Indications and Dosage

Venofer® (iron sucrose injection, USP) is an iron replacement product indicated for the treatment of iron deficiency anemia in adult and pediatric patients 2 years and older with chronic kidney disease (CKD)1:


Venofer® is contraindicated in patients with know hypersensitivity to Venofer®.  Do not use in patients with evidence of iron overload.


Usual Adult Dosage
Most adult 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]). Venofer® treatment may be repeated if iron deficiency reoccurs.

Adult patients with CKD not on dialysis:
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. 


Adult patients with CKD on hemodialysis:
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.  Venofer® should be administered early during the dialysis session.


Adult patients with CKD receiving peritoneal dialysis:
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 each 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. 


Pediatric Patients (2 years of age and older) with HDD-CKD for iron maintenance treatment
The dosing for iron replacement treatment in pediatric patients with HDD-CKD has not been established.

For iron maintenance treatment: Administer Venofer® at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every two weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes. Venofer® treatment may be repeated if necessary.

Pediatric Patients (2 years of age and older) with NDD-CKD or PDD-CKD who are on erythropoietin therapy for iron maintenance treatment
The dosing for iron replacement treatment in pediatric patients with NDD-CKD or PDD-CKD has not been established.

For iron maintenance treatment: Administer Venofer® at a dose of 0.5 mg/kg, not to exceed 100 mg per dose, every four weeks for 12 weeks given undiluted by slow intravenous injection over 5 minutes or diluted in 25 mL of 0.9% NaCl and administered over 5 to 60 minutes. Venofer® treatment may be repeated if necessary.

Monitoring Parameters

  • Monitor patients for signs and symptons of hypersensitivity during and after Venofer® administration for at least 30 minutes and until clinically stable following completion of the infusion.
  • Only administer Venofer® when personnel and therapies are immediately available for the treatment of hypersensitivity reactions.  See Important Safety Information below.
  • Venofer® may cause clinically significant hypotension.  Monitor for signs and symptoms of hypotension following administration of Venofer®.  Hypotension following administration of Venofer® may be related to the rate of administration and/or total dose administered.
  • Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis.  Patients receiving regular parenteral iron therapy require monitoring of hematologic parameters and iron indices (hemoglobin [Hb], hematocrit [Hct], TSAT, and ferritin).  Do not administer Venofer® to patients with evidence of iron overload.  Transferrin saturation values increase rapidly after intravenous administration of iron sucrose; do not perform serum iron measurements for at least 48 hours after intravenous dosing.
  • 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.






Pharmacy Specifications
 
Dosage Form
Venofer® (iron sucrose injection, USP) is available in 2.5 mL, 5 mL and 10 mL single use vials. Each 2.5 mL vial contains 50 mg (20 mg/mL), 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 7 days 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 or non-PVC) containing 0.9% Sodium Chloride Injection, USP at concentrations ranging from 1 mg to 2 mg of elemental iron per mL, has been found to be physically and chemically stable for 7 days at controlled room temperature (25°C ±2°C).2
 

Do not dilute to concentrations below 1 mg/mL.

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.

 

 



 






IMPORTANT SAFETY INFORMATION

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer® (iron sucrose injection, USP).  Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse.  If hypersensitivity reactions or signs of intolerance occur during administration, stop Venofer® immediately.  Monitor patients for signs and symptoms of hypersensitivity during and after Venofer® administration for at least 30 minutes and until clinically stable following completion of the infusion.  Only administer Venofer® when personnel and therapies are immediately available for the treatment of serious hypersensitivity reactions.

Venofer® may cause clinically significant hypotension. Monitor for signs and symptoms of hypotension following each administration of Venofer®. Hypotension following administration of Venofer® may be related to rate of administration and total dose delivered.

Venofer® is contraindicated in patients with known hypersensitivity to Venofer®. Do not administer to patients with evidence of iron overload.

In efficacy studies in non-dialysis dependent-CKD patients (N=139), the most frequent adverse events (≥5%) whether or not related to Venofer® administration, were nausea (8.6%), taste disturbance (7.9%), peripheral edema (7.2%), diarrhea (7.2%), dizziness (6.5%), hypertension (6.5%), infusion site pain or burning (5.8%), dyspnea (5.8%), and vomiting (5.0%).

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 (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%), pain in extremity (5.6%) and diarrhea (5.2%). In the study of peritoneal dialysis dependent-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer® administration, reported by ≥5% of these patients were infections and infestations (nasopharyngitis, sinusitis, upper respiratory tract, pharyngitis) (16.0%), diarrhea (8.0%), vomiting (8.0%), hypertension (8.0%), peripheral edema (5.3%), and nausea (5.3%).

In a randomized open-label dose ranging trial of iron maintenance treatment in pediatric patients with CKD on stable erythropoietin therapy, 57% of the Venofer® treated patients (27/47) receiving 0.5 mg/kg Venofer® experienced a treatment-emergent adverse reaction, 11% of which were serious. The most common treatment-emergent adverse reactions (> 2% of patients) in all patients were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%).



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Venofer® is manufactured under license from Vifor (International) Inc., Switzerland.
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