Composition
Inf 60 mg: Cabazitaxel 60 mg; 1.5 ml solution for infusion in vial plus solvent.
Indications & Dosage
Treatment of hormone refractory metastatic prostate cancer in patients who have previously been treated with a docetaxel (in combination with prednisone or prednisolone): BY IV INF: Adults: 25 mg/m2 IV INF over 1 hr every 3 wk, with daily prednisolone. Premedicate with an antihistamine, corticosteroid and H2 antagonist >30 min before each INF.
Administration
IV as a 1 hour infusion at room temperature. Initially each vial of Cabazitaxel 60 mg per 1.5 ml is mixed with the entire contents of supplied dilu-ent to get the concentration of 10 mg/ml. This dilution requires further dilution that should be done within 30min, dilute it into a sterile 250 ml PVC free container of NaCI 0.9% solution or dextrose 5% solution for infusion. If a dose greater than 65 mg is required, use a larger volume of the infusion vehicle so that a concentration of 0.26 mg/ml is not exceeded. The concentration of the final dilution should be between 0.1 and 0.26 mg/ml.
Stability
Cabazitaxel final dilution should be used immedi-ately or within 8 hours at ambient temperature or within a total of 24 hours if refrigerated. After final dilution of infusion solution is supersaturated, it may crystallize over time; discard it
Contraindications
Hepatic impairment. Ensure contraception and continue for 6 months after treatment.
Precautions
Moderate to severe renal impairment, use with caution if creatinine clearance less than 50ml/minute, anaemia. Consider prophylactic G-CSF to reduce risk of neutropenia. Provide anti-emetic prophylaxis. Ensure adequate hydration. Monitor blood counts weekly during cycle 1 and before each subsequent cycle, measure serum creatinine before treatment and with each blood count. Advise patients to report symptoms of peripheral neuropathy and changes in urinary output. Suspend or reduce dosing if febrile or prolonged grade >3 neutropenia, grade >3 or persistent diarrhoea or grade >2 peripheral neuropathy occurs; discontinue if grade >3 renal failure occurs.
Interactions
Inhibitors or inducers of CYP3A4, live vaccines, St. Johns Wort.
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding.
Side Effects
Hypersensitivity reactions, alopecia, anxiety, arthralgia, atrial fibrillation, bone-marrow suppression, chest pain, chills, confusion, constipation, cough, dehydration, diarrhoea, dizziness, dyspepsia, dyspnea, electrolyte disturbances, erythema, extravasation, flushing, gastroesophageal reflux, haemorrhoids, hyperglycaemia, hypertension, hyperuricaemia, hypoesthesia, hypotension, increased lacrimation, malaise, muscle spasm, myalgia, nausea, oedema, oral mucositis, paraesthesia, peripheral neuropathy, rectal haemorrhage, renal disorders, sciatica, tachycardia, thromboembolism, tinnitus, tumourlysis syndrome, urinary retention, vertigo, vomiting