Europe — EMA
Myleran (Busulfan)
GNH USA supplies Myleran (Busulfan), an alkylating antineoplastic agent for chronic myelogenous leukemia and conditioning before stem cell transplantation.
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What is Busulfan?
Busulfan, the active ingredient in Myleran, is an alkylating agent presented as a tablet for oral use. It is employed in the treatment of chronic myelogenous leukemia and as part of 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.
What is Busulfan used for?
Busulfan is an alkylating antineoplastic agent used in specific hematologic malignancies and transplant preparation.
Chronic myelogenous leukemia: provides disease control and facilitates remission in adult patients. Conditioning regimen for hematopoietic stem cell transplantation: creates myeloablation to enable successful engraftment of donor cells.
What are the side effects of Busulfan?
Busulfan may cause a range of adverse reactions, from mild to severe.
Common Side Effects: - Nausea and vomiting - Mucositis or oral ulceration - Skin rash or hyperpigmentation - Transient fever or chills
Serious or Rare Side Effects: - Hepatic veno‑occlusive disease (VOD) - Pulmonary fibrosis or interstitial pneumonitis - Seizures, especially at high plasma concentrations - Severe bone‑marrow suppression leading to infection or bleeding
What precautions apply to Busulfan?
Careful monitoring and patient counseling are essential when using Busulfan. - Monitor blood counts: perform regular CBCs to detect myelosuppression. - Assess liver function: check hepatic enzymes before and during therapy. - Avoid use in pregnancy: Busulfan is contraindicated in pregnant women (Category D). - Adjust dose in hepatic impairment: reduce dosage or increase interval as clinically indicated. - Provide anticonvulsant prophylaxis when high plasma levels are anticipated. - Store at ambient temperature: keep tablets in the original container, protect from moisture and direct sunlight.
What does Busulfan interact with?
Busulfan can interact with several drug classes, requiring vigilance.
Major Interactions (Avoid): - Concomitant use with other alkylating agents (e.g., cyclophosphamide) increases toxicity. - Co‑administration with azathioprine may exacerbate bone‑marrow suppression. - High‑dose cyclophosphamide together with Busulfan raises risk of hepatic VOD.
Moderate Interactions (Monitor Closely): - CYP2B6 inducers such as rifampin can lower Busulfan plasma levels. - Anticonvulsants like phenytoin may increase Busulfan clearance. - NSAIDs may heighten gastrointestinal irritation and bleeding risk.
Frequently asked questions
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Product details
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