Leaflet IRINOTECAN KABI 20mg / ml concentrate for solution for infusion

Indicated for: colorectal cancer

Route of administration: infusion

Substance: irinotecan (topoisomerase inhibitor)

ATC: L01CE02 (Antineoplastic and immunomodulating agents | Plant alkaloids and other natural products | Topoisomerase 1 (TOP1) inhibitors)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Colitis / severe diarrhea
Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

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.

Genetic test recommended
Genetic test recommended

A genetic test may be needed before treatment.

Irinotecan is a chemotherapy medication used to treat metastatic colorectal cancer, usually in combination with other drugs. It works by inhibiting the enzyme topoisomerase I, which is essential for DNA replication in cancer cells, thereby causing their death.

The medication is administered intravenously under the supervision of an oncologist, and the dosage is adjusted based on body weight and the patient's overall condition.

Side effects may include severe diarrhea, nausea, vomiting, decreased blood cell counts, or hair loss. In rare cases, severe allergic reactions or liver toxicity may occur.

Patients should be closely monitored during treatment and inform their doctor about any other medications they are taking. Pregnant or breastfeeding women should not use this medication.

General data about IRINOTECAN KABI 20mg / ml

  • Substance: irinotecan
  • Date of latest medicines list: 01-06-2026
  • Product code: W65011001
  • Concentration: 20mg / ml
  • Pharmaceutical form: concentrate for solution for infusion
  • Quantity: 1
  • Product type: Generic medicine
  • Price: 69.66 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: FRESENIUS KABI ONCOLOGY PLC - MAREA BRITANIE
  • Holder: FRESENIUS KABI ROMANIA S.R.L. - ROMANIA
  • Number: 8422/2015/01
  • Shelf life: 2 years-dupa ambalarea dupa comercilaizare;after the first opening of the bottle-it is used immediately

Concentrations available for irinotecan

  • 1.5mg/ml
  • 20mg/ml
  • 4.3mg/ml

Compensation lists for IRINOTECAN KABI 20mg / ml Fresenius

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

69.66 RON

61.04 RON

8.62 RON