Cabazitaxel
Neutropenia and Hypersensitivity Reactions
Neutropenia
- Neutropenic deaths have been reported. Monitor for neutropenia with frequent blood cell counts.
- Cabazitaxel Injection is contraindicated in patients with neutrophil counts of ≤1,500 cells/mm 3.
- Primary prophylaxis with G-CSF is recommended in patients with high-risk clinical features.
- Consider primary prophylaxis with G-CSF in all patients receiving a dose of 25 mg/m 2
Severe Hypersensitivity
- Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm.
- Severe hypersensitivity reactions require immediate discontinuation of the Cabazitaxel Injection infusion and administration of appropriate therapy.
- Patients should receive premedication.
- Cabazitaxel Injection is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.
Monitoring data
- In order to monitor the occurence of neutropenia, frequent blood cell counts should be performed on all patients receiving cabazitaxel.
- Cabazitaxel should not be administered to patients with neutrophil counts equal to or less than 1,500 cells/mm3.
- Patients should receive premedication. [See Dosage and Administration]
- Cabazitaxel must not be given to patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80. [See Contraindications]