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Abstract: PO0474

Ferric Pyrophosphate Citrate (Triferic® AVNU): Alternate Intravenous Dosing Strategies Compared to Continuous Infusion over 3 Hours

Session Information

Category: Anemia and Iron Metabolism

  • 200 Anemia and Iron Metabolism

Author

  • Pratt, Raymond D., Rockwell Medical Inc, Wixom, Michigan, United States
Background

Ferric pyrophosphate citrate injection (FPC-IV) is an iron replacement product to maintain hemoglobin by intravenous infusion over 3 to 4 hours. The aim of this study was to investigate FPC-IV pharmacokinetics and confirm safety of alternate dosing strategies.

Methods

An open-label, randomized, multiple period single dose study was conducted in 23 CKD-5HD patients to establish the equivalence of doses between FPC-IV as a 3-hour infusion using the on-machine syringe pump and 5 alternate dosing strategies. The treatments were A) Baseline FPC-IV 6.75 mg Fe/3 hours (approved rate); B) FPC-IV 3.38 mg Fe bolus injections at t=0 and t=3 hours; C) FPC-IV 6.75 mg Fe bolus injection at t=0 hours over 0.5 - 5 min. and D) FPC-IV 2.25 mg Fe bolus injections at t=0, t=1.5 and t=3 hours and E) FPC-IV 6.75 mg Fe by infusion using a spring-driven syringe pump with flow restrictive tubing to deliver 2 mL/hr] . Blood samples were obtained to assess total iron (Fetot), transferrin bound iron (TBI), transferrin saturation (TSAT) and iron binding capacity (TIBC).

Results

The results for TSAT (Fig.1) track the administration group.

FPC-IV was generally well tolerated in all treatments. There was transient flushing and abdominal discomfort of mild to moderate severity associated with treatment C (bolus injection of FPC over 0.5-5 min.) experienced by 15 of 16 patients. All symptoms spontaneously resolved over 2 to 5 minutes and no adverse events or intolerance was reported with any other treatment.

Conclusion

The results of this study demonstrate that FPC-IV can be safely administered as a continuous infusion over 2.5 to 4 hours or as IV bolus administration of 1/2 or 1/3 of the total dose at intervals during the course of dialysis. Bolus administration of the entire dose is not recommended due to the transient intolerance associated with the rapid administration. The study expands the dosing strategies for the administration of FPC.

Fig.1. TSAT profile

Funding

  • Commercial Support –