Adult: As conventional cytarabine (preservative-free preparation): Dose range: 5-75 mg/m2; frequency of administration varies from once daily for 4 days to once every 4 days. Commonly used dosage is 30 mg/m2 once every 4 days until CSF values are normal, followed by 1 additional dose. Dosing schedule usually depends on the type and severity of CNS manifestation and the patient's response to prior therapy. Dosage and treatment recommendations may vary between countries and individual products (refer to latest local or detailed product guidelines).
Intravenous Acute myeloid leukaemia
Adult: As conventional cytarabine: For induction of remission: Monotherapy: 200 mg/m2 daily via continuous IV infusion for 5 days at intervals of approx 2 weeks. In combination with other antineoplastic agents: 100 mg/m2 daily via continuous IV infusion or 100 mg/m2 12 hourly via rapid IV inj, both for 7 days. Alternative dosing regimens: Continuous treatment: 2 mg/kg daily via rapid IV inj for 10 days, may be increased to 4 mg/kg daily thereafter until response or toxicity occurs, or 0.5-1 mg/kg daily via IV infusion over 1-24 hours for 10 days, may be increased to 2 mg/kg daily thereafter until remission or toxicity occurs. Intermittent treatment: 3-5 mg/kg daily for 5 consecutive days, may be repeated after 2-9 days rest period. Continue treatment until response or toxicity occurs. Dosage and treatment recommendations may vary between countries (refer to latest local guidelines).
What are the brands available for Cytarabine in Thailand?
Solution for inj: IV inj or infusion: May dilute with compatible IV solution (e.g. sterile water for inj, NaCl 0.9% solution, dextrose 5% in water). Intrathecal: May dilute with preservative-free NaCl 0.9% solution, Elliot's B solution or lactated Ringer's solution. Instructions on preparation may vary among countries and between individual products (refer to specific product guidelines).
Incompatibility
Incompatible with fluorouracil, heparin sodium, insulin, oxacillin sodium, benzylpenicillin sodium, and methylprednisolone sodium succinate.
Special Precautions
Patient with pre-existing drug-induced bone marrow suppression. Avoid vaccination with live vaccines during treatment. Renal and hepatic impairment. Pregnancy (particularly during 1st trimester) and lactation.
Adverse Reactions
Significant: Bone marrow suppression (e.g. anaemia, leucopenia, thrombocytopenia, megaloblastosis, reduced reticulocytes); cytarabine syndrome (characterised by myalgia, bone pain, fever, occasional chest pain, maculopapular rash, conjunctivitis and malaise); acute pancreatitis; hyperuricaemia secondary to rapid lysis of neoplastic cells. Cardiac disorders: Pericarditis, sinus bradycardia. Eye disorders: Reversible haemorrhagic conjunctivitis, visual disturbances, keratitis. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain, dysphagia, oral and anal inflammation or ulceration. General disorders and administration site conditions: Inj site reactions (e.g. pain, inflammation, thrombophlebitis, cellulitis). Hepatobiliary disorders: Jaundice, hepatic dysfunction. Infections and infestations: Sepsis. Investigations: Increased liver enzymes. Metabolism and nutrition disorders: Anorexia. Nervous system disorders: Headache, dizziness, neuritis, neural toxicity; paraplegia (intrathecal). Renal and urinary disorders: Urinary retention, renal impairment. Respiratory, thoracic and mediastinal disorders: Dyspnoea, sore throat. Skin and subcutaneous tissue disorders: Urticaria, alopecia, skin ulceration, pruritus, rash, erythema. Vascular disorders: Bleeding (all sites), vasculitis. Potentially Fatal: Viral, bacterial, fungal, parasitic, or saprophytic infections; sudden respiratory distress syndrome, pulmonary oedema (high dose). Rarely, anaphylaxis resulting in acute cardiopulmonary arrest.
Women of childbearing potential and men with female partners of childbearing potential must use effective contraception during and up to 6 months after treatment.
Monitoring Parameters
Monitor CBC with differential and platelet count (frequently), bone marrow (frequently once blasts have disappeared from the peripheral blood); LFTs, serum creatinine, BUN (periodically); and serum uric acid. Assess for signs and symptoms of bleeding, infection, neutropenic fever, and tumour lysis syndrome.
Drug Interactions
May inhibit the therapeutic effect of flucytosine. May decrease plasma digoxin concentration. Concomitant use of IV cytarabine with intrathecal methotrexate may increase the risk of severe neurological adverse reactions (e.g. headache, paralysis, coma, stroke-like episodes). Potentially Fatal: Increased risk of serious infections with live vaccines.
Action
Description: Mechanism of Action: Cytarabine, a pyrimidine nucleoside analogue, is an antimetabolite antineoplastic agent. It is converted intracellularly to cytarabine triphosphate which inhibits DNA polymerase, resulting in reduced DNA synthesis and repair. Cytarabine acts specifically for the S phase of the cell cycle. Pharmacokinetics: Distribution: Widely and rapidly distributed in the tissues and fluids. Crosses the placenta and blood-brain barrier (CSF levels of 40-50% of plasma concentration). Volume of distribution: 3 ± 11.9 L/kg. Plasma protein binding: 13%. Metabolism: Metabolised mainly in the liver by deoxycytidine kinase and other nucleoside kinases into aracytidine triphosphate (active metabolite); approx 86-96% of the dose is metabolised to the inactive uracil arabinoside (Ara-U). Excretion: Via urine (approx 80%; 90% as Ara-U metabolite, 10% as unchanged drug). Elimination half-life: IV: 7-20 minutes (initial); 1-3 hours (terminal). Intrathecal: 2-6 hours.
Chemical Structure
Cytarabine Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 6253, Cytarabine. https://pubchem.ncbi.nlm.nih.gov/compound/Cytarabine. Accessed Sept. 24, 2024.
Storage
Intact vial: Store between 15-25°C. Do not refrigerate. Protect from light. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal. Storage recommendations may vary between individual products (refer to specific product guidelines).
L01BC01 - cytarabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
References
Anon. Cytarabine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/06/2024.Brayfield A, Cadart C (eds). Cytarabine. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/06/2024.Cytarabine (Conventional). UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 05/06/2024.Cytarabine 100 mg/mL Solution for Infusion (Pfizer Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/06/2024.Cytarabine 20 mg/mL Solution for Injection/Infusion (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 05/06/2024.Cytarabine CS 100 mg Solution for Injection (Pfizer [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/06/2024.Cytarabine Injection, Solution (Meitheal Pharmaceuticals Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/06/2024.Joint Formulary Committee. Cytarabine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/06/2024.Pfizer New Zealand Limited. Cytarabine BP 20 mg/mL and 100 mg/mL Injection data sheet 3 May 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 05/06/2024.
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