What is FERRLECIT?
Why does iron deficiency anemia occur in chronic hemodialysis patients?
How effective is FERRLECIT?
How is FERRLECIT dosed?
How is FERRLECIT administered?
How is FERRLECIT different from iron dextrans?
What are the contraindications?

What is FERRLECIT?
FERRLECIT is a different form of parenteral iron indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 and older undergoing chronic hemodialysis who are receiving supplemental epotin therapy.

FERRLECIT represents a first line drug therapy option for chronic hemodialysis patients with iron deficiency anemia and can be used for both repletion and continued therapy. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport. Additionally, iron is necessary for metabolism and synthesis of DNA and various enzymatic processes.[1]

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Why does iron deficiency anemia occur in chronic hemodialysis patients?
The etiology of iron deficiency in chronic hemodialysis patients is varied and can include increased iron utilization (e.g., from erythropoietin therapy), blood loss (e.g., from fistula, retention in dialyzer, hematologic testing, menses), decreased dietary intake or absorption, surgery, iron sequestration due to inflammatory process, and malignancy. The administration of exogenous erythropoietin increases red blood cell production and iron utilization. The increased iron utilization and blood losses in the hemodialysis patient may lead to absolute or functional iron deficiency. Iron deficiency is absolute when hematologic indicators of iron stores are low. Patients with functional iron deficiency do not meet laboratory criteria for absolute iron deficiency but demonstrate an increase in hemoglobin/hematocrit or a decrease in erythropoietin dosage with stable hemoglobin/hematocrit when parenteral iron is administered.[1]

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How effective is FERRLECIT?
FERRLECIT has been shown to improve anemia outcomes in chronic hemodialysis patients receiving supplemental erythropoietin therapy. In an open-label, multicenter, randomized comparative study, FERRLECIT produced a mean increase in hemoglobin of 1.0 g/dL 2 days after completion of a 1-gram course of therapy administered over 8 sequential dialysis sessions. [4] In same FERRLECIT study, mean serum ferritin levels increased 320 ng/mL 2 days after completion of therapy, but remained below the K/DOQI-recommended limit and mean TSAT increased to >20% 2 days after completion of therapy.[4]

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How is FERRLECIT dosed?
The recommended dosage of FERRLECIT for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of FERRLECIT (125 mg of elemental iron). For initial repletion, most hemodialysis patients receiving supplemental erythropoietin therapy will require at least 1000 mg of FERRLECIT delivered intravenously, divided (125 mg) over 8 sequential dialysis sessions. If target hemoglobin/ hematocrit is not achieved after this initial course, K/DOQI recommends administration of a second 1000-mg course.[20] When iron stores are replenished and continued therapy is desired, FERRLECIT should be administered at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit, and laboratory parameters of iron storage. Periodic monitoring of laboratory parameters of iron storage may assist in recognition of iron accumulation. FERRLECIT should not be administered to patients with iron overload.[1]

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How is FERRLECIT administered?
FERRLECIT may be diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour. FERRLECIT may also be administered undiluted as a slow IV injection (at a rate of up to 12.5 mg/min). Most patients will require a minimum cumulative dose of 1.0 gram of elemental iron, administered over eight sessions at sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response. Patients may continue to require therapy with intravenous iron at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit, and laboratory parameters of iron storage within acceptable limits. FERRLECIT has been administered at sequential dialysis sessions by infusion or by slow IV injection during the dialysis session itself.[1]

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How is FERRLECIT different from iron dextrans?
FERRLECIT is sodium ferric gluconate complex in sucrose injection and it does not contain the dextran moiety of the iron dextrans. In a post-marketing safety study, FERRLECIT was administered to 144 patients with known sensitivity to iron dextran, 34 of which were classified as anaphylactoid. Logistic regression analysis did not identify cross sensitivity between FERRLECIT and previous iron dextran sensitivity in the incidence of all adverse events. Thus there was no demonstrable cross-reactivity between FERRLECIT and iron dextran.[2] The only life-threatening suspected allergic adverse event (0.7%; 1/144) occurred in a patient with a history of multiple drug allergies, including anaphylaxis to iron dextran.[2]

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What are the contraindications?
All anemias not associated with iron deficiency. Hypersensitivity to FERRLECIT or any of its inactive components. Evidence of iron overload.[1]

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