Cytarabine (Ara-C)

General information

Class/mechanism: Pyrimidine analog, mimics cytosine. Converted intracellularly into cytarabine-5-triphosphate (ara-CTP). Exact mechanism of action not known; believed to inhibit DNA polymerase, incorporate into DNA and RNA, and kill cells undergoing DNA synthesis (S-phase) and sometimes block cells from progressing from the G1 phase to the S-phase.
Route: IV, IT, SC
Extravasation: irritant or neutral, depending on reference

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.

Diseases for which it is established (work in progress)

• Mantle cell lymphoma
• Peripheral T-cell lymphoma

Diseases for which it is used

• Acute myeloid leukemia
• Acute promyelocytic leukemia
• Adult T-cell leukemia-lymphoma
• Anaplastic large cell lymphoma
• Burkitt lymphoma
• B-cell acute lymphoblastic leukemia
• Chronic lymphocytic leukemia
• Chronic myeloid leukemia
• CNS lymphoma
• Diffuse large B-cell lymphoma
• Follicular lymphoma
• HIV-associated lymphoma
• Classical Hodgkin lymphoma
• Hypereosinophilic syndrome
• Langerhans cell histiocytosis
• Myelodysplastic syndrome
• Primary mediastinal B-cell lymphoma
• T-cell acute lymphoblastic leukemia
• Transformed lymphoma

Diseases for which it was used

• Multiple myeloma

Patient drug information

• Cytarabine (Ara-C) package insert
• Cytarabine (Ara-C) patient drug information (Chemocare)
• Cytarabine (Ara-C) patient drug information (UpToDate)

History of changes in FDA indication

• 1969-06-17: initial FDA approval
• 1998-10-15 (oldest label available at Drugs @ FDA): indicated in combination with other approved anticancer drugs for remission induction in acute nonlymphocytic leukemia of adults and pediatric patients. (No supporting studies are cited)
• 1998-10-15 (oldest label available at Drugs @ FDA): indicated in the treatment of acute lymphocytic leukemia and the blast phase of chronic myelocytic leukemia. (No supporting studies are cited)
• 1998-10-15 (oldest label available at Drugs @ FDA): Intrathecal administration is indicated in the prophylaxis and treatment of meningeal leukemia. (No supporting studies are cited)

History of changes in EMA indication

• 2001-07-11: EURD

History of changes in PMDA indication

• 2019-03-26: New indication for the treatment prior to tumor-specific T-cell infusion therapy.
• 2023-05-25: New indication and a new dosage for the treatment of acute leukemia.

Also known as

• Generic names: Ara-C, arabinosylcytosine, arabinofuranosyl cytidine, cytosine arabinoside
• Brand names:

Synonyms
Alcysten	Alexan	ARA	Arabine	Arabitin	Aracitin	Aracytin	Aracytine
Citagenin	Citaloxan	Citarabin	Citarabina	Citarabins	Citarax	Cylocide	Cytarabin
Cytarabins	Cytarabinum	Cytarbel	Cytarine	Cytosar	Cytosar-U	Cytrosar	Erbabin
Erpalfa	Fauldcita	Groven	Ifarab	Iretin	Laracit	Medsara	Novutrax
Remcyta	Starasid	Tabin	Tabine	Udicil