Leaflet MYLERAN 2mg film-coated tablets

Product code:
W58856002
Quantity:
100
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

Precautions:

Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling

Handle with special care.

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Busulfan 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.

Busulfan 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 latest medicines list:
01-06-2026
Product code:
W58856002
Concentration:
2mg
Pharmaceutical form:
film-coated tablets
Quantity:
100
Product type:
Original
Price:
345.08 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

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
345.08 RON
Copayment
345.08 RON
Patient
0.00 RON

NHP 9.1 (C2) - Spinal cord transplant

Price
345.08 RON
Copayment
345.08 RON
Patient
0.00 RON