Pasireotide injection (Signifor LAR)

Signifor LAR (pasireotide) is covered only for FDA‑approved indications (acromegaly and Cushing's disease) and specified off‑label compendial uses (Cushing's patients awaiting surgery or awaiting response after radiotherapy); use outside these listed indications is excluded. Approval requires baseline IGF‑1 > ULN for acromegaly, prescribing by or consultation with an endocrinologist (or Cushing's specialist for Cushing's), documentation of inadequate response or ineligibility for surgery/radiotherapy as applicable, specified lab monitoring to justify dose escalation (GH/IGF‑1 at 3 months for acromegaly; 24‑hr urinary free cortisol at 4 months for Cushing's), and limited approval durations (4 months for certain Cushing's scenarios; 12 months otherwise).

"Signifor LAR is indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option."