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TRIFERIC

Triferic for Anemia Management in Dialysis Patients

triferic | ferric pyrophosphate citrate

TRIFERIC is the first and only FDA-approved treatment indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).1,2

 

First

Formulation

 

The first formulation of TRIFERIC launched in the U.S. in May 2019. Dialysate TRIFERIC is administered through the dialysate (mixed with liquid bicarbonate). Triferic crosses the dialyzer membrane and replaces the iron lost during hemodialysis in real-time to maintain hemoglobin. 2,3

TRIFERIC has a unique and differentiated mechanism of action that has the potential to provide significant patient benefits and operational efficiencies for clinics. Rockwell Medical believes that TRIFERIC represents one of the most innovative medical advancements in patient iron management in the past few decades – with the potential to be the future standard of care.

 

Second

Formulation

 

A new formulation of FPC, also for hemodialysis patients, was approved in 2020 under the brand name TRIFERIC AVNU. TRIFERIC AVNU extends the ability to provide the benefits of this novel physiologic iron maintenance to all patients receiving in-center hemodialysis, regardless of whether HD machines use liquid or dry bicarbonate. Additionally, we believe TRIFERIC AVNU for intravenous infusion will be a more acceptable formulation in markets such as the EU, Canada, China, and Japan where dialysis clinics predominately use dry bicarbonate cartridges.

Visit TRIFERIC.com more information, including Efficacy and Safety Information and Full Prescribing Information.

Visit Triferic.com

 

Important Safety Information for TRIFERIC

Indication

TRIFERIC is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

Limitations of Use

TRIFERIC is not intended for use in patients receiving peritoneal dialysis. TRIFERIC has not been studied in patients receiving home hemodialysis.

Warnings and Precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving TRIFERIC in two randomized clinical trials.

Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.

Adverse Reactions

Most common adverse reactions (incidence ≥3% and at least 1% greater than placebo) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.

To report an Adverse Events (AE) or Product Quality Control (PQC) please call the Medical Information Department at (855) 333-4315 or e-mail at rockwell.pharmacovigilance@​propharmagroup.com.

For more information, please see full Prescribing Information.

Important Safety Information for TRIFERIC AVNU

Indication

TRIFERIC AVNU (ferric pyrophosphate citrate for injection) is an iron-replacement product indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

Warnings and Precautions

Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving parenteral iron products. Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions. Hypersensitivity reactions have been reported in 1 (0.3%) of 292 patients receiving TRIFERIC in two randomized clinical trials.

Iron status should be determined on pre-dialysis blood samples. Post-dialysis serum iron parameters may overestimate serum iron and transferrin saturation.

Adverse Reactions

Most common adverse reactions (incidence ≥3%) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.

For full Safety and Prescribing Information please visit www.Trifericavnu.com.