🔴 Red Flag (Important) Information
• Severe neutropenia and febrile neutropenia are common and potentially fatal → baseline and frequent FBC monitoring mandatory
• Primary G-CSF prophylaxis is strongly recommended in high-risk patients (elderly, prior neutropenia, poor performance status)
• Treatment-related mortality has been reported, especially in patients with poor marrow reserve
• Severe diarrhoea and dehydration can occur → early recognition and aggressive supportive care required
• Avoid in severe hepatic impairment → significantly increased toxicity
• Hypersensitivity reactions possible → mandatory premedication with corticosteroid + antihistamine
Generic name: Cabazitaxel
Class: Taxane (microtubule inhibitor)
Formulation: Concentrate for solution for intravenous infusion
Strength: 60 mg vial
Route: Intravenous (IV infusion)
Mechanism of Action:
Cabazitaxel is a taxane that inhibits microtubule depolymerisation, leading to disruption of mitosis and tumour cell death. It retains activity in tumours resistant to docetaxel.
Prostate Cancer
Cabazitaxel is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC)
who have previously been treated with a docetaxel-containing regimen,
in combination with prednisone or prednisolone.
Standard dose:
• 25 mg/m² IV infusion every 3 weeks
Given in combination with:
• Prednisone or prednisolone 10 mg orally daily
Administration notes:
• Infuse over 1 hour
• Must be administered by experienced oncology personnel
• Premedication required before each dose:
– Corticosteroid
– Antihistamine (H1 antagonist)
– H2 antagonist
Continue treatment until disease progression or unacceptable toxicity.
Haematological toxicity:
• Delay treatment if ANC < 1.5 × 10⁹/L
• Reduce dose to 20 mg/m² after:
– Febrile neutropenia
– Prolonged grade ≥3 neutropenia
Non-haematological toxicity:
• Grade ≥3 diarrhoea or other severe toxicity → withhold until recovery, then resume at reduced dose
Hepatic impairment:
• Mild impairment: dose reduction required
• Moderate–severe impairment: contraindicated
Mandatory:
• Prednisone / prednisolone 10 mg daily
Supportive:
• G-CSF prophylaxis (strongly recommended in high-risk patients)
• Antidiarrhoeals (early use encouraged)
Avoid / caution:
• Strong CYP3A inhibitors or inducers
• Live vaccines during treatment
• Hypersensitivity to cabazitaxel or polysorbate 80
• Baseline neutrophil count < 1.5 × 10⁹/L
• Severe hepatic impairment
• Pregnancy and breastfeeding
• Concomitant live vaccines
Before each cycle:
• Full blood count (mandatory)
• Liver function tests
• Renal function
During treatment:
• Monitor for fever, infection, diarrhoea, dehydration
• Monitor weight, performance status
• PSA and clinical response monitoring
Very common (>10%)
• Neutropenia, anaemia, thrombocytopenia
• Diarrhoea, nausea, vomiting
• Fatigue, asthenia
Common (1–10%)
• Febrile neutropenia
• Peripheral neuropathy
• Renal impairment
• Haematuria
Serious / life-threatening
• Sepsis
• Severe diarrhoea with dehydration
• Treatment-related death
Management:
• Early G-CSF use
• Prompt antibiotics for fever
• Aggressive IV fluids if diarrhoea occurs
• Dose reduction or discontinuation if recurrent toxicity
• Elderly: Higher risk of neutropenia → consider G-CSF
• Renal impairment: Use with caution
• Hepatic impairment: Contraindicated if severe
• Women / paediatrics: Not indicated
Continue until:
• Radiological or clinical disease progression, or
• Unacceptable toxicity
Permanently discontinue if:
• Life-threatening neutropenia despite dose reduction
• Severe hypersensitivity reaction
• Persistent grade ≥3 toxicity despite optimal management
https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2023/11/Final_PI_Cabxel_Applicant.pdf
| Trade Name | |
|---|---|
| Drug Class | 1 |
| Cost | |
| Company | |
|---|---|
| Drug Rep | Admin |
| Indications | Prostate Cancer |
| Dosage |