octreotide

Generic Name: octreotide (injectable) (ok TREE oh tide)Brand Names: Sandostatin, Sandostatin LAR Depot

What is octreotide?

Octreotide is a man-made protein that is similar to a hormone in the body called somatostatin. Octreotide lowers many substances in the body such as insulin and glucagon (involved in regulating blood sugar), growth hormone, and chemicals that affect digestion.

Octreotide is used to treat acromegaly. Octreotide is also used to reduce flushing episodes and watery diarrhea caused by cancerous tumors (carcinoid syndrome) or tumors called vasoactive intestinal peptide tumors (VIP adenomas).

Octreotide may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about octreotide?

Before using octreotide, tell your doctor if you have diabetes, gallbladder disease, heart disease, thyroid problems, pancreatitis, kidney disease, or liver disease.

Octreotide is given as an injection under the skin or into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. Be sure to follow the instructions for the exact type of octreotide your doctor has prescribed for you.

While using octreotide, call your doctor if you have severe stomach pain, fever, bloating, nausea and vomiting, or jaundice (yellowing of the skin or eyes). These may be signs of serious side effects

What should I discuss with my healthcare provider before using octreotide?

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using octreotide, tell your doctor if you have:

• diabetes;

• gallbladder disease;

• heart disease;

• thyroid problems;

• pancreatitis;

• kidney disease;
• liver disease.

FDA pregnancy category B. Octreotide is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Using octreotide can affect certain hormones that may make it easier for you to get pregnant, even if you were unable to get pregnant before. Talk to your doctor about using birth control to avoid unwanted pregnancy. It is not known whether octreotide passes into breast milk. Do not use octreotide without telling your doctor if you are breast-feeding a baby.

How should I use octreotide?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Octreotide is given as an injection under the skin or into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine. Be sure to follow the instructions for the exact type of octreotide your doctor has prescribed for you.

Do not draw your octreotide dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

To be sure this medication is helping your condition, your blood or urine will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Store this medication in the refrigerator, protected from light. Do not allow the medication to freeze.

To reduce discomfort from your injection, take the medicine bottle out of the refrigerator about 30 minutes before using the medication. Allow the medicine to reach room temperature before using, but never warm the medicine in hot water or a microwave.

Throw away any medicine left in the bottle after 14 days of use. Then start a new bottle.

The Sandostatin LAR Depot kit should be kept at room temperature for 30 to 60 minutes before mixing the medicine. Give the injection right away after mixing your dose.

What happens if I miss a dose?

Contact your doctor if you miss a dose of octreotide.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of octreotide is not expected to produce life-threatening side effects.

What should I avoid while using octreotide?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using octreotide.

Octreotide side effects

Stop using octreotide and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• slow or irregular heartbeats;

• gallbladder problems (stomach pain);

• pancreatitis (pain in the upper stomach or back, nausea, vomiting, fever, bloating, yellowing of the skin or eyes);

• thyroid problems (may be detected by blood tests);

• low blood sugar (headache, confusion, drowsiness, weakness, dizziness, fast heartbeat, sweating, tremor, nausea); or

• high blood sugar (increased thirst and urination; flushed or dry skin; drowsiness).

Less serious side effects may include:

• nausea or vomiting;

• diarrhea;

• mild stomach pain or gas;

• constipation; or

• pain or irritation where you injected the medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Octreotide Dosing Information

Usual Adult Dose for Carcinoid Tumor:

