Prescribing guide
Somatuline Depot (lanreotide)For acromegaly: titration, extended dosing, monitoring and prior authorization criteriaFor prescribers and their offices treating acromegaly: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
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.
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.
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.
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.
Give your patient their plan
A one-page handout for starting Somatuline Depot, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/somatulinedepotBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Enroll online | The online Enrollment Form takes about 10 minutes and is completed with the patient, who signs the Patient Authorization. It covers patient, prescriber, prescription, PAP application and authorization. | IPSEN CARES HCP enrollment |
| Or fax the form | The 7-page Enrollment Form goes to 1-888-525-2416; pages 2 to 7 are required, and page 3 may be blank if the patient is not applying for PAP. The prescriber signs the attestation, which is required if the form serves as the prescription for specialty pharmacy triage or PAP. | Enrollment Form |
| Benefits verification | A Patient Access Manager verifies medical and pharmacy benefits and reviews coverage and out-of-pocket costs with prescriber and patient, typically within 1 business day of a complete form. | Enrollment Form |
| Prior authorization | IPSEN CARES advises whether a PA is required and gives information on the payer appeal process. | IPSEN CARES HCP |
| Route the product | The form asks for specialty pharmacy or buy and bill. IPSEN CARES can triage the prescription to a specialty pharmacy; site of care options on the form are physician office, hospital outpatient, infusion center or other. | Enrollment Form |
| Product | Single-dose prefilled syringes, one per carton: 60mg/0.2mL (NDC 15054-1060-4), 90mg/0.3mL (NDC 15054-1090-4), 120mg/0.5mL (NDC 15054-1120-4), with an automatic safety system. | FDA label |
| Appeal paperwork | IPSEN CARES posts a letter of medical necessity template, a letter of appeal template, a Medicare Part D tier exception template and a reimbursement resource guide. | IPSEN CARES HCP resources |
| Payer delay | For commercially insured patients with a coverage delay, IPSEN CARES may be able to provide temporary assistance while the office works toward approval; call for details. | IPSEN CARES HCP financial help |
| Copay program terms | Commercial insurance only, with an annual calendar year maximum. Excluded: Medicare Part B or D, Medicaid, Medigap, VA, DoD, TRICARE and other government programs, residents of Massachusetts and California, and patients using another assistance program or foundation that year. Rhode Island residents get drug cost help only, not the injection service. Claims within 180 days of treatment. | Copay terms |
| Patient Assistance Program | Free drug for patients who are uninsured or functionally uninsured, in financial hardship and meeting financial eligibility criteria, with a valid on-label prescription; eligibility does not guarantee approval. Patients routed by an alternate funding program, such as SHARx or Payer Matrix, are excluded. | PAP terms |
Prior authorization criteria and what to document
One public policy as the example: Cigna, October 15, 2026. Approval one year at a time, with extended approvals if the patient still meets the criteria. This policy took effect October 15, 2026, after the July 2024 label. Its acromegaly criteria last changed on September 15, 2026, adding tumor growth on imaging and oncologists. The preferred product step applies to Cipla's lanreotide, not to Somatuline Depot itself. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Indication | Inadequate response to surgery and/or radiotherapy, not an appropriate candidate, negative effects of tumor size such as optic nerve compression, or signs of tumor growth on imaging | Operative and radiation history, or imaging and visual field reports | Cigna policy |
| Baseline IGF-1 | Pre-treatment IGF-1 above the upper limit of normal for age and gender for the reporting laboratory, before any somatostatin analog, dopamine agonist or pegvisomant | Dated IGF-1 result with the lab's reference range | Cigna policy |
| Prescriber | Prescribed by or in consultation with an endocrinologist or oncologist | Specialty on the request, or the consult note | Cigna policy |
| Dose | Up to 120mg subcutaneously no more frequently than once every 4 weeks; doses outside this go to case-by-case review | Order with strength and interval | Cigna policy |
| Preferred product | For Cipla's lanreotide (J1932, NDC 69097-0870-67), a prior trial of octreotide LAR, Somatuline Depot or generic lanreotide; if a Cipla product is requested, J1930, NDC 69097-0906-67 is preferred | Medication history, if requesting the Cipla product | Cigna policy |
