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 (octreotide acetate for injectable suspension) 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 (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.
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 injection in their gluteal muscle every 28 days, given by a healthcare provider, instead of daily injections.
Sandostatin® LAR Depot is indicated in patients in whom initial treatment with Sandostatin® Injection has been shown to be effective and tolerated.
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. Can Sandostatin® LAR Depot shrink my tumor?
In carcinoid syndrome, Sandostatin® is only approved for control of the severe diarrhea and flushing associated with this syndrome.
In acromegaly, the goal is to reduce GH and IGF-1 levels to normal. Sandostatin® LAR Depot is approved to control levels of both GH and IGF-1, the two hormones responsible for the symptoms of acromegaly.
Sandostatin® LAR Depot is not indicated for tumor shrinkage. 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 injection by 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 eligible patients, therapy may be given in the patient's home through the Nurse Home Injection Program (NHIP).
8. What is the Nurse Home Injection Program (NHIP)?
The NHIP is available for eligible patients with carcinoid syndrome or acromegaly who have appropriate insurance coverage and are recommended by their physicians. It enables eligible patients to receive their therapy with Sandostatin® LAR Depot every 28 days at home from specially trained, registered nurses. To learn more about NHIP, call
1-888-LAR-4759 (1-888-527-4759).
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 should not 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. 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 (NHIP). In the NHIP, your nurse will help you to schedule/reschedule your appointment for your next home injection.
12. What are the possible side effects of Sandostatin® in acromegaly?1,2
As with immediate-release Sandostatin® Injection, the most frequently reported adverse events with Sandostatin® LAR Depot were gallbladder disorders (52%),digestive disorders (7% to 36%), and injection-site pain (2% to 11%). Low blood sugar (2%), high blood sugar (15%), low thyroid hormone (2%), and enlargement of thyroid gland (2%) have been reported. While not measured in acromegalic patients receiving Sandostatin® LAR Depot, electrocardiogram (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.
See the full Prescribing Information for Sandostatin® Injection and the full Prescribing Information for Sandostatin® LAR Depot.
13. What are the possible side effects of Sandostatin® in carcinoid syndrome?1,2
As with immediate-release Sandostatin® Injection, the most frequently reported adverse events with Sandostatin® LAR Depot were gallbladder disorders (62%), digestive disorders (14% to 38%), and injection-site pain (20% to 50%). Low blood sugar (4%), high blood sugar (27%), slow heart rate (19%), nerve signal abnormalities (9%), and irregular heartbeats (3%) have been reported.
See the full Prescribing Information for Sandostatin® Injection and the full Prescribing Information for Sandostatin® LAR Depot.
14. What other drugs will affect Sandostatin®?
Sandostatin® 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, cyclosporine, or bromocriptine may require dose adjustments of these therapeutic agents. Administration with cyclosporine may decrease blood levels of cyclosporine and result in transplant rejection. If you are taking any other drugs and on Sandostatin®, please speak with your doctor to make sure you are taking the appropriate amount of your other medications. There may be other medications that may interact with Sandostatin® so please speak to your physician.
15. 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.
16. Can Sandostatin® LAR Depot be taken by pregnant women?
There are no adequate, well-controlled studies of the use of Sandostatin® LAR Depot in women who are pregnant or nursing, 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 if you are pregnant or nursing.
17. 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.
18. 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 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-HELP (1-877-527-4357).
19. If I have lactose intolerance, can I take Sandostatin® LAR Depot?
Yes.
20. How much does Sandostatin® LAR Depot cost?
How much the drug will cost depends on the local pharmacy where it is dispensed and what your individual insurance plan may cover. 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.
21. 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.
22. Is patient assistance available?
Novartis Pharmaceuticals Corporation is committed to providing access to our medications for those most in need through the Novartis Patient Assistance Fund Inc. (PAF). PAF provides assistance to patients experiencing financial hardship who have no third party insurance coverage for their medicines. For more information, visit www.patientassistancenow.com.
23. What other resources are available to me?
Clearly, your healthcare provider is the best source of information about your individual medical needs. But when patients and families wish to reach out to others, the Internet can be a good source of information and support.
Get carcinoid syndrome resources and support group information.
Get acromegaly resources and support group information.
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.
INDICATIONS AND USAGE
Sandostatin® LAR Depot (octreotide acetate for injectable suspension) is a prescription medicine 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: Treatment with Sandostatin LAR Depot may affect gallbladder function, sugar metabolism, thyroid and heart function, and nutritional absorption, which may require monitoring by your doctor.
Before taking Sandostatin LAR Depot: Tell your doctor if you have a history of heart disease or are taking other medications, including: cyclosporine, insulin, oral hypoglycemic agents, beta-blockers, and bromocriptine.
Common side effects: Most patients experience side effects at some time. Some common side effects you may experience include:
- Acromegaly: diarrhea, gallstones, abdominal pain, and flatulence
- Carcinoid tumors: back pain, fatigue, headache, abdominal pain, nausea, and dizziness
Other information: Patients with carcinoids tumors and VIPomas should adhere closely to their scheduled return visits for reinjection in order to minimize exacerbation of symptoms. Patients with acromegaly should adhere to their return visit schedule to help assure steady control of GH and IGF-1 levels.
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.
