Version May 2024
Note: Triferic ampules (intradialytic formulation) contains 5.44 mg iron (III) per mL. Triferic powder (intradialytic formulation) contains 272 mg iron (III) per packet. Triferic AVNU (IV formulation) contains 1.5 mg iron (III) per mL.
Iron replacement therapy in hemodialysis-dependent patients:
Note: The doses below are considered maintenance doses to replace ongoing iron losses; alternative IV iron products (that can be administered at higher doses) may still be necessary in patients presenting with or developing iron deficiency (Ref).
Intradialytic: After admixture into bicarbonate concentrate dialysate (final concentration 2 micromolar [110 mcg/L]) use at each dialysis session. Therapy may be continued for as long as the patient is receiving maintenance hemodialysis for chronic kidney disease (CKD).
IV: 6.75 mg with each dialysis session. Therapy may be continued for as long as the patient is receiving maintenance hemodialysis for CKD.
No dosage adjustment necessary.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not always defined.
>10%: Cardiovascular: Procedural hypotension (22%)
1% to 10%:
Cardiovascular: Peripheral edema (7%), clotted AV fistula (3%), dialysis access hemorrhage (3%)
Central nervous system: Headache (9%), fatigue (4%), dizziness
Dermatologic: Pruritus
Gastrointestinal: Constipation, nausea
Genitourinary: Urinary tract infection (5%)
Neuromuscular & skeletal: Muscle spasm (10%), limb pain (7%), back pain (5%), weakness (4%)
Respiratory: Dyspnea (6%)
Miscellaneous: Fever (5%)
<1%, postmarketing, and/or case reports: Anaphylaxis, hypersensitivity
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Hypersensitivity: Serious hypersensitivity reactions, including anaphylactic-type reactions (some fatal) have been reported in patients receiving parenteral iron products. Monitor for signs and symptoms of hypersensitivity (eg, shock, hypotension, loss of consciousness, collapse) during and after hemodialysis.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Packet, Hemodialysis:
Triferic: 272 mg (1 ea [DSC], 100 ea [DSC])
Solution, Hemodialysis [preservative free]:
Triferic: 27.2 mg/5 mL (5 mL [DSC])
Solution, Intravenous:
Triferic AVNU: 6.75 mg/4.5 mL (5 mL [DSC])
No
Pack (Triferic Hemodialysis)
272 mg (per each): $96.00
Solution (Triferic AVNU Intravenous)
6.75MG/4.5ML (per mL): $2.88
Solution (Triferic Hemodialysis)
27.2 mg/5 mL (per mL): $2.28
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Intradialytic: Administer after admixed into bicarbonate concentrate dialysate at each dialysis session.
IV: Administer as slow continuous infusion over 3 to 4 hours via the pre-dialyzer infusion line, post-dialyzer infusion line, or via a separate connection to the venous blood line at each dialysis session.
Iron replacement therapy in hemodialysis-dependent patients: Replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD)
Limitations of use: Not intended for use in patients receiving peritoneal dialysis; has not been studied in patients receiving home hemodialysis
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Risk X: Avoid combination
Levonadifloxacin: Iron Preparations may decrease the serum concentration of Levonadifloxacin. Risk X: Avoid combination
The manufacturer recommends effective contraception during therapy and for at least 2 weeks after treatment is complete in females of reproductive potential.
Adverse events were observed in some animal reproduction studies.
Maternal iron requirements increase during pregnancy. Adequate iron concentrations to the fetus can be maintained regardless of maternal iron status, except in severe cases of anemia (IOM 2001).
Iron is present in breast milk (IOM 2001). It is not known if maternal exposure to ferric pyrophosphate citrate significantly changes breast milk concentrations.
According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Monitor for hypersensitivity reactions during and after the dialysis session. Determine iron status on predialysis blood samples, as postdialysis serum iron parameters may overestimate serum iron and transferrin saturation. Patients with chronic kidney disease should have anemia indices (including hemoglobin, hematocrit, and iron studies) assessed as clinically indicated in routine care.
Anemia:
Hemoglobin, whole blood:
Female: 12 to16 g/dL (SI: 120 to 160 g/L) (ABIM 2023).
Male: 13 to 18 g/dL (SI: 130 to 180 g/L) (ABIM 2023; WHO 2011).
Iron deficiency (ABIM 2023):
Ferritin, serum: Note: Ferritin is an acute phase reactant; levels may be elevated in the presence of inflammation or infection which is independent of iron status (WHO 2020).
Female: 24 to 307 ng/mL (SI: 53.9 to 689.8 picomole/L).
Male: 24 to 336 ng/mL (SI: 53.9 to 755 picomole/L).
Iron, serum: 50 to 150 mcg/dL (SI: 9 to 26.9 micromole/L).
Total iron binding capacity, serum: 250 to 310 mcg/dL (SI: 44.8 to 55.5 micromole/L).
Transferrin saturation: 20% to 50%.
Transferrin, serum: 200 to 400 mg/dL (SI: 24.6 to 49.2 micromole/L).
Chronic kidney disease–associated anemia: To achieve and maintain target hemoglobin for patients with nondialysis-dependent chronic kidney disease, patients with a transferrin saturation (TSAT) ≤30% and a serum ferritin level ≤500 ng/mL (SI: 1,123.5 picomole/L) will often respond to iron supplementation (Gutiérrez 2021; KDIGO 2012).
Iron delivered into the circulation binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.
Distribution: Vd: 0.765 to 0.859 L
Half-life elimination: ~1.48 hours
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