Initial dose: 100 to 200 mcg subcutaneously 3 times a day.Maintenance dose: 50 to 300 mcg/day.Maximum dose: 1,500 mcg/day.Octreotide acetate for injectable suspension (depot):Patients who are not currently receiving octreotide should begin therapy with the subcutaneous injection as described above. Patients should be maintained on octreotide subcutaneous injection for at least two weeks to determine tolerance to octreotide. Patients who are considered to be "responders" to the drug, and who tolerate the drug, can then be switched to octreotide acetate for injectable suspension (depot).Patients currently receiving octreotide injection can be switched directly to octreotide acetate for injectable suspension (depot) at a dose of 20 mg IM intragluteally at 4 week intervals for 2 months. (Deltoid injections should be avoided because of the significant discomfort at the injection site when given in that area.) Gluteal injection sites should be alternated to avoid irritation.Because of the need for serum octreotide to reach therapeutically effective levels following the initial injection of octreotide acetate for injectable suspension (depot), carcinoid tumor patients should continue to receive subcutaneous injections for at least 2 weeks in the same dosage they were taking before the switch. Failure to continue subcutaneous injections for this period may result in exacerbation of symptoms. Some patients may require 3 or 4 weeks of subcutaneous injections after the switch to the depot form.After 2 months of a 20 mg depot dosage, the dosage may be increased to 30 mg every 4 weeks if symptoms are not adequately controlled. Patients who achieve good control on a 20 mg dose may have their dose lowered to 10 mg for a trial period. If symptoms recur, dosage should then be increased to 20 mg every 4 weeks. Many patients can be maintained at a 10 mg dosage every 4 weeks. However, a dose of 10 mg is not recommended as a starting dose because therapeutically effective levels of octreotide are reached more rapidly with a 20 mg dose.Dosages higher than 30 mg are not recommended because there is no information on their usefulness.Despite good overall control of symptoms, patients with carcinoid tumors often experience periodic exacerbation of symptoms. During these periods, they may be the subcutaneous injection for a few days at the dosage they were receiving prior to their switch to the depot form. When symptoms are again under control, the subcutaneous injection can again be discontinued.Administration of octreotide acetate for injectable suspension (depot) at intervals greater than four weeks is not recommended because there is no adequate information on whether such patients could be adequately controlled.

Usual Adult Dose for Vasoactive Intestinal Peptide Tumor:

Initial dose: 100 mcg subcutaneously 2 to 3 times a day.Maintenance dose: 150 to 300 mcg/day.Maximum dose: 450 mcg/day.Octreotide acetate for injectable suspension (depot):Patients who are not currently receiving octreotide should begin therapy with the subcutaneous injection as described above. Patients should be maintained on octreotide subcutaneous injection for at least two weeks to determine tolerance to octreotide. Patients who are considered to be "responders" to the drug, and who tolerate the drug, can then be switched to octreotide acetate for injectable suspension (depot).Patients currently receiving octreotide injection can be switched directly to octreotide acetate for injectable suspension (depot) at a dose of 20 mg IM intragluteally at 4 week intervals for 2 months. (Deltoid injections should be avoided because of the significant discomfort at the injection site when given in that area.) Gluteal injection sites should be alternated to avoid irritation.Because of the need for serum octreotide to reach therapeutically effective levels following the initial injection of octreotide acetate for injectable suspension (depot), VIPoma patients should continue to receive subcutaneous injections for at least 2 weeks in the same dosage they were taking before the switch. Failure to continue subcutaneous injections for this period may result in exacerbation of symptoms. Some patients may require 3 or 4 weeks of subcutaneous injections after the switch to the depot form.After 2 months of a 20 mg depot dosage, the dosage may be increased to 30 mg every 4 weeks if symptoms are not adequately controlled. Patients who achieve good control on a 20 mg dose may have their dose lowered to 10 mg for a trial period. If symptoms recur, dosage should then be increased to 20 mg every 4 weeks. Many patients can be maintained at a 10 mg dosage every 4 weeks. However, a dose of 10 mg is not recommended as a starting dose because therapeutically effective levels of octreotide are reached more rapidly with a 20 mg dose.Dosages higher than 30 mg are not recommended because there is no information on their usefulness.Despite good overall control of symptoms, patients with VIPoma often experience periodic exacerbation of symptoms. During these periods, they may be the subcutaneous injection for a few days at the dosage they were receiving prior to their switch to the depot form. When symptoms are again under control, the subcutaneous injection can again be discontinued.Administration of octreotide acetate for injectable suspension (depot) at intervals greater than four weeks is not recommended because there is no adequate information on whether such patients could be adequately controlled.

