ly (5.5)(6)(8.5).
Hepatic impairment: Patients with impaired hepatic function were excluded from the randomized clinical trial. Hepatic impairment is likely to increase the cabazitaxel concentrations. JEVTANA should not be given to patients with hepatic impairment. (5.6)(8.7)
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.
DRUG INTERACTIONS
Use with caution in patients taking concomitant medicines that induce or inhibit CYP3A. (7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 06/2010
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
WARNING
1.INDICATIONS AND USAGE
2.DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Dose Modifications
2.3 Premedication
2.4 Administration Precautions
2.5 Instructions for Preparation
2.6 Administration
3.DOSAGE FORMS AND STRENGTHS
4.CONTRAINDICATIONS
5.WARNINGS AND PRECAUTIONS
5.1 Neutropenia
5.2 Hypersensitivity Reactions
5.3 Gastrointestinal Symptoms
5.4 Renal Failure
5.5 Elderly Patients
5.6Hepatic Impairment
5.7 Pregnancy
6.ADVERSE REACTIONS
6.1 Clinical Trial Experience
7.DRUG INTERACTIONS
7.1 Drugs That May Increase Cabazitaxel Plasma Concentrations
7.2 Drugs That May Decrease Cabazitaxel Plasma Concentrations
8.USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14. CLINICAL STUDIES
15.REFERENCES
16. HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage
16.3 Handling and Disposal
17.PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
WARNING
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/mm3.
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 patient |
