Endocrinology
Acromegaly: the approved drugs compared for prescribers
Palsonify, Sandostatin LAR Depot, Somatuline Depot side by side on what each first fill waits on, what the label requires you to monitor and what an insurer asks to see, with FDA decisions, label changes and open trials for acromegaly.
The 3 acromegaly prescribing guides
One page per drug with the dispensing gate, prior authorization documentation, dosing, monitoring and interactions, each line sourced.
The drugs side by side
Each cell is a summary of that drug's prescribing guide, which carries the full detail and a source on every line. Insurer thresholds are one public policy shown as an example; plans differ.
| Palsonifypaltusotine | Sandostatin LAR Depotoctreotide acetate | Somatuline Depotlanreotide | |
|---|---|---|---|
| Label dated | September 16, 2025 | December 22, 2025 | October 11, 2024 |
| Starting dose | 40mg orally once daily with water on an empty stomach, at least 6 hours after a meal (for example after an overnight fast) and at least 1 hour before the next meal. | Sandostatin injection 50mcg SC three times daily for at least 2 weeks, titratable; most need 100 to 200mcg three times daily, some up to 500mcg. | 90mg deep SC every 4 weeks; 60mg every 4 weeks with moderate or severe renal impairment (CrCl under 60mL/min) or Child-Pugh B or C hepatic impairment. |
| Dispensing gate | No REMS; specialty dispensing through Biologics by McKesson, Orsini or select pituitary centers after prior authorization; CrinetiCARE product enrollment form faxed to 844-CRN-FAXX (844-276-3299) | No REMS. Documented response to and tolerance of Sandostatin injection (at least 2 weeks for octreotide-naive patients, judged by GH and IGF-1); prior authorization, usually under the medical benefit; administration by a trained healthcare provider | No REMS. IPSEN CARES enrollment started by the office with the patient's signed authorization; prior authorization; specialty pharmacy or buy and bill; administration by a healthcare provider in the office or another site of care |
| Required monitoring | Glucose at initiation and each dose change; IGF-1 at 2 to 4 weeks for titration; periodic gallbladder and thyroid assessment; B12 if indicated; adjust bradycardic drugs as needed | GH and IGF-1 at 3 months to set the dose; glucose at initiation and each dose change; baseline and periodic TSH and T4; vitamin B12; periodic gallbladder monitoring; caution with bradycardia and conduction disease | GH and IGF-1 at 3 months and 6 weeks after any move to an extended interval; glucose at initiation and dose changes; periodic gallbladder monitoring; heart rate; thyroid tests where clinically indicated |
| Example PA threshold | Cigna example: age 18 or older, inadequate response to or not a candidate for surgery or radiotherapy, pretreatment IGF-1 above ULN, endocrinologist, prior octreotide LAR or lanreotide | Cigna example: inadequate response to or unsuitability for surgery or radiotherapy, or mass effect; pre-treatment IGF-1 above the ULN; endocrinologist; for employer plans, a prior trial of octreotide ER injectable suspension, Somatuline Depot or lanreotide before the brand | Cigna example: inadequate response to or not a candidate for surgery or radiotherapy, tumor mass effects, or growth on imaging; pre-treatment IGF-1 above the upper limit of normal; endocrinologist or oncologist; up to 120mg no more often than every 4 weeks |
| Support line | CrinetiCARE, 844-CRN-HELP (844-276-4357), benefits investigation, PA and appeals support, copay as low as $0 for commercial plans with up to $25,000 a year, a quick start supply during coverage delays, and a patient assistance program | Novartis Patient Support, 1-800-282-7630; Novartis Oncology Universal Co-pay Program, $25 a month for eligible privately insured patients up to $15,000 a year, 1-877-577-7756; Novartis Patient Assistance Foundation for eligible uninsured or government-insured patients under income limits, 1-800-277-2254 | IPSEN CARES, 866-435-5677, Monday to Friday, 8 AM to 8 PM ET; benefits verification typically within 1 business day, PA and appeal information, a commercial copay program with an annual cap, temporary help for commercial payer delays, and a PAP for the uninsured or functionally uninsured |
- Label dated
- September 16, 2025
- Starting dose
- 40mg orally once daily with water on an empty stomach, at least 6 hours after a meal (for example after an overnight fast) and at least 1 hour before the next meal.
