Classes
DEA Class; Rx
Common Brand Names; Somatuline Depot
- Somatostatin Analogs
Description
Subcutaneous, long-acting analog of somatostatin given as depot injection
Used for the treatment of acromegaly, gastroenteropancreaticneuroendocrine tumors (GEP-NETs), and carcinoid syndrome
May decrease gallbladder motility and lead to gallstone formation; may also affect blood glucose and thyroid function tests, and may cause bradycardia
Indications
Indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option.
For the treatment of unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic malignant neuroendocrine tumor (NET).
For the treatment of carcinoid syndrome, to reduce the frequency of short-acting somatostatin analog rescue therapy.
Contraindications
Hypersensitivity to lanreotide
Adverse Effects
- Abdominal pain (19%)
- Cholelithiasis (20%)
- Diarrhea (57%)
- Nausea (11%)
- Bradyarrhythmia (5% to 18% )
- Injection site reaction (subcutaneous depot, 6% to 22% ; intramuscular, up to 50% )
- Flatulence (up to 14% )
- Anemia (3% to 14% )
- Arthralgia (7%)
- Constipation (8%)
- Headache (7%)
- Loose stools (6%)
- Vomiting (7%)
- Hyper-/hypoglycemia/diabetes (7%)
- Sinus bradycardia (3%)
- Injection site pruritus
- Steatorrhea
- Aortic valve regurgitation
- Allergic skin reaction
- Mitral valve regurgitation
- Pancreatitis
Warnings
Risk of reducing gallbladder motility, which could lead to gallstone formation; monitor periodically
Inhibition of insulin and glucagon secretion; may affect glucose regulation, which can lead to hyper-hypoglycemia; glucose monitoring is recommended; adjust antidiabetic treatment accordingly
Decreases in thyroid function reported; thyroid function tests are recommended where clinically indicated
Bradycardia, hypertension, and sinus bradycardia reported; use with caution in at-risk patients; initiate appropriate medical management in patients who develop symptomatic bradycardia
Pharmacological gastrointestinal effects of lanreotide may reduce the intestinal absorption of concomitant drugs; lanreotide may decrease the relative bioavailability of cyclosporine; concomitant administration of lanreotide and cyclosporine may necessitate the adjustment of cyclosporine dose to maintain therapeutic levels
Cholelithiasis (gallstones) resulting in complications, including cholecystitis, cholangitis, and pancreatitis, and requiring cholecystectomy reported; if complications of cholelithiasis are suspected, discontinue therapy and treat appropriately
Use caution in renal/hepatic impairment, diabetes
Pregnancy and Lactation
Limited available data based on postmarketing case reports, use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes
There is no information available on presence of lanreotide in human milk, effects of drug on breastfed infant, or on milk production
Maximum Dosage
120 mg/dose subcutaneously every 4 weeks.
120 mg/dose subcutaneously every 4 weeks.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Lanreotide
injection solution
- 60mg/0.2mL
- 90mg/0.3mL
- 120mg/0.5mL