Sandostatin (octreotide)
Also marketed as Sandostatin LAR. An approved treatment for Congenital Hyperinsulinism.
The same compound appears under different names depending on the context. Here is how to identify Octreotide wherever you encounter it, plus the key facts at a glance.
- Generic name
- Octreotide
- Brand names
- Sandostatin, Sandostatin LAR
- Development code
- SMS 201-995
- Drug class
- Somatostatin analog
- Manufacturer
- Novartis (Sandostatin); generic octreotide available
- How it's taken
- Injection under the skin several times a day or by pump; monthly long-acting injection once stable
An injected somatostatin analog that HI specialists have used since the late 1980s as the usual next step when diazoxide fails, given as shots under the skin or by a small pump. It is FDA-approved for acromegaly and certain tumors, not for hyperinsulinism, so this is off-label use.
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Where Octreotide fits
Second-line medicine in congenital hyperinsulinism, after diazoxide and usually alongside frequent or continuous feeds, while the team decides whether a focal lesion can be removed or whether diffuse disease needs a near-total pancreatectomy. Long-acting octreotide or lanreotide is used for children who need it long term.
How Octreotide works
Octreotide copies somatostatin, a natural hormone that tells many glands to slow down. On the pancreatic beta cell it dampens insulin release even when the KATP channel is broken, which is why it can help children who do not respond to diazoxide. The effect tends to fade over days to weeks (tachyphylaxis), so doses often climb and some centers combine 2 daytime doses with continuous overnight feeds through a gastrostomy tube.
Long-acting forms, monthly octreotide LAR or lanreotide, replace multiple daily shots in children who have responded; the 2024 guideline says expert consensus converts the total monthly octreotide dose into 1 monthly LAR injection, and that lanreotide 30 mg to 60 mg once a month is a typical starting dose.
Mechanism: Somatostatin analog that binds somatostatin receptors on beta cells and suppresses insulin release
Side effects and safety
- Necrotizing enterocolitis. Serious bowel inflammation in infants, the key safety concern in HI use; highest risk in premature or unstable babies.
- Gallstones and gallbladder sludge. Somatostatin analogs slow gallbladder emptying; the guideline suggests an ultrasound at least every 6 months.
- Slowed growth and low thyroid or growth hormone. Octreotide suppresses growth hormone and thyroid signals; height, IGF-1 and thyroid tests are tracked.
- Blood sugar swings. Octreotide also lowers glucagon and growth hormone, which can blunt the body's own defenses against a low.
- Slow heartbeat. Listed on the Sandostatin label; relevant for babies on cardiac monitors.
- Growth every visit
- Gallbladder ultrasound, liver enzymes, IGF-1 and thyroid tests at least every 6 months
- Blood glucose as for any HI treatment
The 2024 international guideline flags necrotizing enterocolitis, a serious bowel inflammation, as the most important risk, particularly in premature infants and those who are unstable or have an infection. Other effects seen in HI care and on the Sandostatin label include loose or fatty stools, belly pain, nausea, gallstones and sludge, slowed growth, low thyroid hormone, and a slow heartbeat.
Because it suppresses several hormones, the guideline recommends checking growth, a gallbladder ultrasound, liver enzymes, growth factors and thyroid tests at least every 6 months on any somatostatin analog.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Octreotide
Short-acting octreotide is injected under the skin several times a day or given continuously through a small pump; the dose is adjusted to blood sugar and is individualized by the HI team because no FDA label covers this use. Children who respond may be switched to a long-acting form: Sandostatin LAR injected into the muscle once a month by a clinician, or lanreotide (Somatuline Depot) injected deep under the skin once a month.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Generic short-acting octreotide has been available for years and generic Sandostatin LAR was approved in 2023 and 2025. Insurance coverage for an off-label pediatric use can require a prior authorization letter from the HI center.
Help paying for Sandostatin
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Free medicine program
The Novartis Patient Assistance Foundation may provide Sandostatin LAR Depot free to eligible patients who are uninsured or have Medicare or Medicaid and meet income limits, as already recorded on Trial Friend's octreotide (acromegaly) entry. Short-acting generic octreotide, the form most HI infants start on, is not covered by any manufacturer program.
