Neutropenia and Hypersensitivity Reactions

Neutropenia

• Neutropenic deaths have been reported. 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.

Hypersensitivity Reactions

• Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm.
• Severe hypersensitivity reactions require immediate discontinuation of the infusion and administration of appropriate therapy. [See Warnings and Precautions]
• 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]

Urinary Disorders Including Cystitis with Jevtana Kit 

• Cystitis, radiation cystitis, and hematuria, including that requiring hospitalization, has been reported with Jevtana in patients who previously received pelvic radiation. In PROSELICA, cystitis and radiation cystitis were reported in 1.2% and 1.5% of patients who received prior radiation, respectively. Hematuria was reported in 19.4% of patients who received prior radiation and in 14.4% of patients who did not receive prior radiation. Cystitis from radiation recall may occur late in treatment with JEVTANA. Monitor patients who previously received pelvic radiation for signs and symptoms of cystitis while on JEVTANA. Interrupt or discontinue JEVTANA in patients experiencing severe hemorrhagic cystitis. Medical and/or surgical supportive treatment may be required to treat severe hemorrhagic cystitis.