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 solution for oral administration. It is employed in the treatment of chronic myelogenous leukemia and as part of conditioning regimens prior to allogeneic bone marrow transplantation, targeting rapidly dividing malignant cells and supportive care protocols.

GNH India supplies Myleran as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres, pharmacies and clinics worldwide, providing reliable sourcing for clinicians and procurement teams across regulated markets and ensuring compliance with local regulatory requirements.

Manufacturer / TM Owner

Aspen Pharma Trading Limited

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Indications & Clinical Uses

  • Busulfan is an alkylating antineoplastic agent used in hematologic malignancies and transplant conditioning.
  • Chronic myelogenous leukemia: reduces leukemic cell proliferation as part of chemotherapy protocols.
  • Bone marrow transplantation conditioning: eradicates residual disease and creates immunosuppression to facilitate engraftment.

How It Works

  • Busulfan exerts its cytotoxic effect by alkylating the N7 position of guanine residues in DNA, leading to intra‑ and interstrand cross‑links. These cross‑links impede DNA replication and transcription, triggering cell cycle arrest and apoptosis in rapidly dividing hematopoietic cells. The drug’s non‑selective DNA damage underlies its antineoplastic activity in leukemic clones and its utility in myeloablative conditioning.

Side Effects

Busulfan may be associated with a range of adverse reactions, varying from mild to potentially life‑threatening.

Common Side Effects

  • Nausea and vomiting
  • Oral mucositis
  • Alopecia
  • Myelosuppression (decreased blood counts)

Serious or Rare Side Effects

  • Pulmonary fibrosis
  • Hepatic veno‑occlusive disease
  • Seizures
  • Severe bone marrow failure

Precautions & Warnings

  • When using Busulfan, clinicians should observe several safety measures.
  • Blood count monitoring: Perform regular CBC to detect myelosuppression.
  • Liver function assessment: Check hepatic enzymes before and during therapy.
  • Pulmonary evaluation: Baseline and periodic lung function tests are recommended.
  • Pregnancy avoidance: Do not use in pregnant patients; discuss contraception.
  • Dose adjustment in hepatic impairment: Reduce dose or increase monitoring as needed.
  • Store at ambient temperature: Keep in original container, protect from moisture and light.

Avoid Interactions

Busulfan interacts with several medicines that may alter its efficacy or toxicity.

Major Interactions (Avoid)

  • Azathioprine: increased risk of severe myelosuppression.
  • Cyclophosphamide: additive bone marrow toxicity.
  • Phenytoin: may reduce Busulfan plasma concentrations.

Moderate Interactions (Monitor Closely)

  • Acetaminophen: potential increase in Busulfan exposure.
  • Fluconazole (and other azole antifungals): may raise Busulfan levels.
  • Hormonal contraceptives: possible reduction in effectiveness.

Frequently Asked Questions

Myleran contains Busulfan, which is used to treat chronic myelogenous leukemia and as part of the conditioning regimen before allogeneic bone marrow transplantation. It helps eradicate malignant cells and prepares the patient’s marrow for donor stem cell engraftment.

Busulfan alkylates DNA at specific guanine sites, creating cross‑links that block DNA replication and transcription. This damage leads to cell cycle arrest and apoptosis, especially in rapidly dividing hematopoietic and leukemic cells, providing its antineoplastic effect.

The dosage of Myleran is individualized and determined by the prescribing physician based on the patient’s condition, weight, treatment protocol, and laboratory monitoring. Exact dosing regimens should be obtained from the treating clinician.

Busulfan is classified as pregnancy category D, indicating evidence of risk to the fetus. 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 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 and any required import documentation.

Busulfan is an alkylating agent that provides myeloablation through DNA cross‑linking, whereas alternatives such as total body irradiation or other chemotherapeutics (e.g., cyclophosphamide) use different mechanisms. Busulfan offers oral administration and predictable pharmacokinetics but requires careful monitoring for organ toxicity.

Myleran oral solution should be stored at ambient temperature, preferably below 25 °C. Keep the container tightly closed, protect it from moisture and light, and store it in the original packaging until use.

Myleran is supplied as an oral solution and is taken by mouth according to the prescribing physician’s instructions. The dose is usually divided over several days and may be given with or without food, depending on the treatment protocol.

Serious risks include pulmonary fibrosis, hepatic veno‑occlusive disease, seizures, and severe bone marrow failure. Patients should be monitored closely for respiratory symptoms, liver dysfunction, neurological changes, and profound cytopenias throughout therapy.

Myleran is contraindicated in patients with known hypersensitivity to Busulfan, in pregnant or nursing women, and in individuals with severe hepatic or pulmonary impairment where the risk of toxicity outweighs potential benefit.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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