416"],"spl_id":["038a9b4b-a951-4c8c-be74-00a4a64eedd1"],"brand_name":["Cytarabine"],"spl_set_id":["1be2668b-d76f-4c65-aea9-86c5c40889a2"],"package_ndc":["71288-168-50"],"product_ndc":["71288-168"],"generic_name":["CYTARABINE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["CYTARABINE"],"pharm_class_epc":["Nucleoside Metabolic Inhibitor [EPC]"],"pharm_class_moa":["Nucleic Acid Synthesis Inhibitors [MoA]"],"manufacturer_name":["Meitheal Pharmaceuticals Inc."],"application_number":["ANDA206190"],"is_original_packager":[true]},"version":"3","warnings":["WARNINGS ( See boxed WARNING ) Cytarabine is a potent bone marrow suppressant. Therapy should be started cautiously in patients with pre-existing drug-induced bone marrow suppression. Patients receiving this drug must be under close medical supervision and, during induction therapy, should have leucocyte and platelet counts performed daily. Bone marrow examinations should be performed frequently after blasts have disappeared from the peripheral blood. Facilities should be available for management of complications, possibly fatal, of bone marrow suppression (infection resulting from granulocytopenia and other impaired body defenses, and hemorrhage secondary to thrombocytopenia). One case of anaphylaxis that resulted in acute cardiopulmonary arrest and required resuscitation has been reported. This occurred immediately after the intravenous administration of cytarabine. Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of cytarabine) has been reported following some experimental cytarabine dose schedules. These reactions include reversible corneal toxicity, and hemorrhagic conjunctivitis, which may be prevented or diminished by prophylaxis with a local corticosteroid eye drop; cerebral and cerebellar dysfunction, including personality changes, somnolence and coma, usually reversible; severe gastrointestinal ulceration, including pneumatosis cystoides intestinalis leading to peritonitis; sepsis and liver abscess; pulmonary edema, liver damage with increased hyperbilirubinemia; bowel necrosis; and necrotizing colitis. Rarely, severe skin rash, leading to desquamation has been reported. Complete alopecia is more commonly seen with experimental high dose therapy than with standard cytarabine treatment programs. If experimental high dose therapy is used, do not use a diluent containing benzyl alcohol. Cases of cardiomyopathy with subsequent death has been reported following experimental high dose therapy with cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation. A syndrome of sudden respiratory distress, rapidly progressing to pulmonary edema and radiographically pronounced cardiomegaly has been reported following experimental high dose therapy with cytarabine used for the treatment of relapsed leukemia from one institution in 16/72 patients. The outcome of this syndrome can be fatal. Two patients with childhood acute myelogenous leukemia who received intrathecal and intravenous cytarabine at conventional doses (in addition to a number of other concomitantly administered drugs) developed delayed progressive ascending paralysis resulting in death in one of the two patients. Use in Pregnancy Cytarabine can cause fetal harm when administered to a pregnant woman. Cytarabine causes abnormal cerebellar development in the neonatal hamster and is teratogenic to the rat fetus. There are no adequate and well-controlled studies in pregnant women. Women of childbearing potential should be advised to avoid becoming pregnant."],"pregnancy":["Pregnancy See WARNINGS . A review of the literature has shown 32 reported cases where cytarabine was given during pregnancy, either alone or in combination with other cytotoxic agents. Eighteen normal infants were delivered. Four of these had first trimester exposure. Five infants were premature or of low birth weight. Twelve of the 18 normal infants were followed up at ages ranging from six weeks to seven years, and showed no abnormalities. One apparently normal infant died at 90 days of gastroenteritis. Two cases of congenital abnormalities have been reported, one with upper and lower distal limb defects, and the other with extremity and ear deformities. Both of these cases had first trimester exposure. There were seven infants with various problems in the neonatal period, including pancytopenia; transient depression of the WBC, hematocrit or platelets; electrolyte abnormalities; transient eosinophilia; and one case of increased IgM levels and hyperpyrexia possibly due to sepsis. Six of the seven infants were also premature. The child with pancytopenia died at 21 days of sepsis. Therapeutic abortions were done in five cases. Four fetuses were grossly normal, but one had an enlarged spleen and another showed Trisomy C chromosome abnormality in the chorionic tissue. Because of the potential for abnormalities with cytotoxic therapy, particularly during the first trimester, a patient who is or who may become pregnant while on cytarabine should be apprised of the potential risk to the fetus and the advisability of pregnancy continuation. There is a definite, but considerably reduced risk if therapy is initiated during the second or third trimester. Although normal infants have been delivered to patients treated in all three trimesters of pregnancy, follow-up of such infants would be advisable."],"overdosage":["OVERDOSAGE There is no antidote for cytarabine overdosage. Doses of 4.5 g/m 2 by intravenous infusion over 1 hour every 12 hours for 12 doses has caused an unacceptable increase in irreversible CNS toxicity and death. Single doses as high as 3 g/m 2 have been administered by rapid intravenous infusion without apparent toxicity."],"references":["REFERENCES Recommendations for the Safe handling of Parenteral Antineoplastic Drugs, NIH Publications No. 83-2621. For sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402. AMA Council Report, Guidelines for Handling Parenteral Antineoplastics, JAMA, 1985; 2.53 (11): 1590-1592. National Study Commission on Cytotoxic Exposure - Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115. Clinical Oncological Society of Australia, Guidelines and Recommendations for Safe handling of Antineoplastic Agents. Med J Australia, 1983; 1:426-428. Jones RB, et al: Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer Journal of Clinicians, 1983; (Sept/Oct) 258-263. American Society of Hospital Pharmacists Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. Am J. Hosp. Pharm, 1990; 47:1033-1049. Controlling Occupational Exposure to Hazardous Drugs. (OSHA Work Practice Guidelines), Am J. Health- Syst Pharm, 1996; 53: 1669-1685. meitheal ® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2021 Meitheal Pharmaceuticals Inc. Mfd. by Kindos Pharmaceuticals Co., Ltd. Chengdu, China 611731 Revised: August 2021"],"description":["DESCRIPTION Cytarabine Injection, an antineoplastic, is a sterile isotonic solution for intravenous and subcutaneous use, which contains no preservative and is available in 20 mg per mL (1,000 mg per 50 mL) Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. Each mL contains 20 mg Cytarabine, USP and the following inactive ingredients: sodium chloride 0.68% and Water for Injection q.s. When necessary, the pH is adjusted with