HIGHLIGHTS OF PRESCRIBING INFORMATION
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 only
Initial U.S. Approval: 2010
WARNING
See full prescribing information for complete boxed warning.
Neutropenic deaths have been reported. Obtain frequent blood counts to monitor for neutropenia. Do not give JEVTANA if neutrophil counts are ≤1,500 cells/mm3. (2.2)(4)
Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. Discontinue JEVTANA immediately if severe reactions occur and administer appropriate therapy. (2.3)(5.2)
Contraindicated if history of severe hypersensitivity reactions to JEVTANA or to drugs formulated with polysorbate 80. (4)
INDICATIONS AND USAGE
JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen. (1)
DOSAGE AND ADMINISTRATION
Recommended dose: JEVTANA 25 mg/m2 administered every three weeks as a one-hour intravenous infusion in combination with oral prednisone 10 mg administered daily throughout JEVTANA treatment. (2.1)
JEVTANA requires two dilutions prior to administration (2.5)
Use the entire contents of the accompanying diluent to achieve a concentration of 10 mg/mL JEVTANA. (2.5)
PVC equipment should not be used (2.5)
Premedication Regimen: Administer intravenously 30 minutes before each dose of JEVTANA:
Antihistamine (dexchloropheniramine 5 mg or diphenhydramine 25 mg or equivalent antihistamine)
Corticosteroid (dexamethasone 8 mg or equivalent steroid)
H2 antagonist (ranitidine 50 mg or equivalent H2 antagonist) (2.3)
Antiemetic prophylaxis (oral or intravenous) is recommended as needed. (2.3)
Dosage Modifications: See full prescribing information (2.2)
DOSAGE FORMS AND STRENGTHS
Single use vial 60 mg/1.5 mL, supplied with diluent (5.7 mL) for JEVTANA (3)
CONTRAINDICATIONS
Neutrophil counts of ≤1,500/mm3 (2.2)(4)
History of severe hypersensitivity to JEVTANA or polysorbate 80 (4)
WARNINGS AND PRECAUTIONS
Neutropenia, febrile neutropenia: Neutropenic deaths have been reported. Monitor blood counts frequently to determine if initiation of G-CSF and/or dosage modification is needed. Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features. (2.2)(4)(5.1)
Hypersensitivity: Severe hypersensitivity reactions can occur. Premedicate with corticosteroids and H2 antagonists. Discontinue infusion immediately if hypersensitivity is observed and treat as indicated. (4)(5.2)
Gastrointestinal symptoms (nausea, vomiting, diarrhea): Mortality related to diarrhea has been reported. Rehydrate and treat with anti-emetics and anti-diarrheals as needed. If experiencing Grade ≥ 3 diarrhea, dosage should be modified. (2.2)(5.3)
Renal failure, including cases with fatal outcomes, has been reported. Identify cause and manage aggressively. (5.4)
Elderly patients: Patients ≥ 65 years of age were more likely to experience fatal outcomes not related to disease progression and certain adverse reactions, including neutropenia and febrile neutropenia. Monitor close