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 bone marrow transplantation.

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

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

- Chronic myelogenous leukemia (CML): provides disease control by reducing leukemic cell proliferation. - Acute myeloid leukemia (AML) conditioning: contributes to marrow ablation before stem‑cell transplant. - Conditioning regimen for bone marrow transplantation: creates sufficient marrow suppression to allow donor engraftment.

Busulfan may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects: - Nausea and vomiting: gastrointestinal upset occurring shortly after dosing. - Oral mucositis: painful inflammation of the mouth lining. - Fever: low‑grade temperature elevation. - Skin rash: mild erythematous eruptions. - Alopecia: temporary hair loss. - Fatigue: generalized tiredness.

Serious or Rare Side Effects: - Pulmonary fibrosis: progressive scarring of lung tissue. - Hepatic veno‑occlusive disease: blockage of small hepatic veins leading to liver dysfunction. - Seizures: neurologic events, especially at high plasma concentrations. - Severe bone‑marrow suppression: profound neutropenia and thrombocytopenia. - Life‑threatening infections: due to immunosuppression. - Secondary malignancies: increased risk of other cancers with long‑term exposure.

Before initiating Busulfan therapy, clinicians should evaluate patient‑specific risk factors and monitor for toxicity.

- Blood count monitoring: perform regular CBCs to detect marrow suppression. - Liver function assessment: check hepatic enzymes and bilirubin before and during treatment. - Pulmonary evaluation: avoid use in patients with pre‑existing lung disease. - Seizure prophylaxis: consider anticonvulsants for high‑dose regimens. - Dose adjustment: modify dosing in hepatic impairment. - Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Busulfan can interact with several medicines, altering its efficacy or safety profile.

Major Interactions (Avoid): - Concurrent alkylating agents (e.g., cyclophosphamide): increase cumulative toxicity. - Azathioprine: heightened myelosuppression risk. - High‑dose thiotepa: synergistic bone‑marrow suppression.

Moderate Interactions (Monitor Closely): - Antifungal azoles (e.g., itraconazole): may increase busulfan plasma levels. - Antiepileptic enzyme inducers (e.g., phenytoin, carbamazepine): reduce busulfan exposure. - Warfarin: potential alteration of anticoagulant effect. - Antacids containing aluminum or magnesium: may affect oral absorption.