Visit American Regent Website
 
For SAFETY, SPEED, and VERSATILITY
 

Venofer® (iron sucrose injection, USP) is a first-line IV iron choice for the treatment of iron deficiency anemia in the following patients:

  • Non-dialysis Dependent - Chronic Kidney Disease (NDD-CKD) patients receiving or 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

Only Venofer® supports treatment safety and versatility with all of these features:
 

  • Over 50 years of worldwide clinical experience
  • Dextran and preservative free
  • Available in convenient single-dose vials
  • Nondialyzable
  • No test dose required
  • Safety and efficacy confirmed in US clinical trials in non-dialysis and dialysis dependent - CKD patients

  • Usual Dose:
    • NDD-CKD Patients - Administration of a total cumulative dose of 1,000 mg
      • 200 mg slow IV injection over 2 to 5 minutes on 5 different occasions within 14 days* 
    • HDD-CKD Patients - Administration of a total cumulative dose of 1,000 mg over 10 consecutive dialysis sessions:
      • 100 mg slow IV injection over 2 to 5 minutes, or
      • 100 mg IV infusion over at least 15 minutes
    • PDD-CKD Patients - Administration of a total cumulative dose of 1,000 mg over 3 divided doses during a 28 day period 
      • 2 infusions of 300 mg IV infusion over 1.5 hours 14 days apart followed by:
      • One 400 mg IV infusion over 2.5 hours 14 days later
*There is limited experience with administration of an infusion of 500 mg of Venofer® over 3.5 - 4 hours; hypotension occurred in 2 of 30 patients treated.


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.

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

To learn more about Venofer®, click on a link in the column on the left side of this page.

 

   

Full Prescribing Information | Privacy Policy | Terms of Use | Contact Us | Glossary