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

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

Ferric Pyrophosphate Citrate is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

Inspect Ferric Pyrophosphate Citrate ampoule for signs of precipitation prior to mixing with the bicarbonate concentrate. Ferric Pyrophosphate Citrate should only be added to the bicarbonate concentrate and should not be added to acid concentrate mixtures. Add Ferric Pyrophosphate Citrate to bicarbonate concentrate used for generation of hemodialysate. The final concentration of iron (III) in the final hemodialysate is 2 micromolar (110 mcg/L). Multiple ampoules can be added to the master bicarbonate mix at each center at a ratio of one ampoule to each 2.5 gallons of bicarbonate concentrate.

Administer Ferric Pyrophosphate Citrate to patients at each dialysis procedure for as long as patients are receiving maintenance hemodialysis therapy for CKD.

Hemodialysis solutions should be used within 24 hours of the preparation of the Ferric Pyrophosphate Citrate /bicarbonate concentrate mixture.

Hypersensitivity Reactions: Anaphylactic-type reactions, shock, hypotension, loss of consciousness and collapse can occur. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until he/she is clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions.

Iron laboratory testing: Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.

Pregnancy & Lactation

Pregnant women Category C. Lactating mothers It is not known whether Ferric Pyrophosphate Citrate is present in human milk or not.

The most common side effects are headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.

Overdose Effects

No data are available regarding overdose of Ferric Pyrophosphate Citrate.

Hypersensitivity Reactions: Anaphylactic-type reactions, shock, hypotension, loss of consciousness and collapse can occur. Monitor patients for signs and symptoms of hypersensitivity during and after hemodialysis until he/she is clinically stable. Personnel and therapies should be immediately available for the treatment of serious hypersensitivity reactions.

Iron laboratory testing: Iron status should be determined on pre-dialysis blood samples. Post dialysis serum iron parameters may overestimate serum iron and transferrin saturation.

Pregnancy & Lactation

Pregnant women Category C. Lactating mothers It is not known whether Ferric Pyrophosphate Citrate is present in human milk or not.