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.

Dosing & Administration

Multiple Dosing Strengths

FOR THE SEVERE DIARRHEA AND FLUSHING ASSOCIATED WITH METASTATIC CARCINOID TUMORS,

THE ONLY SSA WITH MULTIPLE DOSING OPTIONS

Multiple dosing options can help effectively manage patients' symptoms1

Sandostatin® LAR Depot (octreotide acetate) for injectable suspension is available in 10 mg, 20 mg, and 30 mg for up or down dose titration. Doses higher than 30 mg are not recommended.

Sandostatin® LAR Depot (octreotide acetate) for injectable suspension multiple dosing options

Sandostatin® (octreotide acetate) Immediate-Release Injection is available for treatment initiation and symptom flare-ups

Sandostatin® (octreotide acetate) Immediate-Release Injection is available for treatment initiation and symptom flare-ups

Sandostatin LAR Depot should be administered by a trained health care provider. It is important to closely follow the mixing instructions included in the packaging. Sandostatin LAR Depot must be administered immediately after mixing.

For more information about dosing, watch the video.

OPTIMIZED DOSING

  • Multiple dosing strengths allow up or down dose titration in 10-mg increments from the recommended starting dose of 20 mg. After an initial 2-week starting dose, patients who respond to and tolerate Sandostatin Immediate-Release Injection may switch to Sandostatin LAR Depot, which offers dosing once every 4 weeks. Short-acting Sandostatin Immediate-Release Injection should be continued for at least 2 weeks following initial injection of Sandostatin LAR Depot 20 mg. After 2 months, adjust dose of Sandostatin LAR Depot based on symptom control
  • If symptoms are adequately controlled on 20 mg, you may consider a dose reduction to 10 mg
  • If symptoms are not adequately controlled on 20 mg, you are able to increase the dose to 30 mg
  • Doses higher than 30 mg are not recommended
  • In patients with renal failure requiring dialysis or with established cirrhosis of the liver, the starting dose should be Sandostatin LAR Depot 10 mg every 4 weeks
  • Pain on injection, which is generally mild to moderate and short-lived (usually about 1 hour), is dose related. In carcinoid patients where a diary was kept, pain at the injection site was reported by about 20% to 25% at the 10-mg dose and by about 30% to 50% at the 20- and 30-mg doses
  • For symptom flare-ups, patients may be given supplemental Sandostatin Immediate-Release Injection (at the dosage they were receiving prior to switching to Sandostatin LAR Depot) until symptoms are again controlled as per prescribing information

Dosing Flowchart

Dosing flowchart for Sandostatin® LAR Depot (octreotide acetate) for injectable suspension

 

For Patients not currently receiving octreotide acetate
Begin therapy with Sandostatin Immediate-Release Injection.

For carcinoid tumors: Suggested daily dosage ranges from 100 mcg/d to 600 mcg/d in 2 to 4 divided doses (mean daily dosage is 300 mcg/d) during the first 2 weeks of therapy
  • Some patients may require doses of up to 1500 mcg/d
For VIPomas: Suggested daily dose is 200 mcg to 300 mcg in 2 to 4 divided doses (range, 150 mcg - 750 mcg)
  • Doses may be adjusted on an individual basis
  • Dosages over 450 mcg/d are usually not required

Continue Sandostatin Immediate-Release Injection for at least 2 weeks

Patients who are considered "responders" to octreotide acetate and who tolerate the drug may be switched to Sandostatin LAR Depot according to the dosage regimen described below.

 

Patients currently receiving Sandostatin Immediate-release Injection
Patients who are already controlled with Sandostatin Immediate-Release Injection should add Sandostatin LAR Depot according to the dosing regimen described below.

