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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

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.
  • 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.
  • Do not use PVC infusion containers and polyurethane infusions sets for preparation and administration of JEVTANA infusion solution.
  • Both the JEVTANA Injection and the diluent vials contain an overfill to compensate for liquid loss during preparation.

Dose Modifications

The JEVTANA dose should be reduced to 20 mg/m² if patients experience the following adverse reactions.

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 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 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.

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

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.

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.

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. 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.

Set aside the JEVTANA Injection and supplied diluent vials. The JEVTANA Injection is a clear yellow to brownish-yellow viscous solution, if appropriately stored.

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.

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).

HOW SUPPLIED

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.

Storage And Handling

JEVTANA is supplied as a kit containing one single-use vial of JEVTANA (cabazitaxel) Injection (clear glass vial with a grey rubber closure, aluminum cap and light green plastic flip-off cap) and one vial of Diluent for JEVTANA (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.

Stability of the First Diluted Solution in the Vial:

First diluted solution of JEVTANA should be used immediately (within 30 minutes). Discard any unused portion [see DOSAGE AND ADMINISTRATION].

Stability of the Second (Final) Dilution Solution in the Infusion Bag:

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.

In addition, chemical and physical stability of the infusion solution has been demonstrated for 24 hours under refrigerated conditions. As both the first diluted solution and the second (final) infusion solution are supersaturated, the solutions may crystallize over time. If crystals and/or particulates appear, the solutions must not be used and should be discarded [see DOSAGE AND ADMINISTRATION].

Handling and Disposal

Procedures for proper handling and disposal of antineoplastic drugs should be followed. Several guidelines on this subject have been published [see REFERENCES]. Any unused product or waste material should be disposed of in accordance with local requirements.

REFERENCES

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

3. American Society of Health-System Pharmacists. (2006) ASHP Guidelines on Handling Hazardous Drugs. Am J Health-Syst Pharm 2006; 63:1172-1193.

4. Polovich, M., White, J. M., & Kelleher, L.O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

sanofi-aventis U.S. LLC Bridgewater, NJ 08807.

Last reviewed on RxList: 10/16/2012
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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