Triferic
(ferric pyrophosphate citrate)
THERAPEUTIC CLASS
Iron salt
DEA CLASS
RX
ADULT DOSAGE & INDICATIONS
Iron Replacement
Maint of Hgb in Patients w/ Hemodialysis-Dependent Chronic Kidney Disease (CKD):
Add one 5mL ampule to 2.5 gallons (9.46L) of bicarbonate concentrate
OR
Add one 50mL ampule to 25 gallons (94.6L) of bicarbonate concentrate
OR
Add one pkt of powder to 25 gallons (94.6L) of bicarbonate concentrate
ADMINISTRATION
Parenteral route
- Administer to patients at each dialysis procedure for as long as patients are receiving maintenance hemodialysis therapy for CKD.
- Only add to bicarbonate concentrate used for generation of hemodialysate; do not add to acid concentrate mixtures.
- Multiple 5mL ampules can be added to master bicarbonate mix at each center at a ratio of one 5mL ampule for each 2.5 gallons (9.46L) of bicarbonate concentrate.
- Multiple 50mL ampules can be added to master bicarbonate mix at each center at a ratio of one 50mL ampule for each 25 gallons (94.6L) of bicarbonate concentrate.
- Multiple pkts can be added to master bicarbonate mix at each center at a ratio of 1 packet for each 25 gallons (94.6L) of bicarbonate concentrate.
- Final iron concentration in dialysate should be 110mcg/L
- Use w/in 24 hrs of preparation.
HOW SUPPLIED
Sol: 272mg [5mL, 50mL, pkt]
WARNINGS/PRECAUTIONS
Not for use in patients receiving peritoneal dialysis. Serious hypersensitivity reactions (eg, anaphylactic-type reactions) reported; personnel and therapies should be immediately available for the treatment of these reactions. Iron status should be determined on pre-dialysis blood samples; post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.
ADVERSE REACTIONS
Headache, peripheral edema, asthenia, atrioventricular (AV) fistula thrombosis, UTI, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, dyspnea.
PREGNANCY AND LACTATION
Pregnancy: May cause fetal harm.
Lactation: It is not known whether Triferic is excreted in human milk; caution in nursing.
Females and Males of Reproductive Potential: Use effective contraception measures during treatment and for ≥2 weeks following completion of therapy.
MECHANISM OF ACTION
Iron salt; binds to transferrin for transport to erythroid precursor cells to be incorporated into Hgb.
PHARMACOKINETICS
Distribution: Vd=0.765-0.859L. Elimination: T1/2=approx 1.48 hrs.
ASSESSMENT
Assess for history of reactions to parenteral iron products and pregnancy/nursing status. Determine iron status on predialysis blood samples.
MONITORING
Monitor for signs/symptoms of hypersensitivity during and after hemodialysis until clinically stable, and for other adverse reactions.
PATIENT COUNSELING
Inform of the risks of therapy. Advise to report any signs/symptoms of hypersensitivity that may develop during and after dialysis (eg, rash, dizziness, breathing problems).
STORAGE
20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Protect ampules from light; store in the aluminum pouch