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Basic Drug Info
Drug Name:Venofer
Manufacturer:AMERICAN REGENT, INC.
Other Info:

Peritoneal Dialysis Dependent-Chronic Kidney Disease Patients (PDD-CKD): Venofer® is administered as a total cumulative dose of 1,000 mg in 3 divided doses, given by slow intravenous infusion, within a 28 day period: 2 infusions of 300 mg over 1.5 hours 14 days apart followed by one 400 mg infusion over 2.5 hours 14 days later.

The Venofer® dose should be diluted in a maximum of 250 mL of 0.9% NaCl.



Clinical Trials:


Indications and Usage
Venofer® is indicated in the treatment of iron deficiency anemia in the following patients:non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietinnon-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietinhemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietinperitoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients receiving an erythropoietin.
Iron deficiency anemia -- Anemia characterized by decreased or absent iron stores, low serum iron concentration, low transferrin saturation, and low hemoglobin concentration or hematocrit value. The erythrocytes are hypochromic and microcytic and the iron binding capacity is increased.

Contraindications
The use of Venofer® 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.
Iron Overload -- An excessive accumulation of iron in the body due to a greater than normal absorption of iron from the gastrointestinal tract or from parenteral injection. This may arise from idiopathic hemochromatosis, excessive iron intake, chronic alcoholism, certain types of refractory anemia, or transfusional hemosiderosis. (From Churchill's Illustrated Medical Dictionary, 1989)

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Anemia -- A reduction in the number of circulating erythrocytes or in the quantity of hemoglobin.

Iron deficiency --

Warnings

Hypersensitivity reactions have been reported with injectable iron products.

See PRECAUTIONS and ADVERSE REACTIONS.

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