Dosing and uses of Somatuline Depot (lanreotide)
Adult dosage forms and strengths
injection solution
- 60mg/0.2mL
- 90mg/0.3mL
- 120mg/0.5mL
Acromegaly
Indicated for acromegaly in patients with failed or contraindicated radiation/surgery
60-120 mg (recommended 90 mg) deep SC in superior external quadrant of buttock q4week for 3 months; THEN adjust based on GH and/or IGF-1 levels
Dose adjustments after 3 months (acromegaly)
- GH >1 to ≤2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: Maintain dose at 90 mg q4wk
- GH >2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled: Increase dose to 120 mg q4wk
- GH ≤1 ng/mL, IGF-1 normal and clinical symptoms controlled: Reduce dose to 60 mg q4wk
- Patients controlled on 60-90 mg q4wk may be considered for an extended dosing interval of 120 mg q6-8wk
Renal & hepatic impairment (acromegaly)
- Moderate-to-severe: Initial 60 mg deep SC in superior external quadrant of buttock q4week for 3 months; THEN adjust based on GH and/or IGF-I levels
Gastroenteropancreatic Neuroendocrine Tumors
Indicated for unresectable, well-or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survivaL
120 mg q4wk by deep SC injection
Renal & hepatic impairment (GEP-NETs)
- Mild or moderate renal impairment: No recommendation for dose adjustment
- Severe renal impairment: Insufficient information to recommend a dose
- Hepatic impairment (any severity): Insufficient information to recommend a dose
Carcinoid Syndrome (Orphan)
Treatment of symptoms associated with carcinoid syndrome
Orphan indication sponsor
- Ipsen Pharma; 65 quai George Gorse, 92650 Boulogne Billancourt; France
Administration
Inject by deep SC in the superior external quadrant of the buttock; alternate injection site
Monitoring
Blood glucose
Pediatric dosage forms and strengths
Safety and efficacy not established
Somatuline Depot (lanreotide) adverse (side) effects
>10%
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% )
1-10%
Arthralgia (7%)
Constipation (8%)
Headache (7%)
Loose stools (6%)
Vomiting (7%)
Hyper-/hypoglycemia/diabetes (7%)
Sinus bradycardia (3%)
<1%
Injection site pruritus
Steatorrhea
Aortic valve regurgitation
Allergic skin reaction
Mitral valve regurgitation
Pancreatitis
Postmarketing Reports
Angioedema
Anaphylaxis
Gastrointestinal disorders: Abdominal pain, diarrhea, and steatorrhea
Hepatobiliary disorders: Cholecystitis, pancreatitis
General disorders and administration site conditions: Injection site reactions
Cardiac: Hypertension
Warnings
Contraindications
Hypersensitivity
Cautions
Risk of reducing gallbladder motility, which could lead to gallstone formation
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
Bradycardia, hypertension, and sinus bradycardia reported; use with caution in at-risk patients; initiate appropriate medical management in patients who develop symptomatic bradycardia
Use caution in renal/hepatic impairment, diabetes
Pregnancy and lactation
Pregnancy category: C
Lactation: Not known whether excreted in breast milk, discontinue drug or do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Somatuline Depot (lanreotide)
Mechanism of action
Analog of somatostatin, which is a peptide inhibitor of multiple endocrine, neuroendocrine, and exocrine mechanisms
Pharmacokinetics
Bioavailability: ~69-83%
Vd: 0.2 L/kg
Half-Life: 23-36 days
Excretion: intact urine <5%; feces <0.5%
Peak plasma time: 7-12 hr
Protein binding: 79-83%
