Classes
DEA Class; Rx
Common Brand Names; Sandostatin, Sandostatin LAR, Bynfezia Pen, Mycapssa
- Antidiarrheals;
- Somatostatin Analogs
Description
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
Indications
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).
Contraindications
Hypersensitivity
Adverse Effects
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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
80 mg/day PO for acromegaly. Injectable doses are dependent on indication for therapy, route of administration, and patient response.
80 mg/day PO for acromegaly. Injectable doses are dependent on indication for therapy, route of administration, and patient response.
Dependent on indication for therapy, route of administration, and patient response. For hypothalamic obesity, 15 mcg/kg/day subcutaneously.
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.
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.
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.
How supplied
Octreotide acetate
