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.

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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.

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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.

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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.
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IMPORTANT SAFETY INFORMATION:

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer® (iron sucrose injection, USP). Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer® immediately. Monitor patients for signs and symptoms of hypersensitivity during and after Venofer® administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer Venofer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer® may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer®. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.

Venofer® is contraindicated in patients with known hypersensitivity to Venofer®. Do not administer to patients with evidence of iron overload.

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance

(7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to Venofer® 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 the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).


Please see Full Prescribing Information.