For:
Severe Diarrhea and Flushing Associated With Carcinoid Syndrome
Important Safety Information

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

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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

 

Sandostatin® LAR Depot (octreotide acetate) for injectable suspension for treatment of the severe diarrhea and flushing associated with metastatic carcinoid tumors

The long-standing leader in symptom control The long-standing leader in symptom control

Deliver Control with Sandostatin LAR Depot

 

Reduction in Severe Diarrhea

Reduction in severe diarrhea through week 242,3

42% mean reduction in severe diarrhea associated with metastatic carcinoid tumors 42% mean reduction in severe diarrhea associated with metastatic carcinoid tumors

Diarrhea is the #2 most commonly occurring symptom of carcinoid syndrome Diarrhea is the #2 most commonly occurring symptom of carcinoid syndrome

Reduction in Flushing

Reduction in flushing episodes through week 242,3

84% mean reduction in flushing associated with metastatic carcinoid tumors 84% mean reduction in flushing associated with metastatic carcinoid tumors

Flushing is the #1 most commonly occurring symptom of carcinoid syndrome Flushing is the #1 most commonly occurring symptom of carcinoid syndrome

 

HIGHLIGHTS OF IMPORTANT SAFETY INFORMATION

 

Warnings and Precautions: Treatment with Sandostatin LAR Depot may affect gallbladder function, with postmarketing reports of cholelithiasis (gallstones) resulting in complications; glucose metabolism; thyroid and cardiac function; and nutritional absorption (periodic monitoring is recommended). Cardiac function: use with caution in at-risk patients.

Please see study design details below.

 

Reduction in 5-HIAA

Reduction in 5-HIAA levels through week 242,3

Up to 50% reduction in median 5-HIAA levels Up to 50% reduction in median 5-HIAA levels

5-HIAA, 5-hydroxyindoleacetic acid.

a5-HIAA reductions are within the range reported in published literature for patients treated with octreotide (10%-50%).

 

5-HIAA may indicate effective management of severe diarrhea and flushing related to metastatic carcinoid tumors 5-HIAA may indicate effective management of severe diarrhea and flushing related to metastatic carcinoid tumors

Learn More About the Importance of 5-HIAA

5-HIAA is a critical marker of carcinoid syndrome.4,5,8 Learn more about 5-HIAA testing and why suppressing 5-HIAA levels is important.

Study Design

A 6-month clinical trial of malignant carcinoid syndrome was performed in patients who had previously been shown to be responsive to Sandostatin® (octreotide acetate) Immediate-Release Injection. Patients received 10-mg, 20-mg, or 30-mg doses of Sandostatin LAR Depot every 28 days or continued their Sandostatin Immediate-Release Injection regimen. Patients receiving Sandostatin LAR Depot who experienced symptom flare-ups were permitted to use supplemental Sandostatin Immediate-Release Injection until symptoms were again controlled to screening frequency.2,3

Case-Based Conversation

Sandy Kotiah, MD, and Eric Liu, MD, FACS, share their expert viewpoints on the key symptoms of carcinoid syndrome, biomarker testing, differential diagnosis, and treatment with Sandostatin LAR Depot.

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References: 1. Data on file. Novartis Pharmaceuticals Corp; March 2019. 2. Sandostatin LAR Depot [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019. 3. Rubin J, Ajani J, Schirmer W, et al. Octreotide acetate long-acting formulation versus open-label subcutaneous octreotide acetate in malignant carcinoid syndrome. J Clin Oncol. 1999;17(2):600-606. 4. Creutzfeldt W. Carcinoid tumors: development of our knowledge. World J Surg. 1996;20(2):126-131. 5. McCormick D. Carcinoid tumors and syndrome. Gastroenterol Nurs. 2002;25(3):105-111. 6. Jensen RT, Doherty GM. Carcinoid tumors and the carcinoid syndrome. In: DeVita VT Jr, Hellman S, Rosenberg SA, eds. Cancer: Principles & Practice of Oncology. 7th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2005:1559-1574. 7. National Cancer Institute. Gastrointestinal carcinoid tumors treatment (PDQ®)—Health Professional Version. http://www.cancer.gov/types/gi-carcinoid-tumors/hp/gi-carcinoid-treatment-pdq. Updated May 8, 2020. Accessed May 27, 2020. 8. Öberg K. Carcinoid tumors, carcinoid syndrome, and related disorders. In: Larsen PR, Kronenberg HM, Melmed S, Polonsky KS, eds. Williams Textbook of Endocrinology. 10th ed. Philadelphia, PA: WB Saunders Company; 2003:1857-1876.

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. Antidiabetic 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 ECG 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 (TPN) 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

Adverse Reactions

  • The most common adverse reactions occurring in patients receiving Sandostatin LAR Depot were 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.