Lanreotide

Lanreotide, the active component of Lanreotide Injection, is an octapeptide analog of natural somatostatin. The mechanism of action of lanreotide is believed to be similar to that of natural somatostatin.

• Lanreotide Injection is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

• Lanreotide Injection is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide [ see Adverse Reactions ( 6.3 )] .contraindicated

Administration ( 2.1 ): For deep subcutaneous injection only. Intended for administration by a healthcare provider. Administer in the superior external quadrant of the buttock. Alternate injection sites. Recommended Dosage ( 2.1 ) Acromegaly : 90 mg every 4 weeks for 3 months. Adjust thereafter based on GH and/or IGF-1 levels. See full prescribing information for titration regimen. GEP-NETs : 120 mg every 4 weeks. Carcinoid Syndrome : 120 mg every 4 weeks. If patients are already being treated with Lanreotide Injection for GEP-NET, do not administer an additional dose for carcinoid syndrome. Dosage Adjustment : See full prescribing information for dosage adjustment in patients with acromegaly and renal or hepatic impairment. ( 2.2 , 2.3 ) 2.1 Recommended Dosage Acromegaly The recommended starting dosage of Lanreotide Injection is 90 mg given via the deep subcutaneous route, at 4-week intervals for 3 months. After 3 months, the Lanreotide injection dosage may be adjusted as follows: GH greater than 1 ng/mL to less than or equal to 2.5 ng/mL, IGF-1 normal, and clinical symptoms controlled: maintain dosage at 90 mg every 4 weeks. GH greater than 2.5 ng/mL, IGF-1 elevated, and/or clinical symptoms uncontrolled: increase dosage to 120 mg every 4 weeks. GH less than or equal to 1 ng/mL, IGF-1 normal, and clinical symptoms controlled: reduce dosage to 60 mg every 4 weeks. Thereafter, the dosage should be adjusted according to the response of the patient as judged by a reduction in serum GH and/or IGF-1 levels; and/or changes in symptoms of acromegaly.

Cholelithiasis and Complications of Cholelithiasis : Monitor periodically. Discontinue if complications of cholthiasis are suspected. Gallstones may occur; consider periodic monitoring. ( 5.1 ) Hyperglycemia and Hypoglycemia : Glucose monitoring is recommended and antidiabetic treatment adjusted accordingly. ( 5.2 , 7.1 ) Cardiovascular Abnormalities : Decrease in heart rate may occur. Use with caution in at-risk patients. ( 5.3 ) Thyroid Function Abnormalities : Decreases in thyroid function may occur; perform tests where clinically indicated. ( 5.4 ) Steatorrhea and Malabsorption of Dietary Fats : New onset steatorrhea, stool discoloration, loose stools, abdominal bloating, and weight loss may occur. If new occurrence or worsening of these symptoms are reported, evaluate for potential pancreatic exocrine insufficiency. ( 5.6 ) 5.1 Cholelithiasis and Complications of Cholelithiasis Lanreotide Injection may reduce gallbladder motility and lead to gallstone formation; therefore, patients may need to be monitored periodically [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.2 )] . There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications, including cholecystitis, cholangitis, and pancreatitis, and requiring cholecystectomy in patients taking lanreotide. If complications of cholelithiasis are suspected, discontinue Lanreotide Injection and treat appropriately.

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cholelithiasis and Complications of Cholelithiasis [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Hypoglycemia [see Warnings and Precautions ( 5.2 )] Cardiovascular Abnormalities [see Warnings and Precautions ( 5.3 )] Thyroid Function Abnormalities [see Warnings and Precautions ( 5.4 )] Steatorrhea and Malabsorption of Dietary Fats [see Warnings and Precautions ( 5.6 )] Most common adverse reactions are: Acromegaly : (>5%): diarrhea, cholelithiasis, abdominal pain, nausea and injection site reactions. ( 6.1 ) GEP-NET : (>10%): abdominal pain, musculoskeletal pain, vomiting, headache, injection site reaction, hyperglycemia, hypertension, and cholelithiasis. ( 6.1 ) Carcinoid Syndrome : (≥5% and at least 5% greater than placebo): headache, dizziness and muscle spasm. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. Inc. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Lanreotide Injection was established from adequate and well-controlled studies of another lanreotide injection product [see Clinical Studies ( 14 )] . Adverse reactions observed in these adequate and well-controlled studies are described below.

Lactation : Advise women not to breastfeed during treatment and for 6 months after the last dose. ( 8.2 ) 8.1 Pregnancy Risk Summary Limited available data based on post-marketing case reports with lanreotide use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, decreased embryo/fetal survival was observed in pregnant rats and rabbits at subcutaneous doses 5- and 2-times the maximum recommended human dose (MRHD) of 120 mg, respectively ( see Data) The background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data A reproductive study in pregnant rats given 30 mg/kg of lanreotide by subcutaneous injection every 2 weeks (5 times the human dose, based on body surface area comparisons) resulted in decreased embryo/fetal survival.

