Lanreotide

Summary

Lanreotide is a synthetic cyclic octapeptide analogue of somatostatin used for the treatment of acromegaly, gastroenteropancreatic neuroendocrine tumors (GEP-NETs), and carcinoid syndrome. It is formulated as a long-acting depot preparation (Somatuline Depot/Autogel) administered by deep subcutaneous injection every 4 weeks.

Mechanism of Action

Binds predominantly to somatostatin receptors SSTR2 and SSTR5, inhibiting secretion of growth hormone (GH), IGF-1, insulin, glucagon, and various gastrointestinal hormones; suppresses tumor cell proliferation via antiproliferative signaling

Routes of Administration

Goals & Uses

• Acromegaly managementEndocrinologyHigh
• Carcinoid syndrome symptom controlOncology/GastroenterologyHigh
• Polycystic liver disease volume reductionHepatologyModerate
• Thyroid-stimulating hormone (TSH)-secreting pituitary adenomaEndocrinologyModerate
• GEP-NET tumor controlOncologyHigh

Contraindications

• PregnancyPopulationModeratePotential fetal risk or insufficient safety data
• BreastfeedingPopulationModeratePotential transfer into breast milk or insufficient safety data
• Hypersensitivity to lanreotide or excipientsAllergyHigh

Adverse Effects

• Gallstones / biliary sludgeGastrointestinal/HepatobiliaryCommon
• Hyperglycemia or hypoglycemiaMetabolic/EndocrineUncommon
• Injection site reactionsLocalCommon
• Abdominal pain/discomfortGastrointestinalCommon
• DiarrheaGastrointestinalCommonLoose or frequent stools
• BradycardiaCardiovascularUncommon

Drug Interactions

• QT-prolonging drugsModerate
• Insulin / Oral antidiabeticsModerate
• CyclosporineModerate
• BromocriptineLow

Population Constraints

• Pediatric patientsAgeRelative
• Patients with hepatic impairmentOrgan FunctionRelative
• Patients with cardiac disease (bradycardia, conduction disorders)CardiovascularRelative
• Diabetic PatientsMetabolicRelative

Regulatory Status

• European UnionApprovedApproved: Acromegaly, Symptoms associated with neuroendocrine (particularly carcinoid) tumors, GEP-NETs (grade 1 and grade 2 tumors of pancreatic or midgut origin)Approved as Somatuline Autogel by EMA; authorized since 2001 with expanded indications
• United StatesApprovedApproved: Acromegaly (long-term treatment), Gastroenteropancreatic neuroendocrine tumors (GEP-NETs), unresectable, well- or moderately-differentiated, locally advanced or metastaticFDA approved Somatuline Depot (lanreotide) in 2007 for acromegaly and in 2014 for GEP-NETs
• United KingdomApprovedApproved: Acromegaly, Neuroendocrine tumors (carcinoid symptoms), GEP-NETsRetained approval post-Brexit under MHRA as Somatuline Autogel

Approved by FDA (2007) for acromegaly and GEP-NETs; approved by EMA for acromegaly, GEP-NETs, and carcinoid symptoms. Marketed as Somatuline Autogel (EU/UK) and Somatuline Depot (US).

Evidence & Sources

No sources recorded yet.