What Is Venofer® (iron sucrose injection, USP)?
The Food and Drug Administration approved Venofer® (iron sucrose injection, USP) for use in the United States on November 6, 2000. However, Venofer® has been available in other countries since 1950. Currently, it is sold in more than 79 countries.1 From 1992 through August 2005, more than 92 million units of Venofer® were prescribed worldwide.1
Venofer® is a brown liquid. It contains water and iron. It is used for intravenous injections. Each 5-mL single-dose vial of Venofer® has 100 mg of elemental iron as iron sucrose in water for injection. Venofer® contains no preservatives. It has no dextran polysaccharides, which can cause allergic reactions in some people. Venofer® does not contain benzyl alcohol, a preservative found in other IV iron products.
Venofer® (iron sucrose injection, USP) is used for the treatment of iron deficiency anemia in non-dialysis dependent - chronic kidney disease (NDD-CKD) patients receiving or not receiving an erythropoietin, and in hemodialysis dependent (HDD-CKD) and peritoneal dialysis dependent (PDD-CKD) - chronic kidney disease patients receiving an erythropoietin.2 Erythropoietin (brand names - Epogen® (epoetin), Procrit® (epoetin), or Aranesp® (darbepoietin)) is a special man-made protein that helps to stimulate red blood cell production.1
Venofer® should not be given to patients who:
- Show evidence of iron overload
- Have an abnormal sensitivity to Venofer® or any of its inactive components
- Have anemia not caused by iron deficiency
Venofer® is meant to be used as a first-line therapy. This means if you develop iron deficiency anemia while being treated for chronic kidney disease, your doctor might turn to Venofer® first to help you.
IMPORTANT SAFETY INFORMATION
Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to Venofer® 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 Venofer® 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 Venofer® 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 Venofer® 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 Venofer®, reported by >5% of these patients were diarrhea, peritoneal infection, vomiting, hypertension, pharyngitis, peripheral edema and nausea.
Please see Full Prescribing Information.
Epogen® and Aranesp® are registered trademarks of Amgen, Inc. Procrit ® is a registered trademark of Ortho Biotech Products, L.P.
Venofer® is a registered trademark of Vifor (International) Inc., Switzerland
References
- Data on file. American Regent, Inc., Shirley, NY.
- Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2007.
