Venofer® (iron sucrose injection, USP) is indicated for the treatment of iron deficiency anemia in patients with chronic kidney disease (CKD).
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/or total dose delivered.
Venofer is contraindicated in patients with known hypersensitivity to Venofer. Do not administer to patients with evidence of iron overload.
In multi-dose efficacy studies in hemodialysis dependent (HDD)-CKD patients (N=231), the most frequent adverse events (>2%) 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%), pain in extremity (5.6%), and diarrhea (5.2%).
In the study of peritoneal dialysis dependent (PDD)-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer, reported by ≥2% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract infections, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).
In a randomized open-label dose ranging trial of iron maintenance treatment in pediatric patients with CKD on stable erythropoietin therapy, 57% of the Venofer treated patients (27/47) receiving 0.5 mg/kg Venofer experienced a treatment-emergent adverse reaction, 11% of which were serious. The most common treatment-emergent adverse reactions (>2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).
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To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Medical Care Customer Service at 1-800-323-5188 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.