No serious adverse events reported

Charytan C, Schwenk MH, Al-Saloum MM, Spinowitz BS. Safety of iron sucrose in hemodialysis patients intolerant to other parenteral iron products. Nephron Clin Pract. 2004;96:c63-c66

Background:
An evaluation of 4 US clinical trials (2 pivotal and 2 post-marketing studies) on the safety of Venofer® (iron sucrose injection, USP) administered to iron-deficient hemodialysis patients with a history of intolerance to previous parenteral iron dextran and/or ferric gluconate therapy.

Measures:

  • 1151 chronic epoetin-treated hemodialysis patients received iron sucrose to correct iron deficiency, anemia, and/or maintain iron stores
  • 130 of these patients demonstrated intolerance to previous parenteral iron therapy
  • No test dose was required*
*Some patients in the 2 US pivotal trials received a test dose at physician's discretion.

Results:
No treatment discontinuations or serious adverse drug events (ADEs), and a low incidence of non-serious ADEs in 4 US clinical trials

  • Only 8 of the 130 patients sensitive to iron dextran and/or ferric gluconate experienced 1 or more non-serious ADEs
  • There were 14 non-serious ADEs; the most common were mild taste disturbance (4) and nausea (3)
  • 1 patient experienced 7 events yet was able to tolerate continued therapy



Conclusions:

  • Venofer® is a safe alternative for patients intolerant to other forms of IV iron
  • Venofer® is a proven alternative in patients unable to receive other injectable iron preparations because of their toxicity


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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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