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Treatment and Monitoring

Acromegaly

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 carcinoid 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.

Please see full Prescribing Information.

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.

Approved Use:

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: Treatment with Sandostatin LAR Depot may affect gallbladder function, sugar metabolism, thyroid and heart function, and nutritional absorption, which may require monitoring b

... See More
Approved Use:

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 pa
... See More

Management of acromegaly depends on getting an early diagnosis, proper monitoring, and treatment. This section will highlight what you need to know about this process, including:

  • Therapy options
  • Monitoring acromegaly

Therapy options

The goals of medical treatment in acromegaly are to control growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels, tumor size, and the symptoms of the disease. The American Association of Clinical Endocrinologists recommends the following 3 treatment options for acromegaly

  • Surgery
  • Medical therapy
  • Radiation therapy

Surgery

  • Surgery is usually the first line of treatment for acromegaly
  • The goal of surgery is to remove the tumor to normalize GH and IGF-1 levels
    • In some cases, surgery is not possible or all of the tumor cannot be removed

If you are not a candidate for surgery or if surgery has not been curative, your doctor may consider other therapies.

Medical therapy

Somatostatin is a naturally occurring hormone in the body that signals the pituitary gland to stop the overproduction of GH. When you have a pituitary tumor, too much GH is released into the body. This can be regulated by medical treatment with a somatostatin analogue.

Somatostatin analogues

  • Somatostatin analogues work directly at the site of the pituitary tumor by shutting off the production of GH, which causes the symptoms of acromegaly
  • For over 10 years, Sandostatin® LAR Depot (octreotide acetate for injectable suspension) has demonstrated strong evidence in acromegaly and has been a trusted medical therapy
    • It is a long-acting, monthly injection

Sandostatin® LAR Depot is not indicated for tumor shrinkage.

Radiation therapy

Radiation therapy uses radiation to kill rapidly growing tumor cells. After radiation, tumors typically stop growing and may even begin to shrink. However, radiation therapy typically takes a longer time to be effective compared to the other available treatments for acromegaly.

Monitoring Acromegaly

Your health care team monitors your condition so that therapy is as effective as possible. They will regularly order tests to measure the levels of GH and IGF-1 in your blood.

If you are a candidate for surgery, GH and IGF-1 tests are ordered after the tumor is surgically removed to determine whether the tumor has been fully extracted. If some tumor remains, you might be placed on a drug therapy and monitored regularly to keep track of your hormone levels. Even after successful surgery, pituitary tumors have been reported to grow back in up to 14% of patients. It is important for you to follow up with your health care team to have GH and IGF-1 levels monitored regularly.

How GH is measured

A single measurement of GH provides only limited information because your pituitary gland releases GH in short spurts throughout the day and night. You may, therefore, have a series of GH blood tests, or you may have blood taken for GH levels after a night without food and an early morning drink of an extremely sweet solution. This is called an oral glucose tolerance test (OGTT).

How IGF-1 is measured

  • Because IGF-1 is released more evenly than GH, and these levels remain higher longer, IGF-1 levels can be taken at any time, with a blood test.

Imagery supplied by Getty Images

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 carcinoid 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.

Please see full Prescribing Information.

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.

Approved Use:

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.