Leaflet BUSULFAN ACCORD 6mg / ml concentrate for solution for infusion

Indicated for: conditioning before transplantation; hematologic malignancies

Route of administration: infusion

Substance: busulfan (alkylating antineoplastic agent)

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

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
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 BUSULFAN ACCORD 6mg / ml

  • Substance: busulfan
  • Date of latest medicines list: 01-06-2026
  • Product code: W65792001
  • Concentration: 6mg / ml
  • Pharmaceutical form: concentrate for solution for infusion
  • Quantity: 1
  • Product type: Generic medicine
  • Price: 1196.75 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: WESSLING HUNGARY KFT. - UNGARIA
  • Holder: ACCORD HEALTHCARE POLSKA SP. Z O.O. - POLONIA
  • Number: 13585/2020/01
  • Shelf life: 18 months

Pharmaceutical forms available for busulfan

Concentrations available for busulfan

  • 2mg
  • 6mg/ml

Compensation lists for BUSULFAN ACCORD 6mg / ml Accord

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

1196.75 RON

1196.75 RON

0.00 RON

NHP 9.1 (C2) - Spinal cord transplant

Price

Copayment

Patient

1196.75 RON

1196.75 RON

0.00 RON