Your first 90 days
Your first 90 days on Sandostatin LAR 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.
Sandostatin LAR Depot is not where acromegaly treatment with octreotide begins. The label first asks for a trial of short-acting Sandostatin shots, to prove the medicine works for you and that you tolerate it. Then comes a shot every 4 weeks at your doctor's office or clinic, and a blood test around month 3 that sets the long-term dose. This page lays out that stretch from the FDA label, Novartis's own support programs and one insurer's written rules.
What has to happen before the first bottle ships
Sandostatin LAR Depot has no REMS, but the label puts a step in front of it. You first show that short-acting Sandostatin works for you, and your plan approves the monthly shot. These are the 6 things in the way, in order.
A trial of short-acting Sandostatin
The label says Sandostatin LAR Depot is for people whose first treatment with Sandostatin injection worked and was tolerated.
- Someone new to octreotide starts with 50mcg under the skin 3 times a day, for at least 2 weeks.FDA label
Learning to give the short-acting shots
The short-acting shots go under the skin, and the Sandostatin injection label says patients and helpers should get careful teaching in clean injection technique.
- Ask the endocrinologist's office who will show you, and when.Sandostatin injection label
Blood tests that show you respond
The label lets responders switch to the monthly shot, judged by growth hormone (GH) and IGF-1 blood levels.
- They must also tolerate the medicine, and your endocrinologist reads the results and decides.FDA label
A baseline thyroid test
Octreotide can lower thyroid hormone, so thyroid function gets checked along the way.
- The label recommends thyroid tests (TSH and T4) at the start and from time to time during long-term treatment.FDA label
The insurance approval
Plans often require prior authorization before they pay for the monthly shot.
- Cigna, one example, asks for an IGF-1 above normal before any treatment and an endocrinologist, and its full criteria are further down this page.Cigna policy
Novartis Patient Support
Novartis says its Patient Support program helps eligible patients start, stay, and save on Sandostatin LAR Depot.
- The program's number, listed on Novartis's own site, is 1-800-282-7630.Sandostatin LAR Depot HCP site
The days that matter
Counted from the first Sandostatin LAR Depot shot, with the short-acting trial before it, a shot every 4 weeks and the 3-month blood test. Days before the first shot are estimates, because the trial 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.Insurance approval for the monthly shot
The endocrinologist's office sends your plan the records it asks for, such as IGF-1 results from before treatment.
- This paperwork can run at the same time as the short-acting trial.
Short-acting Sandostatin begins
For anyone new to octreotide, the label starts with 50mcg under the skin 3 times a day.
- The dose may be raised, and this lasts at least 2 weeks.
Thyroid test at the start
The label recommends a baseline check of thyroid function (TSH and T4) during long-term octreotide treatment.
- Your endocrinologist sets the exact day for this blood test.
GH and IGF-1 decide the switch
The label lets responders who tolerate octreotide switch to Sandostatin LAR Depot.
- Your endocrinologist judges the response from GH and IGF-1 blood levels.
First Sandostatin LAR Depot shot, 20mg
A trained healthcare provider mixes the kit and injects it into a buttock muscle right away.
- The label says it is never given into a vein or under the skin.
Blood sugar check
Octreotide can push blood sugar too low or too high.
- The label says to check blood sugar when the monthly shot starts, and to adjust diabetes medicines as needed.
Stomach side effects, mostly early
In the acromegaly studies, diarrhea, belly pain and nausea mostly began in the first month.
- The label says new cases were uncommon after that, and most were mild or moderate.
Shot 2, then every 4 weeks
Each kit holds a single dose, so every visit uses a new kit.
- The label says intervals longer than 4 weeks are not recommended, and urges keeping every return visit.
Shot 2, number 2
Shot 3, the last of the first 3 months
The label's usual start is 20mg every 4 weeks for the first 3 months.
- Blood levels of octreotide reach a steady state after this third shot.
GH and IGF-1 blood test
After 3 months, the label bases the dose on GH, IGF-1 and symptoms.
- Your endocrinologist chooses the draw day, usually before the next shot.
Shot 2, number 3
Dose set for the long run
The dose stays at 20mg, rises to 30mg or drops to 10mg, depending on the results.
- The label says to check blood sugar again whenever the dose changes.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Sandostatin LAR 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 December 22, 2025, read from the FDA's label database today. FDA label
- December 2025
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
- July 2024
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 2024
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
- March 2021
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
- April 2019
On April 11th the label added gallstone complications, including inflamed gallbladder, bile ducts or pancreas, after an FDA request covering all somatostatin analogs.FDA letter
- November 1998
The first approval came on November 25th and included acromegaly. The same approval covered diarrhea and flushing from metastatic carcinoid tumors and watery diarrhea from VIPomas, which are not the subject of this page.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 trained healthcare provider
The label says a trained healthcare provider gives Sandostatin LAR Depot.
- It goes into the buttock muscle, with injection sites rotated, and never into a vein or under the skin.FDA label
- Every 4 weeks, on schedule
The label says intervals longer than 4 weeks are not recommended.
