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Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Triferic is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
Triferic is not intended for use in patients receiving peritoneal dialysis.
Triferic has not been studied in patients receiving home hemodialysis.
History
There is currently no drug history available for this drug.
Other Information
Triferic (ferric pyrophosphate citrate) solution, an iron replacement product, is a mixed-ligand iron complex in which iron (III) is bound to pyrophosphate and citrate. It has a molecular formula of Fe4(C6H4O7)3(H2P2O7)2(P2O7) and a relative molecular weight of approximately 1313 daltons. Ferric pyrophosphate citrate has the following structure:
Triferic (ferric pyrophosphate citrate) solution is a clear, slightly yellow-green color sterile solution containing 27.2 mg iron (III) per 5 mL (5.44 mg iron (III) per mL) filled in a 5 mL low density polyethylene (LDPE) ampule. Each Triferic ampule contains iron (7.5-9.0% w/w), citrate (15-22% w/w), pyrophosphate (15-22% w/w), phosphate (< 2% w/w), sodium (18-25% w/w) and sulfate (20-35%). One ampule is added to 2.5 gallons of bicarbonate concentrate.
Sources
Triferic Manufacturers
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Rockwell Medical, Inc
Triferic | Rockwell Medical, Inc
2.1 Recommended DoseInspect Triferic ampules for signs of precipitation prior to mixing with the bicarbonate concentrate. Triferic ampules appear slightly yellow-green in color.
Triferic should only be added to the bicarbonate concentrate and should NOT be added to acid concentrate mixtures.
Add Triferic to bicarbonate concentrate used for generation of hemodialysate. The final concentration of Triferic iron (III) in the final hemodialysate is 2 micromolar (110 mcg/L). Add one Triferic ampule to 2.5 gallons (9.46 L) of bicarbonate concentrate for preparation of the hemodialysate with 2 micromolar (110 mcg/L) iron (III) final concentration. Multiple ampules can be added to the master bicarbonate mix at each center at a ratio of one (1) ampule to each 2.5 gallons of bicarbonate concentrate.
Triferic 50 mL multiple dose ampules can be added to each 25 gallons of master bicarbonate mix at each center at a ratio of one (1) ampule for each 25 gallons of bicarbonate concentrate.Administer Triferic to patients at each dialysis procedure for as long as patients are receiving maintenance hemodialysis therapy for CKD.
The dosage of Triferic® is expressed as mg of iron (III). Each mL of Triferic contains 5.44 mg of iron as iron (III).
Hemodialysis solutions should be used within 24 hours of the preparation of the Triferic/bicarbonate concentrate mixture.
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