Take IV Iron Therapy to a proven place: No dextrans. No bolded or black box warnings. No test dose!








Iron deficiency commonly complicates anemia in patients with chronic kidney disease1. With the recent safety controversy surrounding ESA therapy,2 the use of IV iron without ESAs may present an attractive and cost effective alternative for treating anemia. IV iron therapy can provide effective anemia management, even in the absence of an erythropoietin, in a substantial portion of these patients.

A stepwise approach to anemia management, with a trial of IV iron as primary therapy, followed by the addition of an ESA, if necessary, provides a practical option for anemia protocols, providing individualized, effective treatment and the lowest possible ESA dose. Efforts to develop and implement this type of protocol can have both significant clinical outcomes as well as economic benefits.3

In addition, The NKF-Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guidelines and Clinical Practice Recommendations for Anemia in CKD (discussed in more detail below) state that iron agents may serve as primary therapy for selected patients (particularly those with NDD-CKD) or as adjuvant therapy for those also undergoing treatment with an ESA. Administered as adjuvants to ESAs, iron agents prevent iron deficiency and serve to minimize the dose of ESA needed to achieve target-range Hb levels.4

Optimization of anemia management in NDD-CKD without ESA therapy
The efficacy of IV iron as primary therapy in anemic patients with non-dialysis dependent-CKD has been studied in 5 clinical trials.5-9 Maintaining iron stores with Venofer® (iron sucrose injection, USP) may allow avoidance or discontinuation of ESA therapy. Clinical trials have shown that in up to one-third of non-dialysis dependent-CKD patients with iron deficiency anemia, treatment with Venofer® corrected anemia without an ESA.6,7 Results from all five clinical studies indicate a hematopoietic response, defined as a rise in Hb of >1 g/dL, in patients treated with IV iron alone. Approximately 1/3 to 1/2 of treated patients were able to reach the target Hb/hematocrit (HCT) defined during the studies.

Optimization of erythropoietin therapy
Aggressive intravenous iron therapy with products such as Venofer® is increasingly recognized as a means of optimizing the response to erythropoietin. Evidence from numerous studies10-20 conducted since 1992, totaling more than 450 patients, shows that intensive intravenous iron supplementation (iron dextran, iron sucrose, or sodium ferric gluconate in sucrose complex) allows a reduction in erythropoietin dose of 19% to 70%.

American Regent. Enriching the lives of anemia patients. ™

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 HDD-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%), and diarrhea (5.2%). In the study of PDD-CKD patients (N=75), the most frequent adverse events, whether or not related to Venofer®, 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%).


Please see Full Prescribing Information.


References