Somatuline Depot Generic Name & Formulations
Legal Class
Rx
General Description
Lanreotide 60mg/0.2mL, 90mg/0.3mL, 120mg/0.5mL; prolonged-release soln for SC inj.
Pharmacological Class
Somatostatin analogue.
How Supplied
Single-dose prefilled syringe—1
Manufacturer
Somatuline Depot Indications
Indications
Treatment of carcinoid syndrome, to reduce the frequency of short-acting somatostatin analogue rescue therapy.
Somatuline Depot Dosage and Administration
Adult
Give by deep SC inj into the superior external quadrant of the buttock. Rotate inj site. 120mg every 4 weeks. Do not give additional dose if already being treated for GEP-NETs.
Children
Not established.
Somatuline Depot Contraindications
Not Applicable
Somatuline Depot Boxed Warnings
Not Applicable
Somatuline Depot Warnings/Precautions
Warnings/Precautions
Discontinue and treat if cholelithiasis complications are suspected. Diabetes. Hypothyroidism. Cardiovascular disease. Renal or hepatic impairment. Monitor growth hormone (GH), IGF-1 levels, thyroid function, gallbladder formation, glucose. Pregnancy. Nursing mothers: not recommended.
Somatuline Depot Pharmacokinetics
See Literature
Somatuline Depot Interactions
Interactions
Potentiates bromocriptine, CYP450 substrates (eg, quinidine, terfenadine), bradycardia-inducing drugs (eg, β-blockers); adjust doses. Antagonizes cyclosporine; adjust dose. May need to adjust antidiabetic agents.
Somatuline Depot Adverse Reactions
Adverse Reactions
Diarrhea, abdominal pain, nausea, vomiting, constipation, flatulence, loose stools, cholelithiasis, inj site reactions, musculoskeletal pain, headache, dizziness, muscle spasm; gallbladder sludge, hyperglycemia, hypoglycemia, sinus bradycardia, hypertension, anemia; rare: hypothyroidism.
Somatuline Depot Clinical Trials
See Literature
Somatuline Depot Note
Not Applicable
Somatuline Depot Patient Counseling
See Literature
Somatuline Depot Generic Name & Formulations
Legal Class
Rx
General Description
Lanreotide 60mg/0.2mL, 90mg/0.3mL, 120mg/0.5mL; prolonged-release soln for SC inj.
Pharmacological Class
Somatostatin analogue.
How Supplied
Single-dose prefilled syringe—1
Manufacturer
Somatuline Depot Indications
Indications
Treatment of unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.
Somatuline Depot Dosage and Administration
Adult
Give by deep SC inj into the superior external quadrant of the buttock. Rotate inj site. 120mg every 4 weeks.
Children
Not established.
Somatuline Depot Contraindications
Not Applicable
Somatuline Depot Boxed Warnings
Not Applicable
Somatuline Depot Warnings/Precautions
Warnings/Precautions
Discontinue and treat if cholelithiasis complications are suspected. Diabetes. Hypothyroidism. Cardiovascular disease. Renal or hepatic impairment. Monitor growth hormone (GH), IGF-1 levels, thyroid function, gallbladder formation, glucose. Pregnancy. Nursing mothers: not recommended.
Somatuline Depot Pharmacokinetics
See Literature
Somatuline Depot Interactions
Interactions
Potentiates bromocriptine, CYP450 substrates (eg, quinidine, terfenadine), bradycardia-inducing drugs (eg, β-blockers); adjust doses. Antagonizes cyclosporine; adjust dose. May need to adjust antidiabetic agents.
Somatuline Depot Adverse Reactions
Adverse Reactions
Diarrhea, abdominal pain, nausea, vomiting, constipation, flatulence, loose stools, cholelithiasis, inj site reactions, musculoskeletal pain, headache, dizziness, muscle spasm; gallbladder sludge, hyperglycemia, hypoglycemia, sinus bradycardia, hypertension, anemia; rare: hypothyroidism.
Somatuline Depot Clinical Trials
See Literature
Somatuline Depot Note
Not Applicable
Somatuline Depot Patient Counseling
See Literature
Somatuline Depot Generic Name & Formulations
Legal Class
Rx
General Description
Lanreotide 60mg/0.2mL, 90mg/0.3mL, 120mg/0.5mL; prolonged-release soln for SC inj.
Pharmacological Class
Somatostatin analogue.
How Supplied
Single-dose prefilled syringe—1
Manufacturer
Somatuline Depot Indications
Indications
Long-term treatment of acromegaly in patients who have had an inadequate response or cannot be treated with surgery and/or radiotherapy.
Somatuline Depot Dosage and Administration
Adult
Give by deep SC inj into the superior external quadrant of the buttock. Rotate inj site. Usual range: 60–120mg every 4 weeks. Initially 90mg every 4 weeks for 3 months. After 3 months, adjust as follows: GH≤1ng/mL, IGF-1 normal and clinical symptoms controlled: reduce to 60mg every 4 weeks; GH>1ng/mL to GH≤2.5ng/mL, IGF-1 normal and clinical symptoms controlled: maintain at 90mg every 4 weeks; GH>2.5ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled: increase to 120mg every 4 weeks. If controlled on 60mg or 90mg, may consider extended dosing interval of 120mg every 6 or 8 weeks; obtain GH and IGF-1 levels 6 weeks after regimen change to evaluate response. Moderate to severe renal or hepatic impairment: initially 60mg every 4 weeks for 3 months; adjust thereafter based on GH and/or IGF-1 levels. Caution when considering extended dosing interval treatment.
Children
Not established.
Somatuline Depot Contraindications
Not Applicable
Somatuline Depot Boxed Warnings
Not Applicable
Somatuline Depot Warnings/Precautions
Warnings/Precautions
Discontinue and treat if cholelithiasis complications are suspected. Diabetes. Hypothyroidism. Cardiovascular disease. Renal or hepatic impairment. Monitor growth hormone (GH), IGF-1 levels, thyroid function, gallbladder formation, glucose. Pregnancy. Nursing mothers: not recommended.
Somatuline Depot Pharmacokinetics
See Literature
Somatuline Depot Interactions
Interactions
Potentiates bromocriptine, CYP450 substrates (eg, quinidine, terfenadine), bradycardia-inducing drugs (eg, β-blockers); adjust doses. Antagonizes cyclosporine; adjust dose. May need to adjust antidiabetic agents.
Somatuline Depot Adverse Reactions
Adverse Reactions
Diarrhea, abdominal pain, nausea, vomiting, constipation, flatulence, loose stools, cholelithiasis, inj site reactions, musculoskeletal pain, headache, dizziness, muscle spasm; gallbladder sludge, hyperglycemia, hypoglycemia, sinus bradycardia, hypertension, anemia; rare: hypothyroidism.
Somatuline Depot Clinical Trials
See Literature
Somatuline Depot Note
Not Applicable
Somatuline Depot Patient Counseling
See Literature