Q: Should I consider IV iron therapy for my pre-dialysis patients even though they are not on an erythropoietin?
A: Iron deficiency commonly complicates anemia in NDD-CKD patients. As many as 25% to 40% of males and 35% to 85% of females with anemia and NDD-CKD show evidence of iron deficiency.1 IV iron therapy can provide effective anemia management, even in the absence of an erythropoietin, in a substantial fraction of these patients.
   
Q: Can Venofer® (iron sucrose injection, USP) lower erythropoietin usage for my patients already receiving ESA therapy?
A: Yes. Studies have shown that if IV iron is added to ESA therapy, the combination has an additive effect on Hct response, and almost all anemic pre-dialysis patients can reach and maintain the target Hct of 35% over a 1-year period.2,3 The advantage of maintaining adequate iron stores with Venofer® (iron sucrose injection, USP) is that lower dosing of ESA may be required to achieve target Hct than if ESA is used alone.
   
Q: Are there any advantages associated with Venofer® versus oral iron for my pre-dialysis patients?
A: Venofer® has an excellent safety profile that has been demonstrated in clinical trials and proven clinically for over 50 years. Oral iron is unlikely to maintain target iron indices in ESA-treated patients. If oral iron is initiated on trial basis but fails to maintain target iron levels, discontinue oral iron and give IV iron. For patients not on ESA, treatment with Venofer® avoids the high incidence of gastrointestinal adverse effects associated with oral therapy. This may improve patient compliance and thereby improve treatment success.
   
Q: How does the iron sucrose compound of Venofer® differ from iron dextrans?
A:  Its distinct iron sucrose formulation contains no dextrans or modified dextrans. And, unlike iron dextran products, Venofer® does not require a test dose prior to therapy. Additionally, iron dextran therapy must be discontinued for 2 weeks prior to performing measurements of iron status. With Venofer®, iron indices can be checked 48 hours after the last dose.
   
Q: If my patient was intolerant to iron dextran can I still try Venofer®?
A: HDD-CKD patients who have experienced previous intolerance to iron dextran and iron gluconate have been treated successfully with Venofer® without serious adverse events.4  One hundred thirty (11%) of the 1,151 patients evaluated in the 4 U.S. trials in HDD-CKD patients (studies A, B, and the two post marketing studies) had prior other intravenous iron therapy and were reported to be intolerant (defined as precluding further use of that iron product).  When these patients were treated with Venofer® there were no occurrences of adverse events that precluded further use of Venofer®.  See Important Safety Information below.
   
Q: What indices of iron status do NKF-KDOQI Guidelines recommend for pre-dialysis patients?
A: In the opinion of the NKF Work Group, sufficient iron should be administered to pre-dialysis patients to generally maintain the following indices of iron status during ESA treatment:

   
Q: If my patient has serum ferritin levels > 500 ng/mL should I consider IV iron therapy?
A: There is insufficient evidence to recommend routine administration of IV iron if serum ferritin level is >500 ng/mL. When ferritin level is >500 ng/mL, decisions regarding IV iron administration should weigh ESA responsiveness, Hb and TSAT level, and the patient's clinical status. A course of IV iron therapy with Venofer® may be warranted.
   
Q: What can cause elevated ferritin levels?
A: Elevated ferritin levels may suggest to the clinician that no further IV iron should be administered. However, ferritin may rise independently of iron administration. For example, inflammation, blood transfusions, infection, malnutrition, liver disease and other non-related factors may all increase levels of ferritin, which is an acute-phase reactant.
   
Q: Are there clinical situations in which IV iron administration may be warranted when the ferritin level exceeds 500 ng/mL?
A: Yes. Patients may have a condition known as ESA hypo-responsiveness due to inflammation-mediated reticuloendothelial blockade (iron trapping), and a course of IV iron may be warranted. Remember, when the ferritin level is >500 ng/mL, decisions regarding IV iron administration should weigh ESA responsiveness, Hb and TSAT level, and the patient's clinical status.
   
Q: What are the side effects associated with Venofer®?
A: Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving Venofer®.  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.  Most reactions associated with intravenous iron preparations occur within 30 minutes of the completion of the infusion.

Venofer® may cause clinically significant hypotension.  Monitor for signs and symptoms of hypotension following each administration of Venofer®.  See Important Safety Information below and Full Prescribing Information for additional information.
   
Q: Why don't I have to administer a test dose for Venofer®?
A: Its safety profile allows for safe administration without a test dose.
   















 
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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