- Dispensing gate
- No REMS; specialty dispensing through Biologics by McKesson, Orsini or select pituitary centers after prior authorization; CrinetiCARE product enrollment form faxed to 844-CRN-FAXX (844-276-3299)
- Required monitoring
- Glucose at initiation and each dose change; IGF-1 at 2 to 4 weeks for titration; periodic gallbladder and thyroid assessment; B12 if indicated; adjust bradycardic drugs as needed
- Example PA threshold
- Cigna example: age 18 or older, inadequate response to or not a candidate for surgery or radiotherapy, pretreatment IGF-1 above ULN, endocrinologist, prior octreotide LAR or lanreotide
- Support line
- CrinetiCARE, 844-CRN-HELP (844-276-4357), benefits investigation, PA and appeals support, copay as low as $0 for commercial plans with up to $25,000 a year, a quick start supply during coverage delays, and a patient assistance program
- Label dated
- December 22, 2025
- Starting dose
- Sandostatin injection 50mcg SC three times daily for at least 2 weeks, titratable; most need 100 to 200mcg three times daily, some up to 500mcg.
- Dispensing gate
- No REMS. Documented response to and tolerance of Sandostatin injection (at least 2 weeks for octreotide-naive patients, judged by GH and IGF-1); prior authorization, usually under the medical benefit; administration by a trained healthcare provider
- Required monitoring
- GH and IGF-1 at 3 months to set the dose; glucose at initiation and each dose change; baseline and periodic TSH and T4; vitamin B12; periodic gallbladder monitoring; caution with bradycardia and conduction disease
- Example PA threshold
- Cigna example: inadequate response to or unsuitability for surgery or radiotherapy, or mass effect; pre-treatment IGF-1 above the ULN; endocrinologist; for employer plans, a prior trial of octreotide ER injectable suspension, Somatuline Depot or lanreotide before the brand
- Support line
- Novartis Patient Support, 1-800-282-7630; Novartis Oncology Universal Co-pay Program, $25 a month for eligible privately insured patients up to $15,000 a year, 1-877-577-7756; Novartis Patient Assistance Foundation for eligible uninsured or government-insured patients under income limits, 1-800-277-2254
- Label dated
- October 11, 2024
- Starting dose
- 90mg deep SC every 4 weeks; 60mg every 4 weeks with moderate or severe renal impairment (CrCl under 60mL/min) or Child-Pugh B or C hepatic impairment.
- Dispensing gate
- No REMS. IPSEN CARES enrollment started by the office with the patient's signed authorization; prior authorization; specialty pharmacy or buy and bill; administration by a healthcare provider in the office or another site of care
- Required monitoring
- GH and IGF-1 at 3 months and 6 weeks after any move to an extended interval; glucose at initiation and dose changes; periodic gallbladder monitoring; heart rate; thyroid tests where clinically indicated
- Example PA threshold
- Cigna example: inadequate response to or not a candidate for surgery or radiotherapy, tumor mass effects, or growth on imaging; pre-treatment IGF-1 above the upper limit of normal; endocrinologist or oncologist; up to 120mg no more often than every 4 weeks
- Support line
- IPSEN CARES, 866-435-5677, Monday to Friday, 8 AM to 8 PM ET; benefits verification typically within 1 business day, PA and appeal information, a commercial copay program with an annual cap, temporary help for commercial payer delays, and a PAP for the uninsured or functionally uninsured
FDA decisions for acromegaly
From the Trial Friend FDA decision calendar, which records each date from the sponsor's or the FDA's own announcement.
- December 18, 2026Oclaiz (octreotide subcutaneous depot), NDA resubmission, CamurusPending
Recent label changes
What changed in each label revision, from the FDA's approval letters and the labels' own revision lists.
