Adzynma™ (ADAMTS13 recombinant-krhn)

Covered only for FDA‑approved prophylactic or on‑demand enzyme replacement therapy in adult and pediatric congenital TTP (excluded for acquired/immune TTP and other indications). Initial authorization requires baseline ADAMTS13 activity <10% (<10 IU/dL) measured before any ADAMTS13 or plasma therapy, absence of anti‑ADAMTS13 autoantibodies, a pathogenic ADAMTS13 gene variant, prescription by or consultation with a hematologist, documentation of indication/dosing (prophylaxis 40 IU/kg IV q2wk, may escalate to 40 IU/kg weekly; on‑demand Day 1 40 IU/kg, Day 2 20 IU/kg, Day 3+ 15 IU/kg until 2 days after resolution), and approval is issued for up to 12 months.

"Presence of anti‑ADAMTS13 autoantibodies excludes use (patient must not have anti‑ADAMTS13 autoantibodies)."

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