Efficacy Results
The Drive Study
 
 
FERRLECIT® IMPROVED ERYTHROPOIESIS
Patients treated with Ferrlecit® had a greater hemoglobin response than patients who did not receive IV iron, and a higher proportion of patients receiving IV iron achieved a hemoglobin response ≥2 g/dL.
HEMOGLOBIN RESPONSE
Patients receiving Ferrlecit® experienced significantly greater increases in TSAT compared with those receiving epoetin only, regardless of baseline serum ferritin.
TSAT RESPONSE
A course of Ferrlecit® therapy was effective in improving iron availability for healthy erythropoiesis, as indicated by the maintenance of CHr levels.
CHr RESPONSE





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Key Points2

  A course of Ferrlecit® therapy
(1 g given over 8 consecutive dialysis sessions) was effective management for anemic hemo-dialysis patients with serum ferritin 500-1200 ng/mL and TSAT ≤25% receiving adequate epoetin doses.

  Hemoglobin increases were greater following IV iron treatment compared to no iron therapy.

  Administration of Ferrlecit® in this patient population overcame functional iron deficiency and inflammation-mediated reticuloendothelial blockade.

  Withholding IV iron in these patients resulted in worsening
of iron-restricted erythropoiesis.

 
 
Important Safety Information3

Ferrlecit® is indicated for the treatment of iron deficiency anemia in chronic hemodialysis patients age 6 years and over receiving supplemental epoetin therapy • Ferrlecit® is contraindicated in non iron-deficient anemias, in patients hypersensitive to Ferrlecit® or its inactive components, or with evidence of iron overload • Hypersensitivity reactions have been reported with injectable iron products • Hypotension has been reported with rapid administration of IV iron • In a single-dose, placebo-controlled safety study (n=1097), the most frequent adverse events occurring after Ferrlecit® administration were hypotension, nausea, and vomiting and/or diarrhea • In multiple-dose studies (n=126), the most frequent adverse events, whether or not related to Ferrlecit® administration were nausea, vomiting and/or diarrhea, injection site pain, hypotension, cramps, hypertension, dizziness, dyspnea, and chest pain