Lanreotide acetate

What is Lanreotide acetate?

• Lanreotide acetate (Somatuline Depot) is a somatostatin analog used to treat gastroenteropancreatic neuroendocrine tumors that are advanced or have spread to other parts of the body.
• These tumors form in the stomach, small and large intestines, rectum, and pancreas.
• Lanreotide acetate is used for tumors that cannot be removed by surgery.
• It is also used to treat carcinoid syndrome and some patients with acromegaly (a condition in which the pituitary gland makes too much growth hormone) .

Lanreotide

What are the uses of this medicine?

Lanreotide acetate (Somatuline Depot) is a prescription medicine used for: the long-term treatment of people with acromegaly when:

• surgery or radiotherapy have not worked well enough or
• they are not able to have surgery or radiotherapy

• the treatment of adults with a type of cancer known as neuroendocrine tumors, from the gastrointestinal tract or the pancreas (GEP-NETs) that has spread or cannot be removed by surgery
• the treatment of adults with carcinoid syndrome to reduce the need for the use of short-acting somatostatin medicine

How does this medicine work?

• Lanreotide (lan ree' oh tide) is a synthetic octapeptide and analogue of somatostatin that is used for its ability to suppress levels and activities of hormones (growth hormone, insulin, gastrin, secretin, glucagon) or active neuropeptides (serotonin, vasoactive intestinal polypeptide [VIP]).
• Natural somatostatin is produced in the hypothalamus and acts to suppress growth hormone release from the pituitary.
• Somatostatin is also found in other neurons throughout the body and particularly in intestinal and pancreatic neurons, where it is active in suppressing release of hormones and neuropeptides such as insulin, glucagon, gastrin, secretin, motilin, VIP, serotonin and cholecystokinin.
• Because of its short half-life (~3 minutes), somatostatin is impractical as a therapeutic agent, and analogues have been developed that have a more favorable pharmacological profile such as octreotide, pasireotide and lanreotide, all three of which have been marketed in long acting release (LRA) forms to allow once weekly or monthly administration.
• Lanreotide appears to interact largely with the somatostatin subtype 2 and possibly subtype 5 receptors, with little effect on subtypes 1, 3 and 4, but otherwise acts in a similar manner to somatostatin.
• Lanreotide therapy has been shown to improve symptoms and complications of several neuroendocrine tumors including abnormal growth in acromegaly due to growth hormone-secreting pituitary tumors, diarrhea due to VIP-secreting intestinal tumors, and flushing due to serotonin-producing carcinoid tumors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to lanreotide.

What drug interactions can this medicine cause?

Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following:

• beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, InnoPran)
• bromocriptine (Cycloset, Parlodel)
• cyclosporine (Gengraf, Neoral, Sandimmune)
• insulin and oral medications for diabetes
• quinidine (in Nuedexta), or terfenadine

Is this medicine FDA approved?

• Lanreotide was approved for use in the United States in 2007 and current listed indications include acromegaly and unresectable, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.

How should this medicine be used?

Recommended dosage: Acromegaly:

• 90 mg every 4 weeks for 3 months.
• Adjust thereafter based on GH and/or IGF-1 levels.

Gastroenteropancreatic neuroendocrine tumors:

• 120 mg every 4 weeks.

Carcinoid Syndrome:

• 120 mg every 4 weeks.
• If patients are already being treated with Somatuline Depot for GEP-NET, do not administer an additional dose for carcinoid syndrome.

Administration:

• You will receive a Somatuline Depot injection every 4 weeks in your healthcare provider's office
• Your healthcare provider may change your dose of Somatuline Depot or the length of time between your injections. Your healthcare provider will tell you how long you need to receive Somatuline Depot
• Somatuline Depot is injected deep under the skin of the upper outer area of your buttock. Your injection site should change (alternate) between your right and left buttock from one injection of Somatuline Depot to the next
• During your treatment with Somatuline Depot for acromegaly, your healthcare provider may do certain blood tests to see if Somatuline Depot is working

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 60 mg/0.2 mL, 90 mg/0.3 mL, and 120 mg/0.5 mL single-dose prefilled syringes

This medicine is available in fallowing brand namesː

• Somatuline Depot

What side effects can this medication cause?

The most common side effects of Somatuline Depot in people with acromegaly include:

• diarrhea
• stomach area (abdominal) pain
• nausea
• pain, itching, or a lump at the injection site

The most common side effects of Somatuline Depot in people with GEP-NET include:

• stomach area (abdominal) pain
• muscle and joint aches
• vomiting
• headache
• pain, itching, or a lump at the injection site

The most common side effects of Somatuline Depot in people with carcinoid syndrome include:

• headache
• dizziness
• muscle spasm

Somatuline Depot may cause serious side effects, including:

• cholelithiasis
• Changes in your blood sugar
• Slow heart rate
• High blood pressure
• Changes in thyroid function

What special precautions should I follow?

• Somatuline Depot may reduce gallbladder motility and lead to gallstone formation; therefore, patients may need to be monitored periodically Monitor periodically. Discontinue if complications of cholelithiasis are suspected. Gallstones may occur; consider periodic monitoring.
• Lanreotide, like somatostatin and other somatostatin analogs, inhibits the secretion of insulin and glucagon. Hence, patients treated with Somatuline Depot may experience hypoglycemia or hyperglycemia. Glucose monitoring is recommended and antidiabetic treatment adjusted accordingly.
• Decrease in heart rate may occur. Use with caution in at-risk patients.
• Slight decreases in thyroid function have been seen during treatment with lanreotide in acromegalic patients, though clinical hypothyroidism is rare Decreases in thyroid function may occur; perform tests where clinically indicated.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Limited available data based on postmarketing case reports with Somatuline Depot use in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes.

Can this medicine be used in children?

• The safety and effectiveness of Somatuline Depot in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: lanreotide acetate
• Inactive ingredients: water for injection and acetic acid (for pH adjustment)

Who manufactures and distributes this medicine?

• Manufactured by: Ipsen Pharma Biotech, Parc d'Activities du Plateau de Signes, Signes, France
• Manufactured for: Ipsen Biopharmaceuticals, Inc., 1 Main Street, Unit 700, Cambridge, MA USA.

What should I know about storage and disposal of this medication?

• Store Somatuline Depot in the refrigerator at 2°C to 8°C (36°F to 46°F).
• Protect from light.
• Store in the original package.

• Dailymed label info on Lanreotide acetate
• FDA Lanreotide acetate

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