hydrochloric acid and/or sodium hydroxide to a target pH of 7.4. Each bottle contains approximately 5.82 mEq sodium. Cytarabine is chemically 4-amino-1-β-D-arabinofuranosyl-2(1H)-pyrimidinone. The structural formula is: Cytarabine is an odorless, white to off-white, crystalline powder which is freely soluble in water and slightly soluble in alcohol and in chloroform. structural formula"],"precautions":["PRECAUTIONS General Precautions Patients receiving cytarabine must be monitored closely. Frequent platelet and leukocyte counts and bone marrow examinations are mandatory. Consider suspending or modifying therapy when drug-induced marrow depression has resulted in a platelet count under 50,000 or a polymorphonuclear granulocyte count under 1,000/mm 3 . Counts of formed elements in the peripheral blood may continue to fall after the drug is stopped and reach lowest values after drug-free intervals of 12 to 24 days. When indicated, restart therapy when definite signs of marrow recovery appear (on successive bone marrow studies). Patients whose drug is withheld until “normal” peripheral blood values are attained may escape from control. When large intravenous doses are given quickly, patients are frequently nauseated and may vomit for several hours post-injection. This problem tends to be less severe when the drug is infused. The human liver apparently detoxifies a substantial fraction of an administered dose. In particular, patients with renal or hepatic function impairment may have a higher likelihood of CNS toxicity after high-dose cytarabine treatment. Use the drug with caution and possibly at reduced dose in patients whose liver or kidney function is poor. Periodic checks of bone marrow, liver and kidney functions should be performed in patients receiving cytarabine. Like other cytotoxic drugs, cytarabine may induce hyperuricemia secondary to rapid lysis of neoplastic cells. The clinician should monitor the patient's blood uric acid level and be prepared to use such supportive and pharmacologic measures as might be necessary to control this problem. Acute pancreatitis has been reported to occur in a patient receiving cytarabine by continuous infusion and in patients being treated with cytarabine who have had prior treatment with L-asparaginase. Information for patient Not applicable. Laboratory tests See General Precautions . Drug Interactions Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without cytarabine or procarbazine. Steady-state plasma digitoxin concentrations did not appear to change. Therefore, monitoring of plasma digoxin levels may be indicated in patients receiving similar combination chemotherapy regimens. The utilization of digitoxin for such patients may be considered as an alternative. An in vitro interaction study between gentamicin and cytarabine showed a cytarabine related antagonism for the susceptibility of K. pneumoniae strains. This study suggests that in patients on cytarabine being treated with gentamicin for a K. pneumoniae infection, the lack of a prompt therapeutic response may indicate the need for reevaluation of antibacterial therapy. Clinical evidence in one patient showed possible inhibition of fluorocytosine efficacy during therapy with cytarabine. This may be due to potential competitive inhibition of its uptake. Carcinogenesis, mutagenesis, impairment of fertility Extensive chromosomal damage, including chromatoid breaks have been produced by cytarabine and malignant transformation of rodent cells in culture has been reported. Pregnancy See WARNINGS . A review of the literature has shown 32 reported cases where cytarabine was given during pregnancy, either alone or in combination with other cytotoxic agents. Eighteen normal infants were delivered. Four of these had first trimester exposure. Five infants were premature or of low birth weight. Twelve of the 18 normal infants were followed up at ages ranging from six weeks to seven years, and showed no abnormalities. One apparently normal infant died at 90 days of gastroenteritis. Two cases of congenital abnormalities have been reported, one with upper and lower distal limb defects, and the other with extremity and ear deformities. Both of these cases had first trimester exposure. There were seven infants with various problems in the neonatal period, including pancytopenia; transient depression of the WBC, hematocrit or platelets; electrolyte abnormalities; transient eosinophilia; and one case of increased IgM levels and hyperpyrexia possibly due to sepsis. Six of the seven infants were also premature. The child with pancytopenia died at 21 days of sepsis. Therapeutic abortions were done in five cases. Four fetuses were grossly normal, but one had an enlarged spleen and another showed Trisomy C chromosome abnormality in the chorionic tissue. Because of the potential for abnormalities with cytotoxic therapy, particularly during the first trimester, a patient who is or who may become pregnant while on cytarabine should be apprised of the potential risk to the fetus and the advisability of pregnancy continuation. There is a definite, but considerably reduced risk if therapy is initiated during the second or third trimester. Although normal infants have been delivered to patients treated in all three trimesters of pregnancy, follow-up of such infants would be advisable. Labor and delivery Not applicable. Nursing mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cytarabine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric use See INDICATIONS AND USAGE ."],"how_supplied":["HOW SUPPLIED Cytarabine Injection is available in a Pharmacy Bulk Package supplied as follows: NDC Cytarabine Injection (20 mg per mL) Package Factor 71288- 168 -50 1,000 mg per 50 mL Pharmacy Bulk Bottle 1 bottle per carton Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Isotonic Solution Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex."],"boxed_warning":["WARNING Only physicians experienced in cancer chemotherapy should use cytarabine. For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction. The physician must judge possible benefit to the patient against known toxic effects of this drug in considering the advisability of therapy with cytarabine. Before making this judgment or beginning treatment, the physician should be familiar with the following text."],"pediatric_use":["Pediatric use See INDICATIONS AND USAGE ."],"effective_time":"20220706","nursing_mothers":["Nursing mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from cytarabine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother."],"laboratory_tests":["Laboratory tests See General Precautions ."],"adverse_reactions":["ADVERSE REACTIONS Expected Reactions Because cytarabine is a bone marrow suppressant, anemia, leukopenia, thrombocytopenia, megaloblastosis and reduced reticulocytes can be expected as a result of administration with cytarabine. The severity of these reactions are dose and schedule dependent. Cellular changes in the morphology of bone marrow and peripheral smears can be expected. Following 5-day constant infusions or acute injections of 50 mg/m 2 to 600 mg/m 2 , white cell depression follows a biphasic course. Regardless of initial count, dosage level, or schedule, there is an initial fall starting