August 3, 2015
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Jevtana

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Jevtana




Indications
Dosage
How Supplied

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 AND ADMINISTRATION

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]:

Antiemetic prophylaxis is recommended and can be given orally or intravenously as needed [see WARNINGS AND PRECAUTIONS].

JEVTANA injection single-use vial requires two dilutions prior to administration [see Preparation and Administration].

Dose Modifications For Adverse Reactions

Reduce or discontinue JEVTANA dosing for adverse reactions as described in Table 1.

Table 1: Recommended Dosage Modifications for Adverse Reactions in Patients Treated with JEVTANA

Toxicity Dosage Modification
Prolonged grade ≥ 3 neutropenia (greater than 1 week) despite appropriate medication including granulocyte-colony stimulating factor (G-CSF) Delay treatment until neutrophil count is > 1,500 cells/mm³, then reduce dosage of JEVTANA to 20 mg/m². Use G-CSF for secondary prophylaxis.
Febrile neutropenia or neutropenic infection Delay treatment until improvement or resolution, and until neutrophil count is > 1,500 cells/mm³, then reduce dosage of JEVTANA to 20 mg/m². Use G-CSF for secondary prophylaxis.
Grade ≥ 3 diarrhea or persisting diarrhea despite appropriate medication, fluid and electrolytes replacement Delay treatment until improvement or resolution, then reduce dosage of JEVTANA to 20 mg/m².
Grade 2 peripheral neuropathy Delay treatment until improvement or resolution, then reduce dosage of JEVTANA to 20 mg/m².
Grade ≥ 3 peripheral neuropathy Discontinue JEVTANA

Discontinue JEVTANA treatment if a patient continues to experience any of these reactions at the 20 mg/m² dosage.

Dose Modifications For Hepatic Impairment

  • Mild hepatic impairment (total bilirubin > 1 to ≤ 1.5 x Upper Limit of Normal (ULN) or AST > 1.5 x ULN): Reduce JEVTANA starting dose to 20 mg/m² .
  • Moderate hepatic impairment (total bilirubin > 1.5 to ≤ 3 x ULN and AST = any): Reduce JEVTANA starting dose to 15 mg/m² based on tolerability data in these patients; however, the efficacy of this dose is unknown.
  • Severe hepatic impairment (total bilirubin > 3 X ULN): Cabazitaxel is contraindicated in patients with severe hepatic impairment [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Dose Modifications For Use With 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 [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

Preparation And Administration

JEVTANA is a cytotoxic anticancer drug. Follow applicable special handling and disposable procedures [see References].1 If JEVTANA first diluted solution, or second (final) dilution for intravenous infusion should come into contact with the skin or mucous, immediately and thoroughly wash with soap and water.

Do not use PVC infusion containers or polyurethane infusions sets for preparation and administration of JEVTANA infusion solution.

JEVTANA should not be mixed with any other drugs.

Preparation

Read this entire section carefully before mixing and diluting. JEVTANA requires two dilutions prior to administration. Follow the preparation instructions provided below, as improper preparation may lead to overdose [see OVERDOSAGE].

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.

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.

Remove the syringe and thoroughly mix the final infusion solution by gently inverting the bag or bottle.

As the final infusion solution is supersaturated, it may crystallize over time. Do not use if this occurs and discard.

Fully prepared JEVTANA 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 for a total of 24 hours (including the one-hour infusion) under the refrigerated conditions.

Discard any unused portion.

Administration

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.

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 administered intravenously as a one-hour infusion at room temperature.

HOW SUPPLIED

Dosage 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

Storage And Handling

JEVTANA is supplied as a kit containing consisting of the following:

  • One single-dose vial of JEVTANA (cabazitaxel) injection: a clear yellow to brownish-yellow viscous solution of 60 mg/1.5 mL in a clear glass vial with a grey rubber closure, aluminum cap, and light green plastic flip-off cap
  • One single-dose vial of Diluent for JEVTANA: a clear colorless solution of 13% (w/w) ethanol in water for injection in a clear glass vial with a grey rubber closure, gold-color aluminum cap, and colorless plastic flip-off cap.

Both items are in a blister pack in one carton.

NDC 0024-5824-11

Storage

JEVTANA injection and Diluent for JEVTANA:

Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).

Do not refrigerate.

Handling And Disposal

JEVTANA is a cytotoxic anticancer drug. Follow applicable special handling and disposable procedures [see References].1

REFERENCES

1. OSHA Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.htmlNIOSH

Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Revised: June 2015

Last reviewed on RxList: 7/8/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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