What is the recommended intravenous dosing, infusion rate, monitoring, contraindications, and adverse effects of ferric pyrophosphate liposomal for an adult with iron‑deficiency anemia who has no known hypersensitivity to iron products?

Ferric Pyrophosphate Liposomal for Iron-Deficiency Anemia

Ferric pyrophosphate liposomal (Triferic AVNU) is FDA-approved exclusively for hemodialysis-dependent chronic kidney disease patients and is administered via dialysate or dialysis bloodlines during hemodialysis sessions—it is not indicated for general iron-deficiency anemia in non-dialysis patients. 1

Critical Indication Limitation

• Ferric pyrophosphate liposomal is NOT a general-purpose intravenous iron formulation. The FDA label restricts its use to hemodialysis-dependent chronic kidney disease (HDD-CKD) patients receiving maintenance hemodialysis. 1
• For adult patients with iron-deficiency anemia who are not on hemodialysis, you must select an alternative IV iron preparation such as ferric carboxymaltose, ferric derisomaltose, or iron sucrose. 2, 3, 4

FDA-Approved Dosing & Administration (Hemodialysis Patients Only)

Dose

• 6.75 mg elemental iron per hemodialysis session, supplied as one 4.5 mL ampule (1.5 mg iron/mL). 1

Route of Administration

• Administer directly into the pre-dialyzer infusion line, post-dialyzer infusion line, or a separate connection to the venous blood line. 1
• Infusion occurs over 3–4 hours during the hemodialysis session. 1

Frequency

• Administered 3 or 4 times per week during each hemodialysis treatment. 1

Monitoring Requirements

• Hemoglobin: Target range 9–12 g/dL; discontinue if hemoglobin exceeds 12 g/dL or if pre-specified hemoglobin criteria indicating need for anemia management change are met. 1
• Transferrin saturation (TSAT): Maintain >20%. 1
• Serum ferritin: Maintain >200 mcg/L. 1
• Timing of reassessment: Iron parameters should not be checked within 4 weeks of IV iron administration due to assay interference. 2

Contraindications

• Hypersensitivity to ferric pyrophosphate citrate or any excipient. 1
• Known serious hypersensitivity to other parenteral iron products. 2, 1
• Anemia not attributed to iron deficiency. 2, 1
• Evidence of iron overload or disturbances in iron utilization. 2, 1
• Hemoglobin >15 g/dL. 2

Adverse Effects

Common

• Hypophosphatemia: Not specifically quantified in the ferric pyrophosphate liposomal label, but other IV iron formulations (e.g., ferric carboxymaltose) cause hypophosphatemia in 47–75% of patients. 2
• Gastrointestinal symptoms and infusion reactions are possible with all IV iron formulations. 5

Serious

• Hypersensitivity reactions: Observe patients for at least 30 minutes post-infusion. 2
• Clastogenic potential: Ferric pyrophosphate citrate was clastogenic in vitro in the presence of metabolic activation. 1
• Maternal and fetal toxicity: At maternally toxic doses (90 mg/kg/day in rats), reductions in live offspring and lower offspring body weights were observed. 1

Infection Precautions

• Withhold during active bacteremia or acute infection. 2, 4

Alternative IV Iron Formulations for Non-Dialysis Patients

If your patient is not on hemodialysis, use one of the following:

Ferric Carboxymaltose

• Dose: 750–1000 mg per infusion, maximum 1000 mg/week. 2
• Infusion time: 15–30 minutes. 2
• Advantages: High single-dose capacity, fewer clinic visits. 2
• Caution: High rate of hypophosphatemia (58%). 2

Ferric Derisomaltose

• Dose: 1000–2000 mg total dose infusion (weight- and hemoglobin-based). 3, 4
• Infusion time: ≥20 minutes for ≤1000 mg; ≥30 minutes for >1000 mg. 4
• Advantages: FDA-approved for total dose infusion, lower hypophosphatemia risk (4%) than ferric carboxymaltose. 3, 6

Iron Sucrose

• Dose: 200 mg per administration. 2
• Infusion time: 2–5 minutes IV push or diluted infusion. 4
• Disadvantage: Requires 4–7 clinic visits to deliver 1000 mg. 2, 4

Common Pitfalls

• Using ferric pyrophosphate liposomal in non-dialysis patients: This is off-label and not supported by FDA approval. 1
• Checking iron parameters too early: Ferritin and TSAT are falsely elevated within 4 weeks of IV iron administration. 2
• Administering IV iron during active infection: Withhold until bacteremia resolves. 2, 4
• Exceeding hemoglobin threshold: Do not administer if hemoglobin >15 g/dL. 2