the first 24 hours with a nadir at days 7 to 9. This is followed by a brief rise which peaks around the twelfth day. A second and deeper fall reaches nadir at days 15 to 24. Then there is a rapid rise to above baseline in the next 10 days. Platelet depression is noticeable at 5 days with a peak depression occurring between days 12 to 15. Thereupon, a rapid rise to above baseline occurs in the next 10 days. Infectious Complications Infection Viral, bacterial, fungal, parasitic, or saprophytic infections, in any location in the body may be associated with the use of cytarabine alone or in combination with other immunosuppressive agents following immunosuppressant doses that affect cellular or humoral immunity. These infections may be mild, but can be severe and at times fatal. The Cytarabine (Ara-C) Syndrome A cytarabine syndrome has been described by Castleberry. It is characterized by fever, myalgia, bone pain, occasionally chest pain, maculopapular rash, conjunctivitis and malaise. It usually occurs 6 to 12 hours following drug administration. Corticosteroids have been shown to be beneficial in treating or preventing this syndrome. If the symptoms of the syndrome are deemed treatable, corticosteroids should be contemplated as well as continuation of therapy with cytarabine. Most Frequent Adverse Reactions Anorexia, hepatic dysfunction, nausea, fever, vomiting, rash, diarrhea, thrombophlebitis, oral and anal inflammation or ulceration, bleeding (all sites). Nausea and vomiting are most frequent following rapid intravenous injection. Less Frequent Adverse Reactions Sepsis, abdominal pain, pneumonia, freckling, cellulitis at injection site, jaundice, skin ulceration, conjunctivitis (may occur with rash), urinary retention, dizziness, renal dysfunction, alopecia, neuritis, anaphylaxis (see WARNINGS ), neural toxicity, allergic edema, sore throat, pruritus, esophageal ulceration, shortness of breath, esophagitis, urticaria, chest pain, pericarditis, headache, bowel necrosis, pancreatitis, sinus bradycardia. Experimental Doses Severe and at times fatal CNS, GI and pulmonary toxicity (different from that seen with conventional therapy regimens of cytarabine) has been reported following some experimental dose schedules of cytarabine. These reactions include reversible corneal toxicity and hemorrhagic conjunctivitis, which may be prevented or diminished by prophylaxis with a local corticosteroid eye drop; cerebral and cerebellar dysfunction, including personality changes, somnolence and coma, usually reversible; severe gastrointestinal ulceration, including pneumatosis cystoides intestinalis leading to peritonitis; sepsis and liver abscess; pulmonary edema, liver damage with increased hyperbilirubinemia; bowel necrosis; and necrotizing colitis. Rarely, severe skin rash, leading to desquamation has been reported. Complete alopecia is more commonly seen with experimental high dose therapy than with standard cytarabine treatment programs. If experimental high dose therapy is used, do not use a diluent containing benzyl alcohol. Cases of cardiomyopathy with subsequent death has been reported following experimental high dose therapy with cytarabine in combination with cyclophosphamide when used for bone marrow transplant preparation. This cardiac toxicity may be schedule dependent. A syndrome of sudden respiratory distress, rapidly progressing to pulmonary edema and radiographically pronounced cardiomegaly has been reported following experimental high dose therapy with cytarabine used for the treatment of relapsed leukemia from one institution in 16/72 patients. The outcome of this syndrome can be fatal. Two patients with adult acute non-lymphocytic leukemia developed peripheral motor and sensory neuropathies after consolidation with high-dose cytarabine, daunorubicin, and asparaginase. Patients treated with high-dose cytarabine should be observed for neuropathy since dose schedule alterations may be needed to avoid irreversible neurologic disorders. Ten patients treated with experimental intermediate doses of cytarabine (1 g/m 2 ) with and without other chemotherapeutic agents (meta-AMSA, daunorubicin, etoposide) at various dose regimens developed a diffuse interstitial pneumonitis without clear cause that may have been related to the cytarabine. Two cases of pancreatitis have been reported following experimental doses of cytarabine and numerous other drugs. Cytarabine could have been the causative agent. To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ."],"contraindications":["CONTRAINDICATIONS Cytarabine is contraindicated in those patients who are hypersensitive to the drug."],"drug_interactions":["Drug Interactions Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion were observed in patients receiving beta-acetyldigoxin and chemotherapy regimens containing cyclophosphamide, vincristine and prednisone with or without cytarabine or procarbazine. Steady-state plasma digitoxin concentrations did not appear to change. Therefore, monitoring of plasma digoxin levels may be indicated in patients receiving similar combination chemotherapy regimens. The utilization of digitoxin for such patients may be considered as an alternative. An in vitro interaction study between gentamicin and cytarabine showed a cytarabine related antagonism for the susceptibility of K. pneumoniae strains. This study suggests that in patients on cytarabine being treated with gentamicin for a K. pneumoniae infection, the lack of a prompt therapeutic response may indicate the need for reevaluation of antibacterial therapy. Clinical evidence in one patient showed possible inhibition of fluorocytosine efficacy during therapy with cytarabine. This may be due to potential competitive inhibition of its uptake."],"how_supplied_table":["<table width=\"100%\" styleCode=\"Noautorules\"><col width=\"25.000%\" align=\"left\"/><col width=\"50.000%\" align=\"left\"/><col width=\"25.000%\" align=\"left\"/><tbody><tr><td align=\"justify\" valign=\"top\"><content styleCode=\"bold\">NDC</content></td><td align=\"justify\" valign=\"top\"><content styleCode=\"bold\">Cytarabine Injection (20 mg per mL)</content></td><td align=\"justify\" valign=\"top\"><content styleCode=\"bold\">Package Factor</content></td></tr><tr><td align=\"justify\" valign=\"top\">71288-<content styleCode=\"bold\">168</content>-50 </td><td align=\"justify\" valign=\"top\">1,000 mg per 50 mL Pharmacy Bulk Bottle </td><td align=\"justify\" valign=\"top\">1 bottle per carton </td></tr></tbody></table>"],"labor_and_delivery":["Labor and delivery Not applicable."],"general_precautions":["General Precautions Patients receiving cytarabine must be monitored closely. Frequent platelet and leukocyte counts and bone marrow examinations are mandatory. Consider suspending or modifying therapy when drug-induced marrow depression has resulted in a platelet count under 50,000 or a polymorphonuclear granulocyte count under 1,000/mm 3 . Counts of formed elements in the peripheral blood may continue to fall after the drug is stopped and reach lowest values after drug-free intervals of 12 to 24 days. When indicated, restart therapy when definite signs of marrow recovery appear (on successive bone marrow studies). Patients whose drug is withheld until “normal” peripheral