Active Ingredient: Cabazitaxel
Cabazitaxel in combination with prednisone or prednisolone is indicated for the treatment of adult patients with metastatic castration resistant prostate cancer previously treated with a docetaxel-containing regimen.
For this indication, competent medicine agencies globally authorize below treatments:
Intravenous
25 - 25 mg per m² of body surface area (BSA)
From 25 To 25 mg per m² of body surface area (BSA) once every 21 day(s)
The recommended premedication regimen should be performed at least 30 minutes prior to each administration of cabazitaxel with the following intravenous medicinal products to mitigate the risk and severity of hypersensitivity:
Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed.
Throughout the treatment, adequate hydration of the patient needs to be ensured, in order to prevent complications like renal failure.
The recommended dose of cabazitaxel is 25 mg/m² administered as a 1 hour intravenous infusion every 3 weeks in combination with oral prednisone or prednisolone 10 mg administered daily throughout treatment.
Dose modifications should be made if patients experience the following adverse reactions (Grades refer to Common Terminology Criteria for Adverse Events [CTCAE 4.0]): Table 1 – Recommended dose modifications for adverse reaction in patients treated with cabazitaxel
| Adverse reactions | Dose modification |
|---|---|
| Prolonged grade ≥3 neutropenia (longer than 1 week) despite appropriate treatment including G-CSF | Delay treatment until neutrophil count is >1,500 cells/mm³, then reduce cabazitaxel dose from 25 mg/m² to 20 mg/m². |
| Febrile neutropenia or neutropenic infection | Delay treatment until improvement or resolution, and until neutrophil count is >1,500 cells/mm³, then reduce cabazitaxel dose from 25 mg/m² to 20 mg/m². |
| Grade ≥3 diarrhoea or persisting diarrhoea despite appropriate treatment, including fluid and electrolytes replacement | Delay treatment until improvement or resolution, then reduce cabazitaxel dose from 25 mg/m² to 20 mg/m². |
| Grade >2 peripheral neuropathy | Delay treatment until improvement, then reduce cabazitaxel dose from 25 mg/m² to 20 mg/m². |
If patients continue to experience any of these reactions at 20 mg/m², further dose reduction to 15 mg/m² or discontinuation of cabazitaxel may be considered. Data in patients below the 20 mg/m² dose are limited.
1 hour intravenous infusion.
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