![]() Venofer® Reimbursement Hotline: 1-800-282-7712 FOR NON-DIALYSIS FACILITIES AND PROVIDERS ONLY American Regent, Inc. has created a toll-free hotline to help physicians and other providers understand payers coverage and reimbursement policies for Venofer® (iron sucrose injection, USP) and, when necessary, address reimbursement issues. Specifically, hotline Reimbursement Specialists assist with the following:
Instructions on Using the Reimbursement Hotline
Patient information will be kept strictly confidential at all times The Reimbursement Specialist will either provide you with the information you request or will contact the insurer for clarification. The Reimbursement Specialist will call you back with the information you requested. There is no limit to the number of times you call or the number of cases you may discuss with the Reimbursement Specialist, and there is no charge for this service. Every attempt is made to provide accurate, up-to-date information. The Venofer® Reimbursement Hotline cannot guarantee successful reimbursement. For more details about coverage and reimbursement, call the Venofer® Reimbursement Hotline at 800-282-7712, Monday through Friday, 9:00 AM to 5:00 PM, Eastern time. For Customer Service or Professional Services Departments, call 800-645-1706. |
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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.

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Venofer® is manufactured under license from Vifor (International) Inc., Switzerland.
© 2009 American Regent, Inc., a Luitpold Pharmaceuticals, Inc. company