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, for intravenous use
Initial U.S. Approval: 2010
WARNING: NEUTROPENIA AND HYPERSENSITIVITY
See full prescribing information for complete boxed warning.
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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)
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Severe hypersensitivity can occur and may include generalized rash/erythema, hypotension and bronchospasm. Discontinue JEVTANA immediately if severe reactions occur and administer appropriate therapy. (2.1)(5.2)
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Contraindicated if history of severe hypersensitivity reactions to JEVTANA or to drugs formulated with polysorbate 80. (4)
RECENT MAJOR CHANGES
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Dosage and Administration (2.2, 2.4) |
11/2014 |
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Dosage and Administration (2.3) |
06/2015 |
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Contraindications (4) |
06/2015 |
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Warnings and Precautions (5.1, 5.6) |
06/2015 |
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)
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JEVTANA requires two dilutions prior to administration (2.5)
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Use the entire contents of the accompanying diluent to achieve a concentration of 10 mg/mL JEVTANA. (2.5)
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PVC equipment should not be used (2.5)
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Premedication Regimen: Administer intravenously 30 minutes before each dose of JEVTANA:
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Antihistamine (dexchloropheniramine 5 mg or diphenhydramine 25 mg or equivalent antihistamine)
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Corticosteroid (dexamethasone 8 mg or equivalent steroid)
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H2 antagonist (ranitidine 50 mg or equivalent H2 antagonist) (2.1)
Antiemetic prophylaxis (oral or intravenous) is recommended as needed. (2.1)
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Dosage Modifications: See full prescribing information (2.2, 2.3, 2.4)
DOSAGE FORMS AND STRENGTHS
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Single dose vial 60 mg/1.5 mL, supplied with diluent (5.7 mL) for JEVTANA (3)
CONTRAINDICATIONS
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Neutrophil counts of ≤1,500/mm3 (2.2)(4)
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History of severe hypersensitivity to JEVTANA or polysorbate 80 (4)
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Severe hepatic impairment (Total Bilirubin > 3 × ULN) (4)
WARNINGS AND PRECAUTIONS
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Bone marrow suppression (particularly neutropenia) and its clinical consequences (febrile neutropenia, neutropenic infections): Monitor blood counts frequently to determine if dosage modification or initiation of G-CSF is needed. Primary prophylaxis with G-CSF should be considered in patients with high-risk clinical features. Use caution in patients with hemoglobin < 10 g/dL. (2.2)(4)(5.1)
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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)
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Gastrointestinal disorders: Nausea, vomiting, and diarrhea may occur. 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) Deaths have occurred due to gastrointestinal hemorrhage, perforation and neutropenic enterocolitis. Delay or discontinue JEVTANA. (5.3)
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Renal failure, including cases with fatal outcomes, has been reported. Identify cause and manage aggressively. (5.4)
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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 closely. (5.5)(6)(8.5)
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Hepatic impairment: Reduce the JEVTANA dose to 20 mg/m2 in patients with mild hepatic impairment and to 15 mg/m2 in patients with moderate hepatic impairment. (2.3)
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JEVTANA can cause fetal harm when administered to a pregnant woman. (5.7)(8.1)
ADVERSE REACTIONS
Most common all grades adverse reactions (≥10%) are neutropenia, anemia, leukopenia, thrombocytopenia, diarrhea, fatigue, nausea, vomiting, constipation, asthenia, abdominal pain, hematuria, back pain, anorexia, peripheral neuropathy, pyrexia, dyspnea, dysgeusia, cough, arthralgia, and alopecia. (6)
To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis U.S. LLC at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Avoid coadministration of JEVTANA with strong CYP3A inhibitors. If patients require co-administration of a strong CYP3A inhibitor, consider a 25% JEVTANA dose reduction. (2.4)(7.1)(12.3)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 6/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
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.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing Information
The individual dosage of JEVTANA is based on calculation of the Body Surface Area (BSA) and is 25 mg/m2 administered as a one-hour intravenous infusion every three weeks in combination with oral prednisone 10 mg administered daily throughout JEVTANA treatment.
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 [see Warnings and Precautions (5.2)]:
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antihistamine (dexchlorpheniramine 5 mg, or diphenhydramine 25 mg or equivalent antihistamine),
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corticosteroid (dexamethasone 8 mg or equivalent steroid),
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H2 antagonist (ranitidine 50 mg or equivalent H2 antagonist).
Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed [see Warnings and Precautions 5.3)].
JEVTANA injection single-use vial requires two dilutions prior to administration [see Dosage and Administration (2.5)].
2.2 Dose Modifications for Adverse Reactions
Reduce or discontinue JEVTANA dosing for adverse reactions as described in Table 1.
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