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Pronunciation
(ok TREE oh tide)
Generic Available (U.S.)
Yes: Excludes depot formulation
Index Terms
U.S. Brand Names
Canadian Brand Names
Pharmacologic Category
Use: Labeled Indications
Control of symptoms (diarrhea and flushing) in patients with metastatic carcinoid tumors; treatment of watery diarrhea associated with vasoactive intestinal peptide-secreting tumors (VIPomas); treatment of acromegaly
Use: Unlabeled/Investigational
Treatment of AIDS-associated diarrhea (including Cryptosporidiosis), chemotherapy-induced diarrhea, graft-versus-host disease (GVHD) associated diarrhea, postgastrectomy dumping syndrome; control of bleeding of esophageal varices; second-line treatment for thymic malignancies; Cushing's syndrome (ectopic); insulinomas; small bowel fistulas; islet cell tumors; Zollinger-Ellison syndrome; congenital hyperinsulinism; hypothalamic obesity; treatment of hypoglycemia secondary to sulfonylurea poisoning; treatment of malignant bowel obstruction
Pregnancy Risk Factor
B
Pregnancy Considerations
Teratogenic effects were not observed in animal studies. Octreotide crosses the human placenta; data concerning use in pregnancy is limited. Women of childbearing potential should use adequate contraception during treatment with octreotide; normalization of IGF-1 and GH may restore fertility in women with acromegaly. In case reports of acromegalic women who received normal doses of octreotide during pregnancy, no congenital malformations were reported.
Lactation
Excretion in breast milk unknown/use caution
Contraindications
Hypersensitivity to octreotide or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Abnormal Schillings test: Chronic treatment has been associated with abnormal Schillings test; monitor vitamin B12 levels.
• Cholelithiasis: May impair gallbladder function (inhibits gallbladder contractility and decreases bile secretion); monitor patients for cholelithiasis. The incidence of gallbladder stone or biliary sludge increases with a duration of therapy of ≥12 months. In patients with neuroendocrine tumors, the NCCN guidelines (v.2.2009) recommend considering prophylactic cholecystectomy in patients undergoing abdominal surgery if octreotide treatment is planned.
• Glucose regulation: Somatostatin analogs may affect glucose regulation. In type I diabetes, severe hypoglycemia may occur; in type II diabetes or patients without diabetes, hyperglycemia may occur. Insulin and other hypoglycemic medication requirements may change. Octreotide may worsen hypoglycemia in patients with insulinomas; use with caution.
• Hypothyroidism: Suppresses secretion of TSH; monitor for hypothyroidism.
• Pancreatitis: May alter absorption of dietary fats; monitor for pancreatitis.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with heart failure or concomitant medications that alter heart rate or rhythm; bradycardia, conduction abnormalities, and arrhythmia have been observed in acromegalic and carcinoid syndrome patients. Cardiovascular medication requirements may change.
• Excessive fluid loss: May reduce excessive fluid loss in patients with conditions that cause such a loss; periodic monitoring for elevations in zinc levels is recommended in such patients that are maintained on total parenteral nutrition (TPN).
• Hepatic impairment: Use caution in patients with hepatic impairment; dosage adjustment required in patients with established cirrhosis
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required in patients receiving dialysis.
Concurrent drug therapy issues:
• QTc-prolonging agents: Octreotide may enhance the adverse/toxic effects of other QTc-prolonging agents.
Dosage form specific issues:
• Depot formulation: Do not use depot formulation for the treatment of sulfonylurea-induced hypoglycemia.
• Vehicle used in depot injection (polylactide-co-glycolide microspheres): Has rarely been associated with retinal artery occlusion in patients with abnormal arteriovenous anastomosis (eg, patent foramen ovale).
Special populations:
• Elderly: Dosage adjustment may be necessary; significant increases in elimination half-life have been observed in older adults.
• Females: Therapy may restore fertility; females of childbearing potential should use adequate contraception.
• Pediatrics: Postmarketing cases of serious and fatal events, including hypoxia and necrotizing enterocolitis, have been reported with octreotide use in children (usually with serious underlying conditions), particularly in children <2 years of age. In studies with octreotide depot, the incidence of cholelithiasis in children is higher than the reported incidences for adults and efficacy was not demonstrated.
