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Octreotide Drug Information Provided by Lexi-Comp

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Medication Safety Issues

Sound-alike/look-alike issues:

Sandostatin® may be confused with Sandimmune®, Sandostatin LAR®, sargramostim, simvastatin

Pronunciation

(ok TREE oh tide)

U.S. Brand Names

  • Sandostatin LAR®
  • Sandostatin®

Index Terms

  • NSC-671663
  • Octreotide Acetate

Generic Available

Yes: Injection solution (excludes depot formulation)

Canadian Brand Names

  • Octreotide Acetate Injection
  • Octreotide Acetate Omega
  • Sandostatin LAR®
  • Sandostatin®

Pharmacologic Category

  • Antidiarrheal
  • Antidote
  • Somatostatin Analog

Use: Labeled Indications

Control of symptoms in patients with metastatic carcinoid and vasoactive intestinal peptide-secreting tumors (VIPomas); treatment of acromegaly

Use: Unlabeled/Investigational

Secretory diarrhea (AIDS-associated [including Cryptosporidiosis], chemotherapy-induced, graft-versus-host disease (GVHD) induced, and postgastrectomy dumping syndrome); control of bleeding of esophageal varices; second-line treatment for thymic malignancies; Cushing's syndrome (ectopic); insulinomas; small bowel fistulas; pancreatic tumors; gastrinoma; Zollinger-Ellison syndrome; congenital hyperinsulinism; hypothalamic obesity; treatment of hypoglycemia secondary to sulfonylurea poisoning

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.

• 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.

• Diabetes: 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.

• 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.

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, 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, intestinal obstruction, intracranial hemorrhage, intraocular pressure increased, ischemia, jaundice, joint effusion, lactation, LFTs increased, libido decreased, malignant hyperpyrexia, menstrual irregularities, MI, migraine, 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

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

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

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. Stability of parenteral admixture is stable in NS for 96 hours at room temperature (25°C) and in D5W for 24 hours. 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) and protect from light. 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 give it 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%, mainly 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 LAR® to 10 mg I.M. every 4 weeks

GH ?2.5 ng/mL, IGF-1 normal, and symptoms controlled: Maintain octreotide LAR® at 20 mg I.M. every 4 weeks

GH >2.5 ng/mL, IGF-1 elevated, and/or symptoms uncontrolled: Increase octreotide LAR® 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:

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.

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: See dosing adjustment for VIPomas.

VIPomas: Adults:

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.

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 carcinoid tumors and 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

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 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 (maximum dose: 50 mcg); repeat in 6-12 hours as needed based upon blood glucose concentrations

Adults:

SubQ (preferred route of administration): 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

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 have ranged from 25-50 mcg/hour for the treatment of esophageal variceal bleeding (unlabeled route/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 route).

pH: 4.0-4.6

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, 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

Do not take any new prescription or over-the-counter medications, or herbal products during therapy without consulting prescriber (especially any other antidiarrheals or “stomach” medications). 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 or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); dizziness, fatigue, or drowsiness (use caution when driving or engaging in tasks that require alertness until response to drug is known); joint or muscle pain (consult prescriber for appropriate analgesia). Report unusual weight gain, swelling of extremities, or 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; or any other persistent adverse effect. Breast-feeding precaution: Inform prescriber if you are breast feeding.

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). Assess all other pharmacological or herbal products patient may be taking for potential interactions or toxicity (eg, may effect response to insulin or sulfonylureas and/or response to cardiovascular medications). See Administration for I.V., I.M., and SubQ specifics. Follow specific dosing directions when switching from SubQ to long-acting depot formulation. Assess results of laboratory tests on a regular basis with chronic therapy. Evaluate therapeutic effectiveness according to purpose for use and adverse effects (eg, hypo-/hyperglycemia, 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 proper use if self-administered (appropriate injection technique and syringe/needle disposal), possible side effects/appropriate interventions, and adverse symptoms to report.

Oncology: Emetic Potential

Very low (<10%)

Oncology: Vesicant

No

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, microspheres for suspension, as acetate [depot formulation]:

Sandostatin LAR®: 10 mg, 20 mg, 30 mg [contains polylactide-co-glycolide; packaged with diluent and syringe]

Injection, solution, as acetate: 0.2 mg/mL (5 mL); 1 mg/mL (5 mL)

Sandostatin®: 0.2 mg/mL (5 mL); 1 mg/mL (5 mL)

Injection, solution, as acetate [preservative free]: 0.05 mg/mL (1 mL); 0.1 mg/mL (1 mL); 0.5 mg/mL (1 mL)

Sandostatin®: 0.05 mg/mL (1 mL); 0.1 mg/mL (1 mL); 0.5 mg/mL (1 mL)

Pricing: U.S. (www.drugstore.com)

Kit (Sandostatin LAR Depot)

20 mg (1): $2311.99

Solution (Sandostatin)

50 mcg/mL (1): $19.99

1000 mcg/mL (5): $1052.89

References

Baillie-Johnson HR, “Octreotide in the Management of Treatment-Related Diarrhoea,” Anticancer Drugs, 1996, 7(Suppl 1):11-5.

