Prescribing guide
Sandostatin LAR Depot (octreotide acetate)For acromegaly: the switch from Sandostatin injection, titration, 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. 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.
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.
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.
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.
Give your patient their plan
A one-page handout for starting Sandostatin LAR 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/sandostatinlardepotBefore 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 |
|---|---|---|
| Establish response on Sandostatin injection | Octreotide-naive: 50mcg subcutaneously three times daily, titratable; most need 100 to 200mcg three times daily, some up to 500mcg. Maintain at least 2 weeks to determine tolerance; switch responders, by GH and IGF-1, who tolerate the drug. | FDA label |
| Teach the subcutaneous phase | The Sandostatin injection label calls for careful instruction in sterile subcutaneous injection technique for patients and anyone else who will administer it. It recommends monitoring GH or IGF-1 every 2 weeks after starting or changing the subcutaneous dose. | Sandostatin injection label |
| Baseline labs | TSH and total and/or free T4 at baseline during chronic therapy; blood glucose when the LAR is started; GH and IGF-1 to document response. The label also recommends vitamin B12 monitoring during therapy. | FDA label |
| Prior authorization | Cigna recommends prior authorization for medical coverage and lists HCPCS J2353, octreotide depot IM, 1mg. The request documents the surgery or radiotherapy history, the pre-treatment IGF-1, the endocrinologist and, for employer plans, the preferred-product step. | Cigna policy |
| Enroll in Novartis support | Novartis describes Novartis Patient Support as helping eligible patients start, stay, and save on Sandostatin LAR Depot, at 1-800-282-7630. The same number is listed for Novartis oncology medications on Novartis's support contacts page. | Sandostatin LAR Depot HCP site |
| Copay program terms | Private insurance only; up to the first $25 per the program instructions, Novartis pays up to $15,000 per calendar year. Not valid under Medicare, Medicaid, TRICARE, VA, DoD or other federal or state programs, without insurance use, or when the product is not covered. The enrollment page flags Sandostatin LAR Depot as not valid for Massachusetts patients and valid in California only with additional criteria. | Copay program |
| Free drug | The Novartis Patient Assistance Foundation, an independent nonprofit, requires US residence, outpatient treatment by a licensed US prescriber and income within guidelines, and mails a decision within 4 weeks. | NPAF |
| Counsel on fertility | Discuss the potential for unintended pregnancy with premenopausal women, since normalizing GH and IGF-1 may improve fertility. | FDA label |
Prior authorization criteria and what to document
One public policy as the example: Cigna, September 15, 2026. Approval 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Surgery or radiotherapy | Inadequate response to surgery and/or radiotherapy, or not an appropriate candidate, or negative effects from tumor size such as optic nerve compression | Operative and radiation history, or the note explaining why neither applies | Cigna policy |
| Baseline IGF-1 | Pre-treatment IGF-1 above the upper limit of normal for age and sex at the reporting laboratory, before any somatostatin analog, dopamine agonist or pegvisomant | The earliest IGF-1 result with its reference range | Cigna policy |
| Prescriber | Prescribed by or in consultation with an endocrinologist | Specialty on the request, or the consult note | Cigna policy |
| Preferred product, employer plans | For Sandostatin LAR Depot in acromegaly, the patient has tried one of octreotide ER injectable suspension, Somatuline Depot or lanreotide subcutaneous injection. The acromegaly row has no already-started exception, unlike the NET row | Prior product, dates and outcome | Cigna policy |
| Dose | Up to 40mg IM, no more frequently than once every 4 weeks | Order and administration record | Cigna policy |
| Approval | 1 year; extended approvals allowed if the patient continues to meet the criteria. The policy has no separate renewal criteria | Updated GH and IGF-1 at renewal is a reasonable record; the policy does not name it | Cigna policy |
| Label step | The label limits the LAR to responders to Sandostatin injection, which Cigna's acromegaly criteria do not restate | Short-acting dose, dates and the GH and IGF-1 response | FDA label |
Sandostatin LAR Depot dosing and titration
| When | Label | Source |
|---|---|---|
| Lead-in, octreotide-naive | 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. | FDA label |
