Dexferrum Injection

General: Circulating iron dextran is removed from the plasma by cells of the reticuloendothelial system, which split the complex into its components of iron and dextran. The iron is immediately bound to the available protein moieties to form hemosiderin or ferritin, the physiological forms of iron, or to a lesser extent to transferrin. This iron which is subject to physiological control replenishes hemoglobin and depleted iron stores.

Dextran, a polyglucose, is either metabolized or excreted. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran.

Studies involving intravenously administered iron dextran to iron deficient subjects who had coexisting end-stage renal disease and other clinical problems, have yielded individual half-life values ranging from 9.4 to 87.4 hours. The average half-life value equaled 58.9 hours. These studies measured the total serum iron directly as well as the transferrin-bound iron, non-radio-isotopically. It should be understood that these half-life values do not represent clearance of iron from the body. Iron is not easily eliminated from the body and accumulation of iron can be toxic.

In vitro studies have shown that removal of iron dextran by dialysis is negligible1,2. Six different dialyzer membranes were investigated (polysulphone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrilate and polyacrylonitrile), including those considered high efficiency and high flux.

CONTAINER

NDC 0517-0234-10

DEXFERRUM® (IRON DEXTRAN INJECTION, USP)

100 mg Elemental Iron per 2 mL (50 mg/mL)

2 mL SINGLE DOSE VIAL

FOR IV USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

CARTON

NDC 0517-0234-10

10 x 2 mL SINGLE DOSE VIALS

DEXFERRUM® (IRON DEXTRAN INJECTION, USP)

100 mg Elemental Iron per 2 mL (50 mg/mL)

2 mL SINGLE DOSE VIAL

FOR INTRAVENOUS USE

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY 11967

U.S. PATENT 5,624,668