Ferric Pyrophosphate Citrate

Ferric Pyrophosphate Citrate solution is a mixed-ligand iron complex in which iron (III) is bound to pyrophosphate and citrate. It is a clear, slightly yellow-green color sterile solution containing 27.2 mg iron (III) per 5 mL.

One ampoule is added to 2.5 gallons (9.46 L) of bicarbonate concentrate.

• Hemoglobin Maintenance in HDD-CKD: Used for iron replacement to maintain hemoglobin in hemodialysis-dependent chronic kidney disease.

Parenteral Iron Preparations

Iron Replacement (Hemodialysis)

Ferric Pyrophosphate Citrate solution is a mixed-ligand iron complex in which iron (III) is bound to pyrophosphate and citrate. Each ampoule contains Iron (7.5-9.0% w/w), Citrate (15-22% w/w), Pyrophosphate (15-22% w/w), Phosphate (<2% w/w), Sodium (18-25% w/w), Sulfate (20-35%).

Ferric Pyrophosphate Citrate provides iron during hemodialysis which binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin.

Adult Dose (Hemodialysis):

• Add 1 ampoule (27.2 mg iron) to bicarbonate concentrate at each dialysis procedure (1 ampoule per 2.5 gallons of bicarbonate concentrate).
• Final concentration of iron in final hemodialysate is 2 micromolar (110 mcg/L).
• Hemodialysis solutions should be used within 24 hours of preparation.

For hemodialysis only. Add ampoule to bicarbonate concentrate; do not add to acid concentrate mixtures. Not for infusion.

If you miss a dose of Ferric Pyrophosphate Citrate, please consult your doctor.

Common Side Effects:

• Headache
• Peripheral edema
• Asthenia
• AV fistula thrombosis
• Urinary tract infection
• AV fistula site hemorrhage
• Pyrexia
• Fatigue
• Hypotension
• Muscle spasms
• Pain in extremity
• Back pain
• Dyspnea

Precautions:

• Hypersensitivity reactions: Anaphylactic-type reactions, shock, hypotension, loss of consciousness can occur; monitor during and after hemodialysis.
• Iron laboratory testing: Iron status should be determined on pre-dialysis blood samples; post-dialysis serum iron parameters may overestimate.

Contraindications: Hypersensitivity.

Drug Interactions: Formal drug interaction studies have not been performed.

Food Interactions: No interactions with food.

Use in Pregnancy: Category C; limited data on use in pregnant women.

Use in Lactation: It is not known whether Ferric Pyrophosphate Citrate is present in human milk.

Pediatric Use: Safety and efficacy not established.

Geriatric Use: No specific dosage adjustment is necessary for elderly patients.

Renal Impairment: Indicated for hemodialysis-dependent CKD patients.

Hepatic Impairment: No specific precautions necessary.

Overdose: No data available regarding overdose.

Storage: Keep in a cool and dry place, away from light. Keep out of reach of children.

Ferric Pyrophosphate Citrate