Arasid-100/Arasid-500/Arasid-1000

Cytarabine

For induction of remission in AML in adults & for other acute leukaemias of adults & childn.

Remission induction Continuous treatment: Rapid inj Initially 2 mg/kg/day for 10 days. Obtain daily blood counts. Increase to 4 mg/kg/day if no antileukaemic effect is noted & there is no apparent toxicity & maintain until therapeutic response or toxicity is evident. Infusion Initially 0.5-1 mg/kg/day may be given in an infusion of up to 24 hr duration. May be increased to 2 mg/kg/day after 10 days subject to toxicity. Continue to toxicity or until remission occurs. Intermittent treatment: 3-5 mg/kg/day IV on each of 5 consecutive days. After a 2- to 9-day rest period, a further course is given. Continue until response or toxicity occurs. Or, 100-200 mg/m²/24 hr, as continuous infusion for 5-7 days alone or in combination w/ other cytostatics including for instance an anthracycline has been used. Additional cycles may be administered at intervals of 2-4 wk, until remission is achieved or unacceptable toxicity occurs. Maintenance therapy 1 mg/kg once or twice wkly by IV or SC inj. Or, 100-200 mg/m², as continuous infusion for 5 days at mthly intervals as monotherapy or in combination w/ other cytostatics. High dosage 2-3 g/m², as IV infusion, for 1-3 hr every 12 hr for 2-6 days as monotherapy or in combination w/ other cytostatics. Total of 12 doses/cycle. Max total treatment dose: 36 g/m².

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.

Patients w/ pre-existing drug-induced bone marrow suppression. Perform leucocyte & platelet counts daily; bone marrow exam frequently after blasts have disappeared from peripheral blood. Severe & at times fatal CNS, GI & pulmonary toxicity including reversible corneal toxicity; cerebral & cerebellar dysfunction, usually reversible; somnolence; convulsion; severe GI ulceration, including pneumatosis cystoides intestinalis, leading to peritonitis; sepsis & liver abscess; & pulmonary oedema. Suspend or modify therapy when drug induced marrow depression has resulted in platelet count <50,000 or polymorphonuclear count <1,000/mm³. Peripheral motor & sensory neuropathies after consolidation w/ high doses of cytarabine, daunorubicin, & asparaginase in adults w/ acute non lymphocytic leukaemia. Observe patients treated w/ high doses for neuropathy since dose schedule alterations may be needed to avoid irreversible neurologic disorders. Severe & sometimes fatal pulmonary toxicity, adult resp distress syndrome & pulmonary oedema following high dose schedules w/ therapy. Avoid giving IV doses quickly. Abdominal tenderness (peritonitis) & guaiac +ve colitis, w/ concurrent neutropenia & thrombocytopenia in patients treated w/ conventional doses in combination w/ other drugs. Delayed progressive ascending paralysis resulting in death in childn w/ AML following intrathecal & IV cytarabine at conventional doses in combination w/ other drugs. Monitor both hepatic & renal function during therapy. Patients w/ pre-existing liver impairment. Perform periodic checks of bone marrow, liver & kidney functions in patients receiving treatment. May induce hyperuricaemia secondary to rapid lysis of neoplastic cells. Monitor patient's blood uric acid level & prepare to use such supportive & pharmacological measures as may be necessary to control this problem. Avoid vaccination w/ live vaccine in patients receiving therapy. Risk of CNS side effects in patients who have previously had CNS treatment as chemotherapy intrathecally or RT. Avoid concurrent granulocyte-transfusion as severe resp insufficiency have been reported. Cardiomyopathy w/ subsequent death following experimental high dose therapy in combination w/ cyclophosphamide when used for bone marrow transplant prep. May impair ability to drive or operate machinery. Hepatic & renal impairment. Not to be administered immediately before or after dialysis. Use effective contraception during & up to 6 mth after treatment in women; & males undergoing treatment & their partner. Pregnancy & lactation. Not established in infants/paed patients. Elderly >60 yr.

Anaemia, megaloblastosis, leucopenia, thrombocytopenia; anorexia, hyperuricaemia; at high doses cerebellar or cerebral influence w/ deterioration of the level of consciousness, dysarthria, nystagmus; reversible haemorrhagic conjunctivitis (photophobia, burning, visual disturbance, increased lacrimation), keratitis; dysphagia, abdominal pain, nausea, vomiting, diarrhoea, oral/anal inflammation or ulceration; reversible effects on the liver w/ increased enzyme levels; reversible undesirable effects to the skin, eg, erythema, bullous dermatitis, urticaria, vasculitis, alopecia; renal impairment, urinary retention; fever, thrombophlebitis at the inj site.

Abolished therapeutic efficacy of 5-fluorocytosine. Reversible decreases in steady-state plasma digoxin conc & renal glycoside excretion in patients receiving β-acetyldigoxin & chemotherapy regimens containing cyclophosphamide, vincristine & prednisone w/ or w/o cytarabine or procarbazine. Cytarabine-related antagonism for the susceptibility of Klebsiella pneumoniae strains w/ gentamicin. Viral, bacterial, fungal, parasitic, or saprophytic infections, in any location in the body w/ use of cytarabine alone or in combination w/ other immunosuppressive agents following immunosuppressant doses that affect cellular or humoral immunity.

Cytotoxic Chemotherapy

L01BC01 - cytarabine ; Belongs to the class of antimetabolites, pyrimidine analogues. Used in the treatment of cancer.

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