Sandostatin® LAR Depot

Posted on October 19th, 2010 by

Class:

Generic Name: Octreotide (AHK-tree-oh-tide), octreotide acetate
Trade Name: Sandostatin®, Sandostatin® LAR Depot

How is this drug used? Octreotide is FDA approved for the management of diarrhea and flushing, as part of carcinoid syndrome caused by carcinoid tumor or vasoactive intestinal peptide (VIP) secreting adenomas. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Octreotide is classified as a somatostatin analogue. Somatostatin is a hormone that is naturally produced in the body by the hypothalamus gland. Somatostatin is responsible for reducing or preventing the production or secretion of many hormones in the body, including hormones responsible for diarrhea or flushing.  Octreotide mimics natural somatostatin to control the overproduction of certain hormones and to control symptoms such as diarrhea or flushing in patients with a carcinoid tumor or VIP.

How is octreotide given (administered)? Octreotide may be administered as an injection under the skin (subcutaneous), or as an injection into a muscle (intramuscular) and the dose depends on several factors, including the condition being treated, the particular regimen being used, and the overall health of the patient. The depot formulation that is administered intramuscularly remains active for longer in the body, requiring fewer injections, usually monthly.  Some patients who are treated with subcutaneous octreotide may be able to administer the injections at home.

How are patients monitored? Patients will usually have scheduled meetings and physical exams with their healthcare provider while they are being treated with octreotide.  Patients will be monitored for gallstones, or abnormalities of the gallbladder. Patients who experience pain following a meal, particularly a meal that is high in fat, should contact their healthcare provider. Levels of hormones and endocrine function may also be monitored from blood tests.

What are the common (occur in 30% or more of patients) side effects of treatment with octreotide?

• Abdominal pain
• Gallstones
• Abnormalities of gallbladder
• Nausea
• Pain at site of injection
• Slow heart rate

What are the less common (occur in 10% to 29% of patients) side effects of treatment with octreotide?

• Vomiting
• Constipation
• Flatulence
• Dizziness
• Headache
• Abnormalities in blood sugar levels

What are the rare (occur in less tha 10% of patients) side effects of treatment with octreotide?

• Respiratory infection
• Fatigue
• Fever
• Back pain
• Chest pain
• Joint pain
• Shortness of breath

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day).
• The subcutaneous injections should be administered in a different site each day as repeated injections in the same area can cause irritation.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Patients who are diabetic should monitor blood sugar carefully. Octreotide may change blood sugar levels and you may need to change your dose. Check with your physician.

When should patients notify their physician?

• Pain following a meal
• Persistent or extreme nausea or vomiting
• Fever
• Changes in heart rate or rhythm
• Severe headache
• Severe abdominal pain
• Persistent cough
• Signs of high blood sugar (frequent urination or severe thirst, confusion, drowsiness, decreased or blurred vision, dry mouth)
• Signs of low blood sugar (chills, cold sweats, headache,  dizziness, lightheadedness)
• Rash, hives, itching
• Shortness of breath, difficulty breathing

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers.  A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

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