| Day 1 of LAR | 20mg IM intragluteally, administered by a trained healthcare provider immediately after mixing. Never IV or SC. Patients already on Sandostatin injection switch directly to this dose; the label's 2-week SC overlap is written for carcinoid tumors and VIPomas, and the acromegaly section has none. | FDA label |
| Every 4 weeks, months 1 to 3 | 20mg; intervals longer than 4 weeks are not recommended. Steady state after the third injection. | FDA label |
| After 3 months | GH 2.5ng/mL or less, normal IGF-1, symptoms controlled: 20mg. GH above 2.5ng/mL, elevated IGF-1 and/or uncontrolled symptoms: 30mg. GH 1ng/mL or less, normal IGF-1, controlled: 10mg. Not controlled on 30mg: 40mg. Above 40mg not recommended. | FDA label |
| Renal and hepatic | Dialysis: start 10mg every 4 weeks. Established cirrhosis: start 10mg every 4 weeks. Other renal impairment: usual 20mg start. Titrate by response. | FDA label |
| Prior pituitary irradiation | Withdraw yearly for about 8 weeks to assess disease activity; resume if GH or IGF-1 rise and signs and symptoms recur. | FDA label |
| Preparation and injection | Kit at room temperature 30 to 60 minutes before mixing; follow the kit's mixing instructions; 1½ inch 19-gauge safety needle supplied, 2 inch 19-gauge (not supplied) for greater skin-to-muscle depth. Rotate gluteal sites; avoid the deltoid. Do not inject diluent alone. Store at 2 to 8 degrees C (36 to 46 degrees F), protected from light. | FDA label |
| Kits | Single-dose kits of 10mg (NDC 0078-0811-81), 20mg (0078-0818-81) and 30mg (0078-0825-81), each with vial, 2mL prefilled diluent syringe, vial adapter and needle; one kit per injection. | FDA label |
| Staff training | Novartis posts mixing and administration videos, a dorsogluteal and ventrogluteal injection guide, the Instructions for Use and a nurse's guide. | Training & Resources |
Monitoring the Sandostatin LAR Depot label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| About month 3, then by response | GH and IGF-1 (somatomedin C) | Set the dose at 10, 20, 30 or 40mg per the label's thresholds | FDA label |
| Initiation and each dose change | Blood glucose | Hypoglycemia about 2% and hyperglycemia about 15% in acromegaly; adjust anti-diabetic treatment | FDA label |
| Baseline and periodic | TSH and total and/or free T4 | TSH suppression may cause hypothyroidism; on Sandostatin injection, 12% biochemical hypothyroidism, 8% goiter, 4% started replacement | FDA label |
| Periodic | Gallbladder | In acromegaly trials, most on LAR 12 months or longer: 52% new biliary abnormalities, 22% new cholelithiasis. Discontinue if complications such as cholecystitis, cholangitis or pancreatitis are suspected | FDA label |
| During therapy | Vitamin B12 | Depressed B12 levels and abnormal Schilling tests reported | FDA label |
| At-risk patients | Heart rate and conduction | On Sandostatin injection in acromegaly, sinus bradycardia under 50 bpm 25%, conduction abnormalities 10%, arrhythmias 9%; beta-blocker doses may need adjustment | FDA label |
| New or worse symptoms | Steatorrhea, stool discoloration, loose stools, bloating, weight loss | Evaluate for pancreatic exocrine insufficiency (section 5.5, 7/2024) | FDA label |
| First month | GI tolerance | Diarrhea, abdominal pain and nausea arose mainly in month 1 and were mostly mild to moderate; diarrhea was dose related. No acromegaly patient on LAR stopped for a GI event | FDA label |
Sandostatin LAR Depot drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Contraindications | None | FDA label |
| Cyclosporine | Octreotide may decrease cyclosporine levels, with transplant rejection reported | FDA label |
| Insulin and oral hypoglycemics | Monitor glucose at initiation and dose changes; adjust anti-diabetic treatment | FDA label |
| Bromocriptine | Coadministration increases bromocriptine availability | FDA label |
| Beta-blockers and other bradycardic drugs | Additive heart-rate lowering; dose adjustment may be necessary | FDA label |
| CYP3A4 substrates with a low therapeutic index | Somatostatin analogs may decrease metabolic clearance; use quinidine and similar drugs with caution | FDA label |
| Oral drugs | Altered nutrient absorption may affect absorption of orally administered drugs | FDA label |
| Lutetium Lu 177 dotatate | Discontinue LAR at least 4 weeks before each dose; relevant to NET patients rather than acromegaly | FDA label |
| Carcinoid tumors and VIPomas, for reference | The same label covers carcinoid tumor diarrhea and flushing and VIPoma diarrhea, with a 2-month titration, a 30mg maximum and a 2-week SC overlap; those are outside this page | FDA label |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Novartis Patient Support
- 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
Questions prescribers' offices ask about Sandostatin LAR Depot
Who can start Sandostatin LAR Depot for acromegaly?