blood values are attained may escape from control. When large intravenous doses are given quickly, patients are frequently nauseated and may vomit for several hours post-injection. This problem tends to be less severe when the drug is infused. The human liver apparently detoxifies a substantial fraction of an administered dose. In particular, patients with renal or hepatic function impairment may have a higher likelihood of CNS toxicity after high-dose cytarabine treatment. Use the drug with caution and possibly at reduced dose in patients whose liver or kidney function is poor. Periodic checks of bone marrow, liver and kidney functions should be performed in patients receiving cytarabine. Like other cytotoxic drugs, cytarabine may induce hyperuricemia secondary to rapid lysis of neoplastic cells. The clinician should monitor the patient's blood uric acid level and be prepared to use such supportive and pharmacologic measures as might be necessary to control this problem. Acute pancreatitis has been reported to occur in a patient receiving cytarabine by continuous infusion and in patients being treated with cytarabine who have had prior treatment with L-asparaginase."],"storage_and_handling":["Storage Conditions Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] Protect from light. Retain in carton until time of use. Isotonic Solution Sterile, Nonpyrogenic, Preservative-free. The container closure is not made with natural rubber latex."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Cell Culture Studies Cytarabine is cytotoxic to a wide variety of proliferating mammalian cells in culture. It exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S-phase) and under certain conditions blocking the progression of cells from the G 1 phase to the S-phase. Although the mechanism of action is not completely understood, it appears that cytarabine acts through the inhibition of DNA polymerase. A limited, but significant, incorporation of cytarabine into both DNA and RNA has also been reported. Extensive chromosomal damage, including chromatoid breaks, have been produced by cytarabine and malignant transformation of rodent cells in culture has been reported. Deoxycytidine prevents or delays (but does not reverse) the cytotoxic activity. Cellular Resistance and Sensitivity Cytarabine is metabolized by deoxycytidine kinase and other nucleotide kinases to the nucleotide triphosphate, an effective inhibitor of DNA polymerase; it is inactivated by a pyrimidine nucleoside deaminase which converts it to the nontoxic uracil derivative. It appears that the balance of kinase and deaminase levels may be an important factor in determining sensitivity or resistance of the cell to cytarabine. Human Pharmacology Cytarabine is rapidly metabolized and is not effective orally; less than 20 percent of the orally administered dose is absorbed from the gastrointestinal tract. Following rapid intravenous injection of cytarabine, labeled with tritium, the disappearance from plasma is biphasic. There is an initial distributive phase with a half-life of about 10 minutes, followed by a second elimination phase with a half-life of about 1 to 3 hours. After the distributive phase, more than 80 percent of plasma radioactivity can be accounted for by the inactive metabolite 1-β-D-arabinofuranosyluracil (ara-U). Within 24 hours about 80 percent of the administered radioactivity can be recovered in the urine, approximately 90 percent of which is excreted as ara-U. Relatively constant plasma levels can be achieved by continuous intravenous infusion. After subcutaneous or intramuscular administration of cytarabine labeled with tritium, peak-plasma levels of radioactivity are achieved about 20 to 60 minutes after injection and are considerably lower than those after intravenous administration. Cerebrospinal fluid levels of cytarabine are low in comparison to plasma levels after single intravenous injection. However, in one patient in whom cerebrospinal levels were examined after 2 hours of constant intravenous infusion, levels approached 40 percent of the steady state plasma level. With intrathecal administration, levels of cytarabine in the cerebrospinal fluid declined with a first order half-life of about 2 hours. Because cerebrospinal fluid levels of deaminase are low, little conversion to ara-U was observed. Immunosuppressive Action Cytarabine is capable of obliterating immune responses in man during administration with little or no accompanying toxicity. Suppression of antibody responses to E. coli-VI antigen and tetanus toxoid have been demonstrated. This suppression was obtained during both primary and secondary antibody responses. Cytarabine also suppressed the development of cell-mediated responses such as delayed hypersensitivity skin reaction to dinitrochlorobenzene. However, it had no effect on already established delayed hypersensitivity reactions. Following 5-day courses of intensive therapy with cytarabine, the immune response was suppressed, as indicated by the following parameters: macrophage ingress into skin windows; circulating antibody response following primary antigenic stimulation; lymphocyte blastogenesis with phytohemagglutinin. A few days after termination of therapy there was a rapid return to normal."],"indications_and_usage":["INDICATIONS AND USAGE Cytarabine Injection in combination with other approved anticancer drugs is indicated for remission induction in acute non-lymphocytic leukemia of adults and children. It has also been found useful in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. Intrathecal administration of Cytarabine Injection is indicated in the prophylaxis and treatment of meningeal leukemia."],"information_for_patients":["Information for patient Not applicable."],"spl_unclassified_section":["meitheal ® PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Rx only"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Cytarabine injection (non-preserved) can be administered by intravenous injection or infusion, subcutaneously, or intrathecally. However, the intent of this Pharmacy Bulk Package is for the preparation of solutions for intravenous infusion only. Intrathecal use of cytarabine injection requires the use of single-dose, unpreserved solutions only. Cytarabine injection is not active orally. The schedule and method of administration varies with the program of therapy to be used. While cytarabine injection may be given by intravenous infusion or injection, or subcutaneously or intrathecally, THE PURPOSE OF THE PHARMACY BULK PACKAGE IS FOR THE PREPARATION OF INTRAVENOUS INFUSIONS. Thrombophlebitis has occurred at the site of drug injection or infusion in some patients, and rarely patients have noted pain and inflammation at subcutaneous injection sites. In most instances, however, the drug has been well tolerated. Patients can tolerate higher total doses when they receive the drug by rapid intravenous injection as compared with slow infusion. This phenomenon is related to the drug's rapid inactivation and brief exposure of susceptible normal and neoplastic cells to significant levels after rapid injection. Normal and neoplastic cells seem to respond in somewhat parallel fashion to these different modes of administration and no