VenoferŪ (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. Hypersensitivity reactions have been reported with IV iron products. Hypotension has been reported frequently in hemodialysis dependent-CKD patients receiving IV iron, and has also been reported in non-dialysis dependent and peritoneal dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of VenoferŪ may be related to rate of administration and total dose delivered.
In multi-dose efficacy studies in hemodialysis dependent-CKD patients (N=231), the most frequent adverse events (>5%), whether or not related to VenoferŪ administration, were hypotension, cramps/leg cramps, nausea, headache, graft complications, vomiting, dizziness, hypertension, chest pain and diarrhea. In post-marketing safety studies in hemodialysis dependent-CKD patients (N=1051), the most frequent adverse events reported (>1%) were congestive heart failure, sepsis and taste perversion. In multi-dose efficacy studies in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to VenoferŪ administration, were taste disturbance, peripheral edema, diarrhea, constipation, nausea, dizziness, and hypertension. In the study of peritoneal dialysis dependent-CKD patients (N=75), the most frequent adverse events, whether or not related to VenoferŪ, reported by ≥5% of these patients were diarrhea, peritoneal infection, vomiting, hypertension, pharyngitis, peripheral edema and nausea.
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1. Data on file, American Regent, Inc., Shirley, NY.
2. Aronoff GR, Bennett WM, Blumenthal S, Charytan C, et al. Iron sucrose in Hemodialysis patients: Safety of replacement and maintenance regimens. Kidney International, Vol 66(2004), pp.1193-1198
3. Rothstein M, Sterret JR, Al-Saloum M, Fadda GZ, Reed JE. Iron sucrose is safe when 200 mg is given IV push over 5 minutes or 100 mg over 2 minutes: results of a US multicenter clinical trial. Presented at: 2002 ASN/ISN World Congress of Nephrology; October 20-November 4, 2002; Philadelphia, PA. Abstract SU-P0628.
4. Charytan C, Schwenk MH, Al-Saloum M, Spinowitz BS. Safety of Iron Sucrose in Hemodialysis Patients Intolerant to Other Parenteral Iron Products. Nephron Clin Pract 2004;96:c63-c66
5. Venofer® Package Insert. Shirley, NY: American Regent, Inc. Revised October, 2005. * FDA approved highest iron dose (for PDD-CKD and NDD-CKD)
6. Charytan C, Levin N, Al-Saloum M, Hafeez T, Gagnon S, Van Wyck DB. Efficacy and safety of iron sucrose for iron deficiency in patients with dialysis-associated anemia: North American clinical trial. Am J Kidney Dis. 2001;37:300-307.
7. Van Wyck DB, Cavallo G, Spinowitz BS, et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial, Am J Kidney Dis. 2000;36:88-97.
8. Van Wyck DB, Roppolo M, Martinez CO, et al. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD, Kidney International 2005;68:2846-2856.
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