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Venofer® (iron sucrose injection, USP) provides first-line IV iron therapy for the treatment of iron deficiency anemia in adult and pediatric patients 2 years and older with chronic kidney disease (CKD). It should not be used in patients with known hypersensitivity to Venofer®.

Venofer® has more than 50 years of worldwide clinical experience in the treatment of CKD-related iron deficiency anemia. American Regent, in addition to bringing Venofer® to market, supports the treatment of iron deficiency anemia and the renal community with important professional and patient education tools such as this web site as well as a Venofer® Patient Assistance Program. American Regent is truly committed to enriching lives of anemia patients with CKD and their families.

Over 26 Million adults have CKD, and millions more at risk.

Early Detection and Pre-dialysis Intervention



 






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 hemodialysis dependent-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%), pain in extremity (5.6%) and diarrhea (5.2%). In the study of peritoneal dialysis dependent-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer® administration, 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%).

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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Venofer® is manufactured under license from Vifor (International) Inc., Switzerland.
© 2014 American Regent, Inc., a Luitpold Pharmaceuticals, Inc. company