clear-cut clinical advantage has been demonstrated for either. In the induction therapy of acute non-lymphocytic leukemia, the usual cytarabine injection dose in combination with other anti-cancer drugs is 100 mg/m 2 /day by continuous intravenous infusion (Days 1 to 7) or 100 mg/m 2 intravenously every 12 hours (Days 1 to 7). The literature should be consulted for the current recommendations for use in acute lymphocytic leukemia. Intrathecal Use in Meningeal Leukemia Cytarabine injection has been used intrathecally in acute leukemia in doses ranging from 5 mg/m 2 to 75 mg/m 2 of body surface area. The frequency of administration varied from once a day for 4 days to once every 4 days. The most frequently used dose was 30 mg/m 2 every 4 days until cerebrospinal fluid findings were normal, followed by one additional treatment. The dosage schedule is usually governed by the type and severity of central nervous system manifestations and the response to previous therapy. If used intrathecally, do not use a solution containing benzyl alcohol. This pharmacy bulk package is not intended to be used for the preparation of intrathecal doses. Cytarabine injection given intrathecally may cause systemic toxicity and careful monitoring of the hemopoietic system is indicated. Modification of other anti-leukemia therapy may be necessary. Major toxicity is rare. The most frequently reported reactions after intrathecal administration were nausea, vomiting and fever; these reactions are mild and self-limiting. Paraplegia has been reported. Necrotizing leukoencephalopathy occurred in 5 children; these patients had also been treated with intrathecal methotrexate and hydrocortisone, as well as by central nervous system radiation. Isolated neurotoxicity has been reported. Blindness occurred in two patients in remission whose treatment had consisted of combination systemic chemotherapy, prophylactic central nervous system radiation and intrathecal cytarabine injection. When cytarabine injection is administered both intrathecally and intravenously within a few days, there is an increased risk of spinal cord toxicity, however, in serious life-threatening disease, concurrent use of intravenous and intrathecal cytarabine injection is left to the discretion of the treating physician. Focal leukemic involvement of the central nervous system may not respond to intrathecal cytarabine injection and may better be treated with radiotherapy. Chemical Stability of Infusion Solutions Chemical stability studies were performed by a stability indicating HPLC assay on cytarabine injection in infusion solutions. These studies showed that when cytarabine injection was diluted with Water for Injection, 5% Dextrose Injection or Sodium Chloride Injection, in both glass and plastic infusion bags, 97 to 100% of the cytarabine was present after 8 days storage at room temperature. This chemical stability information in no way indicates that it would be acceptable practice to infuse a cytarabine injection admixture well after the preparation time. Good professional practice suggests that administration of an admixture should be as soon after preparation as feasible. Parenteral drugs should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Handling and Disposal Procedures for proper handling and disposal of anti-cancer drugs should be considered. Several guidelines on this subject have been published. 1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Direction for Dispensing From Pharmacy Bulk Package The 50 mL Pharmacy Bulk Package is for use in the Pharmacy Admixtures Service only. A single entry through the bottle closure should be made with a sterile dispensing set or transfer device. Transfer individual doses to appropriate intravenous infusion solutions. Use of a syringe with needle is not recommended. Multiple entries will increase the potential of microbial and particulate contamination. The above process should be carried out under a laminar flow hood using aseptic technique. Care should be exercised to protect personnel from aerosolized drug (see DOSAGE AND ADMINISTRATION , REFERENCES ). Discard any unused portion within 4 hours after initial closure entry."],"spl_product_data_elements":["Cytarabine Cytarabine cytarabine cytarabine sodium hydroxide hydrochloric acid water sodium chloride"],"spl_unclassified_section_table":["<table width=\"100%\"><colgroup><col width=\"100.000%\" align=\"left\"/></colgroup><tbody><tr styleCode=\"First Last\"><td styleCode=\"Botrule Lrule Rrule Toprule\" align=\"center\" valign=\"top\"><content styleCode=\"bold\">PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION</content></td></tr></tbody></table>"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL – Cytarabine Injection, 50 mL Bottle Label Caution: Cytotoxic Agent NDC 71288- 168 -50 Cytarabine Injection 1,000 mg per 50 mL (20 mg per mL) PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION Rx only 50 mL Bottle For Intravenous and Subcutaneous Use* 50 mL bottle label","PRINCIPAL DISPLAY PANEL – Cytarabine Injection, 50 mL Carton NDC 71288- 168 -50 1 x 50 mL Bottle Rx only Cytarabine Injection 1,000 mg per 50 mL (20 mg per mL) PHARMACY BULK PACKAGE NOT FOR DIRECT INFUSION For Intravenous and Subcutaneous Use* Caution: Cytotoxic Agent 50 mL carton"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, mutagenesis, impairment of fertility Extensive chromosomal damage, including chromatoid breaks have been produced by cytarabine and malignant transformation of rodent cells in culture has been reported."]},"tags":[{"label":"Nucleoside Metabolic Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"E3 ubiquitin-protein ligase Mdm2","category":"target"},{"label":"MDM2","category":"gene"},{"label":"ACPP","category":"gene"},{"label":"POLA1","category":"gene"},{"label":"L01BC01","category":"atc"},{"label":"Intrathecal","category":"route"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Acute lymphoid leukemia","category":"indication"},{"label":"Acute myeloid leukemia, disease","category":"indication"},{"label":"Acute promyelocytic leukemia, FAB M3","category":"indication"},{"label":"Lymphomatous meningitis","category":"indication"},{"label":"Meningeal Leukemia","category":"indication"},{"label":"Nippon Shinyaku Co., Ltd.","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antimetabolites","category":"pharmacology"},{"label":"Antimetabolites, Antineoplastic","category":"pharmacology"},{"label":"Antineoplastic Agents","category":"pharmacology"},{"label":"Antiviral Agents","category":"pharmacology"},{"label":"Immunologic Factors","category":"pharmacology"},{"label":"Immunosuppressive Agents","category":"pharmacology"},{"label":"Noxae","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":["WARNING Only physicians experienced in cancer chemotherapy should use cytarabine. For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepatic dysfunction. The physician must judge possible benefit to the patient against known toxic effects of this drug in considering the advisability of therapy with cytarabine. Before making this judgment or beginning treatment, the physician should be familiar with the following text."],"safetySignals":[{"date":"","signal":"FEBRILE NEUTROPENIA","source":"FDA FAERS","actionTaken":"7751 