Leaflet TOPOTECAN ZENTIVA 4mg powder for concentrate infusion solution


Indicated for: ovarian cancer; small cell lung cancer

Substance: topotecan (topoisomerase inhibitor)

ATC: L01CE01 (Antineoplastic and immunomodulating agents | Plant alkaloids and other natural products | Topoisomerase 1 (TOP1) inhibitors)

Topotecan is an antineoplastic agent from the class of topoisomerase I inhibitors, used in the treatment of recurrent ovarian cancer, small cell lung cancer, and other types of cancer. It works by inhibiting the enzyme topoisomerase I, which is essential for DNA replication, thereby causing tumor cell death.

Topotecan is administered intravenously or orally, usually in treatment cycles, with the dose adjusted based on the patient's body weight and tolerability. It is often used in combination with other chemotherapeutic agents to enhance treatment efficacy.

Common side effects include neutropenia, anemia, nausea, vomiting, diarrhea, and fatigue. In rare cases, severe adverse reactions such as serious infections or pulmonary toxicity may occur. Careful monitoring of hematological parameters and the patient's overall condition is essential during treatment.

Topotecan is an important therapeutic option for patients with advanced cancer, contributing to disease control and prolonged survival.

General data about TOPOTECAN ZENTIVA 4mg

  • Substance: topotecan
  • Date of last drug list: 01-01-2023
  • Commercial code: W69280001
  • Concentration: 4mg
  • Pharmaceutical form: powder for concentrate infusion solution
  • Quantity: 1
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: SINDAN - PHARMA S.R.L. - ROMANIA
  • Holder: ZENTIVA, K.S. - REPUBLICA CEHA
  • Number: 13395/2020/01
  • Shelf life: 4 years

Concentrations available for topotecan

  • 0.25mg
  • 1mg
  • 1mg/1ml
  • 1mg/ml
  • 4mg
  • 4mg/4ml
  • 500mg