Indications and Dosage1
Venofer® (iron sucrose injection, USP) is indicated in the treatment of iron deficiency anemia in the following patients:
- Non-Dialysis Dependent - Chronic Kidney Disease (NDD-CKD) patients receiving an erythropoietin
- Non-Dialysis Dependent - Chronic Kidney Disease (NDD-CKD) patients not 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 Adult Dosage
Most CKD patients will require a minimum cumulative repletion dose of 1000 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.
Non-Dialysis Dependent - Chronic Kidney Disease (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 to 4 hours on day 1 and day 14; hypotension occurred in 2 of 30 patients treated.
Hemodialysis Dependent - Chronic Kidney Disease (HDD-CKD)
Venofer® 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 session for a total cumulative dose of 1,000 mg.
Peritoneal dialysis Dependent - Chronic Kidney Disease (PDD-CKD)
Venofer® is administered undiluted 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 250 mL 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)
- Sufficient IV iron should be administered to maintain TSAT between 20% and 50%. Iron therapy should be withheld in patients with TSAT ≥50%
- Iron therapy should be withheld in patients with ferritin values ≥800 ng/mL
- Since transferrin saturation values increase rapidly after IV administration of iron sucrose, serum iron values may be reliably obtained 48 hours after IV iron sucrose dosing
IMPORTANT SAFETY INFORMATION
Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to Venofer® or any of its inactive components, and in patients with anemia not caused by iron deficiency. Hypersensitivity reactions have been reported with IV iron products. Hypotension has been reported frequently in hemodialysis dependent-CKD patients receiving IV iron, and has also been reported in non-dialysis dependent and peritoneal dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of Venofer ® may be related to rate of administration and total dose delivered.
In multi-dose efficacy studies in hemodialysis dependent-CKD patients (N=231), the most frequent adverse events (>5%), whether or not related to Venofer ® administration, were hypotension, cramps/leg cramps, nausea, headache, graft complications, vomiting, dizziness, hypertension, chest pain and diarrhea. In post-marketing safety studies in hemodialysis dependent-CKD patients (N=1051), the most frequent adverse events reported (>1%) were congestive heart failure, sepsis and taste perversion. In multi-dose efficacy studies in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were taste disturbance, peripheral edema, diarrhea, constipation, nausea, dizziness, and hypertension. In the study of peritoneal dialysis dependent-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, reported by ≥5% of these patients were diarrhea, peritoneal infection, vomiting, hypertension, pharyngitis, peripheral edema and nausea.
Please see Full Prescribing Information.
References
- Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 2007.
