Injectafer® (ferric carboxymaltose)

Injectafer is covered for FDA‑approved uses (iron deficiency anemia in patients ≥1 year intolerant or unresponsive to oral iron; adult non‑dialysis CKD with IDA; adult NYHA II/III heart‑failure with iron deficiency) and for the compendial off‑label use in dialysis‑dependent CKD; other indications are not covered. Approvals require meeting age limits (≥1 year general IDA, ≥18 for CKD/HF), specialist prescription/consultation when specified (nephrology/hematology for CKD, cardiology/hematology for HF), documentation of prior oral‑iron failure or qualifying clinical circumstances, adherence to specified weight‑based dosing and timing (two doses ≥7 days apart or single 15 mg/kg up to 1,000 mg), maintenance dosing only with ferritin/TSAT criteria, compendial support for dialysis use, documentation of weight/Hb/ferritin/TSAT as applicable, and are limited to 12 months.

"Prescriber/specialist requirements: CKD — "Injectafer is prescribed by or in consultation with a nephrologist or hematologist"; Heart failure — "Injectafer is prescribed by or in consultation with ..."