- It urges people with acromegaly to keep their return visits, to help keep GH and IGF-1 steady.FDA label
- How the dose is set after 3 months
With GH at 2.5ng/mL or less, a normal IGF-1 and controlled symptoms, the dose stays at 20mg.
- Higher GH or IGF-1, or ongoing symptoms, means 30mg, and the label caps the dose at 40mg.FDA label
- A lower dose when levels are very well controlled
The label allows a drop to 10mg every 4 weeks when GH is 1ng/mL or less, IGF-1 is normal and symptoms are controlled.
- Your endocrinologist decides whether any change in dose is right for you.FDA label
- After radiation to the pituitary
For people who had pituitary radiation, the label says to pause the shots yearly for about 8 weeks to check disease activity.
- Treatment may resume if GH or IGF-1 rise and symptoms return.FDA label
- Kidney or liver disease
People on dialysis and people with cirrhosis of the liver start at 10mg every 4 weeks, according to the label.
- Other people with kidney problems start at the usual 20mg.FDA label
- Other medicines
The label says cyclosporine, insulin, diabetes pills, beta-blockers and bromocriptine may need monitoring or a dose change.
- Octreotide can also change how well some pills are absorbed, so share your full medicine list.FDA label
- Pregnancy and fertility
Lowering GH and IGF-1 may improve fertility in women with acromegaly.
- The label says to discuss the chance of an unplanned pregnancy, and its data in pregnancy are limited.FDA label
- Storage, if a kit is kept before the visit
Refrigerated between 36 and 46 degrees Fahrenheit (2 to 8 Celsius), protected from light.
- The kit sits at room temperature for 30 to 60 minutes before mixing, and the shot is given right after mixing.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 or their complications
The label says to contact your healthcare provider for signs of gallstones or of inflamed gallbladder, bile ducts or pancreas.
- In acromegaly trials where most people had the monthly shot for a year or more, 22% developed new gallstones.FDA label
Severe upper belly pain or a swelling belly
The label says stomach side effects can rarely look like a blocked bowel, with a belly that keeps swelling, severe upper belly pain and tenderness.
- The label describes this as rare, but it is worth knowing the signs.FDA label
Fatty, pale or loose stools, bloating or weight loss
The label asks patients to report new or worse fatty stools, stool color changes, loose stools, bloating and weight loss.
- The doctor may check how well the pancreas makes digestive enzymes.FDA label
Blood sugar that runs too low or too high
In acromegaly patients on octreotide, low blood sugar occurred in about 2% and high blood sugar in about 15%.
- The label says diabetes treatment may need adjusting when this happens.FDA label
A slow heartbeat
On short-acting octreotide, 25% of acromegaly patients developed a heart rate under 50 beats a minute.
- The label notes many had heart disease already, and beta-blocker doses may need changing.FDA label
The most common side effects
In 261 people in the acromegaly studies, 36% had diarrhea, 29% belly pain and 25% gas.
- Pain where the shot went in was reported by 9% at 20mg and usually lasted about an hour.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.
- No record of a high IGF-1 before treatmentCigna asks for an IGF-1 above the upper limit of normal before any acromegaly medicine was started. The endocrinologist's office sends the earliest IGF-1 result it has on file.Cigna policy
- Surgery or radiation not addressedCigna asks whether surgery or radiation did not work well enough or is not a fit for you. A tumor pressing on something, such as the optic nerve, also counts, and the office documents which applies.Cigna policy
- The plan wants another long-acting shot tried firstFor employer plans, Cigna's preferred product table asks that the brand be requested after trying octreotide ER injectable suspension, Somatuline Depot or lanreotide. The office can ask the plan which product it prefers or appeal.Cigna policy
- The prescriber is not a specialistCigna requires the monthly shot to be prescribed by or with an endocrinologist. A note from an endocrinology consult usually settles this part of the request.Cigna policy
- A cost you cannot payWith private insurance, the Novartis Oncology Universal Co-pay Program may bring the cost to $25 a month. Novartis pays up to $15,000 a year, and people on Medicare, Medicaid or other government plans cannot use it. The program is not valid for Massachusetts patients, and California patients must meet extra criteria.Copay program
- No insurance, or coverage that leaves the cost out of reachThe Novartis Patient Assistance Foundation lists Sandostatin LAR Depot among the medicines it supports. Call the foundation at 1-800-277-2254 to check whether you are eligible.NPAF medications
- Waiting on a free-drug applicationThe foundation gives Novartis medicines free to eligible people who meet income guidelines and are treated by a US prescriber. It says applicants receive a letter with the decision within 4 weeks.NPAF
Cigna prior authorization policy, September 15, 2026
- Surgery or radiation did not work well enough, is not a fit, or the tumor is causing problems from its size, such as pressing on the optic nerve
- An IGF-1 level above the upper limit of normal for age and sex, measured before any acromegaly medicine
- Prescribed by or with an endocrinologist
- For employer plans, the brand only after trying octreotide ER injectable suspension, Somatuline Depot or lanreotide
- Up to 40mg into the muscle, no more often than once every 4 weeks
Approval length. A year at a time. Cigna allows extended approvals if the patient still meets the criteria.
