Leaflet ELEBER 60mg concentrate and solvent for solution for infusion

Indicated for: prostate cancer

Route of administration: infusion

Substance: cabazitaxel (taxane antineoplastic)

ATC: L01CD04 (Antineoplastic and immunomodulating agents | Plant alkaloids and other natural products | Taxanes)

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.

Cabazitaxel is a medication used for the treatment of metastatic castration-resistant prostate cancer, particularly in patients previously treated with docetaxel. It is a chemotherapeutic agent from the taxane class that interferes with microtubule function, inhibiting cell division and causing cancer cell death.

The medication is administered via intravenous infusion, usually once every three weeks, in combination with prednisone, as directed by a doctor. The treatment requires close monitoring to manage side effects and assess the patient's response.

Common side effects include fatigue, nausea, diarrhea, decreased blood cell counts, and hair loss. In rare cases, severe adverse effects such as febrile neutropenia or allergic reactions may occur.

Cabazitaxel is not recommended for pregnant or breastfeeding women. Patients should inform their doctor about all medications they are taking to avoid drug interactions.

General data about ELEBER 60mg

  • Substance: cabazitaxel
  • Date of latest medicines list: 01-06-2026
  • Product code: W67781001
  • Concentration: 60mg
  • Pharmaceutical form: concentrate and solvent for solution for infusion
  • Quantity: 1
  • Product type: Generic medicine
  • Price: 11692.81 RON
  • 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 LTD. - MALTA
  • Holder: ZENTIVA K.S. - REPUBLICA CEHA
  • Number: 13967/2021/01
  • Shelf life: 3 years

Concentrations available for cabazitaxel

  • 10mg/ml
  • 20mg/ml
  • 60mg

Compensation lists for ELEBER 60mg Zentiva

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

11692.81 RON

9551.03 RON

2141.78 RON