- December 2025Sandostatin LAR Depot. DailyMed carries a new version of the label dated December 22nd. Its highlights still list July 2024 as the latest major change. The FDA's approval letters also stop at July 2024, so the changes below are the approved ones. FDA label
- September 2025Palsonify. The FDA approved Palsonify on September 25th for adults with acromegaly who had an inadequate response to surgery or cannot have surgery. The FDA asked Crinetics to report retinal and other eye findings quickly for 5 years. The label has not been revised since. FDA letter
- October 2024Somatuline Depot. DailyMed carries a version dated October 11th, and its Patient Information still reads Revised 07/2024. The FDA's last approval letter is from July 2024, so the changes below are the approved ones. FDA label
- July 2024Somatuline Depot. A new warning was added on July 11th about fatty stools and poor absorption of dietary fat, which the FDA asked for across somatostatin analogs. FDA letter
- July 2024Sandostatin LAR Depot. A warning was added on July 11th about fatty stools and poor fat absorption, after an FDA request covering all somatostatin analogs. Patients are told to report fatty or loose stools, bloating and weight loss. FDA letter
- January 2024Sandostatin LAR Depot. Wording updates were approved on January 5th, describing the vial as single-dose and the diluent syringe as prefilled. The dose and the schedule for acromegaly did not change with it. FDA letter
- February 2023Somatuline Depot. Shelf life grew from 24 to 36 months in the refrigerator. A sealed syringe may now sit at room temperature up to 72 hours instead of 24. FDA letter
- March 2021Sandostatin LAR Depot. A drug interaction section on Lutathera, a radioactive treatment for neuroendocrine tumors, was added on March 30th. It does not change the dose or schedule for acromegaly. FDA letter
Open trials
Questions prescribers ask about Acromegaly
Which Acromegaly drugs require a REMS?
None of the 3 Acromegaly drugs on this page has a REMS: Palsonify, Sandostatin LAR Depot and Somatuline Depot. Each prescribing guide lists what does gate the first fill.
What monitoring do Acromegaly drugs require?
Palsonify: Glucose at initiation and each dose change; IGF-1 at 2 to 4 weeks for titration; periodic gallbladder and thyroid assessment; B12 if indicated; adjust bradycardic drugs as needed. Sandostatin LAR Depot: GH and IGF-1 at 3 months to set the dose; glucose at initiation and each dose change; baseline and periodic TSH and T4; vitamin B12; periodic gallbladder monitoring; caution with bradycardia and conduction disease. Somatuline Depot: GH and IGF-1 at 3 months and 6 weeks after any move to an extended interval; glucose at initiation and dose changes; periodic gallbladder monitoring; heart rate; thyroid tests where clinically indicated.
What do insurers require before covering Palsonify, Sandostatin LAR Depot and Somatuline Depot?
Each answer below is one public insurer policy, an example rather than every plan. Palsonify: Cigna example: age 18 or older, inadequate response to or not a candidate for surgery or radiotherapy, pretreatment IGF-1 above ULN, endocrinologist, prior octreotide LAR or lanreotide. Sandostatin LAR Depot: Cigna example: inadequate response to or unsuitability for surgery or radiotherapy, or mass effect; pre-treatment IGF-1 above the ULN; endocrinologist; for employer plans, a prior trial of octreotide ER injectable suspension, Somatuline Depot or lanreotide before the brand. Somatuline Depot: Cigna example: inadequate response to or not a candidate for surgery or radiotherapy, tumor mass effects, or growth on imaging; pre-treatment IGF-1 above the upper limit of normal; endocrinologist or oncologist; up to 120mg no more often than every 4 weeks.
Which support programs start Acromegaly patients on therapy?
Palsonify: CrinetiCARE, 844-CRN-HELP (844-276-4357), benefits investigation, PA and appeals support, copay as low as $0 for commercial plans with up to $25,000 a year, a quick start supply during coverage delays, and a patient assistance program. Sandostatin LAR Depot: Novartis Patient Support, 1-800-282-7630; Novartis Oncology Universal Co-pay Program, $25 a month for eligible privately insured patients up to $15,000 a year, 1-877-577-7756; Novartis Patient Assistance Foundation for eligible uninsured or government-insured patients under income limits, 1-800-277-2254. Somatuline Depot: IPSEN CARES, 866-435-5677, Monday to Friday, 8 AM to 8 PM ET; benefits verification typically within 1 business day, PA and appeal information, a commercial copay program with an annual cap, temporary help for commercial payer delays, and a PAP for the uninsured or functionally uninsured.
A reference for licensed professionals, checked on November 7, 2026. Labels and plan policies change; the label on DailyMed and the plan's current policy govern. Not medical advice. For patients: the Acromegaly page and the first 90 days pages for Palsonify, Sandostatin LAR Depot, Somatuline Depot.