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Severe Diarrhea and Flushing Associated With Carcinoid Syndrome
Important Safety Information

Warnings and Precautions: Gallbladder abnormalities may occur: Patients should be monitored periodically. Glucose Metabolism: Hypoglycemia or hyperglycemia may occur. Blood glucose levels should be...

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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 CONTROL1*

Deliver control with Sandostatin LAR Depot

*QuintilesIMS data on file. This information is valid as of January 2018 and is subject to change without notice.

Study Design

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

Severe Diarrhea

Reduction in severe diarrhea through week 242,3

Chart showing a mean reduction in severe diarrhea associated with metastatic carcinoid tumors

42% mean reduction in severe diarrhea associated with metastatic carcinoid tumors (30%-48%; N=92)2,3

Diarrhea is the #2 most commonly occurring symptom of carcinoid syndrome4

 

HIGHLIGHTS OF IMPORTANT SAFETY INFORMATION

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

Flushing

Reduction in flushing episodes through week 242,3

Chart showing a mean reduction in flushing associated with metastatic carcinoid tumors

84% mean reduction in flushing associated with metastatic carcinoid tumors (70%-90%; N=92)2,3

Flushing is the #1 most commonly occurring symptom of carcinoid syndrome4

 

HIGHLIGHTS OF IMPORTANT SAFETY INFORMATION

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.

5-HIAA

Reduction in 5-HIAA levels through week 242,3

Chart showing reduction in median 5-HIAA levels

Up to 50% reduction in median 5-HIAA levels (38%-50%)2,3,a

5-HIAA reduction may indicate effective management of severe diarrhea and flushing related to metastatic carcinoid tumors5-7

5-HIAA, 5-hydroxyindoleacetic acid.

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

Brochure on Understanding 5-HIAA

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

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HIGHLIGHTS OF IMPORTANT SAFETY INFORMATION

Adverse Reactions: The most common adverse reactions occurring in ≥20% of patients are: back pain, fatigue, headache, abdominal pain, nausea, and dizziness.

References: 1. Data on file. Novartis Pharmaceuticals Corp; January 2018. 2. Sandostatin LAR Depot [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2016. 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. 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. 6. 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 February 7, 2018. Accessed June 8, 2018. 7. McCormick D. Carcinoid tumors and syndrome. Gastroenterol Nurs. 2002;25(3):105-111.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions:

  • Gallbladder abnormalities may occur: Patients should be monitored periodically.
  • 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 EKG 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 ReactionsThe 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%), URTI (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.

Indication 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.