Leaflet THIOTEPA MSN 15mg powder for concentrate for solution for infusion

Indicated for: cancer

Route of administration: infusion

Substance: thiotepa (antineoplastic agent)

ATC: L01AC01 (Antineoplastic and immunomodulating agents | Alkylating agents | Ethylene imines)

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.

Thiotepa is an alkylating agent used in the treatment of certain types of cancer, including bladder cancer, ovarian cancer, and breast cancer. It works by interfering with the DNA of cancer cells, thereby inhibiting their growth and division.

The medication is administered intravenously or intravesically, as directed by a doctor, and the dosage is adjusted based on the type of cancer and the patient's condition. It is primarily used as part of a chemotherapy regimen.

Patients should be closely monitored to detect potential side effects, such as bone marrow suppression, nausea, or liver toxicity. It is important for patients to inform their doctor of any unusual symptoms.

Common side effects include nausea, vomiting, decreased blood cell counts, and fatigue. In rare cases, severe reactions such as liver toxicity or serious infections may occur. Patients should be informed of these risks before starting treatment.

General data about THIOTEPA MSN 15mg

  • Substance: thiotepa
  • Date of latest medicines list: 01-10-2025
  • Product code: W71321001
  • Concentration: 15mg
  • Pharmaceutical form: powder for concentrate 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.

Marketing authorisation

  • Manufacturer: PHARMADOX HEALTHCARE LIMITED - MALTA
  • Holder: MSN LABS EUROPE LIMITED - MALTA
  • Number: 16190/2025/01
  • Shelf life: 2 years-after packing for marketing;dupa diluare-it is used immediately

Concentrations available for thiotepa

  • 100mg
  • 15mg
  • 400mg