JEVTANA: Cabazitaxel Concentrate And Solvent For Infusion - Summary Of Product Characteristics.pdf

Key Features:

1. Medicinal Product: JEVTANA 60 mg concentrate and solvent for solution for infusion.
2. Composition:
- One ml of concentrate contains 40 mg cabazitaxel.
- After dilution, each ml of solution contains 10 mg cabazitaxel.
- Excipient: Polysorbate 80 (1.56 g/vial) and ethanol 96% (573.3 mg/solvent vial).
3. Pharmaceutical Form: Sterile concentrate and solvent for infusion (clear yellow to brownish-yellow oily solution).
4. Indications:
- Treated adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing regimen.
5. Posology & Administration:
- Dose: 25 mg/m² administered as a 1-hour intravenous infusion every 3 weeks.
- Premedication recommended to mitigate hypersensitivity reactions (antihistamine, corticosteroid, H2 antagonist).
- Adequate hydration is crucial to prevent complications like renal failure.
6. Dose Adjustments:
- For adverse reactions (Grades refer to CTCAE 4.0), reduce dose as follows:
- Prolonged grade ≥3 neutropenia: from 25 mg/m² to 20 mg/m².
- Febrile neutropenia or neutropenic infection: from 25 mg/m² to 20 mg/m².
- Grade ≥3 diarrhoea: from 25 mg/m² to 20 mg/m², further reduction to 15 mg/m² or discontinuation if persistent.
7. Special Populations:
- Hepatic Impairment: Dose reduction recommended for mild impairment; not recommended for severe impairment.
- Renal Impairment: No dose adjustment needed unless end-stage renal disease (creatinine clearance <15 mL/min/1.73 m²).
- Elderly: No specific dose adjustment recommended.
8. Contraindications:
- Hypersensitivity to cabazitaxel, other taxanes, polysorbate 80, or any excipient listed.
- Neutrophil counts <1,500/mm³.
- Severe hepatic impairment (total bilirubin >3 x ULN).
- Concomitant vaccination with yellow fever vaccine.
9. Special Precautions:
- Hypersensitivity reactions require pre-medication and close observation during infusion.
- Bone marrow suppression may occur, necessitating monitoring for neutropenia, anaemia, thrombocytopenia, or pancytopenia.