Adverse Reactions
Adverse reactions vary by route of administration and dosage form. Frequency of cardiac, endocrine, and gastrointestinal adverse reactions was generally higher in acromegalics.
>16%:
Cardiovascular: Sinus bradycardia (19% to 25%), chest pain (≤20%; non-depot formulations)
Central nervous system: Fatigue (1% to 32%), headache (6% to 30%), malaise (16% to 20%), fever (16% to 20%), dizziness (5% to 20%)
Dermatologic: Pruritus (≤18%)
Endocrine & metabolic: Hyperglycemia (2% to 27%)
Gastrointestinal: Abdominal pain (5% to 61%), loose stools (5% to 61%), nausea (5% to 61%), diarrhea (34% to 58%), flatulence (≤38%), cholelithiasis (13% to 38%; length of therapy dependent), biliary sludge (24%; length of therapy dependent), constipation (9% to 21%), vomiting (4% to 21%), biliary duct dilatation (12%)
Local: Injection site pain (2% to 50%; dose and formulation related)
Neuromuscular & skeletal: Back pain (1% to 27%), arthropathy (8% to 19%), myalgia (≤18%)
Respiratory: Upper respiratory infection (10% to 23%), dyspnea (≤20%; non-depot formulations)
Miscellaneous: Antibodies to octreotide (up to 25%; no efficacy change), flu symptoms (1% to 20%)
5% to 15%:
Cardiovascular: Hypertension (≤13%), conduction abnormalities (9% to 10%), arrhythmia (3% to 9%), palpitation, peripheral edema
Central nervous system: Pain (4% to 15%), anxiety, confusion, hypoesthesia, insomnia
Dermatologic: Rash (15%; depot formulation), alopecia (≤13%)
Endocrine & metabolic: Hypothyroidism (≤12%; non-depot formulations), goiter (≤8%; non-depot formulations)
Gastrointestinal: Anorexia, cramping, tenesmus (4% to 6%), dyspepsia (4% to 6%), steatorrhea (4% to 6%), feces discoloration (4% to 6%)
Hematologic: Anemia (≤15%; non-depot formulations: <1%)
Neuromuscular & skeletal: Arthralgia, myalgia, paresthesia, rigors, weakness
Otic: Earache
Renal: Renal calculus
Respiratory: Cough, pharyngitis, sinusitis, rhinitis
Miscellaneous: Allergy, diaphoresis
1% to 4%:
Cardiovascular: Angina, cardiac failure, edema, flushing, hematoma, phlebitis
Central nervous system: Abnormal gait, amnesia, depression, dysphonia, hallucinations, nervousness, neuralgia, somnolence, vertigo
Dermatologic: Acne, bruising, cellulitis
Endocrine & metabolic: Hypoglycemia (2% to 4%), hypokalemia, hypoproteinemia, gout, cachexia, breast pain, impotence
Gastrointestinal: Colitis, diverticulitis, dysphagia, fat malabsorption, gastritis, gastroenteritis, gingivitis, glossitis, melena, stomatitis, taste perversion, xerostomia
Genitourinary: Incontinence, pollakuria (non-depot formulations), urinary tract infection
Local: Injection site hematoma
Neuromuscular & skeletal: Hyperkinesia, hypertonia, joint pain, neuropathy, tremor
Ocular: Blurred vision, visual disturbance
Otic: Tinnitus
Renal: Albuminuria, renal abscess
Respiratory: Bronchitis, epistaxis
Miscellaneous: Bacterial infection, cold symptoms, moniliasis
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Anaphylactic shock, anaphylactoid reaction, aneurysm, aphasia, appendicitis, arthritis, ascending cholangitis, ascites, atrial fibrillation, basal cell carcinoma, Bell's palsy, biliary obstruction, breast carcinoma, cardiac arrest, cerebral vascular disorder, CHF, cholecystitis, cholestatic hepatitis, CK increased, creatinine increased, deafness, diabetes insipidus, diabetes mellitus, facial edema, fatty liver, galactorrhea, gallbladder polyp, GI bleeding, GI hemorrhage, GI ulcer, glaucoma, gynecomastia, hearing loss, hematuria, hemiparesis, hemorrhoids, hepatitis, hyperesthesia, hypertensive reaction, hypoadrenalism, hypoxia (children), intestinal obstruction, intracranial hemorrhage, intraocular pressure increased, ischemia, jaundice, joint effusion, lactation, LFTs increased, libido decreased, malignant hyperpyrexia, menstrual irregularities, MI, migraine, necrotizing enterocolitis (children), nephrolithiasis, neuritis, orthostatic hypotension, pancreatitis, pancytopenia, paresis, petechiae, pituitary apoplexy, pleural effusion, pneumonia, pneumothorax, pulmonary embolism, pulmonary hypertension, pulmonary nodule, Raynaud's syndrome, rectal bleeding, renal failure, renal insufficiency, retinal vein thrombosis, scotoma, seizure, status asthmaticus, suicide attempt, syncope, tachycardia, thrombocytopenia, thrombophlebitis, thrombosis, urticaria, visual field defect, weight loss, wheal/erythema
