{"entity":{"id":"cytarabine","kind":"drug","name":"Cytarabine","aka":["Ara-C","Cytosine arabinoside","DepoCyt (liposomal, discontinued)"],"tldr":"Cytarabine is the core chemotherapy for acute myeloid leukaemia, given with an anthracycline as the classic 7+3 induction and at high doses for consolidation; it is also injected into the spinal fluid to treat or prevent leukaemia in the brain.","summary":"Cytarabine was approved in 1969 and remains, with an anthracycline, the remission-induction standard in acute non-lymphocytic leukaemia of adults and children; the label also covers acute lymphocytic leukaemia and blast-phase CML, and intrathecal use for prophylaxis and treatment of meningeal leukaemia. High-dose cytarabine consolidation (CALGB 8525) defined post-remission therapy for favourable-risk AML, and it partners fludarabine (FLAG), cladribine and midostaurin, gemtuzumab or venetoclax in modern regimens. A liposomal co-formulation with daunorubicin (CPX-351, Vyxeos) has its own record. Cerebellar toxicity at high doses, conjunctivitis (steroid eye drops) and profound myelosuppression are characteristic.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Cytarabine","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=cytarabine"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/cytarabine"}],"tags":["nci-list","generic"],"related":["cytarabine-7-3","cpx-351"],"cancers":["aml","all-leukemia","cml"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["nct06788756","nct07007312","nct03591510","nct04229979","nct07255872","nct07387926","nct03182244","nct03793478"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Cytosar-U (historic)","modality":"Pyrimidine nucleoside analogue (antimetabolite)","mechanism":"Converted to ara-CTP, which competitively inhibits DNA polymerase and is incorporated into DNA, halting chain elongation during S phase.","approvals":[{"region":"US","year":1969,"indication":"Remission induction in acute non-lymphocytic leukaemia; ALL; blast-phase CML; intrathecal therapy of meningeal leukaemia"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"1999-04-01","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint, with a confirmatory trial required.","indication":"Intrathecal treatment of lymphomatous meningitis"},{"date":"2007-04-19","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 1999 converted to traditional approval 8.0 years after it was granted.","indication":"Intrathecal treatment of lymphomatous meningitis"}]},"route":"/drugs/cytarabine/","neighbours":{"drug":[{"id":"amsacrine","kind":"drug","name":"Amsacrine","route":"/drugs/amsacrine/"},{"id":"cpx-351","kind":"drug","name":"CPX-351 (liposomal daunorubicin-cytarabine)","route":"/drugs/cpx-351/"},{"id":"cytarabine-7-3","kind":"drug","name":"Cytarabine + anthracycline ('7+3')","route":"/drugs/cytarabine-7-3/"},{"id":"idarubicin","kind":"drug","name":"Idarubicin","route":"/drugs/idarubicin/"}],"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-paediatric","kind":"cancer","name":"Acute myeloid leukaemia in children","route":"/cancers/aml-paediatric/"},{"id":"aml-older-unfit","kind":"cancer","name":"Acute myeloid leukaemia in older or unfit patients","route":"/cancers/aml-older-unfit/"},{"id":"burkitt-leukaemia","kind":"cancer","name":"Burkitt leukaemia","route":"/cancers/burkitt-leukaemia/"},{"id":"burkitt-lymphoma","kind":"cancer","name":"Burkitt lymphoma","route":"/cancers/burkitt-lymphoma/"},{"id":"cml","kind":"cancer","name":"Chronic myeloid leukaemia (CML)","route":"/cancers/cml/"},{"id":"cml-advanced-phase","kind":"cancer","name":"Chronic myeloid leukaemia, accelerated and blast phase","route":"/cancers/cml-advanced-phase/"},{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"hepatosplenic-t-cell-lymphoma","kind":"cancer","name":"Hepatosplenic T-cell lymphoma","route":"/cancers/hepatosplenic-t-cell-lymphoma/"},{"id":"all-paediatric-high-risk","kind":"cancer","name":"High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)","route":"/cancers/all-paediatric-high-risk/"},{"id":"all-infant","kind":"cancer","name":"Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year)","route":"/cancers/all-infant/"},{"id":"mantle-cell-lymphoma","kind":"cancer","name":"Mantle cell lymphoma","route":"/cancers/mantle-cell-lymphoma/"},{"id":"mixed-phenotype-acute-leukaemia","kind":"cancer","name":"Mixed-phenotype acute leukaemia","route":"/cancers/mixed-phenotype-acute-leukaemia/"},{"id":"myeloid-leukaemia-of-down-syndrome","kind":"cancer","name":"Myeloid leukaemia of Down syndrome","route":"/cancers/myeloid-leukaemia-of-down-syndrome/"},{"id":"peripheral-t-cell-lymphoma","kind":"cancer","name":"Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)","route":"/cancers/peripheral-t-cell-lymphoma/"},{"id":"primary-cns-lymphoma","kind":"cancer","name":"Primary CNS lymphoma","route":"/cancers/primary-cns-lymphoma/"},{"id":"relapsed-refractory-hodgkin-lymphoma","kind":"cancer","name":"Relapsed and refractory classical Hodgkin lymphoma","route":"/cancers/relapsed-refractory-hodgkin-lymphoma/"},{"id":"all-paediatric-standard-risk","kind":"cancer","name":"Standard-risk B-cell acute lymphoblastic leukaemia in children","route":"/cancers/all-paediatric-standard-risk/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"sterile-injectable-generics-manufacturing","kind":"technology","name":"Generic sterile injectables (the 2023 platinum shortage)","route":"/technologies/sterile-injectable-generics-manufacturing/"}],"trial":[{"id":"nct03591510","kind":"trial","name":"A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML","route":"/trials/nct03591510/"},{"id":"nct01890746","kind":"trial","name":"A Safety and Efficacy Study of Eltrombopag in Subjects With AML","route":"/trials/nct01890746/"},{"id":"nct03416179","kind":"trial","name":"A Study Evaluating Intensive Chemotherapy With or Without Glasdegib or Azacitidine With or Without Glasdegib In Patients With Previously Untreated Acute Myeloid Leukemia","route":"/trials/nct03416179/"},{"id":"nct03182244","kind":"trial","name":"A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation","route":"/trials/nct03182244/"},{"id":"nct07255872","kind":"trial","name":"A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia","route":"/trials/nct07255872/"},{"id":"nct04293562","kind":"trial","name":"A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 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