Brand Name
Jevtana
Generic Name
Cabazitaxel
View Brand Information FDA approval date: June 17, 2010
Form: Kit
What is Jevtana (Cabazitaxel)?
JEVTANA ® is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen. JEVTANA is a microtubule inhibitor indicated in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.
Approved To Treat
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Brand Information
Jevtana (cabazitaxel)
1INDICATIONS AND USAGE
JEVTANA
2DOSAGE FORMS AND STRENGTHS
JEVTANA (cabazitaxel) injection is supplied as a kit consisting of the following:
- Cabazitaxel injection: 60 mg/1.5 mL; a clear yellow to brownish-yellow viscous solution
- Diluent: 5.7 mL of 13% (w/w) ethanol in water; a clear colorless solution
3CONTRAINDICATIONS
JEVTANA is contraindicated in patients with:
- neutrophil counts of ≤1,500/mm
- history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80
- severe hepatic impairment (total bilirubin >3 × ULN)
4ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in another section of the label:
- Bone Marrow Suppression
- Increased Toxicities in Elderly Patients
- Hypersensitivity Reactions
- Gastrointestinal Adverse Reactions
- Renal Failure
- Urinary Disorders Including Cystitis
- Respiratory Disorders
- Use in Patients with Hepatic Impairment
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.
4.2Postmarketing Experience
The following adverse reactions have been identified from clinical trials and/or postmarketing surveillance. Because they are reported from a population of unknown size, precise estimates of frequency cannot be made.
Gastrointestinal: Gastritis, intestinal obstruction.
Respiratory: Interstitial pneumonia/pneumonitis, interstitial lung disease and acute respiratory distress syndrome.
Renal and urinary disorders: Radiation recall hemorrhagic cystitis.
5OVERDOSAGE
There is no known antidote for JEVTANA overdose. Overdose has resulted from improper preparation
In case of overdose, the patient should be kept in a specialized unit where vital signs, chemistry and particular functions can be closely monitored. Patients should receive therapeutic G-CSF as soon as possible after discovery of overdose. Other appropriate symptomatic measures should be taken, as needed.
6DESCRIPTION
JEVTANA (cabazitaxel) injection is an antineoplastic agent belonging to the taxane class that is for intravenous use. It is prepared by semi-synthesis with a precursor extracted from yew needles.
The chemical name of cabazitaxel is (2α,5β,7β,10β,13α)-4-acetoxy-13-({(2R,3S)-3-[(tertbutoxycarbonyl) amino]-2-hydroxy-3-phenylpropanoyl}oxy)-1-hydroxy-7,10-dimethoxy-9-oxo-5,20-epoxytax-11-en-2-yl benzoate – propan-2-one (1:1).
Cabazitaxel has the following structural formula:
Cabazitaxel is a white to almost-white powder with a molecular formula of C
JEVTANA (cabazitaxel) injection 60 mg/1.5 mL is a sterile, non-pyrogenic, clear yellow to brownish-yellow viscous solution and is available in single-dose vials containing 60 mg cabazitaxel (anhydrous and solvent free) and 1.56 g polysorbate 80 (citric acid monohydrate is used to adjust the pH of the polysorbate 80 between 3.3 to 3.8).
Each mL contains 40 mg cabazitaxel (anhydrous) and 1.04 g polysorbate 80.
DILUENT for JEVTANA is a clear, colorless, sterile, and non-pyrogenic solution containing 13% (w/w) ethanol in water for injection, approximately 5.7 mL.
JEVTANA requires two dilutions prior to intravenous infusion. JEVTANA injection should be diluted only with the supplied DILUENT for JEVTANA, followed by dilution in either 0.9% sodium chloride solution or 5% dextrose solution.
7REFERENCES
- OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
9PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 0024-5824-11
Rx only
JEVTANA
60 mg/1.5 mL Before First Dilution*
FOR INTRAVENOUS INFUSION ONLY AFTER SECOND DILUTION
Warning: Cytotoxic Agent
Carton Contains:
sanofi