Drug Interactions
Alfuzosin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Artemether: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Chloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Ciprofloxacin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Ciprofloxacin (Systemic): May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Codeine: Somatostatin Analogs may decrease the metabolism of Codeine. The formation of two major codeine metabolites (morphine and norcodeine) may be impaired by somatostatin analogs. Risk C: Monitor therapy
CycloSPORINE: Somatostatin Analogs may decrease the serum concentration of CycloSPORINE. Risk D: Consider therapy modification
CycloSPORINE (Systemic): Somatostatin Analogs may decrease the serum concentration of CycloSPORINE (Systemic). Risk D: Consider therapy modification
Dronedarone: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Dronedarone. Risk X: Avoid combination
Gadobutrol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk D: Consider therapy modification
Herbs (Hypoglycemic Properties): May enhance the hypoglycemic effect of Hypoglycemic Agents. Risk C: Monitor therapy
Hypoglycemic Agents: May enhance the adverse/toxic effect of other Hypoglycemic Agents. Risk C: Monitor therapy
Lumefantrine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Nilotinib: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Pegvisomant: Somatostatin Analogs may enhance the adverse/toxic effect of Pegvisomant. Specifically, this combination may increase the risk for significant elevations of liver enzymes. Risk C: Monitor therapy
Pimozide: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Pimozide. Risk X: Avoid combination
QTc-Prolonging Agents: May enhance the adverse/toxic effect of other QTc-Prolonging Agents. Their effects can be additive, causing life-threatening ventricular arrhythmias. Risk D: Consider therapy modification
QuiNINE: QTc-Prolonging Agents may enhance the QTc-prolonging effect of QuiNINE. QuiNINE may enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Tetrabenazine: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Tetrabenazine. Risk X: Avoid combination
Thioridazine: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Thioridazine. Risk X: Avoid combination
Toremifene: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Toremifene. The risk for potentially dangerous arrhythmias may be increased. Risk X: Avoid combination
Vandetanib: QTc-Prolonging Agents may enhance the arrhythmogenic effect of Vandetanib. Risk X: Avoid combination
Ziprasidone: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Ziprasidone. The risk of a severe arrhythmia may be increased. Risk X: Avoid combination
Ethanol/Nutrition/Herb Interactions
Herb/Nutraceutical: Avoid hypoglycemic herbs, including alfalfa, aloe, bilberry, bitter melon, burdock, celery, damiana, fenugreek, garcinia, garlic, ginger, ginseng (American), gymnema, marshmallow, and stinging nettle (may enhance the hypoglycemic effect of octreotide).
Storage
Solution: Octreotide is a clear solution and should be stored at refrigerated temperatures between 2°C and 8°C (36°F and 46°F). Protect from light. May be stored at room temperature of 20°C to 30°C (70°F and 86°F) for up to 14 days when protected from light. Stable as a parenteral admixture in NS for 96 hours at room temperature (25°C) and in D5W for 24 hours. Stable for up to 7 days in a polypropylene syringe. Discard multidose vials within 14 days after initial entry.
Suspension: Prior to dilution, store at refrigerated temperatures between 2°C and 8°C (36°F and 46°F). Protect from light. The following stability information has also been reported: May be stored at room temperature for up to 14 days (Cohen, 2007). Depot drug product kit may be at room temperature for 30-60 minutes prior to use. Use suspension immediately after preparation.
Compatibility
Solution: Stable in D5W, NS; incompatible with fat emulsion 10%; variable stability in TPN (The manufacturer states that octreotide solution is not compatible in TPN solutions due to the formation of a glycosyl octreotide conjugate which may have decreased activity; other sources assign limited compatibility.)
