Triferic is a replacement for IV iron as an iron maintenance therapy. Triferic is the only FDA approved drug indicated to replace iron at every dialysis treatment and maintain hemoglobin in adult CKD-HD patients. Triferic delivers iron to hemodialysis patients at every treatment, replacing the iron they lose during dialysis, and it should be used in place of IV iron for iron maintenance therapy for all patients. IV iron should be given sparingly and only according to the approved FDA label for iron deficiency anemia, when patients experience an excessive blood loss leading to a ferritin < 200 µg/L.
Each patient receives approximately 5-7 mg of iron over the course of their dialysis treatment, which is the average amount of iron lost during each dialysis. So, all patients receive the same dose. There is no need to adjust this iron dose. Final concentration of Triferic iron (III) in the final hemodialysate is 2 µM (110 mcg/L).
Triferic is special because once it enters the blood it binds iron immediately and completely to transferrin (iron carrier protein) and is transported directly to red blood cell precursors for hemoglobin synthesis. There is no non-transferrin bound iron present. Triferic works similar to how we get our iron from food to maintain hemoglobin. Triferic is completely different than IV iron, which is designed to travel to the patient’s liver, where it becomes trapped and can cause iron overload and toxicity linked to cardiovascular disease.
Yes, because all patients lose 5-7 mg iron over the course of their dialysis treatment, and just like calcium, magnesium and potassium is replaced every dialysis treatment to maintain homeostasis, iron needs to be replaced with every treatment to maintain ideal iron balance, which is essential for effective erythropoiesis. Triferic is a water-soluble low molecular weight iron complex administered in a very small dose every dialysis treatment via dialysate. Keep in mind that Triferic is not an IV iron product. A typical, weekly 100 mg IV iron dose is given to the patent quickly over about 8-10 minutes, compared to a 5-7 mg dose of Triferic given over 4 hours; and to give an equivalent (to IV iron) 100 mg dose of Triferic it would take 20 administrations, occurring over 7 weeks.
Yes. Patients can stay on Triferic regardless of ferritin value, unless the patient has underlying bacteremia, fungemia or sepsis. Ferritin levels in patients on Triferic will decrease over time. Triferic does not increase iron stores or inflammation because it donates its iron immediately and completely to transferrin, enabling it to be transported directly to the bone marrow for hemoglobin incorporation. Triferic is not processed in the macrophages and it is not metabolized in the liver so it bypasses the hepcidin induced block present in hemodialysis patients. This unique mode-of-action is what enables Triferic to overcome high ferritin and associated toxicity and infections, and Functional Iron Deficiency (FID) which is a serious issue that plagues hemodialysis patients receiving IV iron.
Once patients are receiving Triferic it is important that your IV iron protocol is changed.
Goal of Triferic® Therapy:
|Reduce ESA and IV iron use significantly|
|Lower ferritin level|
Administer Triferic® every HD treatment to all patients (via bicarbonate solution); final concentration of iron in hemodialysate is 2 µM (110 mcg/L).
Administer IV iron (500 mg in divided doses) only if serum iron parameters are:
|TSAT < 25%|
|and/or Ferritin < 300 ng/mL|
|provided Hemoglobin < 9.5 g/dL|
|Hgb and ESA dose are key indicators to determine whether to start IV iron|
|If 40% change in TSAT, perform 2nd confirmatory TSAT value before initiating IV iron|
|Phosphate binders containing iron increase ferritin level and should be avoided|
This recommended protocol is based on the PRIME clinical study where patients received IV iron according to the above (Read More). Clinical judgment should always guide patient therapy.
There is no need for any extra cleaning or sanitization of your bicarbonate loop when using Triferic. Triferic is not an elemental iron. Triferic is comprised of iron tightly bound/complexed to pyrophosphate and citrate, making it a highly soluble and stable iron salt. Triferic iron does not oxidize to rust and does not stick to plastic surfaces. Triferic iron does not leave any residue in the bicarbonate tank or central feed loop. Triferic has been administered in over 45 separate bicarbonate loop systems to approximately 3,600 patients over a combined 462 months (38.5 years) without any incident of bacterial presence and without any change in cleaning protocol. If biofilm is already present in your water system, bicarb mixer or loop distribution system then you may see discoloration, and you will need to eliminate the biofilm to remove the discoloration.
Physicians should consider withholding all iron therapy for patients with underlying bacteremia, fungemia or sepsis syndrome, otherwise Triferic can continue to be given regardless of ferritin level as long as pre-dialysis TSAT does not exceed 45-50% and there is no clinical evidence of hemochromatosis or iron overload.
There is no need for any changes to your current equipment. Triferic is compatible with all brands of dialysis machines, dialyzers, dialysate concentrates and any configuration central feed system.
Regular labs and monitoring as practiced currently in dialysis practice are sufficient, and no additional testing is recommended. Only pre-dialysis blood samples should be used for monitoring iron status.
Triferic has no significant effect on the diffusive transport of these anions during hemodialysis and does not affect their plasma concentrations.
In clinical studies, patients who received Triferic had no effect on serum albumin, C-reactive protein (CRP), IL-6, malondialdehyde or F2 isoprostanes. Triferic does not oversaturate iron binding capacity of transferrin and does not increase levels of non-transferrin bound iron during hemodialysis.
To report suspected adverse reactions, contact Rockwell Medical at 1-855-333-4315 or 1-248-960-9009 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch