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 Erythropoietin 123

  • 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:

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer® (iron sucrose injection, USP). 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.

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 total dose delivered.

Venofer® is contraindicated in patients with known hypersensitivity to Venofer®. Do not administer to patients with evidence of iron overload.

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance

(7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

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 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 infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).


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References