numbness, tingling, pain, or weakness in your hands or feet (neuropathy).
severe infection (sepsis). If you receive ABRAXANE in combination with gemcitabine, infections can be severe and lead to death. Tell your doctor right away if you have a fever (temperature of greater than 100.4° F) or develop signs of infection.
lung or breathing problems. If you receive ABRAXANE in combination with gemcitabine, lung or breathing problems may be severe and can lead to death. Tell your doctor right away if you have a sudden onset of persistent dry cough or shortness of breath.
allergic reactions. Allergic reactions to ABRAXANE may be severe and can lead to death.
The most common side effects of ABRAXANE include:
hair loss
numbness, tingling, pain, or weakness in the hands or feet
abnormal heart beat
tiredness
joint and muscle pain
changes in your liver function tests
rash
low red blood cell count (anemia). Red blood cells carry oxygen to your body tissues. Tell your doctor if you feel weak, tired or short of breath.
nausea and vomiting
infections. If you have a fever (temperature of greater than 100.4° F) or other signs of infection, tell your doctor right away.
Diarrhea
Loss of body fluid (dehydration)
Swelling in the hands or feet
These are not all the possible side effects of ABRAXANE. 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 the safe and effective use of ABRAXANE.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
This Patient Information leaflet summarizes the important information about ABRAXANE. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about ABRAXANE that is written for health professionals.
For more information, call 1-888-423-5436.
What are the ingredients in ABRAXANE?
Active ingredient: paclitaxel (bound to human albumin).
Other ingredient: human albumin (containing sodium caprylate and sodium acetyltryptophanate)
This Patient Information has been approved by the U.S. Food and Drug Administration
Revised: December 2014
Manufactured for: Celgene Corporation
Summit, NJ 07901
ABRAXANE® is a registered trademark of Abraxis BioScience, LLC.
©2005-2014 Abraxis BioScience, LLC.
All Rights Reserved.
Abraxis BioScience, LLC is a wholly owned subsidiary of Celgene Corporation.
U.S. Patent Numbers: See www.celgene.com.
ABRPPI.008 12/14
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 100 mg Vial
NDC 68817-134-50
103450
Abraxane®
for Injectable Suspension
(paclitaxel protein-bound particles for injectable suspension)
(albumin-bound)
100 mg per vial
Single Use Vial
Discard any unused portion.
For Intravenous Use Only
Rx only
Functional properties differ from other
paclitaxel products. DO NOT SUBSTITUTE.
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 100 mg Vial
NDC 68817-134-50
103450
