On this page:
- In-office Support
- Preparation of Sandostatin® LAR Depot (octreotide acetate for injectable suspension)
- 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
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® Therapy Support Hotline (1-877-527-4357) 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
- Allow Sandostatin® LAR Depot vial and diluent-filled syringe to reach room temperature (approximately 30 to 60 minutes)
- Remove plastic cap from vial
- Remove cap from diluent-filled syringe and attach one of the supplied needles-use only 1 1/2", 19-gauge needles
Do not directly inject diluent without preparing vial and allowing to reach room temperature
- Gently tap the vial to settle all powder to the bottom
- Clean vial stopper with supplied alcohol wipe; then insert needle through center of stopper
- Without disturbing powder, inject contents of syringe down inside wall of vial; then remove syringe and retain for later use
- Let vial sit while diluent saturates powder (approximately 5 minutes)
- Check vial for dry spots. Powder must be completely saturated before proceeding
- Once powder is completely saturated, swirl vial for 30 to 60 seconds or until a milky, uniform suspension is achieved
Do not shake vigorously or invert the vial
- Peel off outer syringe label to closely monitor and identify contents of syringe after suspension is drawn
- Fill syringe with air, insert needle through rubber stopper, and slowly inject all of air into vial
- With bevel down and vial tipped at a 45° angle (as shown in diagram), slowly draw vial's contents into syringe without inverting vial—Some residual suspension will remain
- Draw a small amount of air into syringe to allow suspended product to move freely and continually rock syringe to maintain uniform suspension until injection occurs
- Eliminate air from syringe, discard first needle, attach second needle
- Prepare injection site with supplied alcohol wipe
- Continually rock syringe to maintain a uniform suspension
- Insert needle deep into upper outer quadrant of right or left gluteus and, if no blood vessel has been penetrated, immediately inject entire contents of syringe intramuscularly (IM)
If blood vessel is penetrated or if needle clogs, replace with a new 1 1/2", 19-gauge needle, and select another injection site.*
Record injection site on patient's record and alternate monthly.
Before administering, please see the instruction booklet included in the product kit for complete mixing/administration instructions.
*The Sandostatin® LAR Depot product kit is supplied with two 1 1/2", 19-gauge needles.
Important Safety Information
Carcinoid Syndrome:
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 for the 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.
Important Safety Information:
As with immediate release Sandostatin® Injection, the most frequently reported drug-related adverse events were biliary disorders (62%), gastrointestinal disorders (14% to 38%), and injection-site pain (20% to 50%). Hypoglycemia (4%), hyperglycemia (27%), sinus bradycardia (19%), conduction abnormalities (9%), and arrhythmias (3%) have been reported.
The controlled clinical trials that support the marketing clearance for Sandostatin® LAR Depot did not include determination of effect on tumor size or rate of growth. Sandostatin® LAR Depot is not indicated for tumor shrinkage.
Acromegaly
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is indicated for long-term maintenance therapy in acromegalic patients who have had an 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.
Important Safety Information:
As with immediate release Sandostatin® Injection, the most frequently reported drug-related adverse events were biliary disorders (52%), gastrointestinal disorders (7% to 36%), and injection-site pain (2% to 11%). Hypoglycemia (2%), hyperglycemia (15%), and hypothyroidism (2%) have been reported. While not measured in acromegalic patients receiving Sandostatin® LAR Depot, ECG changes have been reported in patients receiving immediate release Sandostatin® Injection; the degree to which these abnormalities are related to octreotide acetate is not clear, as many acromegalics have cardiovascular disease. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
