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 a tablet for oral use. It treats chronic myeloid leukemia, acute myeloid leukemia, and is used in conditioning regimens for bone marrow transplantation.

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

Manufacturer / TM Owner

Aspen Pharma Trading Limited

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Indications & Clinical Uses

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.

How It Works

  • Busulfan alkylates DNA by forming covalent bonds with nucleophilic sites, creating interstrand cross‑links that block DNA replication and transcription. The resulting DNA damage triggers apoptosis, preferentially affecting rapidly dividing hematopoietic and malignant cells, which underlies its antineoplastic activity.

Side Effects

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

Precautions & Warnings

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.

Avoid Interactions

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

Myleran, containing the active ingredient Busulfan, is prescribed for chronic myeloid leukemia, acute myeloid leukemia, and as part of the conditioning regimen before bone marrow transplantation. In each case, it helps to reduce malignant cells and prepares the body for subsequent therapeutic steps.

Busulfan belongs to the alkylating agent class. It binds to DNA, forming cross‑links that prevent DNA strands from separating during replication and transcription. This interference triggers cell death, especially in rapidly dividing cancerous and hematopoietic cells, providing its antineoplastic effect.

The specific dose of Myleran is individualized by the prescribing physician based on the patient’s disease, weight, organ function, and treatment protocol. Dosage calculations are performed by the treating oncologist or transplant specialist to ensure safety and efficacy.

Myleran is classified as Pregnancy Category D, indicating evidence of risk to the fetus. It should not be used by pregnant women, and breastfeeding is not recommended because the drug can be excreted in milk and may harm the infant.

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 often compared with cyclophosphamide or total body irradiation as conditioning agents. Compared with cyclophosphamide, Busulfan provides more predictable pharmacokinetics but requires careful monitoring for hepatic and pulmonary toxicity. Choice depends on the transplant protocol and patient-specific factors.

Myleran tablets should be stored at ambient temperature, preferably below 25 °C. Keep them in the original container, protect from moisture and direct sunlight, and ensure the packaging remains sealed until use.

Myleran is administered orally as a tablet. The prescribing clinician determines the dosing schedule, which may involve single or divided doses over several days, depending on the treatment plan and patient tolerance.

Serious risks include hepatic veno‑occlusive disease, severe bone‑marrow suppression leading to pancytopenia, pulmonary fibrosis, and seizures. Patients should be monitored closely for signs of liver dysfunction, respiratory issues, and neurological symptoms throughout therapy.

Myleran is contraindicated in patients with known hypersensitivity to Busulfan, those who are pregnant, and individuals with severe hepatic impairment or uncontrolled infections. It should also be used with caution in patients with pre‑existing lung disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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