This policy took effect on September 15, 2026, after the July 2024 label it cites. It covers both the brand and generic long-acting octreotide under one set of rules. It does not repeat the label's requirement to try short-acting Sandostatin first, which still applies. 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.
- Novartis Patient Support, which Novartis says helps eligible patients start, stay, and save on Sandostatin LAR Depot
- The Novartis Oncology Universal Co-pay Program for private insurance, where eligible patients may pay $25 a month and Novartis pays up to $15,000 a year (1-877-577-7756)
- No copay help for people on Medicare, Medicaid or any other federal or state health care program, or for Massachusetts patients; California patients must meet extra criteria
Details as the drugmaker publishes them. Sandostatin LAR Depot HCP site
Five questions for the pharmacist or the support line
- Who will teach me to give the short-acting shots, and how many days do I take them before the switch?
- Is the monthly shot billed under my medical benefit or my pharmacy benefit, and what will I owe each visit?
- When is my GH and IGF-1 blood test around month 3, and is it before my fourth shot?
- Do any of my medicines, such as a beta-blocker, insulin or cyclosporine, need a dose change?
- Does my plan prefer a generic octreotide or a lanreotide shot, and does that change what I get?
Questions people ask in the first weeks
Can I start Sandostatin LAR Depot without the short-acting shots?
No, the label says the monthly shot comes after a trial of short-acting shots. It is for people who responded to and tolerated short-acting Sandostatin injection, given under the skin for at least 2 weeks. People who already take the short-acting shots can switch to the monthly shot directly.
How often is Sandostatin LAR Depot given for acromegaly?
Every 4 weeks, by a trained healthcare provider, into a buttock muscle. The usual start is 20mg for 3 months, and the label says intervals longer than 4 weeks are not recommended.
How is the Sandostatin LAR Depot dose changed after 3 months?
The label sets the dose by GH and IGF-1 blood levels and by symptoms. The dose may stay at 20mg, rise to 30mg or drop to 10mg. If control is still poor at 30mg, it may go to 40mg, the highest dose the label recommends.
What tests are needed on Sandostatin LAR Depot?
The label asks for GH and IGF-1 to follow the response, and blood sugar at the start and after dose changes. It also recommends thyroid tests and vitamin B12 levels during treatment, and periodic gallbladder checks.
Why does Sandostatin LAR Depot cause gallstones?
Octreotide can slow the gallbladder and reduce bile flow, according to the label. In acromegaly trials where most people had the monthly shot for a year or more, 22% developed new gallstones. The label says to report signs of gallstones to your healthcare provider.
Why was Sandostatin LAR Depot denied by my insurance?
Plans such as Cigna ask for a high IGF-1 before treatment, a note on surgery or radiation, and an endocrinologist. Some Cigna employer plans also want another long-acting shot tried first. The endocrinologist's office can send the missing records or file an appeal.
Is there help paying for Sandostatin LAR Depot?
Privately insured patients may pay $25 a month through Novartis's copay program, up to $15,000 a year. People without insurance, or on government insurance with a low income, can apply to the Novartis Patient Assistance Foundation.
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Sources
- SANDOSTATIN LAR DEPOT- octreotide acetate kit, Novartis Pharmaceuticals Corporation, via DailyMed, December 22, 2025.
- SANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION, Novartis Pharmaceuticals Corporation, via DailyMed, July 22, 2026.
- Sandostatin® LAR Depot (octreotide acetate) for injectable suspension | HCP, Novartis, November 7, 2026.
- Training & Resources for Sandostatin LAR Depot, Novartis, November 7, 2026.
- Novartis Patient Support | Novartis United States of America, Novartis, November 7, 2026.
- Enroll in the Novartis Oncology Universal Co-pay Program, Novartis, November 7, 2026.
- Novartis Patient Assistance Foundation, Novartis Patient Assistance Foundation, November 7, 2026.
- Select the medication(s) from the list below, Novartis Patient Assistance Foundation, November 7, 2026.
- Drug Coverage Policy IP0489, Somatostatin Analogs – Octreotide Long-Acting Products, Cigna, September 15, 2026.
- NDA 021008/S-049 supplement approval letter, steatorrhea and malabsorption of dietary fats, FDA, July 11, 2024.
- NDA 021008/S-047 supplement approval letter (corrected), FDA, January 5, 2024.
- NDA 021008/S-041 supplement approval letter, Lutathera drug interaction, FDA, March 30, 2021.
- NDA 021008/S-043 supplement approval letter, complications of cholelithiasis, FDA, April 11, 2019.
- NDA 21-008 approval letter, Sandostatin LAR Depot, FDA, November 25, 1998.
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.