Adult Dosing

Suppression of Growth Hormone (Acromegaly)

Sandostatin

• 50-100 mcg SC/IV q8 hrs. Max: 1500 mcg/day
• Patients who tolerate octreotide inj can be switched to LAR depot after 2 wks

Sandostatin LAR

• LAR depot: 20 mg IM intragluteally q4 wks for 3 mo, then adjusted on the basis of growth hormone levels as follows
• GH 1 ng/mL, IGF-1 normal and clinical symptoms controlled: 10 mg IM q4 wks
• GH 2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: 20 mg IM q4 wks
• GH >2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled: 30 mg IM q4 wks
• GH, IGF-1, or symptoms not controlled at 30 mg, increase to 40 mg IM q4 wks

Symptomatic treatment of patients with metastatic carcinoid tumors:

Sandostatin

• Initial dose of 100-600 mcg/day SC/IV divided q6-12 hrs x 2 wks
• Maintenance dose of 450 mcg/day SC/IV. Range is 50-1,500 mcg/day, limited experience with dose >750 mcg
• Usual dosing: 300 mcg/day. Max: 1500 mcg/day
• Patients who tolerate octreotide inj can be switched to LAR depot after 2 wks

Sandostatin LAR

• LAR 20 mg IM intragluteally q4 wks for the next 2 months
• To achieve therapeutically effective level of serum octreotide, continue initial SC doses for 2 wks following LAR therapy
• If symptoms are adequately controlled reduce LAR to 10 mg IM for trial period, If symptoms are not adequately controlled increase LAR to 30 mg IM q4 wk [Max: 30 mg]

Diarrhea associated with vasoactive intestinal peptide tumors

Sandostatin

• Initial dosing: 200-300 mcg/day SC/IV divided q6-12 hrs x 2 wks (range 150-750 mcg/day)
• Maintenance: Adjust to achieve therapeutic response. Usually not more than 450 mcg/day

Sandostatin LAR

• LAR 20 mg IM intragluteally q4 wks for the next 2 months
• To achieve therapeutically effective level of serum octreotide, continue initial SC doses for 2 wks following LAR therapy
• If symptoms are adequately controlled reduce LAR to 10 mg IM for trial period, If symptoms are not adequately controlled increase LAR to 30 mg IM q4 wk [Max: 30 mg]

Hepatorenal Syndrome [Non-FDA approved]

• 100-200 micrograms SC tid

• For IV use, reconstitute octreotide in sterile isotonic saline solutions or dextrose 5% in water in volumes of 50-200 mL and infuse over 15-30 min or administer by IV push over 3 min
• Octreotide long-acting depot formulation should be administered IM intragluteally and never be given IV or SC. Avoid deltoid injection

Pediatric Dosing

• Safety and efficacy in the pediatric population have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses.
• Symptomatic treatment of patients with metastatic carcinoid tumors
• Treatment of the profuse watery diarrhea associated with vasoactive intestinal peptide tumors

• Hypersensitivity to any of the ingredients of the product

• N/A

Renal Dose Adjustment

• Patients requiring dialysis: Start with 10 mg q4 wks
• In other patients with renal function impairment: Start 20 mg q4 wks

Hepatic Dose Adjustment

• Liver cirrhosis: Start 10 mg q4 wks
• Long acting depot has not been studied in patients with renal impairment and hepatic impairment.

• Octreotide acetate inhibit gallbladder contractility and decrease bile secretion thus causing gallstones or sludge, biliary tract abnormalities, acute cholecystitis, ascending cholangitis, biliary obstruction, cholestatic hepatitis, or pancreatitis. Monitor the patient periodically
• Octreotide alters the balance between the counter-regulatory hormones, insulin, glucagon, and growth hormone resulting in hypoglycemia or hyperglycemia, monitor blood glucose levels when treatment is initiated, or dose is altered. Adjust antidiabetic treatment accordingly
• Insulin requirements may be decreased with risk of hypoglycemia, monitoring is highly recommended
• Octreotide can cause hypothyroidism as it suppresses the secretion of thyroid-stimulating hormone. Perform thyroid function test at baseline and periodically during chronic octreotide therapy
• Bradycardia, arrhythmias and conduction abnormalities, ECG changes like QT prolongation, axis shifts, early repolarization, low voltage, R/S transition, early R wave progression, and nonspecific ST-T wave changes were observed with octreotide therapy
• Octreotide alters absorption of dietary fats, and depress vitamin B12 levels; monitor vitamin B12 level during octreotide LAR depot therapy
• Monitor periodically zinc levels in patients on TPN and octreotide as there can be a excessive rise in serum zinc levels
• Monitor at base line and periodically Growth Hormone, IGF-1 in acromegaly patients, 5-HIAA, plasma serotonin, plasma Substance P in carcinoid and VIP (plasma vasoactive intestinal peptide) in VIPoma and also free T4 measurement during chronic therapy
• Can restore fertility in acromegaly patients. Female patients of childbearing potential should be advised to use adequate contraception during treatment with octreotide.

