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 tablet for oral use. It treats chronic myelogenous 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 specific hematologic malignancies and transplant preparation.

  • Chronic myelogenous leukemia (CML): provides disease control by reducing leukemic cell proliferation.
  • Acute myeloid leukemia (AML) conditioning: contributes to marrow ablation before stem‑cell transplant.
  • Conditioning regimen for bone marrow transplantation: creates sufficient marrow suppression to allow donor engraftment.

How It Works

  • Busulfan alkylates DNA by forming covalent cross‑links between DNA strands, which blocks DNA replication and transcription. This interference triggers cell cycle arrest and apoptosis, preferentially affecting rapidly dividing hematopoietic cells and malignant leukemic clones, thereby reducing tumor burden and facilitating marrow ablation before transplantation.

Side Effects

Busulfan may cause a range of adverse reactions that vary in frequency and severity.

Common Side Effects

  • Nausea and vomiting: gastrointestinal upset occurring shortly after dosing.
  • Oral mucositis: painful inflammation of the mouth lining.
  • Fever: low‑grade temperature elevation.
  • Skin rash: mild erythematous eruptions.
  • Alopecia: temporary hair loss.
  • Fatigue: generalized tiredness.

Serious or Rare Side Effects

  • Pulmonary fibrosis: progressive scarring of lung tissue.
  • Hepatic veno‑occlusive disease: blockage of small hepatic veins leading to liver dysfunction.
  • Seizures: neurologic events, especially at high plasma concentrations.
  • Severe bone‑marrow suppression: profound neutropenia and thrombocytopenia.
  • Life‑threatening infections: due to immunosuppression.
  • Secondary malignancies: increased risk of other cancers with long‑term exposure.

Precautions & Warnings

Before initiating Busulfan therapy, clinicians should evaluate patient‑specific risk factors and monitor for toxicity.

  • Blood count monitoring: perform regular CBCs to detect marrow suppression.
  • Liver function assessment: check hepatic enzymes and bilirubin before and during treatment.
  • Pulmonary evaluation: avoid use in patients with pre‑existing lung disease.
  • Seizure prophylaxis: consider anticonvulsants for high‑dose regimens.
  • Dose adjustment: modify dosing in hepatic impairment.
  • Store at below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

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

Major Interactions (Avoid)

  • Concurrent alkylating agents (e.g., cyclophosphamide): increase cumulative toxicity.
  • Azathioprine: heightened myelosuppression risk.
  • High‑dose thiotepa: synergistic bone‑marrow suppression.

Moderate Interactions (Monitor Closely)

  • Antifungal azoles (e.g., itraconazole): may increase busulfan plasma levels.
  • Antiepileptic enzyme inducers (e.g., phenytoin, carbamazepine): reduce busulfan exposure.
  • Warfarin: potential alteration of anticoagulant effect.
  • Antacids containing aluminum or magnesium: may affect oral absorption.

Frequently Asked Questions

Myleran contains the active ingredient busulfan, an alkylating antineoplastic drug. It is prescribed for patients with chronic myelogenous leukemia and as part of the conditioning regimen before allogeneic bone‑marrow or stem‑cell transplantation to achieve adequate marrow ablation.

Busulfan exerts its effect by alkylating DNA strands, creating cross‑links that prevent DNA replication and transcription. This disruption leads to cell cycle arrest and apoptosis, especially in rapidly dividing hematopoietic and leukemic cells, thereby reducing disease burden and preparing the marrow for donor cell engraftment.

The specific dose of Myleran is individualized by the treating physician based on the patient’s diagnosis, body surface area, liver function, and intended use (e.g., leukemia treatment versus transplant conditioning). Only a qualified healthcare professional should determine the appropriate dosing schedule.

The safety of busulfan in pregnancy and lactation has not been established. It is classified as contraindicated for use in pregnant or nursing women because of potential teratogenic and toxic effects on the fetus or infant. Women of child‑bearing potential should use effective contraception during treatment.

To request 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 (including any cold‑chain requirements), and necessary import documentation.

Busulfan is often compared with total body irradiation (TBI) or other alkylators such as cyclophosphamide. Compared with TBI, busulfan offers a purely pharmacologic approach without radiation exposure, but it requires careful therapeutic drug monitoring to avoid toxicity. Unlike cyclophosphamide, busulfan has a different metabolic pathway and distinct side‑effect profile, including a higher risk of hepatic veno‑occlusive disease.

Myleran tablets should be stored at temperatures below 25 °C, in their original blister pack, protected from moisture and direct sunlight. Do not refrigerate or freeze the product. Keep out of reach of children and store in a secure, dry location.

Myleran is supplied as oral tablets that are taken by mouth with water, usually on an empty stomach to improve absorption. The exact schedule (single dose, divided doses, or multiple days) is determined by the prescribing clinician based on the therapeutic intent and patient factors.

The most serious adverse events include pulmonary fibrosis, hepatic veno‑occlusive disease, severe bone‑marrow suppression leading to infections or bleeding, and seizures, particularly at high plasma concentrations. Patients should be monitored closely for respiratory symptoms, liver dysfunction, and neurologic changes throughout therapy.

Myleran is contraindicated in patients with known hypersensitivity to busulfan or any tablet excipients, those with pre‑existing severe pulmonary disease, uncontrolled hepatic impairment, or active uncontrolled infections. It should also be avoided in pregnant or nursing women and in individuals for whom alternative, less toxic conditioning regimens are available.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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