Under the July 2024 label, only patients in whom Sandostatin injection has been shown effective and tolerated. Octreotide-naive patients take Sandostatin injection 50mcg subcutaneously three times daily, titratable, for at least 2 weeks; GH and IGF-1 responders who tolerate it may switch. Patients already on Sandostatin injection can switch directly.
What is the Sandostatin LAR Depot titration for acromegaly?
The July 2024 label starts 20mg IM intragluteally every 4 weeks for 3 months, then: GH 2.5ng/mL or less, normal IGF-1 and controlled symptoms, stay at 20mg; GH above 2.5ng/mL, elevated IGF-1 or uncontrolled symptoms, 30mg; GH 1ng/mL or less with normal IGF-1 and control, 10mg. Uncontrolled at 30mg, 40mg; doses above 40mg are not recommended.
What monitoring does the label require on Sandostatin LAR Depot?
The July 2024 label recommends periodic gallbladder monitoring, blood glucose at initiation and with each dose change, baseline and periodic TSH and total and/or free T4, and vitamin B12 levels during therapy, with GH and IGF-1 to follow response. It cautions in patients at risk for bradycardia, arrhythmia or conduction abnormalities.
Does Sandostatin LAR Depot have a REMS or boxed warning?
Neither; the July 2024 label has no boxed warning and no contraindications, and octreotide is not on the FDA REMS list. The most recent major change is section 5.5, steatorrhea and malabsorption of dietary fats, 7/2024.
What do insurers ask for to approve Sandostatin LAR Depot for acromegaly?
Cigna's policy IP0489, effective September 15, 2026, after the July 2024 label, approves 1 year with inadequate response to or unsuitability for surgery or radiotherapy, or mass effect; pre-treatment IGF-1 above the ULN; and an endocrinologist. Employer plans add a preferred-product step for the brand. Dosing is up to 40mg every 4 weeks.
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Sources
- SANDOSTATIN LAR DEPOT- octreotide acetate kit, Novartis Pharmaceuticals Corporation, via DailyMed, 2025-12-22.
- SANDOSTATIN (OCTREOTIDE ACETATE) INJECTION, SOLUTION, Novartis Pharmaceuticals Corporation, via DailyMed, 2026-07-22.
- Sandostatin® LAR Depot (octreotide acetate) for injectable suspension | HCP, Novartis, 2026-11-07.
- Training & Resources for Sandostatin LAR Depot, Novartis, 2026-11-07.
- Novartis Patient Support | Novartis United States of America, Novartis, 2026-11-07.
- Enroll in the Novartis Oncology Universal Co-pay Program, Novartis, 2026-11-07.
- Novartis Patient Assistance Foundation, Novartis Patient Assistance Foundation, 2026-11-07.
- Select the medication(s) from the list below, Novartis Patient Assistance Foundation, 2026-11-07.
- Drug Coverage Policy IP0489, Somatostatin Analogs – Octreotide Long-Acting Products, Cigna, 2026-09-15.
- NDA 021008/S-049 supplement approval letter, steatorrhea and malabsorption of dietary fats, FDA, 2024-07-11.
- NDA 021008/S-047 supplement approval letter (corrected), FDA, 2024-01-05.
- NDA 021008/S-041 supplement approval letter, Lutathera drug interaction, FDA, 2021-03-30.
- NDA 021008/S-043 supplement approval letter, complications of cholelithiasis, FDA, 2019-04-11.
- NDA 21-008 approval letter, Sandostatin LAR Depot, FDA, 1998-11-25.
A reference drawn from the December 22, 2025 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.