Your first 90 days
Your first 90 days on Somatuline Depot for acromegaly
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Somatuline Depot is not a pill and not something you inject yourself under the current label. A healthcare provider gives it in the office every 4 weeks, so the first 90 days hold 3 visits at the starting dose. Blood tests near the end of month 3 then set the dose from there on. This page lays out that stretch from the FDA label, Ipsen's IPSEN CARES program and one insurer's written rules.
What has to happen before the first bottle ships
Somatuline Depot has no REMS, but it is a specialty drug given in a doctor's office. The first dose waits on an IPSEN CARES enrollment, an insurance approval and a way to get the syringe to the office. These are the 5 things in the way, in order.
An IPSEN CARES enrollment, signed by you and your endocrinologist
Your doctor's office starts enrollment, and you sign the Patient Authorization that lets IPSEN CARES see your health information.
- The form can be done online or printed, signed and faxed.IPSEN CARES
A benefits check
Once the full form arrives, a Patient Access Manager checks your coverage and what you will owe.
- Ipsen says this typically takes 1 business day, and both you and your doctor hear the results.Enrollment Form
The insurance approval
IPSEN CARES tells the office whether a prior authorization is needed and explains the appeal process if a request is denied.
- The criteria one insurer uses are listed further down this page.IPSEN CARES HCP
How the syringe reaches the office
The office chooses between a specialty pharmacy and buying the drug itself to bill your plan.
- IPSEN CARES can send the prescription to the right specialty pharmacy, and the form lists office, hospital outpatient and infusion center as places of care.Enrollment Form
A word about blood sugar and your gallbladder
The label asks for blood sugar checks when treatment starts.
- The Patient Information says your provider may check your gallbladder before and during treatment.
- Tell your endocrinologist about diabetes, heart, thyroid, kidney or liver problems.FDA label
The days that matter
Counted from the first injection, with doses every 4 weeks and the GH and IGF-1 check before the fourth. Days before the first dose are estimates, because paperwork and insurance set the pace. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.Enrollment form signed and sent
You sign the Patient Authorization and your endocrinologist completes the prescriber pages.
- The office submits it online or faxes it to IPSEN CARES.
Benefits check
A Patient Access Manager reviews your coverage and what you will owe with you and your doctor.
- Ipsen says this typically happens within 1 business day of a complete form.
Prior authorization
The office sends the records the insurer asks for.
- Plans such as Cigna want a baseline IGF-1 result and the surgery or radiation history.
The syringe is shipped
A specialty pharmacy ships the dose to the office, or the office buys it and bills your plan.
- The enrollment form asks the office which route it will use.
Dose 1, usually 90mg
A healthcare provider injects it slowly over 20 seconds, deep under the skin of the upper outer buttock.
- People with moderate or severe kidney or liver problems start at 60mg instead.
Blood sugar checks
The label says blood sugar should be checked when treatment starts and when the dose changes.
- If you have diabetes, your diabetes medicine may need adjusting.
The injection site
Pain, a lump or itching where the shot went in affected 9% of people in the pooled acromegaly studies.
- The label says these reactions were more common early in treatment.
Dose 2, then every 4 weeks
Each carton holds a single prefilled syringe, so every visit uses a new one.
- The injection switches between the right and left buttock each time.
Dose 2, number 2
GH and IGF-1 blood tests
The label sets the starting dose for 3 months, then adjusts it by GH and IGF-1 levels and symptoms.
- A blood draw before the fourth visit lets your endocrinologist decide.
Dose 2, number 3
Dose 4, possibly a new dose
Under the label the dose may stay at 90mg, rise to 120mg or drop to 60mg every 4 weeks.
- Your endocrinologist makes that call from your blood results and symptoms.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Somatuline Depot label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated October 11, 2024, read from the FDA's label database today. FDA label
- October 2024
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 2024
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
- February 2023
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
- June 2019
A change to the syringe and container system was approved on June 14th, with updated instructions for use.FDA letter
- April 2019
The gallstone warning was expanded on April 11th to cover the complications that gallstones can cause, at the FDA's request.FDA letter
- September 2017
Carcinoid syndrome was added as a use on September 15th, a use that is not the subject of this page.FDA letter
- December 2014
A use for certain gut and pancreas neuroendocrine tumors was added on December 16th, a use that is not the subject of this page.FDA letter
- March 2011
The option of 120mg every 6 or 8 weeks, for people controlled on 60mg or 90mg, was approved on March 4th.FDA letter
- August 2007
First approval, on August 30th, for long-term treatment of acromegaly when surgery or radiation has not worked well enough or is not an option.FDA letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Given by a healthcare provider, in the office
The label says Somatuline Depot is intended for administration by a healthcare provider.
