Myleran (Busulfan)

Busulfan, the active ingredient in Myleran, is an alkylating agent presented as a oral capsule for oral use. It treats chronic myeloid leukemia and is used as conditioning before bone marrow transplantation.

GNH USA supplies Myleran as a licensed, GDP-compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres and pharmacies worldwide.

Busulfan is an alkylating antineoplastic agent used in hematologic malignancies and transplant conditioning.

- Chronic myeloid leukemia: reduces leukemic cell proliferation and helps achieve disease control. - Bone marrow transplantation conditioning: eradicates residual hematopoietic cells to facilitate donor stem‑cell engraftment. - Acute myeloid leukemia (pre‑transplant): contributes to remission induction when incorporated into conditioning regimens.

Busulfan may cause a range of adverse reactions, varying from mild to severe.

Common Side Effects: - Nausea: mild to moderate gastrointestinal upset. - Oral mucositis: inflammation and ulceration of the mouth lining. - Skin hyperpigmentation: darkening of the skin, especially on the face and hands. - Low blood counts (myelosuppression): decreased neutrophils, platelets, or red cells.

Serious or Rare Side Effects: - Pulmonary fibrosis: progressive scarring of lung tissue. - Hepatic veno‑occlusive disease: obstruction of small hepatic veins causing liver dysfunction. - Seizures: rare neurologic events, especially at high plasma concentrations.

Before initiating therapy, several safety measures should be observed.

- Baseline blood counts: monitor CBC before and during treatment. - Liver function: assess hepatic enzymes and bilirubin prior to therapy. - Pulmonary assessment: perform baseline lung function tests and watch for respiratory symptoms. - Drug interactions: avoid concurrent strong CYP2B6 inducers or inhibitors without dose adjustment. - Pregnancy and lactation: contraindicated unless benefits outweigh risks; discuss with a specialist. - Store at ambient temperature below 25°C: keep capsules in original container, protect from moisture and light.

Busulfan interacts with several medicines that can alter its plasma concentration or toxicity.

Major Interactions (Avoid): - Strong CYP2B6 inducers (e.g., rifampicin, carbamazepine): may reduce busulfan exposure. - Strong CYP2B6 inhibitors (e.g., clozapine, itraconazole): may increase toxicity risk. - Concomitant thiotepa or cyclophosphamide: additive myelosuppression.

Moderate Interactions (Monitor Closely): - Anticonvulsants (e.g., phenytoin, phenobarbital): may alter plasma levels. - Azole antifungals (e.g., fluconazole): may increase busulfan concentrations. - Radiation therapy: may enhance pulmonary toxicity.