Europe — EMA
Myleran (Busulfan)
GNH USA supplies Myleran (Busulfan), an alkylating agent for chronic myeloid leukemia, acute myeloid leukemia and bone marrow transplant conditioning.
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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 treats chronic myeloid leukemia, acute myeloid 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.
What is Busulfan used for?
Busulfan is an alkylating antineoplastic agent used in several hematologic malignancies and transplant protocols. - Chronic Myeloid Leukemia: helps achieve disease control and remission. - Acute Myeloid Leukemia: contributes to cytoreduction and remission induction. - Conditioning regimen for bone marrow transplantation: provides myeloablation to facilitate donor cell engraftment.
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 - Oral mucositis - Diarrhea - Fatigue
Serious or Rare Side Effects: - Hepatic veno‑occlusive disease - Pulmonary fibrosis - Seizures - Severe bone‑marrow suppression (pancytopenia) - Life‑threatening infections
What precautions apply to Busulfan?
When using Busulfan, careful monitoring and specific precautions are recommended. - Dose adjustment: monitor complete blood counts and adjust dose accordingly. - Liver function: assess hepatic status before and during therapy. - Pulmonary function: evaluate baseline lung function and watch for respiratory symptoms. - Concomitant medications: avoid drugs that lower seizure threshold or significantly alter busulfan metabolism. - Pregnancy: contraindicated (Category D) – avoid use in pregnant patients. - Store at ambient temperature: keep below 25°C, retain in original packaging, protect from moisture.
What does Busulfan interact with?
Busulfan interacts with several medicines; some require avoidance, others close monitoring.
Major Interactions (Avoid): - Phenytoin: reduces busulfan exposure, risking treatment failure. - Azole antifungals (e.g., fluconazole, itraconazole): increase busulfan plasma levels, heightening toxicity. - Chloral hydrate: potentiates central nervous system depression and toxicity.
Moderate Interactions (Monitor Closely): - Acetaminophen: may affect hepatic metabolism of busulfan. - Other alkylating agents: additive myelosuppression risk. - Radiotherapy: combined use can increase tissue toxicity.
Frequently asked questions
What conditions is Myleran (Busulfan) used for?+
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What is the usual dose of Myleran?+
Is Myleran safe during pregnancy or breastfeeding?+
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Product details
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