Home » Drug Information » FDA Approved Drugs » 1999
Medical Areas: Hematology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: R&D Laboratories
Approval Status: Approved February 1999
Treatment Area: Anemia
Ferrlecit® is used to replete the total body content of iron.
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.
The total body iron content of an adult ranges from 2 to 4
grams. Approximately 2/3 is in hemoglobin and 1/3 in
reticuloendothelial storage (bone marrow, spleen, liver) and
ferritin. The body highly conserves iron (daily loss of 0.03%)
requiring supplementation of about 1 mg/day to replenish losses in
healthy, non-menstruating adults. The etiology of iron deficiency
in 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.
Study A was a three-center, randomized, open-label study of the
safety and efficacy of two doses of Ferrlecit® administered
intravenously to iron-deficient hemodialysis patients. The study
included both a dose-response concurrent control and an historical
control. Enrolled patients received a test dose of Ferrlecit® (25
mg of elemental iron) and were then randomly assigned to receive
Ferrlecit® at cumulative doses of either 500mg (low dose) or 1000mg
(high dose) of elemental iron. Ferrlecit® was given to both dose
groups in eight divided doses during sequential dialysis sessions
(a period of 16 to 17 days). At each dialysis session, patients in
the low-dose group received Ferrlecit® 62.5 mg of elemental iron
over 30 minutes, and those in the high-dose group received
Ferrlecit® 125mg of elemental iron over 60 minutes. The primary
endpoint was the change in hemoglobin from baseline to the last
available observation through Day 40.
Eligibility for this study included chronic hemodialysis
patients with a hemoglobin below 10 g/dl (or hematocrit at or below
30%) and either serum ferritin below 200 ng/ml or iron saturation
below 18%. Exclusion criteria included significant underlying
disease or inflammatory conditions or an erythropoietin (EPO)
requirement of greater than 10,000 units three times per week.
Parenteral iron and red cell transfusion were not allowed for two
months before the study. Oral iron and red cell transfusion were
not allowed during the study for Ferrlecit®-treated patients.
The historical control population consisted of 25 chronic
hemodialysis patients who received only oral iron supplementation
for 14 months and did not receive red cell transfusion. All
patients had stable EPO doses and hematocrit values for at least
two months before initiation of oral iron therapy.
The evaluated population consisted of 39 patients in the
low-dose Ferrlecit® group, 44 patients in the high-dose Ferrlecit®
group, and 25 historical control patients.
The mean baseline hemoglobin and hematocrit were similar between
treatment and historical control patients: 9.8 g/dl and 29% and 9.6
g/dl and 29% in low- and high-dose Ferrlecit® treated patients,
respectively, and 9.4 g/dl and 29% in historical control patients.
Baseline serum iron saturation was 20% in the low-dose group, 16%
in the high-dose group, and 14% in the historical control. Baseline
serum ferritin was 106 ng/ml in the low-dose group, 88 ng/ml in the
high-dose group, and 606 ng/ml in the historical control. Patients
in the high-dose Ferrlecit® group achieved significantly higher
increases in hemoglobin and hematocrit than either patients in the
low-dose Ferrlecit® group or patients in the historical control
group (oral iron). Patients in the low-dose Ferrlecit® group did
not achieve significantly higher increases in hemoglobin and
hematocrit than patients receiving oral iron.
Side effects include flushing and hypotension, and