Add Sandostatin
LAR Depot
  • Receive 20-mg dose of Sandostatin LAR Depot intragluteally at 4-week intervals for 2 months
  • Carcinoid tumor and VIPoma patients should continue to receive their Sandostatin Immediate-Release Injection dose for at least 2 weeks
    • This allows the serum octreotide to reach therapeutically effective levels following initial injection of Sandostatin LAR Depot
    • Failure to continue subcutaneous injections through this period may result in exacerbation of symptoms. (Note: Some patients may require 3 or 4 weeks of such therapy)
After 2 months, consider dose adjustment
  • Sandostatin LAR Depot 20-mg dose may be increased to 30 mg every 4 weeks if symptoms are not adequately controlled
  • Patients who achieve good control on a 20-mg dose may have their dose lowered to 10 mg for a trial period
    • If symptoms recur, dosage should then be increased to 20 mg every 4 weeks; however, many patients can be satisfactorily maintained at a 10-mg dose every 4 weeks
  • Doses higher than 30 mg are not recommended

Expect periodic symptom exacerbation

  • Despite good overall control of symptoms, patients with carcinoid tumors and VIPomas who take Sandostatin often experience periodic exacerbation of symptoms
  • During these periods, they may be given Sandostatin Immediate-Release Injection for a few days at the dosage they were receiving prior to switching to Sandostatin LAR Depot, until symptoms are again controlled
  • Note: Administration of Sandostatin LAR Depot at intervals greater than 4 weeks is not recommended

 

Dosing for special populations

Renal Failure In patients with renal failure requiring dialysis, the starting dosage should be 10 mg every 4 weeks. In other patients with renal impairment, the starting dosage should be similar to that of a patient without renal failure (ie, 20 mg every 4 weeks)
Hepatic Impairment—Patients With Cirrhosis In patients with established cirrhosis of the liver, the starting dosage should be 10 mg every 4 weeks

 

VIPoma(s), vasoactive intestinal peptide tumor(s). 

*

For patients with carcinoid tumors, starting dosages of Sandostatin Immediate-Release Injection range from 100 mcg/d to 600 mcg/d in 2 to 4 divided doses. For patients with VIPomas, starting dosages range from 200 mcg/d to 300 mcg/d in 2 to 4 divided doses. Read the full Prescribing Information for Sandostatin LAR Depot.

Patient Monitoring

To assess therapeutic efficacy and safety of treatment, continued patient monitoring is necessary.

Cholelithiasis and Gallbladder Sludge

  • 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.

Hyperglycemia and Hypoglycemia

  • Blood glucose levels should be monitored
  • Antidiabetic treatment should be adjusted accordingly

Nutrition

  • Vitamin B12 levels: Octreotide may alter absorption of dietary fats. Long-term therapy may depress vitamin B12 levels and result in abnormal Schilling test results
  • Serum zinc concentrations, in patients receiving total parenteral nutrition (TPN)

Thyroid Function

  • TSH, total and/or free T4

Monitoring: Laboratory Tests

  • 5-HIAA, plasma serotonin, and plasma substance P
  • VIP (plasma vasoactive intestinal peptide)

5-HIAA, 5-hydroxyindoleacetic acid.

Mixing and Administration Demonstration

See the proper mixing and administration of Sandostatin LAR Depot in this video.

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Schedule an in-office demonstration on mixing and administration.
For information and resources, including our downloadable Step-by-Step Guide to Mixing and Administration (Mixing Mat), please visit the Nurse Center.

Mixing and Administration Guide

Injection should be administered by a health care professional immediately after it is mixed.

Successful preparation and administration of Sandostatin LAR Depot relies on proper adherence to the steps below. Not following these steps can result in failure to appropriately deliver the drug.2

 

Step 1 Remove Sandostatin® LAR Depot (octreotide acetate) for injectable suspension from refrigerated storage

Step 1

  • Remove Sandostatin LAR Depot from refrigerated storage
  • Only start the reconstitution process after the injection kit has reached room temperature
  • Let the kit stand at room temperature for a minimum of 30 minutes before reconstitution, but do not exceed 24 hours
  • The injection kit can be rerefrigerated if needed

 

Step 2 Remove plastic cap from vial and clean rubber stopper of vial

Step 2

  • Remove plastic cap from vial and clean rubber stopper of vial with an alcohol wipe