For: no insurance, Medicare, Medicaid · source
Good to know: Octreotide is used off-label in congenital hyperinsulinism, so manufacturer programs written for acromegaly and tumor indications may require the prescriber to document the diagnosis differently; ask the HI center's social worker. Details copied from the existing octreotide record (lastVerified 2026-10-09); re-verify against pap.novartis.com before publishing under this slug.
How congenital hyperinsulinism treatments compare
Diazoxide (Proglycem) is the only medicine the FDA has approved for hyperinsulinism. Octreotide is the usual next step but is used off-label, and the 2 investigational drugs shown are not approved for anyone outside a trial. Your HI team chooses based on the gene result, whether diazoxide works, and whether a focal lesion can be removed by surgery.
Congenital Hyperinsulinism has 1 FDA-approved treatment: Proglycem (and generics) (diazoxide, approved 1976). Also compared, not FDA-approved for congenital hyperinsulinism: Sandostatin (off-label) (octreotide, Off-label (approved 1988 for acromegaly)); Ersodetug (investigational) (ersodetug (RZ358), Phase 3 missed primary endpoint (Dec 2025); FDA recommended a pre-BLA meeting (Oct 2026)); Dasiglucagon pump (investigational) (dasiglucagon, Complete Response Letters Dec 2023 and Oct 2024; resubmission expected H2 2026). Proglycem (and generics) is typically used as first-line for every confirmed diagnosis; works in roughly half of children, mostly those without 2 recessive katp gene changes.
| Drug | How it works | How it’s given | How often | Where you get it | Typical use | FDA status |
|---|---|---|---|---|---|---|
Proglycem (and generics) diazoxide | KATP channel opener: props open the beta cell's potassium gate so it cannot fire and release insulin | Oral suspension by dropper or syringe | Twice or 3 times a day | Home, after a hospital start with close glucose checks | First-line for every confirmed diagnosis; works in roughly half of children, mostly those without 2 recessive KATP gene changes | 1976 |
Sandostatin (off-label) octreotide You are here | Somatostatin analog: dampens insulin release even when the KATP gate is broken | Injection under the skin or continuous pump; monthly octreotide LAR or lanreotide once stable | Several times a day or continuous; monthly for long-acting forms | Home injections or pump after hospital training; clinic for monthly depot shots | Second-line when diazoxide fails or is not tolerated, usually with feeds, while focal versus diffuse disease is sorted out | Off-label (approved 1988 for acromegaly) |
Ersodetug (investigational) ersodetug (RZ358) | Insulin receptor antibody: lets insulin be released but blocks its effect on the body's cells | Infusion (intravenous in the Phase 2 study) | Every 2 weeks at first, then every 4 weeks in the Phase 3 trial | Trial sites only | Studied as an add-on for children and adults with lows despite standard care; could work regardless of gene | Phase 3 missed primary endpoint (Dec 2025); FDA recommended a pre-BLA meeting (Oct 2026) |
Dasiglucagon pump (investigational) dasiglucagon | Stable glucagon analog: tells the liver to release stored sugar to offset the extra insulin | Continuous infusion under the skin from a wearable pump | Around the clock | Trial sites only; designed for hospital start then home | Studied to cut IV dextrose in newborns and to reduce lows in children not controlled by medicines or surgery | Complete Response Letters Dec 2023 and Oct 2024; resubmission expected H2 2026 |
This chart is for understanding, not medical advice. Only diazoxide is FDA-approved for hyperinsulinism; octreotide is prescribed off-label by HI specialists, and ersodetug and dasiglucagon are investigational and available only in clinical studies. Feeds, IV dextrose, emergency glucagon and surgery are also central to HI care and are not shown here. Always discuss options with a hyperinsulinism center.
Clinical trial results
There is no randomized trial of octreotide in congenital hyperinsulinism; the evidence is case series going back to the late 1980s, summarized in the 2024 international guideline, which gives somatostatin analogs a Grade 2 (weak) recommendation for children who are diazoxide-unresponsive, cannot tolerate diazoxide, or cannot obtain it. The guideline notes that loss of effect over time and side effects, including necrotizing enterocolitis, limit its use, and that monthly long-acting forms avoid the pump failures and disconnections that come with continuous octreotide.
