rednisone
n=377
*
Hazard ratio estimated using Cox model; a hazard ratio of less than 1 favors JEVTANA
Overall Survival
Number of deaths (%) 234 (61.9 %) 279 (74%)
Median survival (month) (95% CI) 15.1 (14.1–16.3) 12.7 (11.6–13.7)
Hazard Ratio* (95% CI) 0.70 (0.59–0.83)
p-value <0.0001
Figure 1 - Kaplan-Meier Overall Survival Curves
Investigator-assessed tumor response of 14.4% (95%CI: 9.6–19.3) was higher for patients in the JEVTANA arm compared to 4.4% (95%CI: 1.6–7.2) for patients in the mitoxantrone arm, p=0.0005.
15.REFERENCES
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.
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
American Society of Health-System Pharmacists. (2006) ASHP Guidelines on Handling Hazardous Drugs. Am J Health-Syst Pharm 2006; 63:1172–1193.
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.
16. HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
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
16.2 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 (2.5)].
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 (2.5)].
16.3 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 (15)]. Any unused product or waste material should be disposed of in accordance with local req
