FDA-filed SPL labeling · retrieved through openFDA

Lanreotide Injection

Lanreotide Injection is a somatostatin analog used to treat acromegaly, certain gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome in adults.

Brand names Somatuline DepotSomatuline
Drug class Somatostatin Analog
Rx Form 1 Route Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveSep 1, 2024
Clinical labels in scope 4
AvailabilityRx
Earliest approval/marketing year 2007
FDA-listed product records 30
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 17, 2026
Lanreotide Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Lanreotide Injection is a long-acting hormone-blocking medication used to treat acromegaly, certain gastroenteropancreatic neuroendocrine tumors, and carcinoid syndrome. It is given by a healthcare provider as a deep subcutaneous injection, typically once every 4 weeks. The most important things to watch for are gallstone complications, blood sugar changes, and a slowed heart rate — keep all follow-up appointments and report any new symptoms to your doctor promptly.

📖 Lanreotide Injection: Patient Information Guide

A plain-language walkthrough of Lanreotide Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Lanreotide Injection is a somatostatin analog approved for three distinct conditions in adults:

  • Acromegaly: Long-term treatment for patients whose acromegaly has not responded adequately to surgery and/or radiation, or who cannot undergo those treatments. The goal is to normalize growth hormone (GH) and IGF-1 levels.
  • Gastroenteropancreatic neuroendocrine tumors (GEP-NETs): Treatment of adults with unresectable, well- or moderately-differentiated, locally advanced or metastatic GEP-NETs to improve progression-free survival (how long the disease stays stable without getting worse).
  • Carcinoid syndrome: Treatment in adults to reduce how frequently short-acting somatostatin analog rescue medications are needed. Note: patients already receiving Lanreotide Injection for GEP-NETs should not receive an additional dose for carcinoid syndrome.
⚙️How it works

Lanreotide is a synthetic octapeptide that closely mimics the natural hormone somatostatin. It works by binding tightly to specific somatostatin receptors on cells — particularly receptor subtypes 2 and 5. This binding suppresses the release of growth hormone (GH) and IGF-1 (a protein that promotes growth), which is the key mechanism in controlling acromegaly. It also inhibits other hormones and substances involved in tumor growth and the digestive symptoms of carcinoid syndrome.

Beyond hormones, lanreotide slows gallbladder contractions, affects insulin and glucagon release (which can alter blood sugar), and can modestly reduce heart rate — effects that are important to keep in mind during treatment.

💊How it's taken

Lanreotide Injection is given as a deep subcutaneous injection (under the skin into the upper outer buttock) by a healthcare provider, generally once every 4 weeks. For acromegaly, the dose may be adjusted after the first 3 months based on hormone levels and symptoms; well-controlled patients may be considered for an extended interval of every 6 or 8 weeks. For GEP-NETs and carcinoid syndrome, the standard schedule is once every 4 weeks.

  • Patients with moderate or severe kidney or liver impairment who have acromegaly may start at a lower dose — follow your prescriber's guidance.
  • The injection site should be alternated between the right and left buttock each time.
  • There are no specific food restrictions; follow any instructions given by your healthcare provider.
🤒Side effects — in detail

The most commonly reported side effects with Lanreotide Injection include:

  • Diarrhea, abdominal pain, nausea, flatulence, loose stools, vomiting, constipation
  • Gallstones (cholelithiasis) — reported in about 20% of acromegaly patients in clinical studies
  • Injection site reactions: pain, lump, hardness, or itching at the injection site (usually mild and more common early in treatment)
  • Headache and dizziness
  • Muscle and joint pain
  • High blood sugar (hyperglycemia) and, less commonly, low blood sugar (hypoglycemia)
  • Slow heart rate (bradycardia) or high blood pressure
  • Mild decrease in thyroid function (clinical hypothyroidism is rare)

Serious reactions to act on promptly include severe abdominal pain or jaundice (possible gallstone complications), significant changes in blood sugar, very slow or symptomatic heart rate, signs of a severe allergic reaction (swelling, hives, difficulty breathing), and new or worsening fatty/oily stools or unexplained weight loss.

