NN&I - April 2010
Over 9 million patients treated with over 180 million units* 1 The #1 prescribed IV iron 2 *100 mg vials and ampules worldwide from 1992 to February 2009. References: 1. Data on file.Fresenius Medical Care.Waltham,MA. 2. Based on IMS Health,IMS National Sales Perspective™ (October 2009) 3rd quarter 2009 results-dollar volume ($) and units (100 mg equivalents). Venofer ® is manufactured under license from Vifor (International) Inc.,Switzerland and American Regent,Inc., Shirley,NY.Venofer ® is a trademark of Vifor (International) Inc.used by permission.Millions prescribed.Millions treated. ™ is a trademark of Luitpold Pharmaceuticals,Inc.Fresenius Medical Care is a trademark of Fresenius Medical Care Holdings,Inc.or its affiliated companies.© 2010 Fresenius Medical Care North America. Please see brief prescribing information on following pages. 101226-01 Rev.00 01/2010 Remarkable body of evidence Efficacy thisextensive can only be Millions prescribed. Millions treated.™ Millions prescribed. Millions treated.™ IMPOR T ANT SAFETY INFORMA TION :Venofer ® (iron sucrose injection,USP) is indicated in the treatment of iron deficiency anemia in hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin,and peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin.Venofer ® is contraindicated in patients with evidence of iron overload,in patients with known hypersensitivity to Venofer ® or any of its inactive components,and in patients with anemia not caused by iron deficiency.Hypersensitivity reactions have been reported with IV iron products.Hypotension has been reported frequently in HDD-CKD and PDD-CKD patients receiving IV iron,and may be related to rate of administration and total dose delivered. In multi-dose efficacy studies in HDD-CKD patients,the most frequent adverse events (>5%),whether or not related to Venofer ® administration,were hypotension,muscle cramps,nausea,headache,graft complications,vomiting, dizziness,hypertension,chest pain and diarrhea.In the study of PDD-CKD patients,the most frequent adverse events,whether or not related to Venofer ® , reported by 5% of these patients were diarrhea,peritoneal infection,vomiting, hypertension,pharyngitis,peripheral edema and nausea. FVEN0068 RBE Effi NNI DR 3/8/10 12:31 PM Page 1 Ads_NNI0410.indd 27 3/15/10 8:49:29 AM
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