Usual Adult Dose for Acromegaly:

Initial dose: 50 mcg subcutaneously 3 times a day.Maintenance dose: 100 to 300 mcg/day.Octreotide acetate for injectable suspension (depot):Patients who are not currently receiving octreotide should begin therapy with the subcutaneous injection as described above. Although responsiveness of growth hormone (GH) to octreotide can be ascertained quickly, patients should be maintained on octreotide subcutaneous injection for at least two weeks to determine tolerance to octreotide. Patients who are considered to be "responders" to the drug (based on GH and IGF-1 levels), and who tolerate the drug, can then be switched to octreotide acetate for injectable suspension (depot).Patients currently receiving octreotide injection can be switched directly to octreotide acetate for injectable suspension (depot) at a dose of 20 mg IM intragluteally at 4 week intervals for 3 months. (Deltoid injections should be avoided because of the significant discomfort at the injection site when given in that area.) Gluteal injection sites should be alternated to avoid irritation.At the end of three months octreotide acetate for injectable suspension (depot) may be continued at the same level, increased, or decreased based on the following:GH less than or equal to 2.5 ng/mL, IGF-1 normal and clinical symptoms controlled: maintain the depot dose at 20 mg every 4 weeks.GH greater than 2.5 ng/mL, IGF-1 elevated and/or clinical symptoms uncontrolled: increase the depot dose to 30 mg every 4 weeks.GH less than or equal to 1 ng/mL, IGF-1 normal and clinical symptoms controlled: reduce the depot dose to 10 mg every 4 weeks.Patients whose GH, IGF-1, and symptoms are not adequately controlled at a dose of 30 mg may have the dose increased to 40 mg every four weeks. Doses higher than 40 mg are not recommended.Administration of octreotide acetate for injectable suspension (depot) at intervals greater than four weeks is not recommended because there is no adequate information on whether such patients could be adequately controlled.In patients who have received pituitary irradiation, octreotide acetate for injectable suspension (depot) should be withdrawn yearly for approximately 8 weeks to assess disease activity. If GH or IGF1 levels increase and signs and symptoms recur, octreotide acetate for injectable suspension (depot) should be resumed.

Usual Adult Dose for Gastrinoma:

Initial dose: 100 to 200 mcg subcutaneously 3 times a day.Maintenance dose: 100 to 300 mcg/day.Maximum dose: 1,500 mcg/day.

Usual Adult Dose for Pituitary Adenoma:

Initial dose: 100 to 200 mcg subcutaneously 3 times a day.Maintenance dose: 100 to 300 mcg/day.Maximum dose: 1,500 mcg/day.

Usual Adult Dose for Insulinoma:

Initial dose: 100 to 200 mcg subcutaneously 3 times a day.Maintenance dose: 100 to 300 mcg/day.

Usual Adult Dose for Glucagonoma:

Initial dose: 100 to 200 mcg subcutaneously 3 times a day for 2 weeks.Maintenance dose: 300 to 1,500 mcg/day.

Usual Adult Dose for Small Bowel or Pancreatic Fistula:

50 to 100 mcg subcutaneously 3 times a day for 2 to 3 days.

Usual Adult Dose for Diarrhea:

Initial dose: 50 to 100 mcg subcutaneously 3 times a day.Maintenance dose: 50 to 300 mcg/day. (10 to 300 mcg when AIDS associated).

Usual Adult Dose for Diabetes Mellitus Type I:

Initial dose: 50 mcg subcutaneously 3 times a day.Maintenance dose: 100 to 600 mcg/day.

What other drugs will affect octreotide?

Before using octreotide, tell your doctor if you are taking any of the following medicines:

• bromocriptine (Parlodel);

• cyclosporine (Neoral, Sandimmune, Gengraf);

• a diuretic (water pill);

• diabetes medication such as insulin, glipizide (Glucotrol), glyburide (Diabeta, Micronase), tolbutamide (Orinase), metformin (Glucophage), pioglitazone (Actos), rosiglitazone (Avandia), and others; or

• medicine for heart disease or high blood pressure.

This list is not complete and there may be other drugs that can interact with octreotide. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about octreotide.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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Copyright 1996-2006 Cerner Multum, Inc. Version: 3.01. Revision Date: 10/01/2009 10:28:25 AM.