ual bruising or bleeding.
tiredness
nausea
constipation
weakness
blood in the urine. Tell your doctor or nurse if you see blood in your urine.
back pain
decreased appetite
fever
shortness of breath
stomach (abdominal) pain
change in your sense of taste
cough
joint pain
hair loss
numbness, tingling, burning or decreased sensation in your hands or feet
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of JEVTANA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about JEVTANA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
This leaflet summarizes the most important information about JEVTANA. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about JEVTANA that is written for health professionals.
For more information, go to www.sanofi-aventis.us or call 1-800-633-1610.
What are the ingredients in JEVTANA?
Active ingredient: cabazitaxel
Inactive ingredient: polysorbate 80
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
Issued June 2010
JEVTANA® is a registered trademark of sanofi-aventis
©2010 sanofi-aventis U.S. LLC
PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 0024-5824-11
JEVTANA®
(cabazitaxel)
Injection
60 mg/1.5 mL Before First Dilution*
This carton contains: 1 JEVTANA vial and 1 Diluent vial
*Requires two dilutions before administration-See back panel for details
FOR INTRAVENOUS INFUSION ONLY AFTER SECOND DILUTION
CYTOTOXIC AGENT
RX ONLY
sanofi aventis
PRINCIPAL DISPLAY PANEL - 5.7 mL Label
JEVTANA®
(cabazitaxel) Injection
NDC 0024-5823-15
60 mg/1.5 mL Before First Dilution*
* FOR INTRAVENOUS INFUSION ONLY AFTER SECOND DILUTION
CAUTION: Reconstitute this vial using the entire contents of
the diluent vial (approx 5.7 mL). Following this first dilution,
the resultant solution contains a concentration of 10mg/mL.
Withdraw only the required amount of the first dilution to
prepare the final infusion solution prior to administration.
See package insert for full dilution information.
Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F).
Do not refrigerate.
Single-dose vial.CYTOTOXIC AGENT
sanofi-aventis U.S. LLC/ Origin: United Kingdom 50093662
RX ONLY
PRINCIPAL DISPLAY PANEL - 5.7 mL Label
DILUENT
NDC 0024-5822-01
5.7 mL of 13 % (w/w) ethanol
in water for injection.
Use ONLY for dilution of JEVTANA.
See package insert for full preparation
instructions.
Store at 25°C (77°F); excursions permitted
between 15°-30°C (59°-86°F). Do not
refrigerate.
Single-dose vial.
RX ONLY
sanofi-aventis U.S. LLC/Origin United Kingdom
50093661
JEVTANA
cabazitaxel kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0024-5824
Packaging
# NDC Package Description Multilevel Packaging
1 0024-5824-11 1KITIn1CARTON None
QUANTITY OF PARTS
Part# Package Quantity Total Product Quantity
