Leaflet MYLERAN 2mg film-coated tablets


Indicated for: conditioning before transplantation; hematologic malignancies

Route of administration: oral

Substance: busulfan (alkylating antineoplastic agent)

ATC: L01AB01 (Antineoplastic and immunomodulating agents | Alkylating agents | Alkyl sulfonates)

Busulfanum is a chemotherapeutic medication primarily used for the treatment of chronic myeloid leukemia (CML) and as part of conditioning regimens prior to hematopoietic stem cell transplantation. It is an alkylating agent that interferes with the DNA of cancer cells, inhibiting cell division and causing cell death.

The medication is administered orally or intravenously, as directed by a doctor. The dosage and duration of treatment are adjusted based on the type of cancer, the patient's overall condition, and their response to treatment.

Common side effects include nausea, vomiting, diarrhea, fatigue, and decreased blood cell counts, which may increase the risk of infections. In rare cases, more severe adverse effects such as pulmonary toxicity, hepatotoxicity, or infertility may occur.

Busulfanum is not recommended for pregnant or breastfeeding women, as it may affect fetal development. Patients should inform their doctor about all medications they are taking to avoid drug interactions. Additionally, regular monitoring during treatment is essential to detect and manage potential adverse effects.

General data about MYLERAN 2mg

  • Substance: busulfan
  • Date of last drug list: 01-05-2026
  • Commercial code: W58856002
  • Concentration: 2mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 100
  • Product type: original
  • Price: 345.08 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: EXCELLA GMBH - GERMANIA
  • Holder: ASPEN PHARMA TRADING LIMITED - IRLANDA
  • Number: 546/2008/02
  • Shelf life: 3 years

Pharmaceutical forms available for busulfan

Concentrations available for busulfan

  • 2mg
  • 6mg/ml

Compensation lists for MYLERAN 2mg Aspen

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

345.08 RON

345.08 RON

0.00 RON

NHP 9.1 (C2) - Spinal cord transplant

Price

Copayment

Patient

345.08 RON

345.08 RON

0.00 RON