Dosing & Uses
Dosage Forms & Strengths
Dose expressed as mg of iron (III)
injectable solution
- 1.5mg/mL (4.5-mL single-dose ampule)
Iron Replacement
Indicated for replacement of iron to maintain hemoglobin in patients with hemodialysis-dependent chronic kidney disease (HDD-CKD)
6.75 mg iron (III) IV at each hemodialysis (HD) session
Dosage is expressed as mg of iron (III)
Administer at each dialysis procedure for as long as patients are receiving maintenance HD therapy for CKD
Dosing Considerations
Limitations of use
- Not intended for use in patients receiving peritoneal dialysis
- Not studied in patients receiving home hemodialysis
Safety and efficacy not established
Adverse Effects
>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
Warnings
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 & Lactation
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.Pharmacology
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)
Administration
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)
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Formulary
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