Leaflet OVASTAT 5000mg powder for solution for infusion

Indicated for: cancer

Route of administration: infusion

Substance: treosulfan (antineoplastic agent)

ATC: L01AB02 (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.

Treosulfan is an alkylating agent primarily used as part of conditioning regimens for hematopoietic stem cell transplantation. It works by forming covalent bonds with DNA, leading to the inhibition of cellular replication and the destruction of malignant or existing hematopoietic cells.

Treosulfan is administered intravenously, usually in combination with other drugs such as fludarabine, to prepare patients for transplantation. It is particularly used in patients who cannot tolerate more intensive conditioning regimens due to its lower toxicity profile.

Common side effects include myelosuppression, nausea, vomiting, diarrhea, and fatigue. In rare cases, severe adverse reactions such as hepatotoxicity, pulmonary function impairment, or serious infections may occur. Careful monitoring of hematological parameters and organ function is essential during treatment.

Treosulfan is an important therapeutic option for patients requiring stem cell transplantation, contributing to increased success rates and reduced associated risks.

General data about OVASTAT 5000mg

  • Substance: treosulfan
  • Date of latest medicines list: 01-06-2016
  • Product code: W60302001
  • Concentration: 5000mg
  • Pharmaceutical form: powder for solution for infusion
  • Quantity: 1
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Concentrations available for treosulfan

  • 5000mg
  • 5g