MYLERAN

What it is

MYLERAN contains busulfan 2 mg per tablet. Busulfan is a potent cytotoxic agent and a bifunctional alkylating agent. In aqueous media, release of the methanesulphonate groups produces carbonium ions which can alkylate DNA, thought to be an important biological mechanism for its cytotoxic effect.

Approved indications —

Conditioning prior to haematopoietic stem cell transplantation in combination with cyclophosphamide, melphalan or fludarabine

Key safety warnings

The consequence of treatment with busulfan at the recommended dose and schedule is profound myelosuppression, occurring in all patients. Severe granulocytopenia, thrombocytopenia, anaemia, or any combination thereof may develop. Frequent complete blood counts, including differential white blood cell counts, and platelet counts should be monitored during the treatment and until recovery is achieved. To detect hepatotoxicity, which may herald the onset of hepatic veno-occlusive disease, serum transaminases, alkaline phosphatase and bilirubin should be evaluated daily until transplant day 28. Seizures have been reported with high dose busulfan treatment. Special caution should be exercised when administering the recommended dose of busulfan to patients with a history of seizures. Patients should receive adequate anticonvulsant prophylaxis. Busulfan might induce pulmonary toxicity that may be additive to the effects produced by other cytotoxic agents. Therefore, attention should be paid to this pulmonary issue in patients with prior history of mediastinal or pulmonary radiation.

Contraindications

MYLERAN is contraindicated in patients with hypersensitivity to the active substance busulfan or to any of the excipients. MYLERAN is contraindicated in women who are pregnant and/or lactating.

PBS listing

MYLERAN 2 mg tablet is listed on the PBS as one item with unrestricted supply at an ex-manufacturer price of A$61.41.

Regulatory history

MYLERAN busulfan 2 mg tablet was first registered on the ARTG on 2 March 1999.