Product image of Myleran (Busulfan) supplied by GNH India

Myleran

Active Ingredient:
Busulfan
Origin:
EU

Myleran (Busulfan)

Busulfan, the active ingredient in Myleran, is an alkylating agent presented as an oral capsule for oral use. It is employed in the treatment of chronic myelogenous leukemia, myelodysplastic syndromes, and as part of conditioning regimens for hematopoietic stem cell transplantation.
GNH India supplies Myleran as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres and pharmacies worldwide.

Manufacturer / TM Owner

Aspen Pharma Trading Limited

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Indications & Clinical Uses

  • Busulfan is an alkylating chemotherapy agent used in several hematologic conditions.
  • Chronic myelogenous leukemia: achieves disease control and remission by eradicating malignant leukemic cells.
  • Myelodysplastic syndromes: reduces abnormal marrow proliferation and improves blood counts.
  • Conditioning regimen for hematopoietic stem cell transplantation: provides myeloablation to allow successful engraftment of donor stem cells.

How It Works

  • Busulfan exerts its antineoplastic effect by alkylating DNA bases, forming interstrand cross‑links that block DNA replication and transcription. The resulting DNA damage triggers apoptosis, particularly in rapidly dividing hematopoietic cells, leading to myelosuppression and tumor cell death.

Side Effects

Busulfan may cause a range of adverse reactions.

Common Side Effects

  • Nausea and vomiting
  • Oral mucositis
  • Alopecia (hair loss)
  • Fever or chills

Serious or Rare Side Effects

  • Pulmonary fibrosis or interstitial lung disease
  • Hepatic veno‑occlusive disease (VOD)
  • Seizures, especially at high plasma concentrations
  • Severe bone marrow suppression resulting in pancytopenia and infection risk

Precautions & Warnings

  • When using Busulfan, careful monitoring and risk mitigation are essential.
  • Monitor blood counts: perform regular complete blood count assessments.
  • Assess liver function: evaluate hepatic enzymes before and during therapy.
  • Avoid in pregnancy unless absolutely necessary: Busulfan is classified as Pregnancy Category D.
  • Use anticonvulsant prophylaxis if high‑dose regimens are planned.
  • Adjust dose in hepatic impairment: consider reduced dosing or increased monitoring.
  • Store at ambient temperature: keep capsules in the original container, protect from moisture and direct sunlight.

Avoid Interactions

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

Major Interactions (Avoid)

  • Concomitant use with other alkylating agents (e.g., cyclophosphamide)
  • Strong CYP2B6 inducers such as rifampin, which lower Busulfan exposure
  • Drugs that lower seizure threshold (e.g., bupropion)

Moderate Interactions (Monitor Closely)

  • Azole antifungals (e.g., fluconazole) that increase Busulfan plasma levels
  • Acetaminophen, which may enhance hepatic toxicity
  • Phenytoin, which can reduce Busulfan concentrations

Frequently Asked Questions

Myleran contains Busulfan, an alkylating chemotherapy drug used to treat chronic myelogenous leukemia, manage myelodysplastic syndromes, and serve as a myeloablative agent in conditioning regimens for hematopoietic stem cell transplantation.

Busulfan alkylates DNA, creating cross‑links that prevent DNA replication and transcription. This DNA damage leads to apoptosis of rapidly dividing cells, particularly malignant hematopoietic cells, providing its antineoplastic effect.

The dosage of Myleran is individualized and determined by the prescribing physician based on the specific indication, patient weight, organ function, and treatment protocol. Patients should follow the prescriber’s instructions precisely.

Busulfan is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It should only be used during pregnancy if the potential benefit justifies the risk. Breastfeeding is not recommended while receiving Busulfan because it can be excreted in milk.

To order Myleran, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Busulfan is a widely used alkylating agent for conditioning because of its predictable pharmacokinetics and potent myeloablative effect. Compared with total body irradiation or other alkylators such as cyclophosphamide, Busulfan offers a purely chemical approach, but may carry higher risks of pulmonary and hepatic toxicity, requiring careful monitoring.

Myleran capsules should be stored at ambient temperature, below 25 °C, in the original packaging. Protect them from moisture, heat and direct sunlight to maintain stability and potency.

Myleran is taken orally as a capsule. The exact schedule—single dose, divided doses, or continuous administration—depends on the treatment protocol prescribed by the oncologist or transplant specialist.

Serious risks include pulmonary fibrosis, hepatic veno‑occlusive disease, severe bone‑marrow suppression leading to pancytopenia, and seizures at high plasma concentrations. Prompt medical attention is required if any of these complications arise.

Myleran should be avoided in patients with known hypersensitivity to Busulfan, severe hepatic impairment, uncontrolled infections, or in pregnant women unless the benefit outweighs the risk. It is also contraindicated when used concurrently with other strong alkylating agents without specialist supervision.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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