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Black Box Warning
WARNING : NEUTROPENIA AND HYPERSENSITIVITY:
See full prescribing information for complete Boxed Warning.
WARNING : NEUTROPENIA AND HYPERSENSITIVITY:
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 patients who have a history of severe hypersensitivity reactions to JEVTANA or to other drugs formulated with polysorbate 80
Overview
Cabazitaxel is a antineoplasic agent that is FDA approved for the treatment of patients with hormone-refractory metastatic prostate cancer previously treated with a docetaxel-containing treatment regimen.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
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.
Dosage
2.1 General 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.
Premedication is recommended prior to treatment [see DOSAGE AND ADMINISTRATION (2.3)].
JEVTANA should be administered under the supervision of a qualified physician experienced in the use of antineoplastic medicinal products. Appropriate management of complications is possible only when the adequate diagnostic and treatment facilities are readily available.
JEVTANA Injection single-use vial requires two dilutions prior to administration [see DOSAGE AND ADMINISTRATION (2.5)].
Do not use PVC infusion containers and polyurethane infusions sets for preparation and administration of JEVTANA infusion solution [see DOSAGE AND ADMINISTRATION (2.5)].
Both the JEVTANA Injection and the diluent vials contain an overfill to compensate for liquid loss during preparation.
2.2 Dose Modifications for Adverse Reactions
The JEVTANA dose should be reduced if patients experience the following adverse reactions.
Discontinue JEVTANA treatment if a patient continues to experience any of these reactions at 20 mg/m2.
2.3 Dose Modifications for Drug Interactions
Strong CYP3A inhibitors
Concomitant drugs that are strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole) may increase plasma concentrations of cabazitaxel. Avoid the coadministration of JEVTANA with these drugs. If patients require co-administration of a strong CYP3A inhibitor, consider a 25% JEVTANA dose reduction
DOSAGE FORMS AND STRENGTHS
JEVTANA (cabazitaxel) Injection 60 mg/1.5 mL is supplied as a kit consisting of the following:
JEVTANA Injection 60 mg/1.5 mL: contains 60 mg cabazitaxel in 1.5 mL polysorbate 80,
Diluent for JEVTANA Injection 60 mg/1.5 mL: contains approximately 5.7 mL of 13% (w/w) ethanol in water for injection.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cabazitaxel in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cabazitaxel in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Cabazitaxel in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Cabazitaxel in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Cabazitaxel in pediatric patients.
Contraindications
JEVTANA should not be used in patients with neutrophil counts of ≤ 1,500/mm3.
JEVTANA is contraindicated in patients who have a history of severe hypersensitivity reactions to cabazitaxel or to other drugs formulated with polysorbate 80.
Warnings
WARNING : NEUTROPENIA AND HYPERSENSITIVITY:
See full prescribing information for complete Boxed Warning.
WARNING : NEUTROPENIA AND HYPERSENSITIVITY:
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 patients who have a history of severe hypersensitivity reactions to JEVTANA or to other drugs formulated with polysorbate 80
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Cabazitaxel in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Cabazitaxel in the drug label.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cabazitaxel in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Cabazitaxel during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Cabazitaxel with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Cabazitaxel with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Cabazitaxel with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Cabazitaxel with respect to specific gender populations.
Race
There is no FDA guidance on the use of Cabazitaxel with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Cabazitaxel in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Cabazitaxel in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Cabazitaxel in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Cabazitaxel in patients who are immunocompromised.
Administration and Monitoring
Administration
2.4 Premedication
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:
antihistamine (dexchlorpheniramine 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).
Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed.
2.5 Administration Precautions
JEVTANA is a cytotoxic anticancer drug and caution should be exercised when handling and preparing JEVTANA solutions, taking into account the use of containment devices, personal protective equipment (e.g., gloves), and preparation procedures. Please refer to HANDLING AND DISPOSAL (16.3).
