Venofer (Iron Sucrose) - Summary

VENOFER SUMMARY

Venofer ^®(iron sucrose injection, USP)

Venofer^® (iron sucrose injection, USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use.

Venofer^® 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.

NEWS HIGHLIGHTS

Published Studies Related to Venofer (Iron Sucrose)

Effects of iron supplementation and depletion on hypoxic pulmonary hypertension: two randomized controlled trials. [2009.10.07]
CONTEXT: Hypoxia is a major cause of pulmonary hypertension in respiratory disease and at high altitude. Recent work has established that the effect of hypoxia on pulmonary arterial pressure may depend on iron status, possibly acting through the transcription factor hypoxia-inducible factor, but the pathophysiological and clinical importance of this interaction is unknown. OBJECTIVE: To determine whether increasing or decreasing iron availability modifies altitude-induced hypoxic pulmonary hypertension... CONCLUSION: Hypoxic pulmonary hypertension may be attenuated by iron supplementation and exacerbated by iron depletion. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00952302.

Randomized clinical trial of preoperative intravenous iron sucrose to reduce blood transfusion in anaemic patients after colorectal cancer surgery. [2009.10]
BACKGROUND: The transfusion rate following colorectal cancer resection is between 10 and 30 per cent. Receipt of allogeneic blood is not without risk or cost. A preoperative adjunct that reduced the need for transfusion would mitigate these risks. This study was designed to determine whether iron sucrose reduces the likelihood of postoperative blood transfusion in patients undergoing elective colorectal cancer resection... CONCLUSION: This pilot study provided no support for the use of intravenous iron sucrose as a preoperative adjunct to increase preoperative haemoglobin levels and thereby reduce the likelihood of allogeneic blood transfusion for patients undergoing resectional surgery for colorectal cancer. Registration number: 2005-003608-13UK (Medicines and Healthcare products Regulatory Agency).

Rapid recurrence of IBD-associated anemia and iron deficiency after intravenous iron sucrose and erythropoietin treatment. [2009.06]
OBJECTIVES: Anemia is a common complication of inflammatory bowel disease (IBD) and iron deficiency (ID) is its predominant cause. Therefore, oral and intravenous iron replacements are widely used. This study was performed to evaluate the frequency and timing of anemia and ID recurrence after a successful treatment cycle... CONCLUSIONS: IBD-associated ID and anemia recur surprisingly fast, indicating that maintenance treatment may be needed in a portion of the patient population. Recurrence of ID (but not anemia) can be delayed by aiming for high post-treatment ferritin levels.

Iron prophylaxis in pregnancy: intravenous route versus oral route. [2009.06]
OBJECTIVE: To assess and compare the efficacy and safety of two and three doses of intravenous iron sucrose with daily oral ferrous sulphate in the prophylaxis of iron deficiency anaemia in pregnant women... CONCLUSIONS: There was no clinically significant difference in the haematological, maternal and foetal outcomes in the parenteral route of iron prophylaxis in pregnant women.

[Intravenous iron sucrose in maintenance dialysis patients with renal anemia: a clinical study] [2009.02.24]
OBJECTIVE: To explore the safety and efficacy of intravenous iron sucrose in maintenance dialysis and to establish the optimal administration frequency and dose... CONCLUSION: Intravenous iron sucrose effectively increases the serum iron parameters and hemoglobin levels during maintenance peritoneal dialysis and is well tolerated. Infusing intravenous iron sucrose 200 mg every two weeks can maintain the serum iron parameters and hemoglobin level in maintenance peritoneal dialysis patients and n permits reduction of the required dose of EPO. However, the total cost of intravenous iron treatment is relatively high.

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Clinical Trials Related to Venofer (Iron Sucrose)

Efficacy and Safety of Venofer (Iron Sucrose Injection USP) in Patients Receiving Peritoneal Dialysis [Completed]

Iron Sucrose in Stage 3/4 Kidney Disease [Active, not recruiting]
One of the complications of late stage kidney disease is the development of a low red blood cell count (anaemia/low haemoglobin concentration). The Australian Commonwealth government limits funding of medications (called erythropoietic stimulating agents) to those patients who have already developed anaemia.

There is evidence supporting the beneficial effects of maintaining a higher haemoglobin in these patients. Higher haemoglobin can delay the onset of dialysis and reduce the development of heart enlargement. However, the administration of erythropoietic stimulating agents is not without risk, including a high financial burden, worsening of high blood pressure and a rare complication called pure red cell aplasia.

Previous studies have shown that patients with chronic kidney disease require additional iron to maintain the production of red blood cells. Thus it would be timely to determine if the administration of iron sucrose to these patients can maintain a near normal haemoglobin concentration, without the need to start an erythropoietic stimulating agent and possibly delaying dialysis.

Study Hypothesis: That administration of iron sucrose is superior to standard care in the prevention of anaemia in patients with stage 3 /4 kidney disease.

Randomized Epo and Venofer Trial After Autologous HSCT [Recruiting]

Iron Sucrose in Non-Dialysis Dependent (NDD-CKD) Pediatric Patients [Recruiting]

Trial Comparing the Safety of Two Different Intravenous Iron Formulations [Recruiting]
The purpose of this trial is to compare the safety profile using equal doses of intravenous iron dextran versus iron sucrose. The researchers hypothesize that significantly more patients receiving intravenous iron dextran (using the current intermediate molecular weight product) will have severe adverse outcomes than patients receiving iron sucrose in the adult non-hemodialysis outpatient population. Secondly, since these severe reactions may require additional nursing time and physician interventions that may negate any cost advantage of iron dextran, the researchers hypothesize that iron sucrose will be more cost-effective than iron dextran.

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