Zuellig Pharma
Concise Prescribing Info
Palliative treatment of chronic myeloid leukaemia. Producing prolonged remission in polycythaemia vera particularly in cases w/ marked thrombocytosis. Selected cases of essential thrombocythaemia & myelofibrosis.
Dosage/Direction for Use
Chronic myeloid leukaemia Induction: 0.06 mg/kg daily, initial max dose: 4 mg daily. Maintenance: 0.5-2 mg daily. Polycythaemia vera 4-6 mg daily for 4-6 wk. Essential thrombocythaemia & myelofibrosis 2-4 mg daily.
May be taken with or without food: Take w/ chilled liqd. Swallow whole, do not chew/crush. Ensure adequate fluid intake.
Hypersensitivity. Patients w/ demonstrated resistance to busulfan.
Special Precautions
Discontinue used if lung toxicity develops. Ineffective once blast transformation occurs. Increased risk of hepatic veno-occlusive disease in patients who have received prior radiation therapy, ≥3 cycles of chemotherapy or prior progenitor cell transplant. Closely monitor blood count thoroughout treatment. Correct hyperuricaemia, hyperuricosuria prior to treatment & ensure adequate hydration during treatment. Not be given in conjunction w/ or soon after RT. Not recommended w/ live vaccines, metronidazole. Co-administration of itraconazole. High-dose & long-term use. Renal or hepatic impairment. Ensure adequate contraceptive precautions. May affect oogenesis & spermatogenesis. Avoid use during 1st trimester of pregnancy. Not to be used during lactation. Avoid use in younger or asymptomatic patients.
Adverse Reactions
Dose-related bone marrow failure; male infertility, azoospermia & testicular atrophy. Leukaemia secondary to oncology chemotherapy; ILD; skin pigmentation. High-dose: Idiopathic pneumonia syndrome; nausea, vomiting, diarrhoea, mouth ulceration; hyperbilirubinaemia, jaundice, veno-occlusive liver disease, biliary fibrosis w/ hepatic atrophy & necrosis; ovarian disorder & amenorrhoea w/ menopausal symptoms in pre-menopausal patients, severe & persistent ovarian failure including pubertal failure. Cardiac tamponade; alopecia; haemorrhagic cystitis.
Drug Interactions
Additive effects w/ other cytotoxics-producing pulmonary toxicity. Decreased myeloblative effect w/ phenytoin. Decreased clearance w/ itraconazole, paracetamol. Increased risk of toxicity w/ itraconazole, metronidazole. Reduced incidence of hepatic veno-occlusive & other regimen-related toxicities w/ cyclophosphamide.
MIMS Class
Cytotoxic Chemotherapy
ATC Classification
L01AB01 - busulfan ; Belongs to the class of alkylating agents, alkyl sulfonates. Used in the treatment of cancer.
Myleran FC tab 2 mg
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