Somatuline Depot

— THERAPEUTIC CATEGORIES —
  • Cytoprotective and supportive care agents
  • Pancreatic, thyroid, and other endocrine cancers
  • Pituitary disorders

Somatuline Depot Generic Name & Formulations

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

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

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

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

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

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