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Octreotide

    Brands

    DEA Class; Rx

    Common Brand Names; Sandostatin, Sandostatin LAR, Bynfezia Pen, Mycapssa

    • Antidiarrheals; 
    • Somatostatin Analogs

    Synthetic analog of somatostatin
    Injections used for acromegaly, vasoactive intestinal peptide tumors (VIPomas; watery diarrhea), metastatic carcinoid tumors, AIDS-associated diarrhea, esophageal varices, and other indications; oral formula used for acromegaly in adults
    Gastrointestinal adverse effects are common; cholelithiasis may be a concern with long-term use

    Indicated for the treatment of acromegaly.

    For the treatment of symptoms associated with carcinoid tumors, specifically, diarrhea and cutaneous flushing.

    For the treatment of symptoms associated with vasoactive intestinal peptide tumors (e.g., VIPoma) (i.e., to reduce plasma concentrations of vasoactive intestinal peptide).

    For the treatment of refractory or severe diarrhea or ileostomy-associated diarrhea.
    For the management of chemotherapy-induced diarrhea in pediatric patients.
    For the control of diarrhea secondary to AIDS-associated enteropathy.
    For the treatment of dumping syndrome.
    For the treatment of short bowel syndrome.
    For the treatment of enterocutaneous fistula.
    For reducing output from a pancreatic fistula.
    For the treatment of acute variceal bleeding or nonvariceal upper GI bleeding.
    For the treatment of hyperthyroidism† secondary to thyrotropinoma.

    Hypersensitivity

    Oral

    • Headache (33%)

    • Nausea (30%)

    • Diarrhea (29%)

    • Arthralgia (26%)

    • Asthenia (22%)

    • Hyperhidrosis (21%)

    • Nausea (21%)

    • Diarrhea (18%)

    • Peripheral swelling (16%)

    • Increased blood glucose (14%)

    • Vomiting (14%)

    • Abdominal discomfort (14%)

    • Dyspepsia (11%)

    • Sinusitis (11%)

    • Osteoarthritis (11%)

    Sandostatin

    • Diarrhea, loose stools, nausea and abdominal discomfort (34-61%)

    • Sinus bradycardia (25%)

    • Hyperglycemia (16%)

    • Biochemical hypothyroidism (12%)

    Sandostatin LAR

    • Diarrhea (36.4%)

    • Abdominal pain or discomfort (29.1%)

    • Hyperglycemia (27%)

    • Flatulence (25.7%)

    • Sinus bradycardia (<50 bpm) (25%)

    • Constipation (18.8%)

    • Biochemical hypothyroidism (12%)

    • Nausea (10.3%)

    Use caution in patients with hepatic impairment; patients with established cirrhosis may necessitate dosage adjustment

    Use caution in patients with renal impairment; patients receiving dialysis may necessitate dosage adjustment; in patients with severe renal failure requiring dialysis, the half-life of the drug may be increased, necessitating adjustment of maintenance dosage

    May alter fat absorption in some patients (monitor for pancreatitis)

    Monitor for cholelithiasis; may impair gallbladder function; incidence of gallbladder stone or biliary sludge increases with duration of therapy exceeding 12 months; prophylactic cholecystectomy recommended if octreotide treatment is planned in in patients with gastrointestinal or pancreatic neuroendocrine tumors

    There have been postmarketing reports of cholelithiasis (gallstones) resulting in complications requiring cholecystectomy; if complications of cholelithiasis are suspected, discontinue drug and treat appropriately

    Depressed vitamin B12 levels and abnormal Schilling’s tests reported in some patients receiving therapy; monitoring of vitamin B12 levels is recommended during chronic therapy

    Monitor for hypothyroidism (octreotide suppresses secretion of TSH); baseline and periodic assessment of thyroid function (TSH, total, and/or free T4) recommended during chronic therapy

    Therapy may alter absorption of dietary fats in some patients

    Use caution when giving drug to patients with cardiovascular disease

    May enhance toxicity of QTc-prolonging agents

    Use caution in patients with heart failure or concomitant medications that may alter heart rate or rhythm; arrhythmia, conduction abnormalities, and bradycardia reported in acromegalic and carcinoid syndrome patients; cardiovascular medications requirements may change

    Limited data in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage

    There is no information available on presence of drug in human milk, effects on breastfed infant, or on milk production

    Adults

    80 mg/day PO for acromegaly. Injectable doses are dependent on indication for therapy, route of administration, and patient response.

    Geriatric

    80 mg/day PO for acromegaly. Injectable doses are dependent on indication for therapy, route of administration, and patient response.

    Adolescents

    Dependent on indication for therapy, route of administration, and patient response. For hypothalamic obesity, 15 mcg/kg/day subcutaneously.

    Children

    Dependent on indication for therapy, route of administration, and patient response. For chylothorax, 10 mcg/kg/hour IV continuous infusion is the maximum recommended rate; for congenital hyperinsulinemia, 40 mcg/kg/day subcutaneously or IV; for hypothalamic obesity, 15 mcg/kg/day subcutaneously.

    Infants

    Dependent on indication for therapy, route of administration, and patient response. For chylothorax, 10 mcg/kg/hour IV continuous infusion is the maximum recommended rate; for congenital hyperinsulinemia, 40 mcg/kg/day subcutaneously or IV.

    Neonates

    Dependent on indication for therapy, route of administration, and patient response. For chylothorax, 10 mcg/kg/hour IV continuous infusion is the maximum recommended rate; for congenital hyperinsulinemia, 40 mcg/kg/day subcutaneously or IV.

    Octreotide acetate

    capsule, delayed-release (Mycapssa)

    • 20mg

    injectable solution (Sandostatin)

    • 0.05mg/mL
    • 0.1mg/mL
    • 0.2mg/mL
    • 0.5mg/mL
    • 1mg/mL

    depot injection (Sandostatin LAR Depot)

    • 10mg/kit
    • 20mg/kit
    • 30mg/kit

    injectable solution (Bynfezia Pen)

    • 2500mcg/mL (single-patient-use pen)