Venofer® (iron sucrose injection, USP) is indicated in the treatment of iron deficiency anemia for1:

  • Adult non-dialysis dependent-chronic kidney disease (NDD-CKD) patients receiving an erythropoietin
  • Adult non-dialysis dependent-chronic kidney disease (NDD-CKD) patients not receiving an erythropoietin
  • Adult hemodialysis dependent-chronic kidney disease (HDD-CKD) patients receiving an erythropoietin
  • Adult 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 (Hb) response and to replenish iron stores (ferritin, transferrin saturation [TSAT]). Patients may continue to require therapy with Venofer® at the lowest dose necessary to maintain target levels of Hb, and laboratory parameters of iron storage, within acceptable limits.

NDD-CKD:
Venofer® (iron sucrose injection, USP) is administered as a total cumulative dose of 1000 mg as a 200 mg slow IV injection undiluted over 2 to 5 minutes on 5 different occasions within a 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.

HDD-CKD on erythropoietin:
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 sessions for a total cumulative dose of 1000 mg.

PDD-CKD on erythropoietin:
Venofer® is administered as a total cumulative dose of 1000 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, hematocrit [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%.
  • When serum ferritin is >500 ng/mL, decisions regarding IV iron administration should weigh ESA responsiveness, Hb, TSAT, and patient's clinical status. In particular, when ferritin is >500 ng/mL while concurrently measured TSAT is < 20%, iron deficiency may be present and a course of iron treatment may be considered.
  • 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.




Pharmacy Specifications
 
Dosage Form
Venofer® (iron sucrose injection, USP) is available in 5 mL and 10 mL single dose vials. Each 5 mL vial contains 100 mg (20 mg/mL) and each 10 mL vial contains 200 mg (20 mg/mL) of elemental iron as iron sucrose in water for injection. Venofer® contains no preservatives.1  
 
Syringe Stability
Venofer® when diluted with 0.9% Sodium Chloride for Injection, USP at concentrations ranging from 2 mg to 10 mg of elemental iron per mL, or undiluted (20 mg elemental iron per mL) and stored in a plastic syringe, was found to be physically and chemically stable for 48 hours at controlled room temperature (25°C ±2°C) and under refrigeration (4°C ±2°C).2
 
IV Admixture Stability
Venofer ®, when added to IV infusion bags (PVC) containing 0.9% Sodium Chloride Injection, USP at concentrations ranging from 0.5 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 48 hours at controlled room temperature (25°C ±2°C) and under refrigeration (4°C ±2°C).2
 
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to infusion.

Do not mix Venofer with other medications or add to parenteral nutrition solutions for intravenous infusion.
American Regent. Enriching the lives of anemia patients. ™

IMPORTANT SAFETY INFORMATION: Venofer® (iron sucrose injection, USP) is contraindicated in patients with evidence of iron overload, in patients with known hypersensitivity to VenoferŪ or any of its inactive components, and in patients with anemia not caused by iron deficiency. Serious hypersensitivity reactions have been reported in patients receiving VenoferŪ. In clinical studies, several patients experienced hypersensitivity reactions presenting with wheezing, dyspnea, hypotension, rashes, or pruritus. The post-marketing spontaneous reporting system includes reports of patients who experienced serious or life-threatening reactions (anaphylactic shock, loss of consciousness or collapse, bronchospasm with dyspnea, or convulsion) associated with VenoferŪ administration.

Hypotension has been reported frequently in non-dialysis dependent-CKD patients receiving IV iron. Hypotension following administration of VenoferŪ may be related to rate of administration and total dose delivered.

In a multi-dose efficacy study in non-dialysis dependent-CKD patients (N=91), the most frequent adverse events (≥5%) whether or not related to VenoferŪ administration, were taste disturbance (7.7%), peripheral edema (7.7%), diarrhea (5.5%), constipation (5.5%), nausea (5.5%), dizziness (5.5%), and hypertension (5.5%). In an additional study of VenoferŪ with varying erythropoietin doses in 96 treated NDD-CKD patients, adverse events, whether or not related to VenoferŪ reported by ≥5% of VenoferŪ exposed patients are as follows: diarrhea (16.5%), edema (16.5%), nausea (13.2%), vomiting (12.1%), arthralgia (7.7%), back pain (7.7%), headache (7.7%), hypertension (7.7%), taste disturbance (7.7%), dizziness (6.6%), extremity pain (5.5%), and injection site burning (5.5%).

In multi-dose efficacy studies in HDD-CKD patients (N=231), the most frequent adverse events (> 5%) whether or not related to VenoferŪ administration, were hypotension (39.4%), muscle cramps (29.4%), nausea (14.7%), headache (12.6%), graft complications (9.5%), vomiting (9.1%), dizziness (6.5%) hypertension (6.5%), chest pain (6.1%), and diarrhea (5.2%). In post-marketing safety studies in HDD-CKD patients (N=1051), the most frequent adverse events reported (>1%), whether or not related to VenoferŪ administration, were congestive heart failure, sepsis, and taste disturbance. In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to VenoferŪ, reported by ≥5% of these patients were diarrhea (8.0%), peritoneal infection (8.0%) vomiting (8.0%), hypertension (8.0%), pharyngitis (6.7%), peripheral edema (5.3%), and nausea (5.3%).


Please see Full Prescribing Information.


References