cabazitaxel: clinical use

Prescribing considerations

• Restrict use to specialist cytotoxic services with immediate facilities for managing severe hypersensitivity.
• Give appropriate premedication and consider antiemetic support; ensure adequate hydration.
• Assess neutropenia risk and whether prophylactic granulocyte colony-stimulating factor is appropriate.
• Use caution in hepatic impairment, end-stage renal disease, older or frail patients, and those at increased risk of gastrointestinal complications.
• Review CYP3A-modifying medicines, herbal products, vaccination plans and OATP1B1 substrates.

Contraindications and cautions

• Hypersensitivity to cabazitaxel, another taxane, polysorbate 80 or another excipient
• Neutrophil count below 1,500/mm³
• Severe hepatic impairment
• Concomitant yellow-fever vaccination

Monitoring

• Full blood count before treatment and frequently during therapy
• Liver and renal function, hydration and electrolytes
• Fever, infection, gastrointestinal toxicity and bleeding
• Peripheral neuropathy and new respiratory symptoms
• Infusion hypersensitivity, cardiac symptoms and changes in urine output

Clinical pharmacology

Cabazitaxel is a tubulin-binding taxane metabolised extensively in the liver, predominantly through CYP3A. Elimination is mainly faecal, with little renal excretion, and it has a long terminal half-life.

Formulation and product differences

• This product contains separate concentrate and solvent vials and requires two aseptic dilution stages.
• The entire supplied solvent must be added during the first dilution because both vials contain overfill designed to produce the intended concentration.
• PVC infusion containers and polyurethane infusion sets must not be used.
• The formulation contains polysorbate 80 and ethanol, which may matter in patients with relevant allergy or clinical risk factors.
• Different cabazitaxel presentations can require different preparation processes, creating a medication-error risk if instructions are interchanged.

Solution for infusion

Route: Intravenous

Strengths: 10 mg/mL, 20 mg/mL, 60 mg