reports"},{"date":"","signal":"OFF LABEL USE","source":"FDA FAERS","actionTaken":"4982 reports"},{"date":"","signal":"PYREXIA","source":"FDA FAERS","actionTaken":"4161 reports"},{"date":"","signal":"NEUTROPENIA","source":"FDA FAERS","actionTaken":"3616 reports"},{"date":"","signal":"DRUG INEFFECTIVE","source":"FDA FAERS","actionTaken":"3118 reports"},{"date":"","signal":"SEPSIS","source":"FDA FAERS","actionTaken":"3020 reports"},{"date":"","signal":"THROMBOCYTOPENIA","source":"FDA FAERS","actionTaken":"2881 reports"},{"date":"","signal":"DISEASE PROGRESSION","source":"FDA FAERS","actionTaken":"2769 reports"},{"date":"","signal":"PNEUMONIA","source":"FDA FAERS","actionTaken":"2375 reports"},{"date":"","signal":"DEATH","source":"FDA FAERS","actionTaken":"2135 reports"}],"drugInteractions":[{"drug":"Beta-acetyldigoxin","severity":"Moderate","mechanism":"Chemotherapy regimen interaction","management":"Monitoring of plasma digoxin levels may be indicated; consider digitoxin as alternative","clinicalEffect":"Reversible decreases in steady-state plasma digoxin concentrations and renal glycoside excretion"},{"drug":"Gentamicin","severity":"Moderate","mechanism":"Cytarabine-related antagonism","management":"Reevaluation of antibacterial therapy may be needed","clinicalEffect":"Reduced susceptibility of K. pneumoniae strains; lack of prompt therapeutic response"},{"drug":"Fluorocytosine","severity":"Moderate","mechanism":"Potential competitive inhibition of fluorocytosine uptake","management":"Monitor therapeutic response during concurrent therapy","clinicalEffect":"Possible inhibition of fluorocytosine efficacy"}],"commonSideEffects":[{"effect":"Febrile Neutropenia","drugRate":"60.0%","organSystem":"Blood and lymphatic system disorders","placeboRate":"","totalAtRisk":180,"totalAffected":108,"trialsReporting":2},{"effect":"Nausea","drugRate":"47.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":183,"totalAffected":86,"trialsReporting":3},{"effect":"Diarrhoea","drugRate":"41.0%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":183,"totalAffected":75,"trialsReporting":3},{"effect":"Constipation","drugRate":"37.2%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":183,"totalAffected":68,"trialsReporting":3},{"effect":"Oedema Peripheral","drugRate":"34.4%","organSystem":"General disorders","placeboRate":"","totalAtRisk":180,"totalAffected":62,"trialsReporting":2},{"effect":"Cough","drugRate":"31.1%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":183,"totalAffected":57,"trialsReporting":3},{"effect":"Headache","drugRate":"30.6%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":183,"totalAffected":56,"trialsReporting":3},{"effect":"Fatigue","drugRate":"30.6%","organSystem":"General disorders","placeboRate":"","totalAtRisk":180,"totalAffected":55,"trialsReporting":2},{"effect":"Epistaxis","drugRate":"29.5%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":183,"totalAffected":54,"trialsReporting":3},{"effect":"Decreased Appetite","drugRate":"28.3%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":180,"totalAffected":51,"trialsReporting":2},{"effect":"Vomiting","drugRate":"25.1%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":183,"totalAffected":46,"trialsReporting":3},{"effect":"Rash","drugRate":"24.6%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":183,"totalAffected":45,"trialsReporting":3},{"effect":"Pyrexia","drugRate":"24.0%","organSystem":"General disorders","placeboRate":"","totalAtRisk":183,"totalAffected":44,"trialsReporting":3},{"effect":"Chills","drugRate":"22.8%","organSystem":"General disorders","placeboRate":"","totalAtRisk":180,"totalAffected":41,"trialsReporting":2},{"effect":"Abdominal Pain","drugRate":"21.7%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":180,"totalAffected":39,"trialsReporting":2},{"effect":"Insomnia","drugRate":"19.7%","organSystem":"Psychiatric disorders","placeboRate":"","totalAtRisk":183,"totalAffected":36,"trialsReporting":3},{"effect":"Dyspnoea","drugRate":"19.7%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":183,"totalAffected":36,"trialsReporting":3},{"effect":"Dizziness","drugRate":"18.0%","organSystem":"Nervous system disorders","placeboRate":"","totalAtRisk":183,"totalAffected":33,"trialsReporting":3},{"effect":"Hypotension","drugRate":"17.2%","organSystem":"Vascular disorders","placeboRate":"","totalAtRisk":180,"totalAffected":31,"trialsReporting":2},{"effect":"Pneumonia","drugRate":"19.2%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":156,"totalAffected":30,"trialsReporting":2},{"effect":"Hypoxia","drugRate":"16.7%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":180,"totalAffected":30,"trialsReporting":2},{"effect":"Oropharyngeal Pain","drugRate":"16.7%","organSystem":"Respiratory, thoracic and mediastinal disorders","placeboRate":"","totalAtRisk":180,"totalAffected":30,"trialsReporting":2},{"effect":"Hypertension","drugRate":"15.8%","organSystem":"Vascular disorders","placeboRate":"","totalAtRisk":183,"totalAffected":29,"trialsReporting":3},{"effect":"Mucosal Inflammation","drugRate":"18.3%","organSystem":"General disorders","placeboRate":"","totalAtRisk":153,"totalAffected":28,"trialsReporting":1},{"effect":"Pleural 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disorders","placeboRate":"","totalAtRisk":153,"totalAffected":18,"trialsReporting":1},{"effect":"Haemorrhoids","drugRate":"11.5%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":156,"totalAffected":18,"trialsReporting":2},{"effect":"Mouth Haemorrhage","drugRate":"10.5%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":153,"totalAffected":16,"trialsReporting":1},{"effect":"Oedema","drugRate":"9.6%","organSystem":"General disorders","placeboRate":"","totalAtRisk":156,"totalAffected":15,"trialsReporting":2},{"effect":"Rash Maculo-Papular","drugRate":"8.3%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":180,"totalAffected":15,"trialsReporting":2},{"effect":"Erythema","drugRate":"8.2%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":183,"totalAffected":15,"trialsReporting":3},{"effect":"Dyspepsia","drugRate":"7.7%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":183,"totalAffected":14,"trialsReporting":3},{"effect":"Asthenia","drugRate":"9.2%","organSystem":"General disorders","placeboRate":"","totalAtRisk":153,"totalAffected":14,"trialsReporting":1},{"effect":"Night Sweats","drugRate":"9.2%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":153,"totalAffected":14,"trialsReporting":1},{"effect":"Blood Blister","drugRate":"9.2%","organSystem":"Skin and subcutaneous tissue disorders","placeboRate":"","totalAtRisk":153,"totalAffected":14,"trialsReporting":1},{"effect":"Transfusion Reaction","drugRate":"8.5%","organSystem":"Injury, poisoning and procedural complications","placeboRate":"","totalAtRisk":153,"totalAffected":13,"trialsReporting":1},{"effect":"Fluid Overload","drugRate":"8.5%","organSystem":"Metabolism and nutrition disorders","placeboRate":"","totalAtRisk":153,"totalAffected":13,"trialsReporting":1},{"effect":"Gingival Bleeding","drugRate":"7.8%","organSystem":"Gastrointestinal disorders","placeboRate":"","totalAtRisk":153,"totalAffected":12,"trialsReporting":1},{"effect":"Bacteraemia","drugRate":"7.7%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":156,"totalAffected":12,"trialsReporting":2},{"effect":"Procedural Pain","drugRate":"7.8%","organSystem":"Injury, poisoning and procedural complications","placeboRate":"","totalAtRisk":153,"totalAffected":12,"trialsReporting":1},{"effect":"Fall","drugRate":"7.7%","organSystem":"Injury, poisoning and procedural complications","placeboRate":"","totalAtRisk":156,"totalAffected":12,"trialsReporting":2}],"contraindications":["Hypersensitivity to cytarabine"],"specialPopulations":{"Pregnancy":"Based on anecdotal data of cytarabine in pregnant women and results of studies of daunorubicin and cytarabine in animals, VYXEOS can cause embryo-fetal harm when administered to pregnant woman. There are no adequate and well-controlled studies of VYXEOS, daunorubicin, or cytarabine in pregnant women. Daunorubicin and cytarabine are reproductive and developmental toxicants in multiple species (mice, rats, and/or dogs), starting at dose that was approximately 0.02 times the exposure in patients at the recommended human dose on mg/m2 basis [see Animal Data]. Patients should be advised to avoid becoming pregnant while taking VYXEOS. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential harm to fetus.The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Adverse outcomes in pregnancy occur regardless of the health of the mother or the use of medications. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are to 4% and 15 to 20%, respectively.DataHuman DataCytarabine can cause fetal harm if pregnant woman is exposed to the drug. Four anecdotal cases of major limb malformations have been reported in infants after their mothers received intravenous cytarabine, alone\n\nPregnancy: Pregnancy: Teratogenic Effects: Pregnancy Category D. See WARNINGS.","Geriatric use":"Of the 375 patients who received VYXEOS (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) liposome in clinical studies, 57% were 65 years and over. No overall differences in safety were observed between these patients and younger patients, with the exception of bleeding events, which occurred more frequently in patients 65 years and older compared to younger patients (77% vs. 59%).","Paediatric use":"See INDICATIONS AND USAGE."},"seriousAdverseEvents":[{"event":"Stomatitis","detail":"Gastrointestinal disorders. 1 trial(s).","severity":"serious","incidence":"7.4%"},{"event":"Respiratory Failure","detail":"Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"7.2%"},{"event":"Sepsis","detail":"Infections and infestations. 3 trial(s).","severity":"serious","incidence":"7.1%"},{"event":"Pneumonia","detail":"Infections and infestations. 3 trial(s).","severity":"serious","incidence":"6.0%"},{"event":"Ejection Fraction Decreased","detail":"Investigations. 1 trial(s).","severity":"serious","incidence":"5.9%"},{"event":"Hepatic function abnormal","detail":"Hepatobiliary disorders. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Liver function test abnormal","detail":"Investigations. 1 trial(s).","severity":"serious","incidence":"33.3%"},{"event":"Disease Progression","detail":"General disorders. 1 trial(s).","severity":"serious","incidence":"3.9%"},{"event":"Acute Respiratory Failure","detail":"Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"3.9%"},{"event":"Bacterial Sepsis","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Catheter Site Infection","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Fournier's Gangrene","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Fungal Infection","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Otitis Externa","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Pneumocystis Jirovecii Pneumonia","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Pseudomonal Sepsis","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Generalised Tonic-Clonic Seizure","detail":"Nervous system disorders. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Seizure","detail":"Nervous system disorders. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Aortic Aneurysm","detail":"Vascular disorders. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Anal Fissure","detail":"Gastrointestinal disorders. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Mouth Haemorrhage","detail":"Gastrointestinal disorders. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Neutropenic Colitis","detail":"Gastrointestinal disorders. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Infusion Related Reaction","detail":"Injury, poisoning and procedural complications. 1 trial(s).","severity":"serious","incidence":"3.7%"},{"event":"Appendicitis","detail":"Infections and infestations. 2 trial(s).","severity":"serious","incidence":"3.3%"},{"event":"Septic Shock","detail":"Infections and infestations. 2 trial(s).","severity":"serious","incidence":"2.8%"},{"event":"Bacteraemia","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"2.6%"},{"event":"Syncope","detail":"Nervous system disorders. 1 trial(s).","severity":"serious","incidence":"2.6%"},{"event":"Myocardial Infarction","detail":"Cardiac disorders. 1 trial(s).","severity":"serious","incidence":"2.0%"},{"event":"Central Nervous System Haemorrhage","detail":"Nervous system disorders. 1 trial(s).","severity":"serious","incidence":"2.0%"},{"event":"Hypoxia","detail":"Respiratory, thoracic and mediastinal disorders. 1 trial(s).","severity":"serious","incidence":"2.0%"}]},"trials":[],"aliases":[],"company":"Nippon Shinyaku Co., Ltd.","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=Cytarabine","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:38:06.427995+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Cytarabine","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-19T23:38:14.685225+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"Haiku strategic summary","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:55:27.419188+00:00"},"mechanism":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:34:32.773142+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:38:13.297462+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:38:06.456954+00:00"},"regulatory.us":{"url":"","method":"api_direct","source":"FDA Drugs@FDA","rawText":"","confidence":1,"sourceType":"fda_drugsfda","retrievedAt":"2026-04-19T23:38:03.244548+00:00"},"pharmacokinetics":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T08:34:32.773166+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=Cytarabine","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-19T23:38:14.053452+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":"2026-04-19T23:38:00.378297+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:38:00.378357+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (boxed_warning)","rawText":"WARNING Only physicians experienced in cancer chemotherapy should use cytarabine. For induction therapy patients should be treated in a facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The main toxic effect of cytarabine is bone marrow suppression with leukopenia, thrombocytopenia and anemia. Less serious toxicity includes nausea, vomiting, diarrhea and abdominal pain, oral ulceration, and hepa","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:38:00.378378+00:00"},"safety.safetySignals":{"url":"https://api.fda.gov/drug/event.json","method":"api_direct","source":"FDA