Sandostatin LAR Depot Text

Preparation and Administration

On this page:

• In-Office Support
• Preparation of Sandostatin^® LAR Depot
• Critical Information for First-Time Preparation

In-Office Support

To help healthcare professionals become more familiar with the exact preparation of the Sandostatin^® LAR Depot, Novartis has prepared an in-office program available through your local Sandostatin^® Sales Specialist.

You and/or your staff can receive:

• One-on-one mixing instructions, at your own office, at a time that is convenient for you
• A videotaped demonstration for step-by-step preparation and administration procedures
• A fully detailed mixing and administration manual for easy reference

Clinical Nurse Educators (CNEs) are also available to answer clinical questions and provide tips on how to optimize administration technique. Contact your Sandostatin^® Sales Specialist for more information.

Preparation of Sandostatin^® LAR Depot

Successful preparation and administration of Sandostatin^® LAR Depot relies on proper suspension technique. Follow each of the steps outlined in this instruction manual to ensure complete saturation of the powder and its uniform suspension prior to deep intragluteal injection. Due to the unique aspects of mixing Sandostatin^® LAR Depot, you may want to call the Sandostatin^®   Support Hotline (1-877-LAR-HELP) to schedule an in-office demonstration before you or your staff administer Sandostatin^® LAR Depot for the first time.

It is also important to note that Sandostatin^® LAR Depot and the diluent should be allowed to reach room temperature and then be mixed immediately prior to injection. Ensure that the powder is completely suspended at the time of injection.

Critical Information for First-Time Preparation

Although you and your staff may be familiar with the preparation of drug suspensions and the administration of depot injections, you will want to READ ALL THE INSTRUCTIONS for the preparation of Sandostatin^® LAR Depot.

A practical guide to mixing and administration

Step 1¹

1. Allow Sandostatin^® LAR  Depot vial and diluent-filled syringe to reach room temperature (approximately 30 to 60 minutes)²
2. Remove plastic cap from vial
3. Remove cap from syringe and attach supplied needles—use only 1 1/2", 19-gauge needles
4. Do not directly inject diluent without preparing suspension²

Step 2¹

1. Gently tap the vial to settle all powder to the bottom
2. Clean vial stopper with supplied alcohol wipe; then insert needle through center of stopper
3. Without disturbing powder, inject contents of syringe down inside wall of vial; then remove syringe and retain for later use

Step 3¹

1. Let vial sit while diluent saturates powder (approximately 5 minutes)
2. Check vial for dry spots. Powder must be completely saturated before proceeding
3. Once powder is completely saturated, swirl vial for 30 to 60 seconds or until a milky, uniform suspension is achieved—DO NOT SHAKE OR INVERT VIAL

Step 4¹

1. Peel off outer syringe label to closely monitor and identify contents of syringe after suspension is drawn
2. Fill syringe with air, insert needle through rubber stopper, and slowly inject air into vial

Step 5¹

1. With bevel down and vial tipped at a 45° angle, slowly draw vial's contents into syringe without inverting vial—some residual suspension will remain
2. Draw a small amount of air into syringe so product can move freely, and gently rock syringe to maintain uniform suspension until injection occurs
3. Eliminate air from syringe, discard first needle, attach second needle
   
   

Step 6¹

1. Prepare injection site with supplied alcohol wipe³
2. Continually rock syringe to maintain a uniform suspension
3. Insert needle at a 90° angle to the skin and, after aspirating the needle, depress the plunger until syringe is empty³

If a blood vessel is penetrated or if needle clogs, replace with a new 1 1/2", 19-gauge needle.* Record injection site on patient's record and alternate monthly.

*The Sandostatin^® LAR Depot product kit is supplied with two 1½", 19-gauge needles.

Before administering, please see the instruction booklet included in the product kit for complete mixing/administration instructions.

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%).

References