- Its Patient Information says you receive the injection every 4 weeks in your provider's office, and Ipsen's acromegaly site says the same.FDA label
- Where the shot goes
Deep under the skin of the upper buttock, alternating between right and left at each visit.
- Ipsen's patient site adds that the skin should be spread, not pinched, for the injection.Somatuline Depot treatment page
- How the dose is set after 3 months
The label keeps 90mg when GH is above 1 and up to 2.5ng/mL with a normal IGF-1 and controlled symptoms.
- It raises to 120mg when GH is above 2.5, IGF-1 is high or symptoms are not controlled.
- It lowers to 60mg when GH is 1ng/mL or less with a normal IGF-1.FDA label
- Longer gaps between shots, later on
People controlled on 60mg or 90mg may be considered for 120mg every 6 or 8 weeks.
- GH and IGF-1 should be tested 6 weeks after that change.
- Ipsen counts this as 7 or 9 injections a year instead of 13.Somatuline Depot treatment page
- A missed or late visit
The label gives no instruction for a missed or late dose, so call the office to reschedule.
- Your endocrinologist decides when the next injection should be given.FDA label
- Other medicines
The Patient Information asks you to name insulin or other diabetes medicines, cyclosporine and heart rate lowering medicines such as beta blockers.
- The label says lanreotide may change how some liver-processed medicines are cleared, so bring a full list.FDA label
- Pregnancy, breastfeeding and fertility
The label says there is not enough data to know the risk in pregnancy.
- It advises against breastfeeding during treatment and for 6 months after the last dose, and says it may reduce fertility in women.FDA label
- Generic lanreotide
Drugs@FDA lists Amneal's lanreotide 120mg, approved September 18, 2026, as substitutable for Somatuline Depot.
- A plan or pharmacy may fill your prescription with it, so ask which product you will get.Drugs@FDA, Amneal
- Storage, if the syringe sits with you
Refrigerated between 36 and 46 degrees Fahrenheit (2 to 8 Celsius), in the original package, away from light.
- A sealed pouch left at room temperature, never above 104 degrees Fahrenheit (40 Celsius), for up to 72 hours may go back in the refrigerator.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Signs of gallstones
Sudden pain in the upper right belly, right shoulder or between the shoulder blades, yellow skin or eyes, nausea, or fever with chills.
- The label says gallstones or gallbladder sludge were reported in 20% of people with acromegaly in its studies.FDA label
High or low blood sugar
Thirst, urinating more, fruity breath, or shakiness, sweating, confusion and a fast heartbeat.
- The Patient Information says to tell your healthcare provider right away about these signs.FDA label
A slow heart rate
Dizziness, fainting or near fainting, chest pain, shortness of breath, or extreme tiredness.
- The label asks patients to contact their provider right away if the heart rate slows.FDA label
Low thyroid and fatty stools
Tiredness, weight gain, a puffy face or always feeling cold can point to low thyroid.
- Greasy or pale stools, bloating or weight loss can mean fat is not being absorbed, which the label says should be checked.FDA label
The most common side effects
In pooled acromegaly studies of 416 people, 37% had diarrhea, 19% stomach pain and 11% nausea.
- The label says diarrhea, stomach pain and gas became more common at higher doses.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- 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.Cigna policy
- 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.Cigna policy
- 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.Cigna policy
- 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.IPSEN CARES HCP financial help
- 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.IPSEN CARES HCP resources
- 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.Copay terms
- 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 financial help
Cigna prior authorization policy, October 15, 2026
- An inadequate response to surgery or radiation, or not a candidate for them, or harm from tumor size such as pressure on the optic nerve, or tumor growth on imaging
- A baseline IGF-1 above the upper limit of normal for age and sex, measured before any somatostatin analog, dopamine agonist or Somavert
- Prescribed by or with an endocrinologist or oncologist
- Up to 120mg under the skin, no more often than once every 4 weeks
- Preferred product rules met; for Cipla's lanreotide, a prior try of octreotide LAR, Somatuline Depot or generic lanreotide
Approval length. 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. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- 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
Details as the drugmaker publishes them. IPSEN CARES
Five questions for the pharmacist or the support line
- Will my shots come from a specialty pharmacy or does the office stock them, and is that under my medical or pharmacy benefit?
- Which lanreotide product does my plan prefer, Somatuline Depot or a generic?
- When should I have my GH and IGF-1 blood tests, and who orders them?
- Should I check my blood sugar more often in the first months, and does my diabetes medicine need to change?
- Will you check my gallbladder before I start, and how often after that?
Questions people ask in the first weeks
How is Somatuline Depot given for acromegaly?