⚠️Warnings & precautions
  • Gallstones and gallbladder complications: Lanreotide reduces gallbladder movement and bile flow, leading to gallstone formation in some patients. Complications including gallbladder inflammation, bile duct problems, and pancreatitis have been reported. Periodic monitoring may be recommended, and the medication should be stopped if serious complications develop.
  • Blood sugar changes: Lanreotide can cause both high and low blood sugar by affecting insulin and glucagon. Glucose monitoring is especially important when starting treatment or changing the dose, and diabetes medications may need to be adjusted.
  • Slowed heart rate (bradycardia): Lanreotide can reduce heart rate. Use with extra care in patients who already have heart conditions or take medications that slow the heart. Seek medical attention if symptoms like dizziness or fainting develop.
  • Thyroid function: Slight reductions in thyroid activity can occur. Thyroid tests are recommended if symptoms arise.
  • Fat malabsorption (steatorrhea): Lanreotide can inhibit pancreatic enzymes and bile, leading to fatty/oily stools, bloating, and weight loss. Tell your doctor about any new or worsening digestive symptoms.
🔀What it interacts with

Lanreotide Injection can interact with several medications that are important to discuss with your prescriber or pharmacist:

  • Insulin and oral diabetes medications: Lanreotide affects insulin and glucagon — blood sugar levels need monitoring and antidiabetic medication doses may need adjustment.
  • Cyclosporine (immunosuppressant): Lanreotide may reduce cyclosporine absorption, potentially lowering its effectiveness — dose adjustment and blood level monitoring may be needed.
  • Bromocriptine: Lanreotide may increase bromocriptine absorption, potentially raising its effects and side effects.
  • Heart rate–slowing drugs (e.g., beta-blockers): Combining these with lanreotide can have an additive effect on slowing the heart — close monitoring and possible dose adjustment are needed.
  • CYP3A4-metabolized drugs with a narrow safety margin (e.g., quinidine, terfenadine): Lanreotide may slow the liver's clearance of these drugs, increasing their levels in the blood and the risk of side effects — avoid if possible.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Allergy: Do not use Lanreotide Injection if you have ever had a serious allergic reaction — including anaphylaxis or angioedema (severe swelling) — to lanreotide.
  • Diabetes or blood sugar issues: Blood glucose should be monitored carefully when starting or adjusting lanreotide, as it can cause both high and low blood sugar.
  • Heart conditions: Tell your doctor about any heart rhythm disorders, especially bradycardia (slow heart rate) — extra caution is needed.
  • Gallbladder disease: Inform your doctor if you have a history of gallstones or gallbladder problems.
  • Kidney or liver impairment: Moderate or severe impairment may require a lower starting dose for acromegaly patients — discuss with your prescriber.
  • Pregnancy: Animal studies showed potential harm to the fetus. There are very limited data in human pregnancies. Discuss risks with your doctor if you are pregnant or planning to become pregnant.
  • Breastfeeding: Women should not breastfeed during treatment with Lanreotide Injection or for 6 months after the last dose, due to potential risks to the infant including effects on blood sugar and heart rate.
  • Fertility: Animal studies suggest lanreotide may reduce fertility in females — discuss this with your doctor if relevant.
  • Children: Safety and effectiveness in pediatric patients have not been established.
  • Older adults: No major overall differences in safety have been seen, but dose selection should be careful given that older patients are more likely to have kidney, liver, or heart concerns.
📡Pharmacodynamics — effects in the body

Lanreotide's primary measurable effect is a rapid, sustained reduction in growth hormone (GH) and IGF-1 levels — effects that persist for at least 28 days after a single injection in acromegaly patients, and are dose-dependent. In patients with carcinoid syndrome, it reduces urinary levels of a tumor marker called 5-HIAA compared with placebo. Lanreotide also inhibits the secretion of several digestive hormones (including insulin, glucagon, gastrin, and cholecystokinin), slows gallbladder contractions, reduces pancreatic secretions, and can transiently affect blood sugar levels. It may also modestly suppress thyroid-stimulating hormone (TSH) and reduce prolactin levels with long-term use.

