Ruconest® (recombinant C1 esterase inhibitor)

Ruconest is covered only for the FDA‑approved treatment of acute HAE type I or II attacks and is not supported for routine prophylaxis or other off‑label uses. Coverage requires baseline labs showing functional C1‑INH <50% and low serum C4, prescription by or consultation with an allergist/immunologist or HAE specialist, documented weight for weight‑based dosing (50 U/kg if <84 kg; 4200 U if ≥84 kg; max 4200 U per dose, up to two doses in 24 hours), 12‑month approval, and reauthorization only with prior Ruconest use and documentation of a favorable clinical response.

"FDA-approved indication: Ruconest is indicated for the treatment of acute attacks of Hereditary Angioedema (HAE)."

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