AMERICAN REGENT, INC., (AMERICAN REGENT) is the sole owner of the information collected on this Web site. We will not sell, share, or rent this information to others in ways different from what is disclosed in this statement. When you visit the AMERICAN REGENT Web site, you should be confident that we do our best to respect your privacy. We collect personally identifiable information only to answer your questions and concerns and to learn what improvements we can make to our site and our products.

Mailing Lists
In some places on our site, you can select whether or not you want to receive future e-mails from us to learn about our products, or promotions, or general information about health. If at any time you wish to be taken off an AMERICAN REGENT mailing list, please submit a message using our Contact Us page.

Personally Identifiable Information
We do not require you to disclose any personally identifiable information for general access to our site. Any personally identifiable information you submit is used only to help us satisfy your requests and for internal marketing purposes. Web site visitors may decide to send AMERICAN REGENT personally identifiable information, for example, in a message asking a question about an AMERICAN REGENT product or containing comments about the AMERICAN REGENT Web site. AMERICAN REGENT will use this information only to respond to the matter identified in the e-mail. Please note, however, that if you submit personally identifiable information about an adverse event or injurty associated with the use of one of our products, we may be required to submit that information to FDA or other regulatory agencies.

Non–Personally Identifiable Information
The AMERICAN REGENT Web site may collect non–personally identifiable information, such as type of browser, operating system, domain name, or IP address. An IP address is a number that is automatically assigned to your computer whenever you are surfing the Web. Web servers automatically identify your computer by its IP address. When you visit pages on the AMERICAN REGENT Web site, our servers log your IP address. We do not link IP addresses to any personally identifiable information. This means that your session will be logged, but you remain anonymous to us. Non–personally identifiable information is used only for internal marketing purposes and is then discarded.

If you have any questions or comments about the AMERICAN REGENT Privacy Policy, please submit a message using our Contact Us page.

AMERICAN REGENT reserves the right to change our Privacy Policy from time to time. A revised Privacy Policy will apply to information collected after the date it is changed.
American Regent. Enriching the lives of anemia patients. ™

IMPORTANT SAFETY INFORMATION: Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to VenoferŪ or any of its inactive components, and in patients with anemia not caused by iron deficiency. Serious hypersensitivity reactions have been reported in patients receiving VenoferŪ. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. The post-marketing spontaneous reporting system includes reports of patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with VenoferŪ administration.

Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of VenoferŪ may be related to rate of administration and total dose delivered.

In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to VenoferŪ administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of VenoferŪ with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to VenoferŪ reported by ≥5% of VenoferŪ exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (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 multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to VenoferŪ administration, were hypotension (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 post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to VenoferŪ administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to VenoferŪ, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).


Please see Full Prescribing Information.