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
Venofer® (iron sucrose injection, USP) should not be taken if you have symptoms of too much iron in your blood, a known allergy to Venofer® or any of its inactive components, and if you have anemia not caused by iron deficiency. Serious hypersensitivity reactions (serious allergic reactions) have been reported in patients taking Venofer®, including serious and life threatening reactions (shock, loss of consciousness, collapse, convulsion, severe difficulty in breathing). Hypotension (low blood pressure) has been reported in patients who receive IV iron whether or not they are on dialysis. Hypotension (low blood pressure) following administration of Venofer® may be related to how fast and how much of the drug is given.

In studies in non-dialysis dependent-CKD patients, the most common side effects of Venofer were taste disturbance (7.7%), swelling of the arms and legs (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of non-dialysis dependent-CKD patients treated with erythropoietin, the most common side effects of Venofer were diarrhea (16.5%), swelling of the arms and legs (16.5%), nausea (13.2%), vomiting (12.1%), joint pain (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).

In studies in hemodialysis dependent-CKD patients, the most common side effects of Venofer were low blood pressure (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In additional studies in hemodialysis dependent-CKD patients, the most common side effects were congestive heart failure, severe infections, and taste disturbance. In the study of peritoneal dialysis-dependent CKD patients most common side effects were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), sore throat (6.7%), swelling of the arms and legs (5.3%), and nausea (5.3%).


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.