About Venofer

Venofer® (iron sucrose injection, USP) is used intravenously to replenish body iron stores in patients with iron deficiency anemia. Venofer® is indicated in the treatment of iron deficiency anemia in1 Adult non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin Adult non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin Adult hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin Adult peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin Venofer® is contraindicated in:      Patients with evidence of iron overload      Patients with know hypersensitivity to iron sucrose or any of its inactive components      Patients with anemia not caused by iron deficiency Non-dextran Formula Venofer® is a brown, sterile, aqueous complex of polynuclear iron (III)-hydroxide in sucrose containing 20 mg elemental iron per mL. It contains no dextran or modified dextran. A Test Dose Is Not Required Unlike iron dextran products, Venofer® does not require a test dose prior to therapy. Staff vigilance when administering any intravenous iron product is recommended. Over 50 Years of Worldwide Clinical Experience More than 100 clinical studies and a long history of the use of iron sucrose injection worldwide have established the efficacy and safety of Venofer® in patients with iron deficiency anemia from CKD.2-125 Between 1992 and February 2010, over 12 million patients have been treated with more than 240 million units (100 mg equivalents) in more than 84 countries.2 Large Safety Database A large safety database on Venofer® (iron sucrose injection, USP) is available from clinical trial reports, publications, and post-marketing surveillance. Data on the safety of Venofer® have been collected since its introduction to the European market (Switzerland) in 1950 and during a modern clinical development program begun in 1992. Serious hypersensitivity reactions have occurred with Venofer®.1  See Important Safety Information below. Flexible Administration Venofer® may be dosed in the office or outpatient setting. It may be administered either by undiluted IV push injection or IV infusion. This option gives healthcare providers the flexibility to deliver iron therapy in the most convenient way for the patient. Convenient Single-dose Vials Venofer® is available in both 100 mg/5 mL and 200 mg/10 mL vials. Difficulties associated with glass ampules, such as breakage, splintering, and bodily injury to staff, are eliminated with these convenient single-dose vials. One 5-mL vial of Venofer® provides 100 mg of iron as iron sucrose, the National Kidney Foundation-Kidney Dialysis Outcomes Quality Initiative (NKF-KDOQI)-recommended dose for a single dialysis session.126 Each vial is barcoded with its National Drug Code (NDC) to help prevent medication errors.  For more complete information about Venofer® (iron sucrose injection, USP) you may view and download the Formulary Monograph here.

*Based on IMS Health, IMS National Sales Perspective® (July 2009) 2nd quarter 2009 results-dollar volume ($) and units (100 mg equivalents).

Click here to visit Patient Site.

Venofer iron sucrose injection, USP. Reinvigorating anemia management

• Home
• About Venofer^®
  • Indication and Dosage
  • Pharmacology
  • Efficacy and Safety
  • Comparison Chart
  • Treatment Algorigthm
• Anemia Management
  • Guidelines
  • Diagnosis
  • Protocol Development
  • Current Issue
• Reimbursement and Patient Assistance Program
  • Coverage, Coding, Reimbursement
  • Hotline Information
  • Patient Assistance Program
• Q and A
• Professional Resources
• Request Rep/Literature
• Glossary

American Regent. Enriching the lives of anemia patients. ™

IMPORTANT SAFETY INFORMATION: Venofer^® (iron sucrose injection, USP) 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. Serious hypersensitivity reactions have been reported in patients receiving Venofer®. 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 Venofer® administration.
Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of Venofer® 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 Venofer® 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 Venofer® with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to Venofer® reported by ≥5% of Venofer® 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 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 post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to Venofer® 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 Venofer®, 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%).