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 myelogenous leukemia and serves as a conditioning component in bone marrow transplantation protocols.

GNH India supplies Myleran as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, transplant centres, oncology centres and pharmacies worldwide. The company adheres to stringent quality standards and provides reliable logistics for global distribution. Clients benefit from consistent product availability and regulatory support across multiple markets.

Manufacturer / TM Owner

Aspen Pharma Trading Limited

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Indications & Clinical Uses

Busulfan, an alkylating agent, is used in hematologic malignancies and as part of conditioning regimens for stem cell transplantation.

  • Chronic myelogenous leukemia: reduces leukemic cell proliferation and contributes to disease remission.
  • Bone marrow transplantation (conditioning regimen): eradicates residual host marrow cells to enable successful engraftment of donor stem cells.
  • Acute myeloid leukemia (pre‑transplant preparation): provides cytoreduction before allogeneic transplantation in selected protocols.
  • Myelodysplastic syndromes (intensive therapy): used in combination regimens to achieve disease control prior to transplant.
  • Chronic myeloproliferative disorders (as part of combination therapy): helps control disease burden before definitive treatment.

How It Works

  • Busulfan exerts its antineoplastic effect by alkylating DNA at the N7 position of guanine residues, creating intra‑ and interstrand cross‑links that block DNA replication and transcription. The resulting DNA damage triggers apoptosis in rapidly dividing hematopoietic cells, thereby reducing malignant clone proliferation. The drug is metabolized primarily by glutathione S‑transferase in the liver, and its activity is influenced by hepatic function and concurrent medications that affect conjugation pathways.

Side Effects

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

Common Side Effects

  • Nausea: mild to moderate gastrointestinal upset.
  • Vomiting: occasional episodes, may require antiemetic therapy.
  • Mucositis: inflammation of the oral mucosa causing discomfort.
  • Alopecia: temporary hair loss during treatment.
  • Fever: low‑grade pyrexia without infection.

Serious or Rare Side Effects

  • Pulmonary fibrosis: progressive scarring of lung tissue, may be irreversible.
  • Hepatic veno‑occlusive disease: obstruction of hepatic venules leading to liver dysfunction.
  • Seizures: central nervous system events, especially at high plasma concentrations.
  • Severe bone marrow suppression: profound neutropenia, anemia, and thrombocytopenia increasing infection and bleeding risk.
  • Secondary malignancies: rare development of new cancers after prolonged exposure.

Precautions & Warnings

When using Busulfan, careful monitoring and specific precautions are recommended to minimize toxicity.

  • Dose adjustment: required in patients with hepatic impairment or reduced glutathione S‑transferase activity.
  • Monitor blood counts: perform regular CBCs to detect myelosuppression early.
  • Avoid in pulmonary disease: increased risk of fibrosis warrants caution in pre‑existing lung conditions.
  • Contraception: both male and female patients should use effective contraception during treatment and for a defined period after.
  • Store at ambient temperature: keep below 25°C, protect from moisture and light in the original packaging.

Avoid Interactions

Busulfan can interact with several medicines, altering its efficacy or increasing toxicity.

Major Interactions (Avoid)

  • Azathioprine: additive myelosuppression may lead to severe bone marrow failure.
  • Cyclophosphamide: combined alkylating effect raises risk of organ toxicity.
  • Chloramphenicol: inhibits hepatic metabolism, increasing busulfan plasma levels.

Moderate Interactions (Monitor Closely)

  • Phenytoin: enzyme induction may lower busulfan concentrations, reducing effectiveness.
  • Itraconazole: strong CYP3A4 inhibition can raise busulfan exposure, requiring dose adjustment.
  • Acetaminophen: high doses may compete for conjugation pathways, affecting clearance.

Frequently Asked Questions

Myleran is the brand name for busulfan, an oral alkylating agent indicated for the treatment of chronic myelogenous leukemia and as part of conditioning regimens prior to allogeneic bone marrow or stem‑cell transplantation. It helps eradicate malignant hematopoietic cells and prepares the patient’s marrow for donor cell engraftment.

Busulfan exerts its antineoplastic activity by forming covalent bonds with DNA, primarily at the N7 position of guanine. These alkylations create intra‑ and interstrand cross‑links that block DNA replication and transcription, leading to apoptosis of rapidly dividing hematopoietic cells. The drug’s effect is amplified in cells with limited DNA repair capacity.

The dosage of Myleran is individualized by the prescribing physician based on the patient’s disease, body surface area, liver function, and therapeutic drug monitoring results. Dosing regimens may involve single or divided oral administrations, and adjustments are made to achieve target plasma concentrations while minimizing toxicity. Patients should follow the prescriber’s specific instructions.

The safety of busulfan in pregnancy and lactation has not been established, and the drug is classified as contraindicated for use in pregnant women because of its potential to cause fetal harm. Breastfeeding is also discouraged, as busulfan can be excreted in milk and may affect the infant. Consultation with a specialist is essential before exposure.

To request Myleran, visit the product page on gnhindia.com, enter the desired quantity, and submit the enquiry form. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details—including any required cold‑chain handling—and assistance with import documentation.

The primary alternative to busulfan in conditioning regimens is cyclophosphamide, another alkylating agent. Busulfan offers a more predictable pharmacokinetic profile when therapeutic drug monitoring is applied, and it is associated with lower rates of certain organ toxicities such as cardiotoxicity. However, cyclophosphamide may be preferred when a broader immunosuppressive effect is needed. Choice depends on patient‑specific factors and institutional protocols.

Myleran tablets should be stored at ambient temperature, preferably below 25 °C, in their original blister pack to protect from moisture and light. Do not refrigerate or freeze the product. Keep the medication out of reach of children and store it in a dry place away from direct sunlight to maintain stability throughout its shelf life.

Myleran is taken orally, usually with a glass of water, and may be administered with or without food depending on the prescriber’s guidance. The tablet should be swallowed whole and not crushed or chewed, unless the formulation specifically allows it. Dosing intervals and the total number of doses are determined by the treating physician and may be adjusted based on plasma level monitoring.

The most severe adverse events linked to busulfan include pulmonary fibrosis, hepatic veno‑occlusive disease, severe bone marrow suppression leading to life‑threatening infections or bleeding, and rare occurrences of secondary malignancies. Early detection through regular clinical and laboratory monitoring is critical, and any signs of respiratory distress, liver dysfunction, or unexplained cytopenias should prompt immediate medical evaluation.

Myleran is contraindicated in patients with known hypersensitivity to busulfan or any component of the formulation, those with severe hepatic impairment, and individuals with pre‑existing pulmonary fibrosis. Caution is also advised for patients with active infections, uncontrolled cardiovascular disease, or those who are pregnant or breastfeeding. The prescribing clinician must assess each patient’s medical history before initiating therapy.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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