Adult Dosing

Acromegaly

• 60-120 mg SC q4 wks
• Initial: 90 mg SC q4 wks x3 months; adjust thereafter based on GH and/or IGF-1 levels

Note:

• Inject SC in the superior external quadrant of the buttock. Injection site should be alternated

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Long-term treatment of acromegalic patients who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Moderate-severe impairment: Start 60 mg SC q4 wks x3 months; adjust thereafter based on GH and/or IGF-1 levels

Hepatic Dose Adjustment

• Moderate-severe impairment: Start 60 mg SC q4 wks x3 months; adjust thereafter based on GH and/or IGF-1 levels

• Periodically monitor patients as therapy may reduce gallbladder motility and lead to gallstone formation
• Lanreotide inhibits the secretion of insulin and glucagon, therefore patients may experience hypoglycemia or hyperglycemia during therapy
• Monitor blood glucose levels when therapy is initiated, or when the dose is altered, and antidiabetic treatment should be adjusted accordingly
• Therapy may decrease thyroid function in acromegalic patients. Thyroid function tests are recommended where clinically indicated
• Cardiovascular abnormalities such as sinus bradycardia, bradycardia and hypertension may occur during treatment

Cautions: Use cautiously in

• Mod-severe renal impairment
• Mod-severe hepatic impairment
• Diabetes mellitus
• Hypothyroidism
• Bradycardia

Pregnancy Category:C

Breastfeeding: Safety unknown. Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• CNS: Headache
• CV: Bradycardia, hypertension
• GI: Abdominal pain, diarrhea, gallstones, gallbladder sludge, nausea constipation, flatulence, vomiting, loose stools
• ENDO: Hyperglycemia, hypoglycemia, hypothyroidism
• METABOLIC: Weight loss
• HEMA: Anemia
• MUSC: Arthralgia
• LOCAL: Injection site reactions

• Somatostatin analogue; inhibits growth hormone (GH) and insulin-like growth factor-1 (IGF-1)
• Bioavailabilty: 73-79%
• Metabolized by liver
• Excreted in urine <5%, feces (<0.5% unchanged)
• Half-life: 23-30 days

US Trade Name(s)

• Somatuline Depot

US Availability

Somatuline Depot

• INJ (prefilled syringes): 60 mg/0.2 mL
• INJ (prefilled syringes): 90 mg/0.3 mL
• INJ (prefilled syringes): 120 mg/0.5 mL

Canadian Trade Name(s)

• Somatuline Autogel

Canadian Availability

Somatuline Autogel

• INJ (prefilled syringes): 60 mg/0.3 mL
• INJ (prefilled syringes): 90 mg/0.3 mL
• INJ (prefilled syringes): 120 mg/0.5 mL

UK Trade Name(s)

• Somatuline Autogel
• Somatuline LA

UK Availability

Somatuline Autogel

• INJ (prefilled syringes): 60 mg
• INJ (prefilled syringes): 90 mg
• INJ (prefilled syringes): 120 mg

Somatuline LA

• PWDR for INJ: 30 mg/vial

Australian Trade Name(s)

• Somatuline Autogel
• Somatuline LA

Australian Availability

Somatuline Autogel

• INJ (prefilled syringes): 60 mg/0.3 mL
• INJ (prefilled syringes): 90 mg/0.3 mL
• INJ (prefilled syringes): 120 mg/0.5 mL

Somatuline LA

• PWDR for INJ: 30 mg/vial

[Outline]

Endocrine/Metabolic

Hormones; Miscellaneous