Triferic Generic Name & Formulations
Legal Class
Rx
General Description
Elemental iron (III) (as ferric pyrophosphate citrate) 5.44mg/mL soln; or 272mg per pwd pkt; for hemodialysis use.
Pharmacological Class
Hematinic.
See Also
How Supplied
Ampules (5mL)—5, 40; (50mL)—4, 24; Single-dose ampules (4.5mL)—10, 40; Packets— 1, 100
Manufacturer
Generic Availability
NO
Triferic Indications
Indications
Iron replacement to maintain hemoglobin in adults with hemodialysis-dependent chronic kidney disease (HDD-CKD).
Limitations of Use
Not for use in patients receiving peritoneal dialysis. Not studied in patients receiving home hemodialysis.
Triferic Dosage and Administration
Adult
See full labeling. Must add soln (5mL or 50mL amp) or pwd (1 pkt) to bicarbonate concentrate (2.5 or 25gallons) for generation of hemodialysate. Final concentration (Triferic/in hemodialysate): 2micromolar (100mcg/L). Administer at each dialysis procedure.
Children
Not established.
Triferic Contraindications
Not Applicable
Triferic Boxed Warnings
Not Applicable
Triferic Warnings/Precautions
Warnings/Precautions
Monitor for hypersensitivity reactions during and after hemodialysis until clinically stable. Have personnel and resuscitative equipment immediately available. Determine iron status on pre-dialysis blood samples. Pregnancy. Advise females of reproductive potential to use effective contraception during and for at least 2weeks after therapy completion. Nursing mothers.
Triferic Pharmacokinetics
See Literature
Triferic Interactions
Not Applicable
Triferic Adverse Reactions
Adverse Reactions
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, dyspnea.
Triferic Clinical Trials
See Literature
Triferic Note
Not Applicable
Triferic Patient Counseling
See Literature