Cytarine

Cytarine

cytarabine

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Cytarabine
Indications/Uses
Alone or in combination w/ other antineoplastic agents for induction & maintenance of remission in acute myelocytic leukaemia in adults & childn. Acute lymphoblastic or acute lymphocytic leukaemia, chronic myelocytic leukaemia (blastphase) & erythroleukaemia. Non-Hodgkin's lymphoma in childn.
Dosage/Direction for Use
IV/SC Adult Remission induction in leukemia Continuous dosing: 2 mg/kg daily via rapid IV inj for 10 days. May be increased to 4 mg/kg after 10 days. Alternatively, 0.5-1 mg/kg daily infusion in 1-24 hr for 10 days, then at a rate of 2 mg/kg daily. Intermittent dosing: 3-5 mg/kg daily for 5 consecutive days. May be repeated after 2-9 interval. Remission induction in acute leukemia 100 mg/m2 bid via rapid IV inj, or 100 mg/m2 daily by continuous IV infusion, both for 7 days. Monotherapy: 200 mg/m2 via continuous IV infusion for 5 days at approx 2-wk interval. Maintenance therapy 1 mg/kg once or twice wkly.
Contraindications
Hypersensitivity. Anaemia, leucopenia & thrombocytopenia of non-malignant aetiology eg, bone marrow aplasia. Degenerative & toxic encephalopathies, especially after use of MTX or treatment w/ ionizing radiation. Pregnancy.
Special Precautions
Not to be administered via intrathecal route. Suspend or modify therapy when drug-induced bone marrow depression results in platelet count <50,000 or polymorphonuclear count of <1,000/mm3. Anaphylaxis resulting in cardiopulmonary arrest. Severe & fatal CNS, GI & pulmonary toxicity; neurological effects. Hyperuricaemia secondary to rapid lysis of neoplastic cells. Increased risk of CNS toxicity in high doses in combination w/ another CNS toxic treatment eg, RT or in patients w/ previous CNS chemotherapy treatment. Nausea & vomiting w/ quick IV administration. Patients w/ preexisting drug-induced bone marrow suppression. Perform leucocyte & platelet counts during induction; bone marrow exam; renal & hepatic function & bone marrow determinations. Monitor serum uric acid conc. Abdominal tenderness (peritonitis) & guaiac +ve colitis w/ neutropenia & thrombocytopenia in combination w/ other drugs. Peripheral motor & sensory neuropathies; pulmonary toxicity & edema, adult resp distress syndrome; cardiomyopathy w/ high doses. Concomitant use w/ daunorubicin, asparaginase, or cyclophosphamide. Avoid concurrent granulocyte-transfusion; live vaccines. May impair ability to drive or operate machinery. Hepatic impairment. Gonadal suppression resulting in amenorrhea or azoospermia. Men & women should use effective contraception during & up to 6 mth after treatment. Not to be used during pregnancy (1st trimester) & lactation. Infants. Delayed progressive ascending paralysis in childn w/ AML. Elderly.
Adverse Reactions
Anaemia, megaloblastosis, leucopenia, thrombocytopenia; dysphagia, abdominal pain, nausea, vomiting, diarrhea, oral/anal inflammation or ulceration; reversible undesirable effects to the skin eg, erythema, bullous dermatitis, urticarial vasculitis, alopecia; renal impairment, urinary retention; fever, thrombophlebitis at inj site; reversible liver effects w/ increased enzyme levels; anorexia, hyperuricaemia; cerebellar or cerebral influence w/ deterioration of level of consciousness, dysarthria, nystagmus; reversible haemorrhagic conjunctivitis (photophobia, burning, visual disturbance, increased lacrimation), keratitis.
Drug Interactions
Concomitant use w/ digoxin, other immunosuppressive agents. Antagonism for susceptibility of Klebsiella pneumoniae strains w/ gentamicin. Possible inhibition of fluorocytosine efficacy.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01BC01 - cytarabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.
Presentation/Packing
Form
Cytarine infusion 1 g/10 mL
Packing/Price
1's
Form
Cytarine infusion 100 mg/mL
Packing/Price
1's
Form
Cytarine infusion 500 mg/5 mL
Packing/Price
1's
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