FAERS","rawText":"","confidence":1,"sourceType":"fda_faers","retrievedAt":"2026-04-19T23:38:15.670694+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:27.419183+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL2447907/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:38:14.565652+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (3 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T08:34:33.138637+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + Haiku","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:55:27.419163+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA206190","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-19T23:38:00.378388+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (3 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:55:23.043185+00:00"}},"allNames":["cytarabine hydrochloride","cytarabine","arabinocytosine","Arabinoside C","aracytidine","cyclocide","cytarabin","cytarabinoside","cytosine beta-D-arabinofuranoside","cytarabine liposome","cytarabine HCl"],"offLabel":[],"synonyms":["cytarabine hydrochloride","cytarabine","arabinocytosine","Arabinoside C","aracytidine","cyclocide","cytarabin","cytarabinoside","cytosine beta-D-arabinofuranoside","cytarabine liposome","cytarabine HCl"],"timeline":[{"date":"1969-06-17","type":"positive","source":"DrugCentral","milestone":"FDA approval"},{"date":"1989-08-02","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 1 manufacturer approved"},{"date":"1999-04-01","type":"positive","source":"FDA Orange Book","milestone":"Depocyt approved — 10MG/ML"},{"date":"2001-07-11","type":"positive","source":"DrugCentral","milestone":"EMA approval (Pacira Limited)"},{"date":"2020-08-21","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Nippon Shinyaku Co., Ltd.)"}],"aiSummary":"Cytarabine is an antimetabolite nucleoside analog indicated for remission induction in acute non-lymphocytic leukemia and treatment of acute lymphocytic leukemia and blast phase chronic myelocytic leukemia, with intrathecal use for meningeal leukemia prophylaxis and treatment. It demonstrates potent cytotoxicity through DNA polymerase inhibition and incorporation into DNA/RNA with cell cycle specificity for S-phase. Primary risks include extensive chromosomal damage, rapid metabolism limiting oral bioavailability, and potential drug interactions affecting digoxin and antibiotic efficacy. The drug remains a foundational component of acute leukemia treatment regimens with established clinical utility across multiple hematologic malignancies.","brandName":"Cytarabine","ecosystem":[{"indication":"Acute lymphoid leukemia","otherDrugs":[{"name":"asparaginase","slug":"asparaginase","company":"Merck"},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"clofarabine","slug":"clofarabine","company":"Genzyme"}],"globalPrevalence":453000},{"indication":"Acute myeloid leukemia, disease","otherDrugs":[{"name":"aldesleukin","slug":"aldesleukin","company":"Chiron"},{"name":"azacitidine","slug":"azacitidine","company":"Celgene"},{"name":"daunorubicin","slug":"daunorubicin","company":""},{"name":"decitabine","slug":"decitabine","company":"Astex Pharmaceuticals, Inc."}],"globalPrevalence":800000},{"indication":"Acute promyelocytic leukemia, FAB M3","otherDrugs":[{"name":"arsenic trioxide","slug":"arsenic-trioxide","company":"Cephalon"},{"name":"daunorubicin","slug":"daunorubicin","company":""},{"name":"idarubicin","slug":"idarubicin","company":""},{"name":"mercaptopurine","slug":"mercaptopurine","company":"Stason Pharms"}],"globalPrevalence":null},{"indication":"Lymphomatous meningitis","otherDrugs":[],"globalPrevalence":null},{"indication":"Meningeal Leukemia","otherDrugs":[{"name":"methotrexate","slug":"methotrexate","company":"Dava Pharms Inc"}],"globalPrevalence":null}],"mechanism":{"target":"DNA polymerase","novelty":"Follow-on","targets":[{"gene":"MDM2","source":"DrugCentral","target":"E3 ubiquitin-protein ligase Mdm2","protein":"E3 ubiquitin-protein ligase Mdm2"},{"gene":"ACPP","source":"DrugCentral","target":"Prostatic acid phosphatase","protein":"Prostatic acid phosphatase"},{"gene":"POLA1","source":"DrugCentral","target":"DNA polymerase (alpha/delta/epsilon)","protein":"DNA polymerase alpha catalytic subunit"},{"gene":"POLD1","source":"DrugCentral","target":"DNA polymerase (alpha/delta/epsilon)","protein":"DNA polymerase delta catalytic subunit"},{"gene":"POLE","source":"DrugCentral","target":"DNA polymerase (alpha/delta/epsilon)","protein":"DNA polymerase epsilon catalytic subunit A"},{"gene":"POLB","source":"DrugCentral","target":"DNA polymerase beta","protein":"DNA polymerase beta"}],"moaClass":"Nucleic Acid Synthesis Inhibitors","modality":"Small molecule nucleoside analog","drugClass":"Antimetabolite","explanation":"Cytarabine exhibits cell phase specificity, primarily killing cells undergoing DNA synthesis (S-phase) and under certain conditions blocking progression from G1 phase to S-phase. Although the mechanism of action is not completely understood, cytarabine appears to act through inhibition of DNA polymerase. A limited but significant incorporation of cytarabine into both DNA and RNA has been reported, producing extensive chromosomal damage including chromatoid breaks. Cytarabine is metabolized by deoxycytidine kinase and other nucleotide kinases to the nucleotide triphosphate, an effective inhibitor of DNA polymerase, and is inactivated by pyrimidine nucleoside deaminase which converts it to the nontoxic uracil derivative. The balance of kinase and deaminase levels appears to be an important factor in determining cell sensitivity or resistance to cytarabine.","oneSentence":"Cytarabine inhibits DNA polymerase and incorporates into DNA/RNA, killing cells in S-phase.","technicalDetail":"Cytarabine acts as a nucleoside analog, incorporating into DNA and inhibiting DNA polymerase, which is essential for DNA replication and cell division, ultimately leading to cell death in rapidly dividing cancer cells."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Cytarabine","title":"Cytarabine","extract":"Cytarabine, also known as cytosine arabinoside (ara-C), is a chemotherapy medication used to treat acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL), chronic myelogenous leukemia (CML), and non-Hodgkin's lymphoma. It is given by injection into a vein, under the skin, or into the cerebrospinal fluid. There is a liposomal formulation for which there is tentative evidence of better outcomes in lymphoma involving the meninges.","wiki_history":"==History==\nIsolation of arabinose-containing nucleotides from the Caribbean sponge Cryptotheca crypta (now Tectitethya crypta) together with the realization that these compounds could act as DNA synthesis chain terminators led to exploration of these novel nucleotides as potential anticancer therapeutics. Cytarabine was first synthesized in 1959 by Richard Walwick, Walden Roberts, and Charles Dekker at the University of California, Berkeley.\n\nIt was approved by the United States Food and Drug Administration in June 1969, and was initially marketed in the US by Upjohn under the brand name Cytosar-U."},"commercial":{"launchDate":"1969","_launchSource":"DrugCentral (FDA 1969-06-17, 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