Indications and dosage
Venofer® is indicated in the treatment of iron deficiency anemia in the following
patients:
• Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not
receiving an erythropoietin
• Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving
an erythropoietin
• Hemodialysis dependent chronic kidney disease (HDD-CKD) patients
receiving an erythropoietin
• Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients
receiving an erythropoietin
Venofer® is contraindicated in:
• Patients with evidence of iron overload.
• Patients with known hypersensitivity to iron sucrose or any of its inactive
components.
• Patients with anemia not caused by iron deficiency.
Usual Dosage
Most CKD patients will require a minimum cumulative repletion dose of 1,000 mg of
elemental iron to achieve a favorable hemoglobin response and to replenish iron
stores (ferritin, TSAT). Patients may continue to require therapy with Venofer® at
the lowest dose necessary to maintain target levels of hemoglobin, and laboratory
parameters of iron storage within acceptable limits.
• Hemodialysis Dependent Chronic-Kidney Disease Patients (HDDCKD):
Venofer® (iron sucrose injection, USP) may be administered undiluted
as a 100 mg slow intravenous injection over 2 to 5 minutes or as an
infusion of 100 mg, diluted in a maximum of 100 mL of 0.9% NaCl over a
period of at least 15 minutes per consecutive hemodialysis sessions for a
total cumulative dose of 1,000 mg.
• Non-Dialysis Dependent Chronic-Kidney Disease Patients (NDD-CKD):
Venofer® is administered as a total cumulative dose of 1,000 mg over a 14
day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5
different occasions within the 14 day period. There is limited experience
with administration of an infusion of 500 mg of Venofer®, diluted in a maximum
of 250 mL of 0.9% NaCl, over a period of 3.5-4 hours on day 1 and
day 14; hypotension occurred in 2 of 30 patients treated.
• Peritoneal Dialysis Dependent-Chronic Kidney Disease Patients (PDDCKD):
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 250mL of 0.9% NaCl.
Monitoring Parameters
• Patients receiving regular parenteral iron therapy require monitoring of
hematologic parameters and iron indices (Hb, Hct, TSAT, and ferritin).
• In order to prevent iron overload, serum iron values may be reliably
obtained 48 hrs. after IV iron sucrose dosing.
Venofer® is indicated in the treatment of iron deficiency anemia in the following
patients:
• Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not
receiving an erythropoietin
• Non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving
an erythropoietin
• Hemodialysis dependent chronic kidney disease (HDD-CKD) patients
receiving an erythropoietin
• Peritoneal dialysis dependent-chronic kidney disease (PDD-CKD) patients
receiving an erythropoietin
Venofer® is contraindicated in:
• Patients with evidence of iron overload.
• Patients with known hypersensitivity to iron sucrose or any of its inactive
components.
• Patients with anemia not caused by iron deficiency.
Usual Dosage
Most CKD patients will require a minimum cumulative repletion dose of 1,000 mg of
elemental iron to achieve a favorable hemoglobin response and to replenish iron
stores (ferritin, TSAT). Patients may continue to require therapy with Venofer® at
the lowest dose necessary to maintain target levels of hemoglobin, and laboratory
parameters of iron storage within acceptable limits.
• Hemodialysis Dependent Chronic-Kidney Disease Patients (HDDCKD):
Venofer® (iron sucrose injection, USP) may be administered undiluted
as a 100 mg slow intravenous injection over 2 to 5 minutes or as an
infusion of 100 mg, diluted in a maximum of 100 mL of 0.9% NaCl over a
period of at least 15 minutes per consecutive hemodialysis sessions for a
total cumulative dose of 1,000 mg.
• Non-Dialysis Dependent Chronic-Kidney Disease Patients (NDD-CKD):
Venofer® is administered as a total cumulative dose of 1,000 mg over a 14
day period as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5
different occasions within the 14 day period. There is limited experience
with administration of an infusion of 500 mg of Venofer®, diluted in a maximum
of 250 mL of 0.9% NaCl, over a period of 3.5-4 hours on day 1 and
day 14; hypotension occurred in 2 of 30 patients treated.
• Peritoneal Dialysis Dependent-Chronic Kidney Disease Patients (PDDCKD):
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 250mL of 0.9% NaCl.
Monitoring Parameters
• Patients receiving regular parenteral iron therapy require monitoring of
hematologic parameters and iron indices (Hb, Hct, TSAT, and ferritin).
• In order to prevent iron overload, serum iron values may be reliably
obtained 48 hrs. after IV iron sucrose dosing.
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