Europe — EMA
Myleran (Busulfan)
GNH USA supplies Myleran (Busulfan), an alkylating agent for chronic myeloid leukemia and bone marrow transplant conditioning. Request a quote for supply.
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What is Busulfan?
Busulfan, the active ingredient in Myleran, is an alkylating agent presented as an oral tablet for oral use. It is employed in the treatment of chronic myeloid leukemia and as part of conditioning regimens prior to bone marrow transplantation. It is approved in the European Union and is prescribed by oncologists and hematologists.
GNH USA supplies Myleran as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution.
What is Busulfan used for?
Busulfan is an alkylating antineoplastic agent used in specific hematologic malignancies and transplant protocols. - Chronic myeloid leukemia (CML): reduces leukemic cell proliferation and improves survival when combined with other agents. - Bone marrow transplantation conditioning: eradicates residual disease and creates immunosuppression to facilitate engraftment. - Acute myeloid leukemia (AML) conditioning: incorporated into high‑dose regimens to achieve myeloablation before stem cell rescue.
What are the side effects of Busulfan?
Busulfan may cause a range of adverse reactions, varying from mild to severe.
Common Side Effects: - Nausea and vomiting: gastrointestinal upset occurring early in treatment. - Oral mucositis: inflammation and ulceration of the mouth lining. - Skin hyperpigmentation: diffuse darkening, especially on sun‑exposed areas. - Bone marrow suppression: decreased blood cell counts leading to fatigue and infection risk.
Serious or Rare Side Effects: - Pulmonary fibrosis: progressive scarring of lung tissue, potentially life‑threatening. - Hepatic veno‑occlusive disease: obstruction of small hepatic veins causing liver dysfunction. - Seizures: central nervous system events, particularly at high plasma concentrations.
What precautions apply to Busulfan?
When prescribing Busulfan, clinicians should observe several safety measures to minimize risks. - Therapeutic drug monitoring: adjust dose based on plasma levels to avoid toxicity. - Hepatic function assessment: evaluate liver enzymes before and during therapy. - Concomitant anticonvulsant use: consider prophylactic antiepileptic medication in high‑risk patients. - Avoid in patients with severe pulmonary disease: risk of exacerbating lung injury. - Store at ambient temperature: keep tablets in original container, protect from moisture and heat.
What does Busulfan interact with?
Busulfan interacts with several agents that can alter its plasma concentration or increase toxicity.
Major Interactions (Avoid): - Azathioprine: combined use markedly increases myelosuppression. - Chloramphenicol: inhibits hepatic metabolism, raising Busulfan levels. - Phenytoin: induces metabolism, potentially reducing efficacy.
Moderate Interactions (Monitor Closely): - Acetaminophen: may compete for glutathione pathways, modestly affecting clearance. - Rifampin: enzyme induction can lower Busulfan exposure. - Concomitant radiation therapy: additive bone marrow toxicity.
Frequently asked questions
What is Myleran used for?+
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What determines the usual dose of Myleran?+
Is Myleran safe during pregnancy or breastfeeding?+
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Product details
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