These highlights do not include all the information needed to use JEVTANA safely and effectively. See full prescribing information for JEVTANA.  JEVTANA (cabazitaxel) Injection, 60 mg/1.5 mL, for intravenous infusion onlyInitial U.S. Approval: 2010
Neutropenic deaths have been reported. In order to monitor the occurrence of neutropenia, frequent blood cell counts should be performed on all patients receiving JEVTANA. JEVTANA should not be given to patients with neutrophil counts of ≤1,500 cells/mm.

Severe hypersensitivity reactions can occur and may include generalized rash/erythema, hypotension and bronchospasm. Severe hypersensitivity reactions require immediate discontinuation of the JEVTANA infusion and administration of appropriate therapy [see Warnings and Precautions (5.2)]. Patients should receive premedication [see Dosage and Administrations (2.3)]. JEVTANA must not be given to patients who have a history of severe hypersensitivity reactions to JEVTANA or to other drugs formulated with polysorbate 80 [see Contraindications (4)] .

JEVTANA is a microtubule inhibitor indicated in combination with prednisone for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.

The JEVTANA dose should be reduced to 20 mg/m if patients experience the following adverse reactions.

Discontinue JEVTANA treatment if a patient continues to experience any of these reactions at 20 mg/m.

Table 1: Recommended Dosage Modifications for Adverse Reactions in Patients Treated with JEVTANA Toxicity Dosage Modification
Prolonged grade ≥ 3 neutropenia (greater than 1 week) despite appropriate medication including G-CSF Delay treatment until neutrophil count is
> 1,500 cells/mm3, then reduce dosage of JEVTANA to 20 mg/m2. Use G-CSF for secondary prophylaxis.
Febrile neutropenia Delay treatment until improvement or resolution, and until neutrophil count is
> 1,500 cells/mm3, then reduce dosage of JEVTANA to 20 mg/m2. Use G-CSF for secondary prophylaxis.
Grade ≥ 3 diarrhea or persisting diarrhea despite appropriate medication, fluid and electrolytes replacement Delay treatment until improvement or resolution, then reduce dosage of JEVTANA to 20 mg/m2.

Premedicate at least 30 minutes prior to each dose of JEVTANA with the following intravenous medications to reduce the risk and/or severity of hypersensitivity:

Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed.

JEVTANA is a cytotoxic anticancer drug and caution should be exercised when handling and preparing JEVTANA solutions, taking into account the use of containment devices, personal protective equipment (e.g., gloves), and preparation procedures. Please refer to Handling and Disposal (16.3) .

If JEVTANA Injection, first diluted solution, or second (final) dilution for intravenous infusion should come into contact with the skin, immediately and thoroughly wash with soap and water. If JEVTANA Injection, first diluted solution, or second (final) dilution for intravenous infusion should come into contact with mucosa, immediately and thoroughly wash with water.

Do not use PVC infusion containers or polyurethane infusions sets for preparation and administration of JEVTANA infusion solution.

Read this entire section carefully before mixing and diluting. JEVTANA requires tw