Sandostatin LAR Depot Text

Supply and Storage

Here's What You Need to Know About the Supply and Storage of Sandostatin^® LAR Depot.

On this page:

• Supply
• Storage

Supply

For convenient dose titration, Sandostatin^® LAR Depot is available in 3 strengths delivering 10 mg, 20 mg, or 30 mg of octreotide acetate. Each package is a single-use kit, and is clearly marked with the dosage strength and a color that differentiates it from the other strengths:

	10-mg Sandostatin® LAR Depot (dark blue package) NDC 0078-0340-61
	20-mg Sandostatin® LAR Depot (orange package) NDC 0078-0341-61
	30-mg Sandostatin® LAR Depot (dark red package) NDC 0078-0342-61

Before prescribing Sandostatin^® LAR Depot you should refer to the full
Prescribing Information. Please note that general dosage guidelines
recommend beginning with the 20-mg dose.

Also, before administering the product, check the package to see that the required contents are intact. Each package of Sandostatin^® LAR  Depot should contain:

1. One vial containing Sandostatin^® LAR Depot
2. One diluent-filled syringe
3. Two 1-1/2", 19-gauge needles
4. Two alcohol wipes
5. Instruction booklet

Do not substitute syringes or needles other than the sizes specified.

Storage

Prolonged storage of Sandostatin^® LAR Depot requires refrigeration. Store at temperatures of 2°C to 8°C (36°F to 46°F) and protect from light until time of use. Prior to using Sandostatin^® LAR Depot, remove the product package from refrigeration and allow the product to reach room temperature. This may take from 30 to 60 minutes. Remember, however, that after preparation of the suspension, the drug must be administered immediately.

Caution: Sandostatin^® LAR Depot must be protected from high temperatures. This may include temporary storage areas that become hot, such as warehouses or car interiors. If this occurs, please call the Sandostatin^®   Support Hotline at 1-877-LAR-HELP.

Note: Rubber stoppers contained in this package contain latex.

Learn about preparation and administration of Sandostatin^® LAR Depot

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 maintenance therapy in acromegalic patients who have had inadequate response to surgery and/or radiotherapy or for whom surgery and/or radiotherapy is not an option (the goal of treatment in acromegaly is to reduce GH and IGF-1 levels to normal).
• 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.

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, 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 are:

• Acromegaly: biliary abnormalities (52%), diarrhea (36-48%), cholelithiasis (13-38%), abdominal pain or discomfort (11-29%), flatulence (26%), influenza-like symptoms (20%), constipation (19%), headache (15%), anemia (15%), hyperglycemia (15%), injection site pain (2-14%), hypertension (13%), dizziness (12%), fatigue (11%), nausea (10%), vomiting (7%), hypothyroidism (2%), hypoglycemia (2%), and goiter (2%).
• Carcinoid Tumors and VIPomas: 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%).