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 myelogenous leukemia and is used in conditioning regimens for hematopoietic stem cell 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 antineoplastic agent employed in specific hematologic malignancies and transplant conditioning.

  • Chronic myelogenous leukemia: provides disease control as part of systemic therapy.
  • Conditioning regimen for hematopoietic stem cell transplantation: eradicates residual malignant cells and creates immunosuppression to facilitate graft acceptance.
  • Myeloproliferative neoplasms: reduces proliferative activity as part of disease‑modifying treatment.

How It Works

  • Busulfan alkylates DNA by forming covalent cross‑links between DNA strands, which blocks DNA replication and transcription. The resulting DNA damage triggers cell‑cycle arrest and apoptosis, preferentially affecting rapidly dividing hematopoietic and malignant cells, thereby exerting its antineoplastic effect.

Side Effects

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

Common Side Effects

  • Nausea and vomiting
  • Mucositis or oral ulceration
  • Alopecia (hair loss)
  • Skin rash or hyperpigmentation
  • Elevated liver enzymes
  • Fatigue or weakness

Serious or Rare Side Effects

  • Pulmonary fibrosis or interstitial lung disease
  • Hepatic veno‑occlusive disease (sinusoidal obstruction syndrome)
  • Seizures, especially at high plasma concentrations
  • Severe bone‑marrow suppression leading to aplastic anemia
  • Life‑threatening infections due to neutropenia
  • Hemorrhagic cystitis

Precautions & Warnings

Before initiating therapy, several safety considerations should be addressed.

  • Monitor blood counts: perform regular CBC to detect marrow suppression.
  • Assess liver function: check hepatic enzymes and bilirubin before and during treatment.
  • Evaluate pulmonary status: obtain baseline lung function tests and monitor for respiratory symptoms.
  • Avoid concomitant nephrotoxic drugs: adjust dosing if renal impairment is present.
  • Consider seizure prophylaxis: use anticonvulsants when high‑dose regimens are planned.
  • Store at ambient temperature: keep below 25°C, protect from moisture and light.

Avoid Interactions

Busulfan interacts with several medications that can alter its efficacy or toxicity.

Major Interactions (Avoid)

  • Azathioprine: increased myelosuppression risk.
  • Cyclophosphamide: additive bone‑marrow toxicity.
  • Thiopurines (e.g., 6‑mercaptopurine): heightened hematologic toxicity.

Moderate Interactions (Monitor Closely)

  • Azole antifungals (e.g., fluconazole): may raise busulfan plasma levels.
  • Phenytoin or carbamazepine: can reduce busulfan concentrations.
  • Warfarin: potential alteration of INR requiring closer monitoring.

Frequently Asked Questions

Myleran, containing the active ingredient busulfan, is prescribed primarily for chronic myelogenous leukemia and as part of the conditioning regimen before hematopoietic stem cell transplantation. In these settings, it helps eradicate malignant cells and creates the immunosuppression needed for successful graft engraftment.

Busulfan belongs to the alkylating agent class. It forms covalent bonds with DNA, creating cross‑links that prevent DNA replication and transcription. This DNA damage leads to cell‑cycle arrest and apoptosis, especially in rapidly dividing cancerous and hematopoietic cells, providing its antineoplastic effect.

The exact dose of Myleran is individualized by the prescribing physician. Dosing is typically based on body surface area, the specific clinical indication, and therapeutic drug monitoring results. Adjustments may be made for liver function, renal function, and potential drug interactions.

Safety data for busulfan in pregnancy and lactation are limited, and the drug is generally considered contraindicated. Women of childbearing potential should use effective contraception, and breastfeeding is not recommended while receiving Myleran. Consultation with a healthcare professional is essential.

To order Myleran, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request verification of trade or institutional credentials. The team then provides pricing, availability, shipping details and any necessary import documentation.

Compared with cyclophosphamide, another common conditioning agent, busulfan offers a more predictable pharmacokinetic profile but carries a higher risk of hepatic veno‑occlusive disease and pulmonary toxicity. Choice of agent depends on disease characteristics, patient comorbidities, and institutional protocols.

Myleran tablets should be stored at ambient temperature, below 25 °C, in the original container to protect them from moisture and light. Keep the medication out of reach of children and avoid exposing it to excessive heat or humidity.

Myleran is taken orally as a tablet, usually with a full glass of water. The prescribing physician will specify the dosing schedule, which may involve single or divided doses. Patients should follow the exact timing and any food‑related instructions provided by their healthcare provider.

Serious risks include pulmonary fibrosis, hepatic veno‑occlusive disease, severe bone‑marrow suppression leading to aplastic anemia, seizures, and life‑threatening infections. Patients should promptly report respiratory difficulty, unexplained jaundice, persistent fever, or any neurological symptoms to their physician.

Myleran is contraindicated in patients with known hypersensitivity to busulfan, severe hepatic impairment, pre‑existing pulmonary fibrosis, or uncontrolled infections. It should also be avoided in pregnant or breastfeeding women unless the benefits outweigh the risks, and in individuals for whom the required monitoring cannot be ensured.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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