PRIVACY POLICY 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.



INDICATION
Venofer® (iron sucrose injection, USP) is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Venofer® is contraindicated in patients with known hypersensitivity to Venofer.
WARNINGS AND PRECAUTIONS
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer. 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. Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion.
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/or total dose delivered.
Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. All adult and pediatric patients receiving Venofer require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Do not administer Venofer to patients with evidence of iron overload. Transferrin saturation (TSAT) values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing.
ADVERSE REACTIONS
The most common adverse reactions (≥2%) following the administration of Venofer are diarrhea, nausea, vomiting, headache, dizziness, hypotension, pruritus, pain in extremity, arthralgia, back pain, muscle cramp, injection site reactions, chest pain and peripheral edema. Additional adverse reactions include infusion site pain or burning, graft complications, and nasopharyngitis, sinusitis, upper respiratory tract infections and pharyngitis.
In pediatric patients, more than 50% of the patients experienced at least one treatment-emergent reaction. The most common adverse reactions (≥2%) were headache, respiratory tract viral infection, peritonitis, vomiting, pyrexia, dizziness, cough, renal transplant, nausea, arteriovenous fistula thrombosis, hypotension and hypertension.
In post-marketing safety studies of Venofer in 1,051 patients with HDD-CKD, adverse reactions reported by > 1% were cardiac failure congestive, sepsis and dysgeusia.
Because adverse reactions from post-marketing experience are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In addition to potential serious hypersensitivity reactions, the following adverse reactions have been identified during post-approval use of Venofer® (iron sucrose injection, USP): bronchospasm, dyspnea, convulsions, light-headedness, confusion, angioedema, swelling of the joints, hyperhidrosis, bradycardia and chromaturia.
Symptoms associated with Venofer total dosage or infusing too rapidly included hypotension, dyspnea, headache, vomiting, nausea, dizziness, joint aches, paresthesia, abdominal and muscle pain, edema and cardiovascular collapse. These adverse reactions have occurred up to 30 minutes after the administration of Venofer injection. Reactions have occurred following the first dose or subsequent doses of Venofer. Slowing the infusion rate may alleviate symptoms.
Injection site discoloration has been reported following extravasation. Assure stable intravenous access to avoid extravasation.
PP-VE-US-0001 10/2016
To report adverse events, please contact American Regent at 1-800-734-9236.
You may also contact the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
This site is intended for use only by US healthcare professionals.


Venofer® is manufactured under license from Vifor (International) Inc., Switzerland.
© 2017 American Regent, Inc., a Luitpold Pharmaceuticals, Inc. company