Lanreotide (Somatuline Depot)

Lanreotide (Somatuline Depot) is covered only for the FDA‑approved non‑oncology indication of long‑term treatment of acromegaly (off‑label/non‑FDA indications are excluded). Approval requires documentation of acromegaly and inadequate response to or ineligibility for surgery/radiotherapy (or tumor mass effects), a baseline IGF‑1 above the age/gender upper limit of normal, endocrinologist involvement, a 12‑month authorization starting at 90 mg every 4 weeks for 3 months with GH/IGF‑1‑guided dosing adjustments (maintain 90 mg if GH 1–2.5 ng/mL with normal IGF‑1; increase to 120 mg if GH >2.5 ng/mL and/or IGF‑1 elevated; reduce to 60 mg if GH ≤1 ng/mL and IGF‑1 normal) and an option to convert controlled patients on 60/90 mg to 120 mg every 6–8 weeks with GH/IGF‑1 checked 6 weeks after the interval change.

"Lanreotide is indicated for the long-term treatment of acromegaly in individuals who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not a..."