Chronic myeloid leukaemia

Active Ingredient: Busulfan

Indication for Busulfan

Population group: only adults (18 - 65 years old)

For this indication, competent medicine agencies globally authorize below treatments:

0.03-0.06 mg/kg once daily

Route of admnistration

Oral

Defined daily dose

0.03 - 0.06 mg per kg of body weight

Dosage regimen

From 0.03 To 0.06 mg per kg of body weight once every day

Loading dose

0.06 mg per kg of body weight

Detailed description

Induction in adults

Treatment is usually initiated as soon as the condition is diagnosed. The dose is 0.06 mg/kg/day, with an initial daily maximum of 4 mg, which may be given as a single dose.

There is individual variation in the response to busulfan and in a small proportion of patients the bone marrow may be extremely sensitive.

The blood count must be monitored at least weekly during the induction phase and it may be helpful to plot counts on semilog graph paper.

The dose should be increased only if the response is inadequate after three weeks.

Treatment should be continued until the total leucocyte count has fallen to between 15 and 25 × 109 per litre (typically 12 to 20 weeks). Treatment may then be interrupted, following which a further fall in the leucocyte count may occur over the next two weeks. Continued treatment at the induction dose after this point or following depression of the platelet count to below 100 × 109 per litre is associated with a significant risk of prolonged and possibly irreversible bone marrow aplasia.

Maintenance in adults

Control of the leukaemia may be achieved for long periods without further Busulfan treatment; further courses are usually given when the leucocyte count rises to 50 × 109 per litre, or symptoms return.

Some clinicians prefer to give continuous maintenance therapy. Continuous treatment is more practical when the duration of unmaintained remissions is short.

The aim is to maintain a leucocyte count of 10 to 15 × 109 per litre and blood counts must be performed at least every 4 weeks. The usual maintenance dosage is on average 0.5 to 2 mg/day, but individual requirements may be much less. Should a patient require an average daily dose of less than the content of one tablet, the maintenance dose may be adjusted by introducing one or more Busulfan free days between treatment days.

Note: Lower doses of Busulfan should be used if it is administered in conjunction with other cytotoxic agents.

Active ingredient

Busulfan

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.

Read more about Busulfan

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