As a deep injection under the skin of the upper outer buttock, every 4 weeks. The label says it is intended for a healthcare provider to give, and the Patient Information says you receive it in your provider's office.
What is the starting dose of Somatuline Depot?
The label's usual start is 90mg every 4 weeks for 3 months. People with moderate or severe kidney or liver problems start at 60mg, and your endocrinologist sets the dose.
When does the Somatuline Depot dose change?
After 3 months, the label adjusts it by GH and IGF-1 levels and symptoms, to 60mg, 90mg or 120mg every 4 weeks. People controlled on 60mg or 90mg may later move to 120mg every 6 or 8 weeks, with blood tests 6 weeks after.
Can I give Somatuline Depot to myself at home?
Not under the current US label, which says it is intended for administration by a healthcare provider. Ipsen's acromegaly site also says a healthcare professional gives it, so ask your care team where your visits will be.
What tests do I need on Somatuline Depot?
GH and IGF-1 blood tests to judge the response, and blood sugar checks when starting or changing the dose. The label also asks for periodic gallbladder monitoring and thyroid tests when your doctor thinks they are needed.
Is there a generic Somatuline Depot?
Yes, the FDA approved Amneal's lanreotide 120mg as a substitutable generic on September 18, 2026. Drugs@FDA lists the earlier InvaGen (Cipla) generic as discontinued, and your plan may prefer one product.
Why was Somatuline Depot denied by my insurance?
Plans such as Cigna ask for a baseline IGF-1 above normal and a reason surgery or radiation is not enough. IPSEN CARES explains the appeal process, and the office can use Ipsen's appeal templates.
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Sources
- SOMATULINE DEPOT (lanreotide) injection, for subcutaneous use (Patient Information Revised: 07/2024), Ipsen Biopharmaceuticals, via DailyMed, October 11, 2024.
- Treatment | Somatuline® Depot (lanreotide), Ipsen Biopharmaceuticals, November 7, 2026.
- Somatuline Depot Patient Support & Resources | Ipsen Cares®, Ipsen Biopharmaceuticals, November 7, 2026.
- Somatuline Depot HCP Patient Support Services | Ipsen Cares®, Ipsen Biopharmaceuticals, November 7, 2026.
- Enroll Your Patient in Somatuline Depot Support Program | Ipsen Cares®, Ipsen Biopharmaceuticals, November 7, 2026.
- Somatuline Depot Copay & Financial Assistance Options | Ipsen Cares®, Ipsen Biopharmaceuticals, November 7, 2026.
- Somatuline Depot Copay & Patient Assistance Details for HCPs | Ipsen Cares®, Ipsen Biopharmaceuticals, November 7, 2026.
- Somatuline Depot HCP Resources & Forms | Ipsen Cares®, Ipsen Biopharmaceuticals, November 7, 2026.
- IPSEN CARES® Copay Eligibility, Terms & Conditions, Ipsen Biopharmaceuticals, November 7, 2026.
- IPSEN CARES® Patient Assistance Program (PAP) Eligibility, Terms & Conditions, Ipsen Biopharmaceuticals, November 7, 2026.
- IPSEN CARES® Enrollment Form, Somatuline Depot (SMD-US-003650 V5.0), Ipsen Biopharmaceuticals, November 7, 2026.
- Drug Coverage Policy IP0323, Somatostatin Analogs – Lanreotide Products, Cigna, October 15, 2026.
- Abbreviated New Drug Application (ANDA): 218217, Lanreotide Acetate (Amneal), FDA, Drugs@FDA, November 7, 2026.
- Abbreviated New Drug Application (ANDA): 217193, Lanreotide Acetate (InvaGen Pharms), FDA, Drugs@FDA, November 7, 2026.
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- NDA 022074/S-026 supplement approval letter, shelf life and temperature excursion, FDA, February 24, 2023.
- NDA 022074/S-021 supplement approval letter, container closure system, FDA, June 14, 2019.
- NDA 022074/S-024 supplement approval letter, complications of cholelithiasis, FDA, April 11, 2019.
- NDA 022074/S-017 supplement approval letter, carcinoid syndrome indication, FDA, September 15, 2017.
- NDA 022074/S-011 supplement approval letter, GEP-NET indication, FDA, December 16, 2014.
- NDA 022074/S-010 supplement approval letter, contraindication and postmarketing allergic reactions, FDA, December 22, 2014.
- NDA 022074/S-003 supplement approval letter, 120mg every 6 to 8 weeks, FDA, March 4, 2011.
- NDA 022074 approval letter, FDA, August 30, 2007.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing endocrinologist. Found an error? Use the report link in the footer and it will be checked against the source.