Triferic is a replacement for IV iron as an iron maintenance therapy. 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 only according to the approved FDA label for iron deficiency anemia.
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).
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 perfect iron balance, which is essential for effective erythropoiesis. Triferic is not a mineral iron that is insoluble. Triferic is a water-soluble low molecular weight iron salt administered in a very small dose every dialysis treatment via dialysate; 20 administrations of Triferic over about 7 weeks is equivalent to a single 100 mg typical IV iron patient dose. Patients with serum ferritin above 1200 µg/L should be given Triferic at the discretion of their doctor.
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 trend down 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 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.
Triferic is an iron salt. It is administered via dialysate. It crosses the dialyzer membrane and directly enters the blood, where it immediately binds to transferrin, the iron carrier protein. Transferrin delivers the iron directly to red blood cell precursors in bone marrow for hemoglobin synthesis.
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 central feed system configuration.
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. Triferic iron does not stick to plastic surfaces. Triferic iron does not leave any residue in the bicarbonate tank or central feed loop. In clinical studies, Triferic was administered in 1500 dialysis machines for approximately 3 years without any change in cleaning procedure and without any incident of bacterial presence. Mixing of Triferic into the bicarbonate tank, tubing and bicarbonate jugs over a period of up to 3 years during the clinical trials resulted in zero bacterial growth or contamination.
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.
While receiving Triferic as an iron maintenance therapy, patients can receive loading doses of IV iron when they develop iron deficiency anemia. The following serum iron parameters are recommended for administering IV iron once patients are receiving Triferic:
- serum ferritin is less than 100 µg/L, or
- serum ferritin is 100-200 µg/L and TSAT is less than 25%, or
- decline in hemoglobin or increase in ESA dose resulting from iron deficient state
This recommended protocol is based on the PRIME clinical study where patients received IV iron according to the above parameters (Read More). Clinical judgment should always guide patient therapy.
Triferic can be administered to patients who have had allergic reactions to IV or oral iron. In clinical studies, Triferic was administered over 100,000 times with no occurrence of serious hypersensitivity reactions, and patients with a history of allergy to IV or oral iron were included in the study. Patients with a history of allergic reactions to IV iron should be observed during the initial dialysis treatment with Triferic for any signs and symptoms of hypersensitivity that may develop during and after the dialysis session, such as rash, itching, dizziness, lightheadedness, swelling and breathing problems.
Physicians should consider withholding all iron therapy for patients with active bacteremia, fungemia or sepsis syndrome.
Triferic has been 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.