Fast Answers
On this page you'll find answers to questions you may have about acquisition and usage. If you have additional questions, call:
1-877-LAR-HELP
(1-877-527-4357)
Monday through Friday 8 AM to 7 PM EST
The Hotline provides information to assist you with acquisition and other issues so that you can get Sandostatin® LAR Depot to your patients easily and conveniently. Depending on your needs, the Hotline staff can help with:
- Identifying distributors available to ship Sandostatin® (in temperature-controlled packaging) to any requested location
- Directing calls for medical information
- Providing mixing and administration information and guidance on handling product replacement requests
Our pledge is to provide a comprehensive selection of professional programs designed to make your experience with once-a-month Sandostatin® LAR Depot as easy for you as it is for your patients.
Q & A
Q: How do I start a patient on Sandostatin®?
A: After verifying the patient's insurance, you can use the Easy Access program. It's a fast and convenient way to obtain Sandostatin® LAR Depot.
Q: Why should I switch a patient from immediate-release Sandostatin® Injection to once-a-month Sandostatin® LAR Depot?
A:Sandostatin® LAR Depot provides the same control as immediate-release Sandostatin® Injection, but over a 28-day period. Sandostatin® LAR Depot is administered once-monthly by a patient's healthcare team.
Q: When can I call 1-877-LAR-HELP (1-877-527-4357)?
A: Monday through Friday, 8 AM to 7 PM EST
Q: What types of support or programs can I expect from 1-877-LAR-HELP?
A: Any information you need on acquisition, reimbursement, billing, coding, claims appeal, and obtaining the drug. You can also call 1-877-LAR-HELP for any other question you may have.
Q: Where can Sandostatin® be shipped?
A: To almost any location, and it will arrive in temperature-controlled packaging for immediate refrigeration.
Sandostatin® LAR Depot Q & A
To save you time, we've answered questions that may come up with initial use of Sandostatin® LAR Depot. Of course, if your question is not answered here, simply call the Sandostatin® Therapy Support Hotline at 1-877-LAR-HELP. For additional information about Sandostatin® LAR Depot, please refer to the full Prescribing Information.
Q: What is the difference between immediate-release Sandostatin® (octreotide acetate) Injection and Sandostatin® LAR Depot?
A: Sandostatin® LAR Depot is a long-acting depot dosage form, consisting of microspheres of a biodegradable polymer containing octreotide acetate which allows injection once every 28 days. It exhibits all of the clinical and pharmacologic characteristics of the immediate dosage form of Sandostatin® Injection with the added feature of slow release. This reduces the need for frequent administration.
Q: What is the recommended dosage interval?
A: To maintain optimal control, Sandostatin® LAR Depot must be administered once every 28 days.
Q: How do you administer Sandostatin® LAR Depot?
A: Sandostatin® LAR Depot should be administered by a trained healthcare professional at 28-day intervals. It is administered via deep intragluteal injection. It is absolutely critical that the product is not injected subcutaneously, or intravenously, or in any muscle other than the gluteus.
Q: What if the powder does not seem to be saturated completely in 5 minutes?
A: Continue to check the vial every 30 seconds until the powder is evenly wet. The powder must be saturated with the diluent before you begin to swirl the vial.
Q: What if the suspension "clumps" or flocculates while in the vial?
A: Shaking or inverting the vial during the preparation process may cause the product to become solid and incapable of being drawn up into the syringe. If the product "clumps" or flocculates, it is not usable. You will need to start the preparation process again with a new vial of Sandostatin® LAR Depot. Contact 1-877-LAR-HELP, and ask for assistance. Never shake or invert the vial while preparing Sandostatin® LAR Depot.
Q: It looks as though there is still some product left in the vial after I draw out the suspension. Why?
A: This is normal. It is not necessary to draw all the suspended drug into the syringe. The vial has been slightly "overfilled" with powder to allow for ease of mixing, and it is expected that some of the product will coat the side and remain in the bottom of the vial. To draw up the accurate amount of drug, tilt the vial at a 45º angle and, with the bevel of the needle down, slowly draw the contents of the vial into the syringe. Do not invert the vial when filling the syringe. Draw the suspension from the bottom of the vial.
Q: What can be done if the product seems to come out of suspension after it has been drawn into the syringe?
A: You should moderately rock the syringe back and forth to maintain suspension. Do not invert the syringe. Remember that Sandostatin® LAR Depot must be administered immediately after the product has been prepared for injection.
Q: What should I do if the needle clogs while injecting Sandostatin® LAR Depot?
A: Replace the needle with another 1-1/2", 19-gauge needle. This size is necessary to handle the microsphere formulation.
Q: What should I do if I have any other questions during the preparation and/or administration of Sandostatin® LAR Depot?
A: For personal instruction and information regarding the preparation and/or administration of Sandostatin® LAR Depot, call the Sandostatin® Support Hotline at 1-877-LAR-HELP.
Q: What should I do if a vial of Sandostatin® LAR Depot becomes unusable?
A: Immediately call 1-877-LAR-HELP for information about the Novartis returned goods program.
Q: Is patient educational information available?
A: Yes, Novartis Pharmaceuticals Corporation makes information available to patients taking Sandostatin® LAR Depot. Carcinoid patients can obtain information from www.SandostatinControl.com. Patients with acromegaly can get answers at www.MySandostatinInfo.com.
Q: How should patients and/or healthcare professionals address reimbursement issues?
A: For help with insurance questions, patients and healthcare professionals should call the Sandostatin® Support Hotline at: 1-877-LAR-HELP.
This Hotline will help answer questions from healthcare professionals concerning benefit investigation, determination of in-network specialty pharmacy requirement, referral to the Patient Assistance Program (PAP), billing code information, and policy coverage research. A reimbursement guide is available from your Sandostatin® Sales Specialist.
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%).
