Package(a):
TABLETS: 100 x 2 mg. Dosage(a):
See prescribing information for full details. Prescribing Restrictions:
Package(b):
TABLETS: 25 x 2 mg. This package has been discontinued. Dosage(b):
Prescribing Restrictions: None
Indications:
Chronic myelocytic leukemia. Contra-Indications:
Patients whose disease has demonstrated resistance to busulphan. Hypersensitive reaction to busulphan or any other component of the preparation. Special Precautions:
Myleran is an active cytotoxic agent for use only under the direction of physicians experienced in the administration of such agents. Should be discontinued if lung toxicity develops. Should not generally be given in conjunction with or soon after radiotherapy. Is ineffective once blast transformation has occurred. Hyperuricaemia and/or hyperuricosuria should be corrected before starting treatment. Very careful consideration should be given to the use for the treatment of polycythaemia vera and essential thrombocythaemia. If high-dose is prescribed, patients should be given prophylactic anticonvulsant therapy with preferably a benzodiazepine rather than phenytoin. Careful attention must be paid to monitoring the blood counts throughout treatment. On the basis of short-term tests, Myleran has been classified as potentially carcinogenic by the IARC. Use in pregnancy and lactation: Adequate contraceptive precautions should be advised when either partner is receiving therapy. Should be avoided whenever possible during pregnancy, particularly during the first trimester. The expected benefit of treatment to the mother must be weighed against the possible risks to the fetus. Mothers receiving therapy should not breast feed their infants. See prescribing information for full details. Side Effects:
Bone marrow depression, particularly thrombocytopenia. Nausea, vomiting and diarrhea. Interstitial pulmonary fibrosis, with progressive dyspnoea and a persistent, non-productive cough has occurred rarely. It is possible that subsequent radiotherapy can augment subclinical lung injury caused by Myleran. See prescribing information for full details. Drug Interactions:
Cyclophosphamide, thioguanine.
