Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Packet, Hemodialysis:
Triferic: 272 mg (1 ea, 100 ea)
Solution, Hemodialysis:
Triferic: 27.2 mg/5 mL (50 mL [DSC])
Solution, Hemodialysis [preservative free]:
Triferic: 27.2 mg/5 mL (5 mL)
Pharmacology
Mechanism of Action
Iron in the form of ferric pyrophosphate citrate and added to hemodialysate solution is administered to patients by transfer across the dialyzer membrane. Iron delivered into the circulation binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.
Pharmacokinetics/Pharmacodynamics
Distribution
Vd: 0.765 to 0.859 L
Half-Life Elimination
~1.48 hours
Use: Labeled Indications
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
Contraindications
There are no contraindications listed in the manufacturer's labeling.
Dosage and Administration
Dosing: Adult
Note: Triferic ampules contains 5.44 mg iron (III) per mL. Triferic powder contains 272 mg iron (III) per packet.
Iron replacement therapy in hemodialysis-dependent patients: 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 CKD.
Reconstitution
Solution in ampules may appear slightly yellow-green in color. Add solution or powder to bicarbonate concentrate used for generation of hemodialysate (2 micromolar [110 mcg/L] iron [III] final concentration). Multiple single dose 5 mL ampules can be added to the master bicarbonate mix at each dialysis center at a ratio of one 5 mL ampule to each 9.46 L (2.5 gallons) of bicarbonate concentrate. Multiple 50 mL ampules or powder packets can be added to the master bicarbonate mix at each dialysis center at a ratio of one 50 mL ampule or 1 powder packet to each 94.6 L (25 gallons) of bicarbonate concentrate.
Administration
Intradialytic: Administer after admixed into bicarbonate concentrate dialysate at each dialysis session.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect ampules from light. Use hemodialysate within 24 hours of preparation.
Drug Interactions
Dimercaprol: May enhance the nephrotoxic effect of Iron Preparations. Avoid combination
Adverse Reactions
Note: 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
Warnings/Precautions
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.
Other warnings/precautions:
- Iron status testing: Determine iron status on predialysis blood samples, as postdialysis serum iron parameters may overestimate serum iron and transferrin saturation.
Monitoring Parameters
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 CKD should have anemia indices (including hemoglobin, hematocrit, and iron studies) assessed as clinically indicated in routine care.
Pregnancy
Pregnancy Considerations
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).
The manufacturer recommends effective contraception during therapy and for at least 2 weeks after treatment is complete in females of reproductive potential.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience painful extremities, headache, loss of strength and energy, back pain, or muscle spasms. Have patient report immediately to prescriber signs of a urinary tract infection (blood in the urine, burning or painful urination, passing a lot of urine, fever, lower abdominal pain, or pelvic pain), dizziness, passing out, shortness of breath, or swelling of arms or legs (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