Barrons RW, “Octreotide in Hyperinsulinism,” Ann Pharmacother, 1997, 31(2):239-41.

Behrman RE, Kliegman RM, and Jenson HB, Nelson's Textbook of Pediatrics, 17th ed, Philadelphia, PA: WB Saunders Co, 2004.

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.

Carr R and Zed PJ, “Octreotide for Sulfonylurea-Induced Hypoglycemia Following Overdose,” Ann Pharmacother, 2002, 36(11):1727-32.

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.

Erstad BL, “Octreotide for Acute Variceal Bleeding,” Ann Pharmacother, 2001, 35(5):618-26.

Heikenen JB, Pohl JF, Werlin SL, et al, “Octreotide in Pediatric Patients,” J Pediatr Gastroenterol Nutr, 2002, 35(5):600-9.

Hejna M, Schmidinger M, and Raderer M, “The Clinical Role of Somatostatin Analogues as Antineoplastic Agents: Much Ado About Nothing?” Ann Oncol, 2002, 13(5):653-68.

Jaros W, Biller J, Greer S, et al, “Successful Treatment of Idiopathic Secretory Diarrhea of Infancy With the Somatostatin Analogue SMS 201-995,” Gastroenterology, 1988, 94(1):189-93.

Jenkins SA, “Somatostatin in Acute Bleeding Oesophageal Varices. Clinical Evidence,” Drugs, 1992, 44(Suppl 2):36-55.

Katz MD and Erstad BL, “Octreotide, A New Somatostatin Analogue,” Clin Pharm, 1989, 8(4):255-73.

Lustig RH, Hinds PS, Ringwald-Smith K, et al, “Octreotide Therapy of Pediatric Hypothalamic Obesity: A Double-Blind, Placebo-Controlled Trial,” J Clin Endocrinol Metab, 2003, 88(6):2586-92.

McLaughlin SA, Crandall CS, and McKinney PE, “Octreotide: An Antidote for Sulfonylurea-Induced Hypoglycemia,” Ann Emerg Med, 2000, 36(2):133-6.

Mordel A, Sivilotti ML, Old AC, et al, “Octreotide for Pediatric Sulfonylurea Poisoning,” J Toxicol Clin Toxicol, 1998, 36(5):437.

Mulvihill SJ, “Perioperative Use of Octreotide in Gastrointestinal Surgery,” Digestion, 1993, 54(Suppl 1):33-7.

Pollak M, “The Potential Role of Somatostatin Analogues in Breast Cancer Treatment,” Yale J Biol Med, 1997, 70(5-6):535-9.

Tang J, and Weiter JJ, “Branch Retinal Artery Occlusion After Injection of a Long-Acting Risperidone Preparation,” Annals Intern Med, 2007, 147(4): 283-3.

Tassiopoulos AK, Baum G, and Halverson JD, “Small Bowel Fistulas,” Surg Clin North Am, 1996, 76(5):1175-81

von Werder K, Muller OA, and Stalla GK, “Somatostatin Analogs in Ectopic Corticotropin Production,” Metabolism, 1996, 45(8 Suppl 1):129-31.

International Brand Names

  • Cryostatin (MX)
  • Nomactril (MX)
  • Octride (CO, TH)
  • Proclose (MX)
  • Sandostatin (AE, AR, AT, AU, BD, BE, BG, BH, BR, CH, CL, CN, CY, CZ, DE, DK, EG, ES, FI, FR, GB, GR, HK, HN, ID, IE, IL, IN, IQ, IR, IT, JO, JP, KP, KW, LB, LY, MY, NL, NO, OM, PE, PH, PK, PL, PT, PY, QA, RU, SA, SE, SG, SY, TH, TR, TW, UY, VE, YE)
  • Sandostatin LAR (AR, AU, BR, CH, CN, EC, EE, ID, IL, KP, MY, NO, PE, PH, PL, SE, SG, TH, TW, UY)
  • Sandostatina (IT, MX, PT)
  • Sandostatine (BE, FR, NL)

Lexi-Comp.com

Last full review/revision August 2009

Content last modified August 2009

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