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 myeloid leukemia in adult patients and is employed as part of conditioning regimens for bone marrow or stem cell transplantation.

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. Deliveries are coordinated through a network of certified partners to ensure timely access.

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 Myeloid Leukemia: reduces leukemic cell proliferation and helps achieve disease control.
  • Bone Marrow Transplant Conditioning: provides myeloablative effect to facilitate donor graft engraftment.
  • Stem Cell Transplant Conditioning: creates immunosuppression and marrow ablation for successful stem cell engraftment.

How It Works

  • Busulfan alkylates DNA by forming covalent cross‑links at the N7 position of guanine bases. These cross‑links prevent DNA strand separation during replication and transcription, inhibiting cell division and triggering apoptosis of rapidly proliferating hematopoietic and leukemic cells.

Side Effects

Busulfan may cause a range of adverse reactions.

Common Side Effects

  • Nausea
  • Vomiting
  • Oral mucositis
  • Low blood counts (neutropenia, thrombocytopenia)

Serious or Rare Side Effects

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

Precautions & Warnings

  • When using Myleran, careful monitoring and specific precautions are required.
  • Monitor blood counts: perform regular CBC to detect myelosuppression.
  • Assess liver function: evaluate hepatic enzymes before and during therapy.
  • Avoid in pregnancy: drug is contraindicated due to fetal risk.
  • Use anticonvulsant prophylaxis: consider seizure prophylaxis in high‑risk patients.
  • Adjust dose in renal/hepatic impairment: follow prescriber guidance.
  • Store at ambient temperature: keep below 25°C, retain original packaging, protect from moisture.

Avoid Interactions

Busulfan interacts with several medicines; some require avoidance while others need monitoring.

Major Interactions (Avoid)

  • Concomitant use with other alkylating agents: increased toxicity.
  • Concurrent azathioprine or cyclophosphamide: additive myelosuppression.
  • Strong CYP2C9 inhibitors (e.g., fluconazole): increased busulfan exposure.

Moderate Interactions (Monitor Closely)

  • Anticonvulsants (phenytoin, carbamazepine): may lower busulfan levels.
  • Acetaminophen: may affect metabolism.
  • NSAIDs: may increase bleeding risk due to thrombocytopenia.

Frequently Asked Questions

Myleran contains busulfan, an alkylating antineoplastic agent. It is indicated for the treatment of chronic myeloid leukemia (CML) in adult patients and as part of conditioning regimens prior to allogeneic bone marrow or peripheral blood stem cell transplantation. The drug works by destroying rapidly dividing malignant cells and creating a myeloablative environment that facilitates engraftment of donor stem cells.

Busulfan exerts its antineoplastic effect by alkylating DNA. It forms covalent cross‑links at the N7 position of guanine residues, which prevents DNA strand separation during replication and transcription. This interference leads to inhibition of cell division and ultimately triggers apoptosis of rapidly proliferating hematopoietic and leukemic cells, providing the cytotoxic basis for its use in leukemia and transplant conditioning.

The specific dose of Myleran is individualized by the treating physician based on factors such as the patient’s age, body surface area, disease status, and whether it is being used for leukemia treatment or transplant conditioning. Dosing regimens are calculated to achieve target plasma concentrations and are adjusted according to therapeutic drug monitoring and clinical response. Patients should follow the prescriber’s instructions precisely.

Busulfan is classified as Pregnancy Category D, indicating evidence of fetal risk. It can cause congenital malformations and should be avoided in pregnant women. Women of childbearing potential must use effective contraception during treatment and for a defined period after the last dose. Breastfeeding is not recommended because the drug may be excreted in milk and could harm the infant.

To place an order, visit the product page for Myleran on the GNH India website (gnhindia.com) and submit an enquiry with the required quantity. GNH India supplies hospitals, pharmacies, and procurement teams worldwide and will request verification of trade or institutional credentials. After confirmation, the sales team provides pricing, availability, shipping details—including any special handling—and assists with import documentation.

Myleran (busulfan) is an oral alkylating agent commonly used alongside cyclophosphamide or fludarabine in myeloablative conditioning protocols. Compared with total body irradiation, busulfan offers a fully pharmacologic approach with adjustable dosing based on plasma levels, but it carries risks such as hepatic veno‑occlusive disease and pulmonary toxicity. Choice of conditioning regimen depends on disease type, patient comorbidities, and transplant centre experience.

Myleran tablets should be stored at ambient temperature, preferably below 25 °C (77 °F). Keep the medication in its original container, tightly closed, and protect it from moisture, heat, and direct sunlight. Do not refrigerate or freeze the tablets, and keep them out of reach of children. Proper storage helps maintain potency throughout the shelf life.

Myleran is supplied as oral tablets that are taken by mouth with a glass of water, usually on an empty stomach to improve absorption. The prescribing physician determines the total daily dose and may split it into multiple administrations over several days, especially when used for transplant conditioning. Patients should not alter the dosing schedule or chew the tablets unless instructed.

The most serious adverse reactions to Myleran include hepatic veno‑occlusive disease, which can lead to liver failure; pulmonary fibrosis, a potentially irreversible lung condition; severe bone marrow suppression resulting in prolonged neutropenia or thrombocytopenia; and seizures, particularly at high plasma concentrations. Prompt recognition and supportive care are essential, and therapeutic drug monitoring is often employed to minimize these risks.

Myleran is contraindicated in patients with known hypersensitivity to busulfan or any component of the tablet formulation. It should not be used in pregnant women due to teratogenic risk, and caution is advised in nursing mothers. Individuals with severe hepatic impairment, active uncontrolled infections, or pre‑existing pulmonary fibrosis should avoid the drug unless the benefits clearly outweigh the risks and close monitoring is ensured.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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