| Approval | 1 year, with extended approvals while criteria and dosing are still met | Renewal request with current dosing | Cigna policy |
| Billing code | HCPCS J1930, injection, lanreotide, 1mg; J1932 for the Cipla product | Claim | Cigna policy |
Somatuline Depot dosing and titration
| When | Label | Source |
|---|---|---|
| Months 1 to 3 | 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. | FDA label |
| After 3 months | GH over 1 to 2.5ng/mL, IGF-1 normal, symptoms controlled: 90mg. GH over 2.5ng/mL, IGF-1 elevated and/or symptoms uncontrolled: 120mg. GH 1ng/mL or less, IGF-1 normal, symptoms controlled: 60mg. All every 4 weeks. | FDA label |
| Thereafter | Adjust by reduction in serum GH and/or IGF-1 and changes in symptoms; continued monitoring with dose adjustment as necessary is recommended. | FDA label |
| Extended interval | Patients controlled on 60mg or 90mg may be considered for 120mg every 6 or 8 weeks; obtain GH and IGF-1 6 weeks after the change. Use caution with moderate or severe renal or hepatic impairment. | FDA label |
| Preparation | Remove from the refrigerator 30 minutes before injection; keep the pouch sealed until just before use. A sealed pouch kept at room temperature, not above 40 degrees C (104 degrees F), up to 72 hours may be returned to the refrigerator. Store at 2 to 8 degrees C (36 to 46 degrees F), protected from light. | FDA label |
| Injection | Slowly over 20 seconds, deep SC in the superior external quadrant of the buttock, alternating right and left. Contents are a white to pale yellow gel and may hold micro bubbles. | FDA label |
| Missed dose | The label gives no missed-dose instruction; timing of a late dose is the prescriber's decision. | FDA label |
| Generic | Amneal's lanreotide acetate injection label (DailyMed, September 2026) carries the same acromegaly dosing and states it is intended for administration by a healthcare provider. It supplies only the 120mg/0.5mL syringe. | Amneal lanreotide label |
Monitoring the Somatuline Depot label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Month 3, then ongoing | GH and IGF-1 | Titrate to 60, 90 or 120mg per section 2.2; goal is normal GH and IGF-1 | FDA label |
| 6 weeks after an interval change | GH and IGF-1 | Confirms persistence of response on 120mg every 6 or 8 weeks | FDA label |
| Initiation and each dose change | Blood glucose | Hypo- and hyperglycemia can occur; adjust antidiabetic treatment. Dysglycemia in 14% (47/332) of acromegaly patients | FDA label |
| Periodically | Gallbladder | Reduced motility and gallstones; cholelithiasis or sludge in 20% of 416, 17% of 167 with routine ultrasound had gallstones at baseline and new cholelithiasis was reported in 12%. Discontinue if complications such as cholecystitis, cholangitis or pancreatitis are suspected | FDA label |
| At start, especially with bradycardia | Heart rate | Sinus bradycardia 3% in pooled acromegaly studies; manage symptomatic bradycardia; additive effect with beta-blockers | FDA label |
| Where clinically indicated | Thyroid function | Slight decreases seen; clinical hypothyroidism under 1% | FDA label |
| Any time | Steatorrhea, stool discoloration, loose stools, bloating, weight loss | Evaluate for pancreatic exocrine insufficiency and manage accordingly (added July 2024) | FDA letter |
Somatuline Depot drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Contraindications | History of hypersensitivity to lanreotide; angioedema and anaphylaxis have been reported | FDA label |
| Insulin and oral antidiabetics | Monitor glucose at initiation and dose changes and adjust antidiabetic treatment | FDA label |
| Cyclosporine | Absorption may decrease; cyclosporine dose adjustment may be needed | FDA label |
| Bromocriptine | Absorption may increase, per limited published data | FDA label |
| Bradycardia-inducing drugs, such as beta-blockers | Additive heart rate reduction; dose adjustment of the concomitant drug may be necessary | FDA label |
| CYP3A4 substrates with a low therapeutic index | Avoid, for example quinidine or terfenadine; drugs metabolized by the liver may be cleared more slowly, so consider dose reductions | FDA label |
| Lactation and fertility | Advise against breastfeeding during treatment and for 6 months after the last dose; may reduce female fertility | FDA label |
| Generic substitution | Drugs@FDA lists Amneal's ANDA 218217, lanreotide acetate 120mg/0.5mL, approved September 18, 2026, as AB-rated and available by prescription | Drugs@FDA, Amneal |
| Other lanreotide products | Drugs@FDA lists InvaGen's (Cipla) ANDA 217193, approved May 21, 2024, as discontinued, in all 3 strengths | Drugs@FDA, InvaGen |
Why a first fill stalls, and the fix
- The plan wants a baseline IGF-1Cigna asks for an IGF-1 above the normal range from before any somatostatin analog, dopamine agonist or Somavert was started. The endocrinologist's records usually hold it, and older results count.
