Myleran (Busulfan)

Busulfan, the active ingredient in Myleran, is an alkylating agent presented as an oral tablet for oral use. It treats chronic myelogenous leukemia and is used in conditioning regimens for hematopoietic stem cell 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 employed in specific hematologic malignancies and transplant conditioning.

- Chronic myelogenous leukemia: provides disease control as part of systemic therapy. - Conditioning regimen for hematopoietic stem cell transplantation: eradicates residual malignant cells and creates immunosuppression to facilitate graft acceptance. - Myeloproliferative neoplasms: reduces proliferative activity as part of disease‑modifying treatment.

Busulfan may cause a range of adverse reactions, from mild to life‑threatening.

Common Side Effects: - Nausea and vomiting - Mucositis or oral ulceration - Alopecia (hair loss) - Skin rash or hyperpigmentation - Elevated liver enzymes - Fatigue or weakness

Serious or Rare Side Effects: - Pulmonary fibrosis or interstitial lung disease - Hepatic veno‑occlusive disease (sinusoidal obstruction syndrome) - Seizures, especially at high plasma concentrations - Severe bone‑marrow suppression leading to aplastic anemia - Life‑threatening infections due to neutropenia - Hemorrhagic cystitis

Before initiating therapy, several safety considerations should be addressed.

- Monitor blood counts: perform regular CBC to detect marrow suppression. - Assess liver function: check hepatic enzymes and bilirubin before and during treatment. - Evaluate pulmonary status: obtain baseline lung function tests and monitor for respiratory symptoms. - Avoid concomitant nephrotoxic drugs: adjust dosing if renal impairment is present. - Consider seizure prophylaxis: use anticonvulsants when high‑dose regimens are planned. - Store at ambient temperature: keep below 25°C, protect from moisture and light.

Busulfan interacts with several medications that can alter its efficacy or toxicity.

Major Interactions (Avoid): - Azathioprine: increased myelosuppression risk. - Cyclophosphamide: additive bone‑marrow toxicity. - Thiopurines (e.g., 6‑mercaptopurine): heightened hematologic toxicity.

Moderate Interactions (Monitor Closely): - Azole antifungals (e.g., fluconazole): may raise busulfan plasma levels. - Phenytoin or carbamazepine: can reduce busulfan concentrations. - Warfarin: potential alteration of INR requiring closer monitoring.