Prostate cancer

Active Ingredient: Cabazitaxel

Indication for Cabazitaxel

Population group: men, only adults (18 years old or older)

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:

25 mg/m² once

Route of admnistration

Intravenous

Defined daily dose

25 - 25 mg per m² of body surface area (BSA)

Dosage regimen

From 25 To 25 mg per m² of body surface area (BSA) once every 21 day(s)

Detailed description

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:

  • antihistamine (dexchlorpheniramine 5 mg or diphenhydramine 25 mg or equivalent),
  • corticosteroid (dexamethasone 8 mg or equivalent), and
  • H2 antagonist (ranitidine or equivalent).

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.

Posology

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 adjustments

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 reactionsDose modification
Prolonged grade ≥3 neutropenia (longer than 1 week) despite appropriate treatment including G-CSFDelay 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 infectionDelay 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 replacementDelay treatment until improvement or resolution, then reduce cabazitaxel dose from 25 mg/m² to 20 mg/m².
Grade >2 peripheral neuropathyDelay 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.

Dosage considerations

1 hour intravenous infusion.

Active ingredient

Cabazitaxel

Cabazitaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells. Cabazitaxel binds to tubulin and promotes the assembly of tubulin into microtubules while simultaneously inhibiting their disassembly.

Read more about Cabazitaxel

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