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Ferric Pyrophosphate Citrate

Medically reviewed by Drugs.com. Last updated on May 26, 2020.

Pronunciation

(FER ik pye roe FOS fate SIT rate)

Index Terms

  • Ferric Pyrophosphate
  • Soluble Ferric Pyrophosphate (SFP)

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)

Brand Names: U.S.

  • Triferic

Pharmacologic Category

  • Iron Preparations

Pharmacology

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.

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.

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.

Reproductive Considerations

The manufacturer recommends effective contraception during therapy and for at least 2 weeks after treatment is complete in females of reproductive potential.

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).

Patient Education

What is this drug used for?

• It is used to replace iron in people with kidney disease who are on dialysis.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Painful extremities

• Headache

• Loss of strength and energy

• Back pain

• Muscle spasms

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Urinary tract infection like 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

• Swelling of arms or legs

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.