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12/15 ONC-1130276
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For: Severe Diarrhea and Flushing Associated With Carcinoid Syndrome

 * Efficacy
 * Safety Profile
 * Dosing & Administration
 * On-Demand Training & Resources
 * Mechanism of Action
 * Access
 * Patient Resources

For:
Severe Diarrhea and Flushing Associated With Carcinoid Syndrome
 * Acromegaly

IMPORTANT SAFETY INFORMATION AND INDICATION


QUICK LINKS

 * Group Created with Sketch. Prescribing Information
 * Visit Patient Site
 * Training & Resources
 * Patient Services

Important Safety Information

Warnings and Precautions Gallbladder abnormalities may occur. There have been
postmarketing reports of cholelithiasis (gallstones) resulting in complications,
including cholecystitis, cholangitis, ...

See More

Indication Sandostatin® LAR Depot (octreotide acetate) for injectable suspension
is indicated for long-term treatment of the severe diarrhea and flushing
episodes associated with metastatic carcinoid tumors and long-term treatment of
the profuse watery diarrhea associated with VIP-secreting tumors in patients in
whom initial treatment with immediate-release Sandostatin® (octreotide acetate)
Injection has been shown to be effective and tolerated. In patients with
carcinoid syndrome and VIPomas, the effect of Sandostatin Injection and
Sandostatin LAR Depot on tumor size, rate of growth, and development of
metastases has not been determined.


EFFICACY

 * Reduction in Severe Diarrhea
 * Reduction in Flushing
 * Reduction in 5-HIAA
 * Study Design
 * Case-Based Conversation


SAFETY PROFILE

 * Warnings and Precautions
 * Drug Interactions
 * Adverse Reactions


DOSING & ADMINISTRATION

 * Flexible Dosing
 * Mixing & Administration


ON-DEMAND TRAINING & RESOURCES

 * How to Mix
 * How to Administer
 * How to Administer Dorsogluteal and Ventrogluteal Injections
 * Clinical Considerations
 * Dosing
 * Additional Resources


MECHANISM OF ACTION

 * About Sandostatin LAR Depot


ACCESS

 * Universal Co-pay Program
 * Patient Assistance Now Oncology
 * Reimbursement FAQs
 * GPO Discount Information


PATIENT RESOURCES

 * Mobile Administration Program (MAP)
 * RealSupport™
 * Sandostatin Immediate-Release Injection Sample Program



IMPORTANT SAFETY INFORMATION

Warnings and Precautions

 * Gallbladder abnormalities may occur. There have been postmarketing reports of
   cholelithiasis (gallstones) resulting in complications, including
   cholecystitis, cholangitis, pancreatitis, and requiring cholecystectomy in
   patients taking Sandostatin LAR Depot. Patients should be monitored
   periodically. If complications of cholelithiasis are suspected, discontinue
   Sandostatin LAR Depot and treat appropriately
 * Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Blood glucose
   levels should be monitored when Sandostatin LAR Depot treatment is initiated
   or when the dose is altered. Anti-diabetic treatment should be adjusted
   accordingly
 * Thyroid Function: Hypothyroidism may occur. Baseline and periodic assessment
   of thyroid function (TSH, total and/or free T4) is recommended
 * Cardiac Function: Bradycardia, arrhythmia, conduction abnormalities, and
   other electrocardiogram changes may occur. The relationship of these events
   to octreotide acetate is not established because many of these patients have
   underlying cardiac disease. Use with caution in at-risk patients
 * Nutrition: Octreotide may alter absorption of dietary fats. Monitoring of
   vitamin B12 levels is recommended during therapy with Sandostatin LAR Depot.
   Patients on total parenteral nutrition and octreotide should have periodic
   monitoring of zinc levels

Drug Interactions

 * The following drugs require monitoring and possible dose adjustment when used
   with Sandostatin LAR Depot: cyclosporine, insulin, oral hypoglycemic agents,
   beta-blockers, and bromocriptine. Octreotide has been associated with
   alterations in nutrient absorption, so it may have an effect on absorption of
   orally administered drugs. Drugs mainly metabolized by CYP3A4 and which have
   a low therapeutic index should be used with caution
 * Octreotide competitively binds to somatostatin receptors and may interfere
   with the efficacy of lutetium Lu 177 dotatate. Discontinue Sandostatin LAR
   Depot at least 4 weeks prior to each lutetium Lu 177 dotatate dose

Adverse Reactions

 * The most common adverse reactions occurring in patients receiving Sandostatin
   LAR Depot are biliary abnormalities (62%), injection-site pain (20%-50%),
   nausea (24%-41%), abdominal pain (10%-35%), fatigue (8%-32%), headache
   (16%-30%), hyperglycemia (27%), back pain (8%-27%), constipation or vomiting
   (15%-21%), dizziness (18%-20%), sinus bradycardia (19%), pruritus (18%),
   upper respiratory tract infection (10%-18%), myalgia (4%-18%), flatulence
   (9%-16%), arthropathy (8%-15%), rash (15%), generalized pain (4%-15%),
   sinusitis (5%-12%), conduction abnormalities (9%), hypoglycemia (4%), and
   arrhythmia (3%)

Please see full Prescribing Information.

Indications and Usage

Sandostatin® LAR Depot (octreotide acetate) for injectable suspension is
indicated for patients in whom initial treatment with immediate-release
Sandostatin® (octreotide acetate) Injection has been shown to be effective and
tolerated for

 * Long-term treatment of the severe diarrhea and flushing episodes associated
   with metastatic carcinoid tumors
 * Long-term treatment of the profuse watery diarrhea associated with
   VIP-secreting tumors

In patients with carcinoid syndrome and VIPomas, the effect of Sandostatin
Injection and Sandostatin LAR Depot on tumor size, rate of growth, and
development of metastases has not been determined.


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