TERMS OF USE Please read the following Terms and Conditions before using the American Regent, Inc., (American Regent) Web site. By accessing and using the site, you acknowledge that you have read, understood, and agree to comply with these Terms and Conditions. Amendment of Terms
American Regent may amend these Terms and Conditions at any time. Your continued use of this Web site is conditioned on the Terms and Conditions stated at the time of your use. You should visit this page prior to using this Web site to determine the current Terms and Conditions to which you are bound.
Content Disclaimer
The information on this Web site applies only to the products discussed herein as approved in the United States of America.
The information provided on this Web site is not intended to substitute for the advice of a physician or other health care provider. You should not use the information provided on this Web site to diagnose or treat any medical condition or to make any other decision. Read and follow all instructions provided with products or as directed by your health care provider.

The information found on this Web site is up-to-date only through its date of last revision, and may become out of date over time. American Regent accepts no liability for the accuracy or completeness or use of, nor any liability to update, the information provided on this Web site.

Limitation of Warranties
The information provided on this Web site is provided “AS IS” WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NONINFRINGEMENT, to the extent allowed by applicable law.

Use Restriction
American Regent gives you permission to electronically copy and print in hard copy portions of the Web site for your personal, noncommercial use only. However, American Regent retains the copyright on all text, content, and graphics found on this Web site. This means that any other use, including, but not limited to, modification, distribution, or republication without American Regent's prior written permission is strictly prohibited. Nothing herein shall be considered to confer or grant any license or right under any copyright of American Regent, Inc.

Corporate Identification and Trademarks
The marks on the Web site are trademarks of American Regent, Inc., except for VENOFER® and DEXFERRUM®, which are registered trademarks of VIFOR (International) Inc., St. Gallen, Switzerland, used with permission under license ("the Licensed Marks"). You may not use, copy, reproduce, republish, upload, post, transmit, distribute, or modify these marks in any way without American Regent's prior written permission. The use of American Regent's trademarks, including the Licensed Marks, on any other Web site is prohibited.

Links
American Regent prohibits the use of American Regent's trademarks, including the Licensed Marks, as a "link" on or to any other Web site unless American Regent has approved the link in advance.

Nonconfidentiality
Any information supplied by a visitor to this Web site shall be deemed as nonconfidential.
American Regent shall have no obligation of any kind with respect to such information and shall be free to reproduce, use, disclose, and distribute the information to others without limitation. American Regent shall be free to use any ideas, concepts, know-how or techniques contained in such information for any purpose whatsoever including, but not limited to, developing, manufacturing, and marketing products incorporating such information.




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