Leaflet TRABECTEDINA STADA 1mg powder for concentrate for solution for infusion

Indicated for: cancer

Route of administration: infusion

Substance: trabectedin (antineoplastic agent)

ATC: L01CX01 (Antineoplastic and immunomodulating agents | Plant alkaloids and other natural products | Other plant alkaloids and natural products)

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.

Trabectedin is an antineoplastic agent used in the treatment of advanced soft tissue sarcomas and recurrent ovarian cancer. It is a compound derived from a natural product extracted from a marine organism, Ecteinascidia turbinata, and works by binding to DNA, inhibiting gene transcription, and inducing apoptosis in tumor cells.

Trabectedin is administered intravenously, usually in 3-week cycles, with the dose adjusted based on the patient's body weight and tolerability. It is often used in combination with pegylated liposomal doxorubicin for ovarian cancer treatment.

Common side effects include nausea, vomiting, fatigue, neutropenia, and elevated liver enzyme levels. In rare cases, severe adverse reactions such as rhabdomyolysis, liver failure, or serious infections may occur. Careful monitoring of hematological and liver parameters is essential during treatment.

Trabectedin is a valuable therapeutic option for patients with sarcomas and ovarian cancer, contributing to prolonged survival and improved quality of life.

General data about TRABECTEDINA STADA 1mg

  • Substance: trabectedin
  • Date of latest medicines list: 01-06-2026
  • Product code: W70189001
  • Concentration: 1mg
  • Pharmaceutical form: powder for concentrate for solution for infusion
  • Quantity: 1
  • Product type: Generic medicine
  • Price: 4926.34 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: PRESTIGE PROMOTION VERKAUFSFÖRDERUNG - GERMANIA
  • Holder: STADA ARZNEIMITTEL AG - GERMANIA
  • Number: 15334/2024/01
  • Shelf life: 2 years-after packing for marketing;after the first opening of the bottle-it is used immediately

Concentrations available for trabectedin

  • 0.25mg
  • 1mg

Compensation lists for TRABECTEDINA STADA 1mg STADA

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

4926.34 RON

3198.58 RON

1727.76 RON