 

Step 3 Remove lid film of vial adapter packaging and attach vial adapter to the vial

Step 3

  • Remove lid film of vial adapter packaging; do not remove vial adapter from its packaging
  • Place the vial on a flat surface. Holding the vial adapter packaging, position the vial adapter on top of the vial and push it fully down so that it snaps in place, confirmed by an audible “click"
  • Lift packaging off vial adapter with a vertical movement

 

Step 4 Peel off syringe label and inspect syringe

Step 4

  • Peel off outer syringe label and inspect syringe to ensure there are no visible particles

 

Step 5 Remove cap from syringe and screw syringe onto vial adapter

Step 5

  • Remove cap from syringe and screw syringe onto vial adapter
  • Slowly push plunger all the way down to transfer all the diluent solution in the vial

 

Step 6 Let vial stand for a minimum of  two minutes up to five minutes

Step 6

  • Let vial stand for a minimum of 2 minutes and up to 5 minutes to ensure that the diluent has fully saturated the powder
  • It is normal that the plunger rod may move up if there is overpressure in the vial
  • At this stage, prepare patient for injection

 

Step 7 Ensure plunger is pushed all the way down in the syringe and shake vial moderately in a horizontal direction for a minimum of 30 seconds

Step 7

  • After the saturation period, ensure plunger is pushed all the way down in the syringe
  • Keep plunger pressed and shake vial moderately in a horizontal direction for a minimum of 30 seconds so the powder is completely suspended (uniform milky suspension). Repeat moderate shaking for another 30 seconds if the powder is not completely suspended

 

Step 8 Turn Syringe and vial upside down, slowly pull plunger back, and draw contents from vial

Step 8

  • Turn syringe and vial upside down, slowly pull plunger back, and draw entire contents from vial into syringe
  • Unscrew syringe from vial adapter

 

Step 9 Gently tap the syringe to remove and expel any visible bubbles

Step 9

  • Prepare injection site with an alcohol wipe
  • Screw safety injection needle onto syringe
  • Gently reshake syringe to a milky uniform suspension
  • Pull protective cover off needle and gently tap syringe to remove and expel any visible bubbles
  • Proceed immediately to Step 10 for administration to the patient, as any delay may result in sedimentation

 

Step 10 Sandostatin® LAR Depot (octreotide acetate) for injectable suspension must be given only by deep intragluteal injection never intravenously

Step 10

  • Sandostatin LAR Depot must be given only by deep intragluteal injection, NEVER intravenously
  • Insert needle fully into left or right gluteus at a 90° angle to the skin
  • Slowly pull back plunger to check that no blood vessel has been penetrated (if so, reposition)
  • Depress plunger with steady pressure until syringe is empty and then withdraw needle

 

Step 11 Activate safety guard over the needle

Step 11

  • Activate safety guard over the needle by either:
    • pressing hinged section of safety guard down onto a hard surface or
    • pushing hinge forward with your finger
  • An audible “click” confirms the proper activation
  • Record injection site on patient’s record; alternate monthly

 

Step 12 Immediately dispose of syringe in a sharps container

Step 12

  • Immediately dispose of syringe in a sharps container
  • Special precautions for disposal: Any unused product or waste material should be disposed of in accordance with local requirements

 

Schedule an in-office demonstration on mixing and administration.

For information and resources, including our downloadable Step-by-Step Guide to Mixing and Administration (Mixing Mat), please visit the Nurse Center.

Instruction Booklet

Download the full mixing and preparation instructions

Download PDF

If you still have questions about preparation and/or administration of Sandostatin LAR Depot, please call 1-888-NOW-NOVA (1-888-669-6682).

 

For prolonged storage, Sandostatin LAR Depot should be stored at refrigerated temperatures between 2°C to 8°C (36°F to 46°F) and protected from light until the time of use.1

References: 1. Sandostatin LAR Depot [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2019. 2. Instruction Booklet: Preparation and Administration of Sandostatin LAR Depot (octreotide acetate for injectable suspension). East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2016.

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.