Cautions: Use cautiously in

• Hepatic impairment
• Renal impairment
• Diabetes mellitus
• History of cardiac disease
• Thyroid diseases
• Biliary diseases

Pregnancy Category:B

Breastfeeding: The excretion of octreotide into breastmilk has not been studied, it is unlikely to adversely affect the breastfed infant as it is poorly absorbed orally and has been safely administered directly to infants by injection. Carefully monitor infant especially if the infant is under 2 months when administering octreotide to nursing mothers, based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 Jan 2011). However manufacturer advises caution as many drugs are excreted in human milk.

• CNS: Headache, dizziness
• GI: Diarrhea, abdominal pain, flatulence, constipation, cholelithiasis, diarrhea, nausea, vomiting, dyspepsia, steatorrhea, discoloration of feces, tenesmus, cholecystitis, biliary obstruction, cholestatic hepatitis, pancreatitis, ascending cholangitis
• CV: Hypertension, sinus bradycardia, arrhythmias, conduction abnormalities
• RESP: Influenza-Like Symptoms, sinusitis, URTI
• HEMA: Anemia
• ENDO: Hypoglycemia, hyperglycemia, hypothyroidism
• MUSC: Arthropathy, back Pain, musculoskeletal pain, myalgia
• DERM: Myalgia, rash, alopecia
• EENT: Vision abnormality
• LOCAL: Injection site pain
• MISC: Fatigue, develops antibody, edema

• Long-acting octapeptide; inhibits growth hormone, glucagon, and insulin, suppresses LH response to GnRH, decreases splanchnic blood flow, and inhibits release of serotonin, gastrin, vasoactive intestinal peptide, secretin, motilin, pancreatic polypeptide and TSH
• Octreotide is well absorbed following SC and IM administration of depot form
• Metabolized by liver
• Renally excreted (32% unchanged)
• Half-life:
• Adults: 1.7-1.9 hrs
• Elderly: 2.5 hrs
• Renal impairment: 2.4 - 3.1 hrs
• Liver cirrhosis: 3.7 hrs

US Trade Name(s)

• Sandostatin
• Sandostatin LAR

US Availability

Octreotide (generic)

• INJ: 50 mcg/mL (1 mL amp)
• INJ: 100 mcg/mL (1 mL amp)
• INJ: 500 mcg/mL (1 mL amp)
• INJ: 200 mcg/mL (5 mL multidose vial)
• INJ: 1000 mcg/mL (5 mL multidose vial)

Sandostatin

• INJ: 50 mcg/mL (1 mL amp)
• INJ: 100 mcg/mL (1 mL amp)
• INJ: 500 mcg/mL (1 mL amp)
• INJ: 200 mcg/mL (5 mL multidose vial)
• INJ: 1000 mcg/mL (5 mL multidose vial)

Sandostatin LAR

• PWDR for INJ: 10 mg/vial
• PWDR for INJ: 20 mg/vial
• PWDR for INJ: 30 mg/vial

Canadian Trade Name(s)

• Sandostatin
• Sandostatin LAR

Canadian Availability

Octreotide (generic)

• INJ: 50 mcg/mL (1 mL amp)
• INJ: 100 mcg/mL (1 mL amp)
• INJ: 500 mcg/mL (1 mL amp)
• INJ: 200 mcg/mL (5 mL multidose vial)

Sandostatin

• INJ: 50 mcg/mL (1 mL amp)
• INJ: 100 mcg/mL (1 mL amp)
• INJ: 500 mcg/mL (1 mL amp)
• INJ: 200 mcg/mL (5 mL multidose vial)

Sandostatin LAR

• PWDR for INJ: 10 mg/vial
• PWDR for INJ: 20 mg/vial
• PWDR for INJ: 30 mg/vial

UK Trade Name(s)

• Sandostatin
• Sandostatin LAR

UK Availability

Octreotide (generic)

• INJ: 50 mcg/mL (1 mL amp)
• INJ: 100 mcg/mL (1 mL amp)
• INJ: 500 mcg/mL (1 mL amp)
• INJ: 200 mcg/mL (5 mL multidose vial)

Sandostatin

• INJ: 50 mcg/mL (1 mL amp)
• INJ: 100 mcg/mL (1 mL amp)
• INJ: 500 mcg/mL (1 mL amp)
• INJ: 200 mcg/mL (5 mL multidose vial)

Sandostatin LAR

• PWDR for INJ: 10 mg/vial
• PWDR for INJ: 20 mg/vial
• PWDR for INJ: 30 mg/vial

Australian Trade Name(s)

• Sandostatin
• Sandostatin LAR

Australian Availability

Octreotide (generic)

• INJ: 50 mcg/mL (1 mL amp)
• INJ: 100 mcg/mL (1 mL amp)
• INJ: 500 mcg/mL (1 mL amp)

Sandostatin

• INJ: 50 mcg/mL (1 mL amp)
• INJ: 100 mcg/mL (1 mL amp)
• INJ: 500 mcg/mL (1 mL amp)

Sandostatin LAR (modified release injection)

• PWDR for INJ: 10 mg/vial
• PWDR for INJ: 20 mg/vial
• PWDR for INJ: 30 mg/vial

[Outline]

Endocrine/Metabolic

Hormones; Miscellaneous

Pricing data from www.DrugStore.com in U.S.A.

• SandoSTATIN 50 MCG/ML SOLN [Ampule] (NOVARTIS)
  1 ml = $107.99
  3 ml = $305.97

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.