FERRIC DERISOMALTOSE INJ
Clinical Criteria Summary
Indications & Patient Population
- Treatment of iron deficiency anemia (IDA) in adult patients
- Patients with intolerance to oral iron or unsatisfactory response to oral iron
- Patients with non-hemodialysis dependent chronic kidney disease (NDD-CKD)
Dosing & Administration Criteria
- Available as 1000 mg/10 mL single-dose vial
- For patients weighing ≥50 kg: Administer 1,000 mg as a single IV infusion over at least 20 minutes
- For patients weighing <50 kg: Administer 20 mg/kg actual body weight as a single IV infusion over at least 20 minutes
- Dilute in 100 mL to 500 mL of 0.9% Sodium Chloride Injection, USP
- Repeat dose if IDA reoccurs
Contraindications
- History of serious hypersensitivity to ferric derisomaltose or any of its components
Warnings & Precautions
- Hypersensitivity reactions: Serious, life-threatening, and fatal anaphylactic-type reactions have been reported (including shock, clinically significant hypotension, loss of consciousness, collapse)
- Iron overload: Excess iron storage, iatrogenic hemosiderosis, or hemochromatosis can occur with excessive IV iron therapy; do not administer to patients with iron overload
Monitoring Requirements
- Monitor for signs and symptoms of hypersensitivity during and after administration for at least 30 minutes until clinically stable
- Monitor hemoglobin, hematocrit, serum ferritin, and transferrin saturation during IV iron therapy
Clinical Decision Criteria
- Decision to manage IDA with oral versus IV iron therapy depends on etiology of anemia, response/tolerability to iron supplementation, convenience of administration, and cost
- May be considered as preferred therapy based on economic considerations or convenience on a case-by-case basis at the local level