Since Venofer® (iron sucrose injection, USP) was first approved in Switzerland in 1950, a large body of evidence in the form of study reports and publications has been produced that demonstrates the safety and efficacy of intravenous iron sucrose. The clinical evaluation of Venofer® in treating iron deficiency is based on results from more than 100 studies1-124 involving more than 7000 subjects.

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Efficacy vs Oral Iron in Adult NDD-CKD121

  • Venofer® was superior to oral iron in achieving a rise in Hb ≥1.0 g/dL
  • Venofer® significantly increased iron stores


Adult HDD-CKD Patients Intolerant to Other IV Iron Therapies125

  • 130 hemodialysis patients intolerant to iron dextran, ferric gluconate, or both were successfully treated with Venofer® in 4 clinical trials
  • No serious adverse events were reported


Optimizing ESA Usage126

  • Venofer® improved anemia with 55% of patients reaching recommended target Hb (11g/dL) without any ESA
  • Venofer® significantly increased iron status indicators


Clinical Trial in Adult PDD-CKD Patients on Erythropoietin123

  • Venofer® treated patients showed a calculated net dose decrease in ESA
  • Venofer® administered as 300 mg and 400 mg infusions provides a practical approach for iron repletion


 
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 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%).


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References