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 formulation for oral use. It is employed in the treatment of chronic myeloid leukemia and as part of conditioning regimens for bone marrow 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 specific hematologic malignancies and transplant preparation.
  • Chronic myeloid leukemia (CML): provides disease control by reducing leukemic cell proliferation.
  • Conditioning regimen for bone marrow transplantation: delivers myeloablation to facilitate donor cell engraftment.

How It Works

  • Busulfan exerts its antineoplastic effect by alkylating DNA strands, forming cross‑links that impede DNA replication and transcription. This disruption leads to cell cycle arrest and apoptosis, preferentially affecting rapidly dividing malignant hematopoietic cells while sparing most normal tissues.

Side Effects

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

Common Side Effects

  • Nausea and vomiting
  • Mucositis or oral ulceration
  • Alopecia (hair loss)
  • Skin rash or discoloration

Serious or Rare Side Effects

  • Pulmonary fibrosis or interstitial lung disease
  • Hepatic veno‑occlusive disease (VOD)
  • Severe bone marrow suppression leading to pancytopenia
  • Seizures, especially at high plasma concentrations
  • Secondary malignancies with long‑term use
  • Life‑threatening infections due to immunosuppression

Precautions & Warnings

Before initiating therapy, several safety considerations should be addressed.

  • Monitor blood counts: perform regular complete blood counts to detect myelosuppression.
  • Assess liver function: evaluate hepatic enzymes and bilirubin prior to dosing.
  • Evaluate pulmonary status: baseline lung function tests are recommended.
  • Avoid in patients with known hypersensitivity to busulfan or related alkylating agents.
  • Adjust dose in hepatic impairment: consider reduced dosing or increased monitoring.
  • Store at below 25°C: keep in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Busulfan can interact with other medicines, influencing its efficacy or toxicity.

Major Interactions (Avoid)

  • Cyclophosphamide: combined use increases risk of severe myelosuppression.
  • Azathioprine: concurrent administration may potentiate bone marrow toxicity.
  • Phenytoin: enzyme induction reduces busulfan plasma levels, compromising therapeutic effect.

Moderate Interactions (Monitor Closely)

  • Azole antifungals (e.g., fluconazole, itraconazole): may raise busulfan concentrations, requiring dose adjustment.
  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): increase bleeding risk when thrombocytopenia is present.
  • Acetaminophen: concurrent high‑dose use may add hepatic stress, warranting liver function monitoring.

Frequently Asked Questions

Myleran contains busulfan, an alkylating chemotherapy drug used primarily to treat chronic myeloid leukemia and to provide myeloablation as part of conditioning regimens before bone marrow or stem cell transplantation.

Busulfan alkylates DNA, creating cross‑links that block DNA replication and transcription. This interference triggers cell cycle arrest and apoptosis, especially in rapidly dividing malignant hematopoietic cells, thereby reducing tumor burden.

The specific dose of Myleran is determined by the prescribing physician based on the patient’s condition, body surface area, and treatment protocol. Dosage regimens are individualized and should follow the clinician’s instructions.

Busulfan is classified as potentially harmful to the fetus and is generally contraindicated during pregnancy. It is also excreted in breast milk, so breastfeeding is not recommended while receiving treatment. Consultation with a healthcare professional is essential.

To place an order, submit an enquiry on the Myleran 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.

Compared with agents such as cyclophosphamide, busulfan has a longer half‑life and a higher propensity for hepatic and pulmonary toxicity. It is often selected for its potent myeloablative effect in transplant conditioning, whereas other alkylators may be preferred for different malignancies or toxicity profiles.

Myleran should be stored at temperatures below 25 °C, in its original packaging, protected from moisture and direct sunlight. Maintaining a stable environment helps preserve drug potency and prevents degradation.

Myleran is taken orally as prescribed, usually in divided doses over several days. The exact schedule, dose, and duration are defined by the treating physician and may be adjusted based on therapeutic response and laboratory monitoring.

Serious risks include severe bone marrow suppression leading to pancytopenia, hepatic veno‑occlusive disease, pulmonary fibrosis, seizures, and the potential for secondary malignancies. Patients should be closely monitored for these complications throughout therapy.

Myleran is contraindicated in individuals with known hypersensitivity to busulfan or other alkylating agents, in patients with severe hepatic impairment, and in those with active, uncontrolled infections. It should also be avoided in pregnant women and breastfeeding mothers.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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