Cabazitaxel

Indications & Dose:

With prednisolone for hormone-refractory meta-static prostate cancer previously treated with docetaxel.

DOSAGE:

Adults: 25 mg/m2 by IV inf over 1 hr every 3 wk, with daily prednisolone. Premedicate with an antihistamine, cor-ticosteroid and H2 antagonist >30 min before each inf.

Children: Not applicable.

Administration: IV as a 1 hour infusion at room temperature

Initial dilution: Each vial of Cabazitaxel 60 mg per 1.5 mL must first be mixed with the entire contents of supplied dilu-ent to get the concentration of 10 mg/mL. This dilution re-/ quires further dilution before administration and it should be done within 30 min.

Final dilution: Withdraw the recommended dose from the 10 mg/mL and further dilute 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 fi-nal 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. Because the final dilution of infusion solution is supersaturated, it may crystallize over time. Do not use and discard if this occurs

Contraindications:

Hepatic impairment (bilirubin > x ULN or I AST/ALT >1.5 x ULN), neutrophils <1500/mm3. Ensure / contraception and continue for 6 months after treatment.

Side Effects:

Cautions:

Precautions:

Moderate to severe renal impairment (CrCI <50 mL/min), 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. Ad-/ vise 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 oc-curs; discontinue if grade >3 renal failure occurs. 

Interaction:

Inhibitors or inducers of CYP3A4, live vaccines, St. John’s Wort

Warnings:

Adverse Effects:

Infections, blood dyscrasias, anorexia, de-hydration, hyperglycaemia, hypokalaemia, anxiety, confu-sion, dysgeusia, peripheral neuropathy, dizziness, head-ache, paraesthesia, fatigue, hypoesthesia. increased lacrimation, tinnitus, vertigo, arrhythmias, blood pressure changes, DvT, hot flushes, flushing, dyspnoea, cough, oropharyngeal pain, Gl upset, haemorrhoids, rectal haemor-rhage, dry mouth, alopecia, dry skin, erythema, musculo-skeletal pain, muscle spasm, flank pain, renal failure, dysuria, renal colic, haematuria, pollakiuria, hydronephro-sis, urinary retention ad incontinence, ureteric obstruction, pelvic pain, asthenia, fever, oedema, mucosal inflammation, chest pain, chills, weight loss, raised liver enzymes

Pregnancy: Contraindicated in pregnancy.
Lactation: Contraindicated or not recommended.

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: