Jevtana: Package Insert and Label Information (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — Kit Carton

NDC 0024-5824-11
Rx only

JEVTANA®
(cabazitaxel)
Injection

60 mg/1.5 mL Before First Dilution*

FOR INTRAVENOUS INFUSION ONLY AFTER SECOND DILUTION
*Requires two dilutions before administration. See back panel for details.

Warning: Cytotoxic Agent

Carton Contains:
One single-dose JEVTANA vialOne single-dose Diluent vial

SANOFI

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
JEVTANA cabazitaxel kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0024-5824
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0024-5824-11 1 KIT in 1 CARTON None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, GLASS 5.7 mL
Part 2 1 VIAL, GLASS 5.7 mL
Part 1 of 2
JEVTANA cabazitaxel injection, solution, concentrate
Product Information
Item Code (Source) NDC:0024-5823
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
cabazitaxel (cabazitaxel) cabazitaxel 60 mg in 1.5 mL
Inactive Ingredients
Ingredient Name Strength
Polysorbate 80 1.56 g in 1.5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0024-5823-15 5.7 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201023 06/17/2010
Part 2 of 2
DILUENT alcohol and water injection
Product Information
Item Code (Source) NDC:0024-5822
Route of Administration INTRAVENOUS DEA Schedule
Inactive Ingredients
Ingredient Name Strength
alcohol
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0024-5822-01 5.7 mL in 1 VIAL, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201023 06/17/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA201023 06/17/2010
Labeler — Sanofi-Aventis U.S. LLC (824676584)
Establishment
Name Address ID/FEI Operations
Sanofi Chimie 291592785 ANALYSIS (0024-5824), API MANUFACTURE (0024-5824)
Establishment
Name Address ID/FEI Operations
Sanofi-Aventis Deutschland GmbH 313218430 ANALYSIS (0024-5824), LABEL (0024-5824), MANUFACTURE (0024-5824), PACK (0024-5824)

Revised: 02/2021 Sanofi-Aventis U.S. LLC

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