Jevtana (Cabazitaxel Injection) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 27, 2012

Jevtana

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JEVTANA
(cabazitaxel) Injection, 60 mg/1.5 mL, for Intravenous Infusion Only

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 (cabazitaxel injection) . JEVTANA (cabazitaxel injection) 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 (cabazitaxel injection) infusion and administration of appropriate therapy [see WARNINGS AND PRECAUTIONS]. Patients should receive premedication [see DOSAGE AND ADMINISTRATIONS]. JEVTANA (cabazitaxel injection) must not be given to patients who have a history of severe hypersensitivity reactions to JEVTANA (cabazitaxel injection) or to other drugs formulated with polysorbate 80 [see CONTRAINDICATIONS].

DRUG DESCRIPTION

JEVTANA (cabazitaxel) is an antineoplastic agent belonging to the taxane class. 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-9oxo-5,20-epoxytax-11-en-2-yl benzoate – propan-2-one(1:1).

Cabazitaxel has the following structural formula:

JEVTANA (cabazitaxel) Structural Formula Illustration

Cabazitaxel is a white to off-white powder with a molecular formula of C₄₅H₅₇NO₁₄•C₃H₆O and a molecular weight of 894.01 (for the acetone solvate) / 835.93 (for the solvent free). It is lipophilic, practically insoluble in water and soluble in alcohol.

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-use vials containing 60 mg cabazitaxel (anhydrous and solvent free) and 1.56 g polysorbate 80. Each mL contains 40 mg cabazitaxel (anhydrous) and 1.04 g polysorbate 80.

DILUENT for JEVTANA (cabazitaxel injection) is a clear, colorless, sterile, and non-pyrogenic solution containing 13% (w/w) ethanol in water for injection, approximately 5.7 mL.

JEVTANA (cabazitaxel injection) requires two dilutions prior to intravenous infusion. JEVTANA (cabazitaxel injection) injection should be diluted only with the supplied DILUENT for JEVTANA (cabazitaxel injection) , followed by dilution in either 0.9% sodium chloride solution or 5% dextrose solution.

What are the precautions when taking cabazitaxel injection (Jevtana)?

Before receiving cabazitaxel, tell your doctor or pharmacist if you are allergic to it; or to polysorbate 80; or if you have any other allergies. This product may contain other inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), recent/current infections.

Cabazitaxel can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as...

Read All Potential Precautions of Jevtana »

Last reviewed on RxList: 7/14/2010
This monograph has been modified to include the generic and brand name in many instances.