Venofer® SELECTED CLINICAL STUDIESBack to clinical studies
This study led to the FDA approval of Venofer. Always refer to the approved Full Prescribing Information and Important Safety Information below.
Venofer is a well-tolerated option for hemodialysis-dependent chronic kidney disease (HDD-CKD) and was studied in patients with iron dextran intolerance.1
Venofer is an efficacious and well-tolerated option for HDD-CKD patients who had previous reactions to iron dextran1,2
Twenty-three hemodialysis patients who experienced an adverse reaction while taking iron dextran were given Venofer (iron sucrose injection, USP) 100 mg for their iron replacement across 10 consecutive dialysis sessions. They were stratified by their manifestation of their reaction. There were no serious adverse drug reactions recorded with the use of Venofer.
Study B was an open-label, single-arm, prospective study to assess the safety of IV iron sucrose injection without test-dose administration for the treatment of iron deficiency in hemodialysis patients administered epoetin therapy for dialysis-associated anemia who had previously shown evidence of anaphylactic reaction to iron dextran. The study also included patients whose reactions did not meet the criteria for anaphylaxis but had been sufficiently severe to preclude them from further iron dextran therapy. Adult patients undergoing chronic hemodialysis who were administered epoetin alfa therapy for dialysis-associated anemia and who had documented evidence of sensitivity to iron dextran administration and a hemoglobin (Hb) level less than 11.0 g/dL were eligible to participate in the study. Patients with a history of mild reactions to iron dextran, including urticaria, pruritus or back pain, were assigned to group A.
Patients with a history of severe anaphylactic reaction, defined by standard criteria and including dyspnea, wheezing, stridor, hypotension or angioedema, were assigned to group B. Eligibility for assignment to group B also required evidence of iron deficiency (transferrin saturation < 20% and ferritin level ≤ 300 ng/mL). Groups A and B received iron sucrose by IV push over 5 minutes to group A patients and by IV push over 5 minutes or IV infusion over 15 to 30 minutes to group B patients.
The primary outcome measure was an increase in Hb level greater than 0.5 g/dL. Secondary outcome measures included increases in serum transferrin saturation and ferritin level and decreases in serum iron-binding capacity.
Most Severe Manifestation of Iron Dextran Sensitivity in Study Patients to Determine Group (Prior to Venofer Administration Study)2
(mild reactions to iron dextran) (n=16)
(severe reactions to iron dextran) (n=7)
Urticaria or rash
Pruritus, nausea and vomiting
Back or flank pain
Nausea and vomiting
Hypotension with dyspnea
Hypotension with dyspnea or arrest
Bronchospasm, cough or dyspnea
*Group A: Patients with a history of mild reactions to iron dextran, including urticaria, pruritus or back pain.
†Group B: Patients with a history of severe anaphylactic reaction, including dyspnea, wheezing, stridor, hypotension or angioedema.
There were no serious adverse drug reactions recorded with the use of Venofer IN THIS STUDY2
- No serious adverse drug reactions
- No episodes of anaphylaxis
- No patient withdrawals
- No drug discontinuation caused by drug-related adverse events
Adverse events found related to Venofer included pruritus (n=4) and metallic taste (n=1). All adverse events were considered mild.
HDD-CKD patients with a prior history of sensitivity to iron dextran who were treated with Venofer demonstrated significant increases in hemoglobin, hematocrit, serum ferritin and transferrin saturation.2
Venofer has been shown to have a positive effect on several hematological indices related to iron supplementation and to epoetin dose stabilization/reduction
Anemia management indices after initiating therapy with iron sucrose injection. Arrows show timing of administration of 10 doses of 100 mg each during consecutive dialysis sessions. Hemoglobin (Hb), mean corpuscular volume (MCV), mean corpuscular Hb (MCH), serum iron, serum transferrin saturation (TSAT), and serum ferritin values each increased significantly. Serum total iron-binding capacity (TiBC) decreased significantly. The decrease in epoetin dose did not reach statistical significance (P = 0.18). Patients administered iron sucrose showed a significant increase in Hb levels within 15 days after initiating therapy and after being administered only 600 mg of iron sucrose.
Anaphylactic reactions are associated with some iron products
Anaphylactic reactions are serious, life-threatening events associated with some iron products. While serious anaphylactic reactions have been reported with the use of Venofer, a recent study of several iron replacement formulations demonstrated that iron dextran has twice the risk of anaphylactic reactions as the other iron products combined. Both iron dextran and iron gluconate were associated with an increased risk of anaphylaxis (OR, 3.6; 95% CI, 2.4-5.4 and OR, 2.0; 95% CI, 1.2-3.5, respectively) compared with Venofer.1
Because of the high risk of anaphylactic reactions, iron dextran requires a test dose prior to administration.2
Venofer was proven safe for patients who experienced adverse reactions to iron dextran3
This study was the first to evaluate the safety of Venofer specifically in patients who had a reaction to iron dextran (mild or severe). The study demonstrated that Venofer can be safely administered by either IV push or infusion to patients who previously experienced reactions to iron dextran.
This adds to the nearly 65 years of clinical literature that clearly establishes that iron sucrose is well tolerated in patients requiring iron replacement. Due to its tolerability profile, Venofer does not need a prior test dose.
1. Wang C, Graham DJ, Kane RC, et al. Comparative risk of anaphylactic reactions associated with intravenous iron products. JAMA. 2015;314(19):2062-2068.
2. INFeD. Package insert. Allergan USA, Inc; 2018.
3. Van Wyck DB, Cavalla G, Spinowitz BS, et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis. 2000;36(1):88-97.
1. Venofer® [package insert]. Shirley, NY: American Regent, Inc.; 9/2020.
2. Van Wyck DB, Cavalla G, Spinowitz BS, et al. Safety and efficacy of iron sucrose in patients sensitive to iron dextran: North American clinical trial. Am J Kidney Dis. 2000;36(1):88-97.