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

Product code:
W70189001
Quantity:
1
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
4926.34 RON
Copayment
3198.58 RON
Patient
1727.76 RON