Jevtana
Metastatic castration-resistant prostate cancer (mCRPC) — in combination with prednisone, in patients previously treated with a docetaxel-containing regimen.
25 mg/m² IV over 1 hour every 3 weeks (with oral prednisone 10 mg daily)
20 mg/m² may be used for dose reduction or based on clinical judgment
Pre-medication: Antihistamine (diphenhydramine 25 mg or equivalent), corticosteroid (dexamethasone 8 mg or equivalent), H2 antagonist, and antiemetic — all at least 30 minutes before
G-CSF: Consider primary prophylaxis in high-risk patients
Injection: 60 mg/1.5 mL concentrate (requires dilution with supplied diluent before further dilution with infusion fluid)
Neutrophil count ≤1,500/mm³. History of severe hypersensitivity to cabazitaxel or polysorbate 80. Severe hepatic impairment (total bilirubin >3× ULN).
- Neutropenia: Grade 3-4 in 82%. Febrile neutropenia in 8%. Fatal neutropenic infections. Monitor CBC weekly Cycle 1, then before each cycle.
- Hypersensitivity: Severe reactions (including generalized rash/erythema, hypotension, bronchospasm) reported (in 1%). Immediately D/C for severe reactions.
- GI Disorders: Nausea (34%), vomiting (22%), diarrhea (47%). GI hemorrhage/perforation, ileus, and colitis reported.
- Renal Failure: Including fatal cases. Risk factors: age ≥65, dehydration, pre-existing renal impairment.
- Elderly: Patients ≥65 at greater risk for fatal outcomes.
Neutropenia (94%), anemia (97%), leukopenia (96%), diarrhea (47%), fatigue (37%), nausea (34%), vomiting (22%), asthenia (20%), constipation (20%), hematuria (17%), back pain (16%), abdominal pain (11%), arthralgia (11%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Cabazitaxel is a semi-synthetic taxane derived from a natural taxoid precursor extracted from yew needles. Like docetaxel and paclitaxel, it stabilizes microtubules by promoting tubulin assembly and inhibiting depolymerization, leading to mitotic arrest and cell death. However, cabazitaxel was specifically selected for poor affinity for P-glycoprotein (P-gp/MDR1), the drug efflux pump that confers resistance to docetaxel and paclitaxel. This allows cabazitaxel to maintain activity in docetaxel-resistant tumors, including those with P-gp overexpression.
Half-life: 95 hours (terminal). Vd: 4,870 L (extensive tissue distribution). Protein binding: 89-92%. Metabolized by CYP3A4/5 (>20 metabolites). Clearance: 48.5 L/h. Excreted in feces (76%) and urine (3.7%).
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
- TROPIC — Cabazitaxel + prednisone vs. mitoxantrone + prednisone in mCRPC after docetaxel. Phase III, n=755.