Y-site administration: Incompatible: Micafungin. Variable (consult detailed reference): Pantoprazole, TPN.
Compatibility when admixed: Compatible: Heparin. Incompatible: Pantoprazole.
Mechanism of Action
Mimics natural somatostatin by inhibiting serotonin release, and the secretion of gastrin, VIP, insulin, glucagon, secretin, motilin, and pancreatic polypeptide. Decreases growth hormone and IGF-1 in acromegaly. Octreotide provides more potent inhibition of growth hormone, glucagon, and insulin as compared to endogenous somatostatin. Also suppresses LH response to GnRH, secretion of thyroid-stimulating hormone and decreases splanchnic blood flow.
Pharmacodynamics/Kinetics
Duration: SubQ: 6-12 hours
Absorption: SubQ: Rapid and complete; I.M. (depot formulation): Released slowly (via microsphere degradation in the muscle)
Distribution: Vd: 14 L (13-30 L in acromegaly)
Protein binding: 65%, primarily to lipoprotein (41% in acromegaly)
Metabolism: Extensively hepatic
Bioavailability: SubQ: 100%; I.M: 60% to 63% of SubQ dose
Half-life elimination: 1.7-1.9 hours; Increased in elderly patients; Cirrhosis: Up to 3.7 hours; Fatty liver disease: Up to 3.4 hours; Renal impairment: Up to 3.1 hours
Time to peak, plasma: SubQ: 0.4 hours (0.7 hours acromegaly); I.M.: 1 hour
Excretion: Urine (32% as unchanged drug)
Dosage
Acromegaly: Adults:
SubQ, I.V.: Initial: 50 mcg 3 times/day; titrate to achieve growth hormone levels <5 ng/mL or IGF-I (somatomedin C) levels <1.9 units/mL in males and <2.2 units/mL in females. Usual effective dose 100-200 mcg 3 times/day; range: 300-1500 mcg/day. Note: Should be withdrawn yearly for a 4-week interval (8 weeks for depot injection) in patients who have received irradiation. Resume if levels increase and signs/symptoms recur.
I.M. depot injection: Patients must be stabilized on subcutaneous octreotide for at least 2 weeks before switching to the long-acting depot. Upon switch: 20 mg I.M. intragluteally every 4 weeks for 3 months, then the dose may be modified based upon response.
Dosage adjustment for acromegaly: After 3 months of depot injections, the dosage may be continued or modified as follows:
GH ≤1 ng/mL, IGF-1 normal, and symptoms controlled: Reduce octreotide depot to 10 mg I.M. every 4 weeks
GH ≤2.5 ng/mL, IGF-1 normal, and symptoms controlled: Maintain octreotide depot at 20 mg I.M. every 4 weeks
GH >2.5 ng/mL, IGF-1 elevated, and/or symptoms uncontrolled: Increase octreotide depot to 30 mg I.M. every 4 weeks
Note: Patients not adequately controlled at a dose of 30 mg may increase dose to 40 mg every 4 weeks. Dosages >40 mg are not recommended.
Carcinoid tumors: Adults:
Manufacturer labeling:
SubQ, I.V.: Initial 2 weeks: 100-600 mcg/day in 2-4 divided doses; usual range: 50-750 mcg/day (some patients may require up to 1500 mcg/day)
I.M. depot injection: Patients must be stabilized on subcutaneous octreotide for at least 2 weeks before switching to the long-acting depot. Upon switch: 20 mg I.M. intragluteally every 4 weeks for 2 months, then the dose may be modified based upon response.
NCCN guidelines (Neuroendocrine Tumor, v.2.2009):
SubQ: 150-250 mcg 3 times daily; dose and frequency may be increased if needed for symptom control
I.M. depot injection: 20-30 mg every 4 weeks; dose and frequency may be increased if needed for symptom control; SubQ octreotide may be used for breakthrough symptoms
Note: Patients should continue to receive their SubQ injections for the first 2 weeks at the same dose in order to maintain therapeutic levels (some patients may require 3-4 weeks of continued SubQ injections). Patients who experience periodic exacerbations of symptoms may require temporary SubQ injections in addition to depot injections (at their previous SubQ dosing regimen) until symptoms have resolved.
