Resources

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 a once-a-month intragluteal injection.

What is Sandostatin LAR® Depot used for?

Sandostatin LAR® Depot (octreotide acetate for injectable suspension) 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 GH and 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.

What is the difference between Sandostatin LAR® Depot and immediate release Sandostatin® Injection?

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 once-a-month intragluteal injections, given by a health care provider, instead of daily self-administered injections.

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.

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.

How do I take Sandostatin LAR® Depot?

Sandostatin LAR® Depot is administered in once-a-month injections by your health care provider — either your doctor, a nurse, nurse practitioner, or any other health care professional qualified to administer intramuscular injections.

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.

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 injection. It cannot be administered subcutaneously or intravenously.

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.

How does the microsphere delivery system work?

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 one-month period.

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 (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.

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 (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.

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.

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 also provide guidance on the dosing of Sandostatin LAR® Depot.

What are the possible side effects in acromegaly?

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 (PDF 332KB) for Sandostatin LAR® Depot

What are the possible side effects in carcinoid syndrome?

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 (PDF 332KB) for Sandostatin LAR® Depot

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.

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.

I purchased Sandostatin LAR® Depot from the pharmacy for administration by my doctor. How long can it remain unrefrigerated?

Sandostatin LAR® Depot should remain refrigerated between 36º-46º 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 30-60 minutes before your health care 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).

If I have lactose intolerance, can I take Sandostatin LAR® Depot?

Yes.

Where can I find full prescribing information for Sandostatin LAR® Depot?

Get the prescribing information (PDF 332KB) for Sandostatin LAR® Depot.

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.

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.