- The plan wants a reason surgery is not enoughCigna accepts an inadequate response to surgery or radiation, not being a candidate for them, effects of tumor size, or tumor growth on imaging. The office records which reason applies to you.
- The plan prefers a different lanreotide productCigna's policy covers both Somatuline Depot and Cipla's lanreotide, with its own step rules for the Cipla product. The endocrinologist's office can ask which product the plan prefers before the first shipment.
- Prior authorization is pending or deniedFor commercial insurance, Ipsen says IPSEN CARES may be able to give temporary help during a coverage delay. The office calls IPSEN CARES while it works toward approval.
- The office needs paperwork for an appealIPSEN CARES offers the office a letter of medical necessity template, a letter of appeal template and a Medicare Part D tier exception template. A Patient Access Manager can also walk you through the appeal steps.
- A copay you cannot payThe copay program is for people with commercial insurance only. People on Medicare, Medicaid, TRICARE, VA or other government programs cannot use it, and neither can residents of Massachusetts or California.
- No insurance, or a plan that will not cover itThe Patient Assistance Program may give Somatuline Depot free to people who are uninsured or whose plan does not cover it. They must be enrolled in IPSEN CARES and meet its financial eligibility rules.
IPSEN CARES
- A dedicated Patient Access Manager who reviews your coverage, helps you prepare to talk with your doctor, specialty pharmacy or insurer, and looks for financial help you may qualify for
- A review of your insurance coverage, with guidance to your doctor's office on what to send for prior authorization and appeals
- Copay support for eligible people with commercial insurance
- A Patient Assistance Program for eligible people experiencing financial hardship
- Ongoing coverage support for as long as you are on Somatuline Depot and enrolled in IPSEN CARES
Questions prescribers' offices ask about Somatuline Depot
What is the Somatuline Depot starting dose for acromegaly?
The July 2024 label sets 90mg by deep subcutaneous injection every 4 weeks for 3 months, or 60mg every 4 weeks for 3 months with moderate or severe renal impairment (CrCl under 60mL/min) or moderate or severe hepatic impairment (Child-Pugh B or C). It is intended for administration by a healthcare provider, in the superior external quadrant of the buttock, alternating sides.
How is Somatuline Depot titrated after 3 months?
Under the July 2024 label: GH above 1 and up to 2.5ng/mL with normal IGF-1 and controlled symptoms, stay at 90mg; GH above 2.5ng/mL, elevated IGF-1 or uncontrolled symptoms, increase to 120mg; GH 1ng/mL or less with normal IGF-1 and controlled symptoms, reduce to 60mg, all every 4 weeks. Thereafter adjust by GH and/or IGF-1 and symptoms.
Who qualifies for extended dosing every 6 or 8 weeks?
Patients controlled on 60mg or 90mg every 4 weeks may be considered for 120mg every 6 or 8 weeks, per the July 2024 label, with GH and IGF-1 obtained 6 weeks after the change. The label advises caution with moderate or severe renal or hepatic impairment. The regimen was approved in March 2011.
What monitoring does the Somatuline Depot label require?