If JEVTANA Injection, first diluted solution, or second (final) dilution for intravenous infusion should come into contact with the skin, immediately and thoroughly wash with soap and water. If JEVTANA Injection, first diluted solution, or second (final) dilution for intravenous infusion should come into contact with mucosa, immediately and thoroughly wash with water.
2.6 Instructions for Preparation
Do not use PVC infusion containers or polyurethane infusions sets for preparation and administration of JEVTANA infusion solution.
Read this entire section carefully before mixing and diluting. JEVTANA requires two dilutions prior to administration. Please follow the preparation instructions provided below, as improper preparation may lead to overdose [see OVERDOSAGE (10)].
Note: Both the JEVTANA Injection and the diluent vials contain an overfill to compensate for liquid loss during preparation. This overfill ensures that after dilution with the entire contents of the accompanying diluent, there is an initial diluted solution containing 10 mg/mL JEVTANA.
The following two-step dilution process must be carried out under aseptic conditions to prepare the second (final) infusion solution.
Inspect the JEVTANA Injection and supplied diluent vials. The JEVTANA Injection is a clear yellow to brownish-yellow viscous solution.
Step 1 – First Dilution
Each vial of JEVTANA (cabazitaxel) 60 mg/1.5 mL must first be mixed with the entire contents of supplied diluent. Once reconstituted, the resultant solution contains 10 mg/mL of JEVTANA.
When transferring the diluent, direct the needle onto the inside wall of JEVTANA vial and inject slowly to limit foaming. Remove the syringe and needle and gently mix the initial diluted solution by repeated inversions for at least 45 seconds to assure full mixing of the drug and diluent. Do not shake.
Let the solution stand for a few minutes to allow any foam to dissipate, and check that the solution is homogeneous and contains no visible particulate matter. It is not required that all foam dissipate prior to continuing the preparation process.
The resulting initial diluted JEVTANA solution (cabazitaxel 10 mg/mL) requires further dilution before administration. The second dilution should be done immediately (within 30 minutes) to obtain the final infusion as detailed in Step 2.
Step 2 – Second (Final) Dilution
Withdraw the recommended dose from the JEVTANA solution containing 10 mg/mL as prepared in Step 1 using a calibrated syringe and further dilute into a sterile 250 mL PVC-free container of either 0.9% sodium chloride solution or 5% dextrose solution for infusion. If a dose greater than 65 mg of JEVTANA is required, use a larger volume of the infusion vehicle so that a concentration of 0.26 mg/mL JEVTANA is not exceeded. The concentration of the JEVTANA final infusion solution should be between 0.10 mg/mL and 0.26 mg/mL.
JEVTANA should not be mixed with any other drugs.
Remove the syringe and thoroughly mix the final infusion solution by gently inverting the bag or bottle.
JEVTANA final infusion solution (in either 0.9% sodium chloride solution or 5% dextrose solution) should be used within 8 hours at ambient temperature (including the one-hour infusion) or within a total of 24 hours if refrigerated (including the one-hour infusion).
As the final infusion solution is supersaturated, it may crystallize over time. Do not use if this occurs and discard.
Inspect visually for particulate matter, any crystals and discoloration prior to administration. If the JEVTANA first diluted solution or second (final) infusion solution is not clear or appears to have precipitation, it should be discarded.
Discard any unused portion.
2.7 Administration
The final JEVTANA infusion solution should be administered intravenously as a one-hour infusion at room temperature.
Use an in-line filter of 0.22 micrometer nominal pore size (also referred to as 0.2 micrometer) during administration.
The final JEVTANA infusion solution should be used immediately. However, in-use storage time can be longer under specific conditions, i.e. 8 hours under ambient conditions (including the one-hour infusion) or for a total of 24 hours if refrigerated (including the one-hour infusion)
Monitoring
There is limited information regarding Monitoring of Cabazitaxel in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Cabazitaxel in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Cabazitaxel in the drug label.
Pharmacology
There is limited information regarding Cabazitaxel Pharmacology in the drug label.