Metabolism

Lanreotide Injection is thought to form a drug depot at the injection site due to the interaction of the formulation with physiological fluids. The most likely mechanism of drug release is a passive diffusion of the precipitated drug from the depot towards the surrounding tissues, followed by the absorption to the bloodstream.

• Aug 30, 2007NDANDA022074Ipsen Pharma
• Dec 17, 2021NDANDA215395Invagen Pharms
• May 21, 2024ANDAANDA217193Invagen Pharms

1. 1Off Label Use1,40918%
2. 2Diarrhoea1,38218%
3. 3Death1,16315%
4. 4Fatigue93012%
5. 5Nausea6989.2%
6. 6Injection Site Pain5777.6%
7. 7Abdominal Pain5507.2%
8. 8Headache4856.4%
9. 9Malaise4225.5%
10. 10Dizziness4025.3%
11. 11Asthenia3975.2%
12. 12Pain3795.0%
13. 13Weight Decreased3744.9%
14. 14Injection Site Mass3654.8%
15. 15Product Dose Omission Issue3634.8%

The 10 most recently updated of 117 ClinicalTrials.gov registrations naming Lanreotide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Trial to Assess Efficacy and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET
  Active not recruiting · Phase 3 · Interventional · 332 enrolled · Camurus AB
  NCT05050942updated 2026-06-11
• Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen
  Recruiting · Phase 3 · Interventional · 141 enrolled · Crinetics Pharmaceuticals Inc.
  NCT07087054updated 2026-04-30
• Analysis of Optimal Treatment Sequencing of Surufatinib and Somatostatin Analogs in Neuroendocrine Tumors: A Retrospective Cohort Study
  Active not recruiting · Observational · 500 enrolled · West China Hospital
  NCT07534371updated 2026-04-16
• Cabozantinib and Lanreotide as Treatment for Gastroenteropancreatic Neuroendocrine Tumors
  Recruiting · Phase 1 · Phase 2 · Interventional · 49 enrolled · National Health Research Institutes, Taiwan
  NCT05048901updated 2026-04-09
• Lanreotide In Polycystic Kidney Disease Study
  Completed · Phase 3 · Interventional · 159 enrolled · Assistance Publique - Hôpitaux de Paris
  NCT02127437updated 2026-04-08
• Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
  Recruiting · Phase 3 · Interventional · 274 enrolled · SWOG Cancer Research Network
  NCT06807437updated 2026-03-31
• Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
  Recruiting · Phase 3 · Interventional · 338 enrolled · RayzeBio, Inc.
  NCT05477576updated 2026-03-30
• Study to Evaluate the Safety, PK, and Dose Response of Paltusotine in Subjects With Carcinoid Syndrome
  Completed · Phase 2 · Interventional · 36 enrolled · Crinetics Pharmaceuticals Inc.
  NCT05361668updated 2026-03-19
• LAnreotide in Metastatic Pheochromocytoma / PARAganglioma (LAMPARA)
  Active not recruiting · Phase 2 · Interventional · 10 enrolled · Antonio Fojo
  NCT03946527updated 2026-03-02
• A Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Debio 4126 in Participants With Acromegaly or Functioning Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)
  Terminated · Phase 1 · Interventional · 19 enrolled · Debiopharm International SA
  NCT05364944updated 2025-11-17

Frequently asked questions

How does Lanreotide work?

Lanreotide, the active component of Lanreotide Injection, is an octapeptide analog of natural somatostatin. The mechanism of action of lanreotide is believed to be similar to that of natural somatostatin.

What is Lanreotide used for?

According to FDA labeling, Lanreotide carries indications including: Lanreotide Injection is a somatostatin analog indicated for: the long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. ( 1.1 ) the treatment of adult patients with unresectable, well- or moderately- differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Lanreotide?

Lanreotide is classified as Somatostatin and analogues, Somatostatin Analog, Somatostatin Receptor Agonists, Decreased Growth Hormone Secretion.

What are the brand names for Lanreotide?

Lanreotide is marketed under brand names including Somatuline.

What are the contraindications for Lanreotide?

Lanreotide labeling lists contraindications including: Lanreotide Injection is contraindicated in patients with history of a hypersensitivity to lanreotide. Allergic reactions (including angioedema and anaphylaxis) have been reported following administration of lanreotide [ see Adverse Reactions ( 6.3 )] .. Always consult the full prescribing information and a clinician.