The July 2024 label recommends blood glucose monitoring at initiation and after dose changes, periodic gallbladder monitoring, thyroid function tests where clinically indicated, and care when starting in patients with bradycardia. GH and IGF-1 track response. New or worse steatorrhea should prompt evaluation for pancreatic exocrine insufficiency.
What do insurers ask for to approve Somatuline Depot for acromegaly?
The Cigna policy on this page, effective October 15, 2026, after the July 2024 label, asks for inadequate response to or unsuitability for surgery or radiotherapy, tumor mass effects, or growth on imaging. It also asks for a pre-treatment IGF-1 above the upper limit of normal and an endocrinologist or oncologist. Approval runs 1 year, up to 120mg no more often than every 4 weeks.
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Sources
- SOMATULINE DEPOT (lanreotide) injection, for subcutaneous use (Patient Information Revised: 07/2024), Ipsen Biopharmaceuticals, via DailyMed, 2024-10-11.
- Treatment | Somatuline® Depot (lanreotide), Ipsen Biopharmaceuticals, 2026-11-07.
- Somatuline Depot Patient Support & Resources | Ipsen Cares®, Ipsen Biopharmaceuticals, 2026-11-07.
- Somatuline Depot HCP Patient Support Services | Ipsen Cares®, Ipsen Biopharmaceuticals, 2026-11-07.
- Enroll Your Patient in Somatuline Depot Support Program | Ipsen Cares®, Ipsen Biopharmaceuticals, 2026-11-07.
- Somatuline Depot Copay & Financial Assistance Options | Ipsen Cares®, Ipsen Biopharmaceuticals, 2026-11-07.
- Somatuline Depot Copay & Patient Assistance Details for HCPs | Ipsen Cares®, Ipsen Biopharmaceuticals, 2026-11-07.
- Somatuline Depot HCP Resources & Forms | Ipsen Cares®, Ipsen Biopharmaceuticals, 2026-11-07.
- IPSEN CARES® Copay Eligibility, Terms & Conditions, Ipsen Biopharmaceuticals, 2026-11-07.
- IPSEN CARES® Patient Assistance Program (PAP) Eligibility, Terms & Conditions, Ipsen Biopharmaceuticals, 2026-11-07.
- IPSEN CARES® Enrollment Form, Somatuline Depot (SMD-US-003650 V5.0), Ipsen Biopharmaceuticals, 2026-11-07.
- Drug Coverage Policy IP0323, Somatostatin Analogs – Lanreotide Products, Cigna, 2026-10-15.
- Abbreviated New Drug Application (ANDA): 218217, Lanreotide Acetate (Amneal), FDA, Drugs@FDA, 2026-11-07.
- Abbreviated New Drug Application (ANDA): 217193, Lanreotide Acetate (InvaGen Pharms), FDA, Drugs@FDA, 2026-11-07.
- LANREOTIDE ACETATE INJECTION [AMNEAL PHARMACEUTICALS LLC], Amneal Pharmaceuticals, via DailyMed, 2026-09-23.
- NDA 022074/S-032 supplement approval letter, steatorrhea and malabsorption of dietary fats, FDA, 2024-07-11.
- NDA 022074/S-026 supplement approval letter, shelf life and temperature excursion, FDA, 2023-02-24.
- NDA 022074/S-021 supplement approval letter, container closure system, FDA, 2019-06-14.
- NDA 022074/S-024 supplement approval letter, complications of cholelithiasis, FDA, 2019-04-11.
- NDA 022074/S-017 supplement approval letter, carcinoid syndrome indication, FDA, 2017-09-15.
- NDA 022074/S-011 supplement approval letter, GEP-NET indication, FDA, 2014-12-16.
- NDA 022074/S-010 supplement approval letter, contraindication and postmarketing allergic reactions, FDA, 2014-12-22.
- NDA 022074/S-003 supplement approval letter, 120mg every 6 to 8 weeks, FDA, 2011-03-04.
- NDA 022074 approval letter, FDA, 2007-08-30.
A reference drawn from the October 11, 2024 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 7, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.