Dosage adjustment for carcinoid tumors: After 2 months of depot injections, the dosage may be continued or modified as follows:
Increase to 30 mg I.M. every 4 weeks if symptoms are inadequately controlled
Decrease to 10 mg I.M. every 4 weeks, for a trial period, if initially responsive to 20 mg dose
Dosage >30 mg is not recommended
VIPomas:
Manufacturer labeling:
SubQ, I.V.: Initial 2 weeks: 200-300 mcg/day in 2-4 divided doses; titrate dose based on response/tolerance. Range: 150-750 mcg/day (doses >450 mcg/day are rarely required)
I.M. depot injection: Patients must be stabilized on subcutaneous octreotide for at least 2 weeks before switching to the long-acting depot. Upon switch: 20 mg I.M. intragluteally every 4 weeks for 2 months, then the dose may be modified based upon response.
NCCN guidelines (Neuroendocrine Tumor, v.2.2009):
SubQ: 150-250 mcg 3 times daily; dose and frequency may be increased if needed for symptom control
I.M. depot injection: 20-30 mg every 4 weeks dose and frequency may be increased if needed for symptom control; SubQ octreotide may be used for breakthrough symptoms
Note: Patients receiving depot injection should continue to receive their SubQ injections for the first 2 weeks at the same dose in order to maintain therapeutic levels (some patients may require 3-4 weeks of continued SubQ injections). Patients who experience periodic exacerbations of symptoms may require temporary SubQ injections in addition to depot injections (at their previous SubQ dosing regimen) until symptoms have resolved.
Dosage adjustment for VIPomas: After 2 months of depot injections, the dosage may be continued or modified as follows:
Increase to 30 mg I.M. every 4 weeks if symptoms are inadequately controlled
Decrease to 10 mg I.M. every 4 weeks, for a trial period, if initially responsive to 20 mg dose
Dosage >30 mg is not recommended
Congenital hyperinsulinism (unlabeled use): Infants and Children: SubQ: Doses of 3-40 mcg/kg/day have been used
Diarrhea (unlabeled use):
Infants and Children: I.V., SubQ: Doses of 1-10 mcg/kg every 12 hours have been used in children beginning at the low end of the range and increasing by 0.3 mcg/kg/dose at 3-day intervals. Suppression of growth hormone (animal data) is of concern when used as long-term therapy.
Adults: I.V.: Initial: 50-100 mcg every 8 hours; increase by 100 mcg/dose at 48-hour intervals; maximum dose: 500 mcg every 8 hours
Diarrhea associated with chemotherapy (unlabeled use):
Low grade or uncomplicated: SubQ: 100-150 mcg every 8 hours (Benson, 2004; Kornblau, 2000)
Severe: Initial: SubQ: 100-150 mcg every 8 hours; may increase to 500-1500 mcg I.V. or SubQ every 8 hours (Kornblau, 2000)
Complicated: I.V., SubQ: Initial: 100-150 mcg 3 times daily or I.V. Infusion: 25-50 mcg/hour; may escalate to 500 mcg 3 times a day until controlled (Benson, 2004)
Diarrhea associated with GVHD (unlabeled use): I.V.: 500 mcg every 8 hours; discontinue within 24 hours of resolution; Maximum duration of therapy if diarrhea is not resolved: 7 days (Kornblau, 2000)
Esophageal varices bleeding (unlabeled use): Adults: I.V. bolus: 25-50 mcg followed by continuous I.V. infusion of 25-50 mcg/hour
Hypoglycemia in sulfonylurea poisoning (unlabeled use): Note: SubQ is the preferred route of administration; repeat dosing, dose escalation, or initiation of a continuous infusion may be required in patients who experience recurrent hypoglycemia. Duration of treatment may exceed 24 hours. Optimal care decisions should be made based upon patient-specific details:
Children: SubQ: 1-1.5 mcg/kg; repeat in 6-12 hours as needed based upon blood glucose concentrations
Adults:
SubQ: 50-100 mcg; repeat in 6-12 hours as needed based upon blood glucose concentrations
I.V.: Doses up to 100-125 mcg/hour have been used successfully
Islet cell tumors (unlabeled use): SubQ: 150-250 mcg 3 times daily or I.M. (depot): 20-30 mg every 4 weeks dose and frequency may be increased if needed for symptom control; SubQ octreotide may be used for breakthrough symptoms (NCCN Neuroendocrine Tumor guidelines v.2.2009)
Malignant bowel obstruction (unlabeled use): SubQ: 150-300 mcg twice daily (Mercadante, 2007; NCCN Palliative Care guidelines v.1.2010)
Elderly: Elimination half-life is increased by 46% and clearance is decreased by 26%; dose adjustment may be required. Dosing should generally begin at the lower end of dosing range.
