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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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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