On this page, you'll find links to answers to common questions about Sandostatin® LAR Depot (octreotide acetate for injectable suspension). Please keep in mind that these answers are not a substitute for consultation with your healthcare team. Please ask your doctor, pharmacist, or nurse any questions you may have.
Questions About Sandostatin® LAR Depot
1. What is Sandostatin® LAR Depot?
Sandostatin® LAR Depot is a synthetic analogue of the naturally occurring hormone somatostatin. It is formulated as a suspension in microspheres that slowly dissolve over the course of 28 days, so it can be administered as an every 28-day intragluteal injection.
2. What is Sandostatin® LAR Depot used for?
Sandostatin® LAR Depot is indicated for long-term maintenance therapy in acromegalic patients for whom medical treatment is appropriate and who have been shown to respond to and can tolerate immediate release Sandostatin® (octreotide acetate) Injection. The goal of treatment in acromegaly is to reduce growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels to normal. Sandostatin® LAR Depot can be used in patients who have had an inadequate response to surgery or in those for whom surgical resection is not an option. It may also be used in patients who have received radiation and have had an inadequate therapeutic response.
Sandostatin® LAR Depot is also 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® Injection has been shown to be effective and tolerated.
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.
3. What is the difference between Sandostatin® LAR Depot and immediate release Sandostatin® Injection?1,2
Sandostatin® LAR Depot is a reformulation of immediate release Sandostatin® Injection, the most prescribed, most studied medical therapy for acromegaly and carcinoid syndrome. The active ingredient (octreotide acetate) is the same in both formulations. However, the reformulation allows patients to receive an intragluteal injection every 28 days, given by a healthcare provider, instead of daily self-administered injections.
4. How does Sandostatin® LAR Depot work?
Sandostatin® LAR Depot is similar to somatostatin, a hormone that occurs naturally in the body. Both work in the same way to reduce excess hormones and other metabolic activities involved in acromegaly, carcinoid syndrome, and VIPomas. Sandostatin® LAR Depot remains in the body much longer than somatostatin.
5. Does Sandostatin® LAR shrink tumors in acromegaly?
Please speak to your physician regarding the options on how to control tumor volume.
6. What makes Sandostatin® LAR Depot last for 28 days?
Each injection of Sandostatin® LAR Depot delivers multiple microspheres which contain the active ingredient (octreotide acetate) encapsulated in a polymer coating. Once injected, the polymer coating begins to dissolve, and slowly the octreotide acetate is gradually released over a 28-day period.
7. How do I take Sandostatin® LAR Depot?
Sandostatin® LAR Depot is administered every 28-days via your healthcare provider—either your doctor, a nurse, nurse practitioner, or any other healthcare professional qualified to administer intramuscular injections. The professional office is the usual location for receiving your injections. For appropriate patients with acromegaly, therapy may be given in the patient's home through the Nurse Home Injection Program.
8. What is the Nurse Home Injection Program?
The Nurse Home Injection Program is available only for patients with acromegaly who have appropriate insurance coverage and are recommended by their physicians. It enables qualified patients to receive their therapy with Sandostatin® LAR Depot every 28 days at home from specially trained, registered nurses.
www.acromegalytreatmentathome.com
9. Can Sandostatin® LAR Depot be administered by intravenous or subcutaneous injection?
No. Sandostatin® LAR Depot is a suspension of microspheres which must be administered via intragluteal (into the muscle of the buttocks) injection. It cannot be administered subcutaneously or intravenously.
10. When can I start therapy?
If you are not currently taking immediate release Sandostatin® Injection (the self-administered formulation) and think that Sandostatin® LAR Depot may be right for you, you should schedule an appointment with your doctor to discuss your options. If you both agree to proceed with therapy, for the first 2 weeks your treatment will begin with daily self-administered injections of immediate release Sandostatin® Injection. This will allow you and your doctor to assess how well the active ingredient (octreotide acetate) is working, whether you are experiencing side effects, and it will help doctors determine the dosing of Sandostatin® LAR Depot.
11. How soon can I expect to see improvement?
This depends on the condition being treated, but some improvement in certain symptoms usually occurs within the first week of therapy with immediate release Sandostatin® Injection.