Dosage adjustment in renal impairment:
Nondialysis-dependent renal impairment: No dosage adjustment required
Dialysis-dependent renal impairment: Depot injection: Initial dose: 10 mg I.M. every 4 weeks; titrate based upon response (clearance is reduced by ~50%)
Dosage adjustment in hepatic impairment: Patients with established cirrhosis of the liver: Depot injection: Initial dose: 10 mg I.M. every 4 weeks; titrate based upon response
Administration: I.M.
Depot formulation: Administer I.M. intragluteal (avoid deltoid administration); alternate gluteal injection sites to avoid irritation. Do not administer Sandostatin LAR® intravenously or subcutaneously; must be administered immediately after mixing.
Administration: I.V.
Regular injection only (not suspension): IVP should be administered undiluted over 3 minutes. IVPB should be administered over 15-30 minutes. Continuous I.V. infusion rates (unlabeled administration rate) have ranged from 25-50 mcg/hour for the treatment of esophageal variceal bleeding (unlabeled use); continuous I.V. infusion rates of 100-125 mcg/hour have been used for the treatment of sulfonylurea-induced hypoglycemia (unlabeled use).
Administration: Other
SubQ: Regular injection formulation (not depot) can be administered SubQ. Use the concentration with smallest volume to deliver dose to reduce injection site pain. Rotate injection site; may bring to room temperature prior to injection.
Administration: I.V. Detail
Do not use if solution contains particles or is discolored. I.V. administration may be IVP, IVPB, or continuous I.V. infusion (unlabeled rate).
pH: Solution: ~4.2
Monitoring Parameters
Acromegaly: Growth hormone, somatomedin C (IGF-1)
Carcinoid: 5-HIAA, plasma serotonin and plasma substance P
VIPomas: Vasoactive intestinal peptide
Chronic therapy: Thyroid function (baseline and periodic), vitamin B12 level, blood glucose, glycemic control and antidiabetic regimen (patients with diabetes mellitus), cardiac function (heart rate, ECG), zinc level (patients with excessive fluid loss maintained on TPN)
Reference Range
Vasoactive intestinal peptide: <75 ng/L; levels vary considerably between laboratories
Dietary Considerations
Schedule injections between meals to decrease GI effects. May alter absorption of dietary fats.
Patient Education
If self-administered, follow instructions for injection and syringe/needle disposal. Schedule injections between meals to decrease GI effects. Consult prescriber about appropriate diet. If you have diabetes, monitor serum glucose closely and notify prescriber of significant changes (this drug may alter the effects of insulin or sulfonylureas). May cause skin flushing, nausea, vomiting, dizziness, fatigue, drowsiness, or joint or muscle pain. Report unusual weight gain; swelling of extremities; respiratory difficulty; acute or persistent GI distress (eg, diarrhea, vomiting, constipation, abdominal pain); muscle weakness or tremors or loss of motor function; chest pain or palpitations; blurred vision; depression; or redness, swelling, burning, or pain at injection site.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation), gingivitis, glossitis, stomatitis, taste perversion, and dysphagia.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
Octreotide is one of the drugs confirmed to prolong the QT interval and is accepted as having a risk of causing torsade de pointes. The risk of drug-induced torsade de pointes is extremely low when a single QT interval prolonging drug is prescribed. In terms of epinephrine, it is not known what effect vasoconstrictors in the local anesthetic regimen will have in patients with a known history of congenital prolonged QT interval or in patients taking any medication that prolongs the QT interval. Until more information is obtained, it is suggested that the clinician consult with the physician prior to the use of a vasoconstrictor in suspected patients, and that the vasoconstrictor (epinephrine, mepivacaine and levonordefrin [Carbocaine® 2% with Neo-Cobefrin®]) be used with caution.