🔬Pharmacokinetics — how your body processes it

After a deep subcutaneous injection, lanreotide forms a depot (a slow-release reservoir) at the injection site. The drug gradually diffuses from this depot into surrounding tissue and then into the bloodstream, giving it a long half-life of 23 to 30 days — which is why a once-monthly injection is sufficient. Bioavailability after subcutaneous injection in healthy subjects averages roughly 70–78% depending on dose. Drug levels remain detectable and therapeutically relevant throughout the full 28-day dosing interval.

📦How to store it

Store SOMATULINE DEPOT in the refrigerator at 2°C to 8°C (36°F to 46°F). Protect from light. Store in the original package.

📄 Written from Lanreotide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

13

Supplements & herbs that interact with Lanreotide Injection

13 supplements and herbal products have documented interactions with Lanreotide Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Moderate · 12
  • Minor · 1
Every supplement checked against Lanreotide Injection — ranked by severity The full interaction hub: 12 moderate · 1 minor · every one linked to its full report. Check Lanreotide Injection against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Lanreotide Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What conditions does lanreotide actually treat?
Lanreotide is used for three things: acromegaly (when your body makes too much growth hormone), certain neuroendocrine tumors of the gut and pancreas (called GEP-NETs), and carcinoid syndrome (which causes flushing and diarrhea from hormone-producing tumors). Your doctor will have prescribed it for one of these specific reasons, and the dosing schedule can differ depending on which condition is being treated.
How is the injection given, and do I have to do it myself?
Lanreotide Injection is meant to be given by a healthcare provider — not self-injected at home. It goes as a deep injection under the skin in the upper outer area of your buttock, and the injection site is alternated left and right each time. The medication is thick and must be pushed in slowly over about 20 seconds. You typically come in for an injection once every 4 weeks.
What side effects should I actually expect?
The most common ones are digestive issues — diarrhea, stomach pain, and nausea are very frequent, especially at higher doses. You might also notice some soreness or a small lump at the injection site after the shot, which usually settles down over time. Gallstones are a real concern with long-term use, so your doctor may check your gallbladder periodically. Blood sugar changes can happen too, so if you have diabetes, your medication may need adjusting.
When should I call my doctor right away?
Call your doctor promptly if you have severe abdominal pain, fever, or yellowing of your skin or eyes — these could signal gallstone complications like a blocked bile duct or pancreatitis. Also call if you feel your heart beating unusually slowly, or if you feel faint or dizzy. Signs of a severe allergic reaction — throat swelling, difficulty breathing, or hives — need emergency medical attention immediately. And if you have diabetes, watch for unusual swings in your blood sugar.
Is it safe to breastfeed while taking this medication?
No — you should not breastfeed while taking Lanreotide Injection, and you'll need to wait at least 6 months after your last dose before breastfeeding. The concern is that the medication could affect your baby's blood sugar and heart rate. Talk to your doctor about your options if you are planning to breastfeed.
Are there any medications I should tell my doctor about before starting?
Yes — a few important ones. If you take cyclosporine (for organ transplant or autoimmune conditions), lanreotide can reduce how well it's absorbed, so your levels will need to be watched. If you take beta-blockers or other drugs that slow the heart, the combination can lower your heart rate further. And if you take insulin or any diabetes medication, your blood sugar management will likely need to be re-evaluated when you start lanreotide. Always give your full medication list to your prescribing doctor.
Is Lanreotide Injection available over the counter?
Lanreotide Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Lanreotide Injection first available?
Lanreotide Injection has been available in the United States since at least 2007, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Lanreotide Injection?
Lanreotide Injection is supplied by 4 manufacturers listed in the FDA NDC Directory, including Cipla USA Inc., Ipsen Biopharmaceuticals, Inc., Exelan Pharmaceuticals, Inc..

