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SOMATULINE DEPOT
Cytoprotective and supportive care agents
Pancreatic, thyroid, and other endocrine cancers
Pituitary disorders
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Drug Name:

SOMATULINE DEPOT Rx

Generic Name and Formulations:
Lanreotide 60mg/0.2mL, 90mg/0.3mL, 120mg/0.5mL; prolonged-release soln for SC inj.

Company:
Ipsen Biopharmaceuticals, Inc.

Therapeutic Use:

Indications for SOMATULINE DEPOT:

Treatment of carcinoid syndrome, to reduce the frequency of short-acting somatostatin analogue rescue therapy.

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.

Warnings/Precautions:

Diabetes. Hypothyroidism. Cardiovascular disease. Renal or hepatic impairment. Monitor growth hormone (GH), IGF-1 levels, thyroid function, gallbladder, glucose. Pregnancy. Nursing mothers: not recommended.

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.

Pharmacological Class:

Somatostatin analogue.

Adverse Reactions:

Diarrhea, cholelithiasis, abdominal pain, nausea, vomiting, inj site reactions, musculoskeletal pain, headache, dizziness, muscle spasm; gallbladder sludge, gallstones, hyperglycemia, hypoglycemia, sinus bradycardia, hypertension, anemia; rare: hypothyroidism.

How Supplied:

Single-dose prefilled syringe—1

Indications for SOMATULINE DEPOT:

Treatment of unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors (GEP-NETs) to improve progression-free survival.

Adult:

Give by deep SC inj into the superior external quadrant of the buttock. Rotate inj site. 120mg every 4 weeks.

Children:

Not established.

Warnings/Precautions:

Diabetes. Hypothyroidism. Cardiovascular disease. Renal or hepatic impairment. Monitor growth hormone (GH), IGF-1 levels, thyroid function, gallbladder, glucose. Pregnancy. Nursing mothers: not recommended.

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.

Pharmacological Class:

Somatostatin analogue.

Adverse Reactions:

Diarrhea, cholelithiasis, abdominal pain, nausea, vomiting, inj site reactions, musculoskeletal pain, headache, dizziness, muscle spasm; gallbladder sludge, gallstones, hyperglycemia, hypoglycemia, sinus bradycardia, hypertension, anemia; rare: hypothyroidism.

How Supplied:

Single-dose prefilled syringe—1

Indications for SOMATULINE DEPOT:

Long-term treatment of acromegaly in patients who have had an inadequate response or cannot be treated with surgery and/or radiotherapy.

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.

Warnings/Precautions:

Diabetes. Hypothyroidism. Cardiovascular disease. Renal or hepatic impairment. Monitor growth hormone (GH), IGF-1 levels, thyroid function, gallbladder, glucose. Pregnancy. Nursing mothers: not recommended.

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.

Pharmacological Class:

Somatostatin analogue.

Adverse Reactions:

Diarrhea, cholelithiasis, abdominal pain, nausea, vomiting, inj site reactions, musculoskeletal pain, headache, dizziness, muscle spasm; gallbladder sludge, gallstones, hyperglycemia, hypoglycemia, sinus bradycardia, hypertension, anemia; rare: hypothyroidism.

How Supplied:

Single-dose prefilled syringe—1

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