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 is employed in the treatment of chronic myelogenous leukemia and as part of conditioning regimens prior to bone marrow or stem cell transplantation in adult patients.

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 across regulated markets.

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 conditioning.
  • Chronic myelogenous leukemia (CML): reduces leukemic cell burden and helps achieve remission.
  • Allogeneic stem cell transplantation conditioning: creates myeloablation to enable donor cell engraftment.
  • Autologous stem cell transplantation conditioning: facilitates collection and reinfusion of the patient’s own stem cells.

How It Works

  • Busulfan alkylates DNA by forming covalent bonds with nucleophilic sites, leading to interstrand cross‑links that block DNA replication and transcription. This interference triggers cell cycle arrest and apoptosis, preferentially affecting rapidly dividing hematopoietic cells and malignant clones, thereby providing cytoreductive and myeloablative effects essential for leukemia control and transplant preparation.

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.
  • Alopecia: temporary hair loss.

Serious or Rare Side Effects

  • Pulmonary fibrosis: progressive scarring of lung tissue.
  • Hepatic veno‑occlusive disease: blockage of small liver veins.
  • Seizures: neurological events, especially at high plasma concentrations.
  • Severe bone marrow suppression: leading to pancytopenia and heightened infection risk.

Precautions & Warnings

  • Busulfan requires careful monitoring and specific safety measures.
  • Dose adjustment: required in patients with hepatic impairment.
  • Renal function: monitor as excretion may be altered.
  • Pregnancy: category D; avoid unless benefits outweigh risks.
  • Concomitant therapy: avoid drugs that inhibit glutathione S‑transferase.
  • Monitoring: perform regular blood counts and liver function tests.
  • Store at ambient temperature: keep in the original container, protect from moisture and light.

Avoid Interactions

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

Major Interactions (Avoid)

  • Azathioprine: increased myelosuppression.
  • Cyclophosphamide: additive bone marrow toxicity.
  • Chloramphenicol: impaired metabolism leading to heightened toxicity.

Moderate Interactions (Monitor Closely)

  • Phenytoin: may alter busulfan clearance.
  • Antifungal azoles (e.g., fluconazole): may increase systemic exposure.
  • Acetaminophen: may affect hepatic metabolism and increase risk of liver injury.

Frequently Asked Questions

Myleran contains busulfan, an alkylating chemotherapy drug used primarily to treat chronic myelogenous leukemia and to prepare patients for bone marrow or stem cell transplantation by providing myeloablation that facilitates donor cell engraftment.

Busulfan alkylates DNA, creating cross‑links that block replication and transcription. This damage triggers cell cycle arrest and apoptosis, especially in rapidly dividing cancerous and hematopoietic cells, thereby reducing disease burden and creating space for transplanted stem cells.

The dosing regimen for Myleran is individualized and determined by the prescribing physician based on the patient’s condition, body surface area, liver function, and treatment goals. Patients should follow the specific instructions provided by their healthcare professional.

Busulfan is classified as pregnancy category D, indicating evidence of risk to the fetus. It should be avoided during pregnancy unless the potential benefit justifies the risk. Breastfeeding is not recommended 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 necessary import documentation.

Compared with other alkylating agents such as cyclophosphamide, busulfan offers a distinct pharmacokinetic profile with a longer half‑life and a higher propensity for pulmonary and hepatic toxicity. Choice of agent depends on disease specifics, patient comorbidities, and transplant protocol preferences.

Myleran tablets should be stored at ambient temperature, below 25 °C, in the original packaging to protect them from moisture and light. Keep the product out of reach of children and avoid storing in humid or excessively hot environments.

Myleran is supplied as oral tablets that are taken by mouth with water, usually on an empty stomach as directed by the treating physician. The exact schedule—single dose or divided doses—depends on the therapeutic plan and patient tolerance.

Serious risks include pulmonary fibrosis, hepatic veno‑occlusive disease, severe bone marrow suppression leading to pancytopenia, and seizures, particularly at high plasma concentrations. Patients should be monitored closely for respiratory symptoms, liver dysfunction, and blood count abnormalities.

Myleran is contraindicated in patients with known hypersensitivity to busulfan or any component of the formulation, in those with severe hepatic impairment, and in pregnant women unless the therapeutic benefit outweighs the potential fetal risk. Caution is also advised for individuals with pre‑existing lung disease.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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