💬 Answers drafted from Lanreotide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Lanreotide Injection comes

Lanreotide Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Under the skin
Brands Somatuline Depot
How this form is used
What it may be used for
  • Used for the long-term treatment of acromegaly in patients who have not responded adequately to or cannot have surgery or radiation therapy
  • Used to improve progression-free survival in adults with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs)
  • Used to treat carcinoid syndrome in adults, reducing the need for short-acting rescue therapy
Important instructions
  • Lanreotide Acetate and Somatuline Depot are each given as a deep subcutaneous injection into the upper outer area of the buttock by a healthcare provider
  • Alternate the injection site between the right and left buttock with each administration
  • Remove the pre-filled syringe from the refrigerator 30 minutes before injecting; inject the medication slowly over 20 seconds
  • Do not touch or attempt to open the green needle shield on the device — it is a self-activating safety mechanism, not a removable cap
Available strengths 3 strengths
30 FDA-listed product records

📊 Lanreotide Injection across the U.S. market

How Lanreotide Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
4
Manufacturers
2
Brand names
30
FDA-listed product records
2007
First marketed
Cipla USA Inc.40%
Ipsen Biopharmaceuticals, Inc.30%
Exelan Pharmaceuticals, Inc.20%
Synergy Health AST, LLC10%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Lanreotide Injection is used

A general measure of how commonly Lanreotide Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Lanreotide Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

4,864
Medicaid prescriptions filled (Q1–Q4 2025)
$24.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Lanreotide Injection prescribed? Of the 1,596 medications we measure, Lanreotide Injection ranks #1,048 by Medicaid prescriptions — more than 34% of them.

Where Lanreotide Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Lanreotide Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 0.5 mL / 240 mg/mL prefilled syringe is the most-dispensed Lanreotide Injection product — about 97% of these Medicaid prescriptions.

0.5 ML lanreotide 240 MG/ML Prefilled Syringe Most dispensed

4,719 Medicaid prescriptions (Q1–Q4 2025) 97% of Lanreotide Injection prescriptions shown $23.7M gross reimbursement (before rebates) ≈ $5,012 per prescription (gross)

Summed across the 3 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 749814

0.2 ML lanreotide 300 MG/ML Prefilled Syringe

103 Medicaid prescriptions (Q1–Q4 2025) 2% of Lanreotide Injection prescriptions shown $526,121 gross reimbursement (before rebates) ≈ $5,108 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 749811

0.3 ML lanreotide 300 MG/ML Prefilled Syringe

42 Medicaid prescriptions (Q1–Q4 2025) <1% of Lanreotide Injection prescriptions shown $343,191 gross reimbursement (before rebates) ≈ $8,171 per prescription (gross)

Summed across the 1 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 749817

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Lanreotide Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 5 of 15 listed Lanreotide Injection NDCs with Medicaid activity.

🔍 Compare Lanreotide Injection products

A representative set of FDA-listed product records for Lanreotide Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 30 of 30 products — FDA National Drug Code Directory. See every product, package size and price: browse all 30 Lanreotide Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Lanreotide Injection RxCUI 68092 1 dose form · 3 strengths

Look up RxCUI 68092 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Somatuline Depot Somatuline

🏭 Manufacturers & labelers

Cipla USA Inc. 12 Ipsen Biopharmaceuticals, Inc. 9 Exelan Pharmaceuticals, Inc. 6 Synergy Health AST, LLC 3

RxNorm drug class

Lanreotide Injection belongs to the Somatostatin Analog class.

Pharmacologic class Somatostatin Analog
Drug family (ATC) Somatostatin and analogues
How it works Somatostatin Receptor Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 1, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lanreotide Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Lanreotide Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
NDC products indexed
30
Distinct labelers/manufacturers represented
4
Linked representative label
Cipla USA Inc.
Linked label effective
Sep 1, 2024
Composite sections available
21
Linked SPL Set ID
11da176a-99bc-4ada-8b3f-6bd2b37a6313
Linked SPL Document ID
fd205110-15eb-4707-82b2-185e5bbf616b
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 4 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Cipla USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.