Development history
Octreotide was created at Sandoz and approved by the FDA as Sandostatin in October 1988 for acromegaly and hormone-secreting tumors; the monthly Sandostatin LAR Depot followed in 1998. HI specialists adopted it soon after its approval as a way to avoid or follow pancreatectomy, and lanreotide and octreotide LAR were later reported in small HI case series. None of these uses has been submitted to the FDA, so hyperinsulinism remains absent from every somatostatin analog label.
Explore Congenital Hyperinsulinism trials
Other Congenital Hyperinsulinism treatments
Common questions about Octreotide
▸What is Octreotide (Sandostatin)?
An injected somatostatin analog that HI specialists have used since the late 1980s as the usual next step when diazoxide fails, given as shots under the skin or by a small pump. It is FDA-approved for acromegaly and certain tumors, not for hyperinsulinism, so this is off-label use.
▸How does Octreotide work?
Octreotide copies somatostatin, a natural hormone that tells many glands to slow down. On the pancreatic beta cell it dampens insulin release even when the KATP channel is broken, which is why it can help children who do not respond to diazoxide. The effect tends to fade over days to weeks (tachyphylaxis), so doses often climb and some centers combine 2 daytime doses with continuous overnight feeds through a gastrostomy tube. Long-acting forms, monthly octreotide LAR or lanreotide, replace multiple daily shots in children who have responded; the 2024 guideline says expert consensus converts the total monthly octreotide dose into 1 monthly LAR injection, and that lanreotide 30 mg to 60 mg once a month is a typical starting dose.
▸What are the side effects of Octreotide?
The 2024 international guideline flags necrotizing enterocolitis, a serious bowel inflammation, as the most important risk, particularly in premature infants and those who are unstable or have an infection. Other effects seen in HI care and on the Sandostatin label include loose or fatty stools, belly pain, nausea, gallstones and sludge, slowed growth, low thyroid hormone, and a slow heartbeat. Because it suppresses several hormones, the guideline recommends checking growth, a gallbladder ultrasound, liver enzymes, growth factors and thyroid tests at least every 6 months on any somatostatin analog.
▸How is Octreotide taken?
Short-acting octreotide is injected under the skin several times a day or given continuously through a small pump; the dose is adjusted to blood sugar and is individualized by the HI team because no FDA label covers this use. Children who respond may be switched to a long-acting form: Sandostatin LAR injected into the muscle once a month by a clinician, or lanreotide (Somatuline Depot) injected deep under the skin once a month.
▸Is Octreotide FDA approved?
Yes, Octreotide (Sandostatin) is FDA approved (1988) for the treatment of Congenital Hyperinsulinism.
▸Is octreotide approved for congenital hyperinsulinism?
No. Octreotide is FDA-approved for acromegaly and some hormone-producing tumors. Its use in hyperinsulinism is off-label, based on decades of case series and a weak recommendation in the 2024 international guideline. Diazoxide is the only approved drug for HI.
▸When do HI doctors use octreotide?
When a child does not respond to diazoxide, cannot tolerate it, or cannot get it. It is usually combined with feeds while the team works out whether the disease is focal (and curable by surgery) or diffuse.
▸What are the biggest risks of octreotide in babies?
Necrotizing enterocolitis, a serious bowel inflammation, especially in premature or sick infants. Over time, gallstones, slowed growth and low thyroid hormone are watched for, and the drug's effect can fade so doses rise.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Hormone Research in Paediatrics · 2024. International Guidelines for the Diagnosis and Management of Hyperinsulinism. https://pubmed.ncbi.nlm.nih.gov/37454648/
- Novartis. Sandostatin LAR Depot (octreotide acetate) prescribing information. https://www.novartis.com/us-en/sites/novartis_us/files/sandostatin_lar.pdf
- U.S. Food and Drug Administration, openFDA · 2026-10-18. Drug labels whose indications mention hyperinsulinism (only diazoxide suspensions match). https://api.fda.gov/drug/label.json?search=indications_and_usage:%22hyperinsulinism%22