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 is employed in the treatment of chronic myelogenous leukemia 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 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.

How It Works

  • Busulfan exerts its antineoplastic effect by alkylating DNA bases, leading to cross‑link formation that blocks DNA replication and transcription. This DNA damage triggers cell‑cycle arrest and apoptosis, preferentially affecting rapidly dividing hematopoietic cells and malignant clones.

Side Effects

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

Precautions & Warnings

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.

Avoid Interactions

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

Myleran contains Busulfan, an oral alkylating agent used primarily to treat chronic myelogenous leukemia and to provide myeloablation as part of conditioning regimens before hematopoietic stem cell transplantation.

Busulfan alkylates DNA, forming cross‑links that prevent DNA replication and transcription. This damage leads to cell‑cycle arrest and apoptosis, especially in rapidly dividing malignant and hematopoietic cells.

The specific dose of Myleran is individualized by the prescribing clinician based on the patient’s disease, body surface area, and treatment protocol. Dosage regimens are not standardized and must follow a qualified prescriber’s instructions.

Busulfan is classified as Pregnancy Category D, indicating evidence of fetal risk. It should not be used during pregnancy, and breastfeeding is contraindicated 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 necessary import documentation.

Busulfan is often compared with total body irradiation or other alkylators such as cyclophosphamide. It offers oral administration and predictable pharmacokinetics, but requires careful monitoring for hepatic toxicity and drug interactions, whereas alternatives may have different toxicity profiles or administration routes.

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

Myleran is taken orally as a tablet, usually with water. The exact schedule—single dose, divided doses, or multiple days—depends on the therapeutic protocol prescribed by the treating physician.

Serious risks include hepatic veno‑occlusive disease, severe bone‑marrow suppression leading to infection or bleeding, pulmonary fibrosis, and seizures at high plasma concentrations. Prompt recognition and supportive care are essential.

Myleran should not be used by pregnant women, individuals with severe hepatic impairment, or patients with known hypersensitivity to Busulfan or any tablet excipients. Clinicians must also avoid use in patients receiving contraindicated concomitant therapies.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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