CYTARABINE

What it is

DBL Cytarabine Injection is a clear, colourless sterile solution of cytarabine in water for injections. It is a clear, colourless sterile solution for injection. It is presented in ONCO-TAIN® vials containing 1000 mg/10 mL or 2000 mg/20 mL of cytarabine solution.

Approved indications

— Induction of remission of leukaemia, particularly for acute myeloid leukaemia, in adults and children. — Remission induction in acute lymphocytic leukaemia. — Remission induction in chronic myeloid leukaemia. — Remission induction in erythroleukaemia. — Treatment and maintenance therapy of meningeal leukaemia and other meningeal neoplasms.

Dosing overview

Dosage of cytarabine must be based on the clinical and haematological response and tolerance of the patient so as to obtain optimum therapeutic results with minimum adverse effects. For single-drug therapy in induction remission in adults with acute myelocytic leukaemia, cytarabine 200 mg/m² daily by continuous IV infusion over 24 hours for 5 days (120 hours) — total dose 1000 mg/m² is used, with the course repeated approximately every 2 weeks. For intrathecal use in meningeal leukaemia, cytarabine has been used in doses ranging from 5 mg/m² to 75 mg/m² of body surface area, with the most frequently used dose being 30 mg/m² every 4 days until cerebrospinal fluid findings were normal, followed by one additional treatment.

Key safety warnings

The main toxic effect of cytarabine is bone marrow suppression with leukopenia, thrombocytopenia and anaemia. Cytarabine is a potent bone marrow suppressant and the severity depends on the dose of the drug and schedule of administration; therapy should be started cautiously in patients with pre-existing drug-induced bone marrow suppression. Consider suspending or modifying therapy when drug-induced marrow depression has resulted in a platelet count under 50 × 10⁹ L or a polymorphonuclear granulocyte count under 1 × 10⁹ L. When cytarabine is administered both intrathecally and intravenously within a few days, there is an increased risk of spinal cord toxicity. Cases of severe neurological adverse reactions that ranged from headache to paralysis, coma and stroke-like episodes have been reported mostly in juveniles and adolescents given intravenous cytarabine in combination with intrathecal methotrexate. Anaphylactic reactions have occurred with cytarabine treatment; anaphylaxis that resulted in acute cardiopulmonary arrest and required resuscitation has been reported immediately after intravenous administration of cytarabine. Administration of live or live-attenuated vaccines in patients immunocompromised by chemotherapeutic agents including cytarabine may result in serious or fatal infections; vaccination with a live vaccine should be avoided in patients receiving cytarabine.

Contraindications

Cytarabine is contraindicated in patients with known hypersensitivity to the drug.

Regulatory history

DBL Cytarabine Injection was first approved on 16 September 1992. Cytarabine ACC and Cytarabine Accord formulations were first listed on the ARTG on 16 April 2019 in multiple strengths ranging from 40 mg/2 mL to 5000 mg/50 mL.