12. What should I do if I miss an appointment?
If you miss your monthly appointment for your injection, you should call your doctor's office immediately to reschedule your visit. If keeping office appointments is difficult for you, find out if you qualify for the Nurse Home Injection Program. In the Nurse Home Injection Program, your nurse will help you to schedule/reschedule your appointment for your next home injection.
13. What are the possible side effects of Sandostatin® in acromegaly?1,2
In the treatment of acromegaly, the most frequently reported drug-related adverse events with Sandostatin® LAR Depot and immediate release Sandostatin® Injection 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. Contraindications: sensitivity to this drug or any of its components.
See the full Prescribing Information for Sandostatin® Injection and the full Prescribing Information for Sandostatin® LAR Depot.
14. What are the possible side effects of Sandostatin® in carcinoid syndrome?1,2
As with immediate release Sandostatin® Injection, the most frequently reported drug-related adverse events with Sandostatin® LAR Depot 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. Contraindications: sensitivity to this drug or any of its components.
See the full Prescribing Information for Sandostatin® Injection and the full Prescribing Information for Sandostatin® LAR Depot.
15. What other drugs will affect Sandostatin® LAR Depot?
Sandostatin® LAR Depot has been associated with alterations in nutrient absorption, so it may have an effect on the absorption of orally administered drugs. Patients receiving insulin, oral hypoglycemic agents, beta-blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may require dose adjustments of these therapeutic agents. Administration with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection.
16. Who should not take Sandostatin® LAR Depot?
The decision as to which medications are best for each patient should be made by an individual's physician.
17. Can Sandostatin® LAR Depot be taken by pregnant women?
There are no adequate, well controlled studies of the use of Sandostatin® LAR Depot in pregnant women, and therefore it should be used by these patients only when there is a clear medical need to do so. Please consult your physician for additional information.
18. Does Sandostatin® LAR Depot contain latex, gelatin, or gluten?
There is no latex, gelatin, or gluten present in Sandostatin® LAR Depot. However, there is latex in the rubber stopper for the vial of Sandostatin® LAR Depot powder.
19. I purchased Sandostatin® LAR Depot from the pharmacy for administration by my doctor (or home injection nurse). How long can it remain unrefrigerated?
Sandostatin® LAR Depot should remain refrigerated between 36ºF to 46ºF Fahrenheit prior to administration. It should also be protected from light until the time of use. Sandostatin® LAR Depot should remain at room temperature for 30 to 60 minutes before your healthcare professional prepares the drug suspension for administration. For answers to specific questions about the storage of Sandostatin® LAR Depot, call 1-877-LAR-INFO (1-877-527-4357).
20. If I have lactose intolerance, can I take Sandostatin® LAR Depot?
Yes.
21. How much does Sandostatin® LAR Depot cost?
How much the drug will cost depends on the local pharmacy where it is dispensed. This amount can vary. If you have insurance questions about Sandostatin® LAR Depot, call 1-877-LAR-HELP (1-877-527-4357) to be connected to a reimbursement specialist. He or she will help you find out more about your health plan's coverage for Sandostatin® LAR Depot and whether you would be eligible for other kinds of assistance.
22. What are my options for reimbursement?
Many health plans provide full or partial coverage for Sandostatin® LAR Depot through either the medical or pharmacy benefit. To find out more about your plan's coverage, call 1-877-LAR- HELP (1-877-527-4357) to be connected to a Sandostatin® LAR Depot reimbursement specialist. If someone is not available when you call, make sure to leave a message because all calls are returned within 1 business day.
23. Is there a Patient Assistance Program (PAP)?
Novartis is committed to providing access to our medications for those most in need through the Novartis Patient Assistance Program. PAP provides assistance to patients experiencing financial hardship who have no third party insurance coverage for their medicines. In 2004, Novartis provided over $273 million worth of free medicine to over 180,000 individuals—and our assistance continues to grow. For more information, visit www.pap.novartis.com.
24. Where can I find full Prescribing Information for Sandostatin® LAR Depot?
Get the full Prescribing Information for Sandostatin® LAR Depot.
25. Can I stop taking Sandostatin® LAR Depot if I feel better?
Only after consulting with your doctor. It is most likely that you feel better because of the action of Sandostatin® LAR Depot, but the underlying problem still exists. Stopping the drug might cause the symptoms to reappear.
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. 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.
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.
