By mail:   American Regent, Inc.
One Luitpold Drive
P.O. Box 9001
Shirley, NY 11967
     
By fax:   631-924-1731
     
By e-mail:   inquiry@americanregent.com
     
By phone:   631-924-4000
     
Customer Service/Drug Information:   800-645-1706 (8:30 AM-7 PM Eastern time, Monday through Friday)
     
To Report Adverse Drug Events (ADEs):   800-734-9236
     
Venofer® (iron sucrose injection, USP)
Reimbursement Hotline and
Patient Assistance Program:		   800-282-7712 (9 AM-5 PM, Eastern time)

 
American Regent. Enriching the lives of anemia patients. ™

Important Safety Information

Serious allergic type reactions, including anaphylactic-type reactions, some of which have been life-threatening and resulted in death, have been reported in patients receiving Venofer® (iron sucrose injection, USP). Patients may experience shock, clinically significant hypotension (low blood pressure), loss of consciousness, and/or collapse. If allergic type reactions occur during use, use of Venofer® should stop immediately. Patients should be observed for signs and symptoms of allergic type reactions during and after use of Venofer® for at least 30 minutes and until clinical symptoms are normal. Venofer® should only be given when people, equipment and drugs are immediately available for the treatment of serious allergic type reactions.

Significant hypotension (low blood pressure) has been reported in patients who receive Venofer®. Hypotension (low blood pressure) following administration of Venofer® may be related to how fast and how much of the drug is given.

Venofer® should not be taken if you have symptoms of too much iron in your blood (including low blood pressure, taste disturbance, joint aches, and nausea/vomiting), or if you have a known allergy to Venofer®.

In studies, the most common side effects of Venofer® included a temporary drop in blood pressure, infections, taste disturbance, muscle cramps, swelling of the arms and legs, nausea, headache, and diarrhea. These are not all the possible side effects of Venofer®. For more information ask your healthcare professional or contact American Regent at 1-800-645-1706.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see Full Prescribing Information.