Dental Comment
Octreotide is known to prolong the QT interval. The QT interval is measured as the time and distance between the Q point of the QRS complex and the end of the T wave in the ECG tracing. After adjustment for heart rate, the QT interval is defined as prolonged if it is more than 450 msec in men and 460 msec in women. A long QT syndrome was first described in the 1950s and 60s as a congenital syndrome involving QT interval prolongation and syncope and sudden death. Some of the congenital long QT syndromes were characterized by a peculiar electrocardiographic appearance of the QRS complex involving a premature atria beat followed by a pause, then a subsequent sinus beat showing marked QT prolongation and deformity. This type of cardiac arrhythmia was originally termed “torsade de pointes” (translated from the French as “twisting of the points”). Octreotide is considered as having a risk of causing torsade de pointes. Since it is not known what effect vasoconstrictors in the local anesthetic regimen will have in patients with a known history of congenital prolonged QT interval or in patients taking any medication that prolongs the QT interval, a medical consult is suggested.
Mental Health: Effects on Mental Status
May cause drowsiness, dizziness, or depression; may rarely cause anxiety
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Use caution in presence of renal and/or hepatic impairment (dosage adjustment may be necessary). May effect response to insulin or sulfonylureas. Follow specific dosing directions when switching from SubQ to long-acting depot formulation. Evaluate therapeutic effectiveness according to use and adverse effects (eg, hyper-/hypoglycemia, hypothyroidism, cardiovascular changes, GI disturbances, CNS changes, dyspnea). Caution patients with diabetes to monitor serum glucose closely; may affect response to insulin or sulfonylureas. Teach patient appropriate injection technique and syringe/needle disposal.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, microspheres for suspension [depot formulation]:
SandoSTATIN LAR®: 10 mg, 20 mg, 30 mg [contains polylactide-co-glycolide; supplied with diluent]
Injection, solution: 100 mcg/mL (1 mL); 200 mcg/mL (5 mL); 1000 mcg/mL (5 mL)
SandoSTATIN®: 200 mcg/mL (5 mL); 1000 mcg/mL (5 mL)
Injection, solution [preservative free]: 50 mcg/mL (1 mL); 100 mcg/mL (1 mL); 200 mcg/mL (5 mL); 500 mcg/mL (1 mL)
SandoSTATIN®: 50 mcg/mL (1 mL); 100 mcg/mL (1 mL); 500 mcg/mL (1 mL)
Pricing: U.S. (www.drugstore.com)
Kit (SandoSTATIN LAR Depot)
20 mg (1): $2399.99
Solution (SandoSTATIN)
50 mcg/mL (1): $107.99
1000 mcg/mL (5): $1052.99
References
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Behrman RE, Kliegman RM, and Jenson HB, Nelson's Textbook of Pediatrics, 17th ed, Philadelphia, PA: WB Saunders Co, 2004.
Benson AB 3rd, Ajani JA, Catalano RB, et al, “Recommended Guidelines for the Treatment of Cancer Treatment-Induced Diarrhea,” J Clin Oncol, 2004, 22(14):2918-26.
Braatvedt GD, “Octreotide for the Treatment of Sulphonylurea Induced Hypoglycaemia in Type 2 Diabetes,” N Z Med J, 1997, 110(1044):189-90.
Bui L, Adler D, and Keller KH, “Prolonged Octreotide Infusion to Treat Glyburide-Induced Hypoglycemia,” J Toxicol Clin Toxicol, 2000, 38(5):576.
Calello DP, Osterhoudt KC, Henretig FM, et al, “Octreotide for Pediatric Sulfonylurea Overdose: Review of 5 Cases,” Clin Toxicol, 2005, 43:671.
Carr R and Zed PJ, “Octreotide for Sulfonylurea-Induced Hypoglycemia Following Overdose,” Ann Pharmacother, 2002, 36(11):1727-32.
Cohen V, Jellinek SP, Teperikidis L, et al, “Room-Temperature Storage of Medications Labeled for Refrigeration,” Am J Health-Syst Pharm, 2007, 64(16):1711-15.
Corley DA, Cello JP, Adkisson W, et al, “Octreotide for Acute Esophageal Variceal Bleeding: A Meta-analysis,” Gastroenterology, 2001, 120(4):946-54.
Couper RT, Berzen A, Berall G, et al, “Clinical Response to the Long-Acting Somatostatin Analogue SMS 201-995 in a Child With Congenital Microvillus Atrophy,” Gut, 1989, 30(7):1020-4.
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Last full review/revision June 2011
Content last modified June 2011
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