Pasireotide injection (Signifor LAR®)

Signifor LAR (pasireotide) is covered for FDA‑approved acromegaly and Cushing’s disease and for specified compendial off‑label uses (Cushing’s while awaiting surgery or radiotherapy response); uses outside these listed indications are excluded. Approval requires documented diagnosis and prior treatment status, baseline labs (pre‑treatment IGF‑1 >ULN for acromegaly; objective urinary free cortisol change for Cushing’s), prescription by or consultation with an endocrinologist (or Cushing’s specialist), adherence to dosing limits (acromegaly 40 mg IM q4w, may increase to 60 mg after 3 months if GH/IGF‑1 not normalized; Cushing’s 10 mg IM q4w, may increase to 40 mg after 4 months if UFC not normalized) and duration limits (4 months for temporary Cushing’s use; 12 months otherwise), with objective evidence required for dose escalation or continuation.

"Approved Off-label Compendial Use: Cushing's Disease - Patients Awaiting Therapeutic Response After Radiotherapy."