ferric pyrophosphate IV (Rx)

>10%

Procedural hypotension (22%)

1-10%

Muscle spasms (10%)

Headache (9%)

Peripheral edema (7%)

Pain in extremity (7%)

Dyspnea (6%)

Pyrexia (5%)

Urinary tract infection (5%)

Back pain (5%)

Asthenia (4%)

Fatigue (4%)

Arteriovenous fistula thrombosis (3%)

Arteriovenous fistula site hemorrhage (3%)

<1%

Hypersensitivity reactions (0.3%)

Frequency Not Defined

Pruritus

Constipation

Nausea

Intradialytic hypotension

Contraindications

None

Cautions

Determine iron status on predialysis blood samples; postdialysis serum iron parameters may overestimate serum iron and transferrin saturation

Hypersensitivity reactions

• Serious hypersensitivity reactions, including anaphylactic-type reactions, some life-threatening and fatal, have been reported in patients receiving parenteral iron products
• Patients may present with shock, clinically significant hypotension, loss of consciousness, and/or collapse
• Monitor for signs and symptoms of hypersensitivity during and after HD until clinically stable
• Personnel and therapies should be immediately available to treat, if necessary

Pregnancy

No data available on use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Animal data

• In animal reproduction studies, IV administration of ferric pyrophosphate citrate to pregnant rats and rabbits during organogenesis caused adverse developmental outcomes at maternally toxic dose levels that resulted in reductions in the number of live offspring and lower offspring body weights

Lactation

There are no data on the presence of ferric pyrophosphate citrate in human milk, the effects on the breastfed child, or the effect on milk production

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Product contains iron in the form of ferric pyrophosphate citrate

Iron binds to transferrin for transport to erythroid precursor cells to be incorporated into hemoglobin

Absorption

Peak plasma concentration

• Total plasma iron: 170 mcg/dL (predialyzer infusion line); 164 mcg/dL (postdialyzer infusion line)
• Transferrin bound iron: 180 mcg/dL (predialyzer infusion line); 169 mcg/dL (postdialyzer infusion line)

AUC

• Total plasma iron: 1260 mcg⋅hr/dL (predialyzer infusion line); 1230 mcg⋅hr/dL (postdialyzer infusion line)
• Transferrin bound iron: 1250 mcg⋅hr/dL (predialyzer infusion line); 1190 mcg⋅hr/dL (postdialyzer infusion line)

IV Preparation

Each ampule is intended for single-use only

Visually inspect solution for signs of precipitation before use; solution should appear clear and slightly yellow-green in color

Remove any remaining solution in the cap by holding and shaking the top of the ampule with one downward movement

To open, twist ampule body and head in opposite directions until neck breaks off the top

Attach a Luer-lock syringe to ampule and withdraw the contents (6.75 mg/4.5 mL)

Connect syringe to attached predialyzer infusion line, postdialyzer infusion line, or a separate connection to the venous blood line

Mount syringe on an infusion pump

IV Administration

Administer IV as a slow continuous infusion over 3-4 hr

Discard unused portion

Storage

Protect from light

Store at room temperature (20-25ºC [68-77ºF]); excursions permitted to 15-30ºC (59-86ºF)