Sandostatin LAR Depot injection

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 purposes not listed in this medication guide.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

Store octreotide in the original carton in the refrigerator. Protect from light.

Octreotide should be at room temperature when you inject it. Take the medicine out of the refrigerator 30 to 60 minutes before preparing your dose. Do not heat the medicine. After mixing your dose, give the injection right away. Do not save it for later use.

Prepare your dose only when you are ready to give yourself an injection. Do not use octreotide if it has changed colors or has particles in it. Call your pharmacist for new medication.

Your care provider will show you the best places on your body to inject octreotide. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

While using octreotide, you may need frequent medical tests.

Each single-use ampul is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

If refrigeration is not available, you may store an unopened single-use ampul or multi-dose vial at room temperature for up to 14 days. Keep away from moisture and heat.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain or tenderness, severe constipation;

• slow or uneven heartbeats;

• severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss;

• low blood sugar--headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; or

• underactive thyroid--extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain.

Common side effects may include:

• diarrhea, constipation;

• vomiting, upset stomach;

• bloating, gas;

• headache, dizziness; or

• pain when injecting the medicine.

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.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with octreotide, especially:

• bromocriptine (Cycloset, Parlodel);

• cyclosporine (Neoral, Sandimmune, Gengraf);

• insulin or oral diabetes medicine;

• a diuretic or "water pill"; or

• medicine for heart disease or high blood pressure.

This list is not complete. Other drugs may interact with octreotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Applies to octreotide: powder for solution, powder for suspension, solution

Along with its needed effects, octreotide (the active ingredient contained in Sandostatin LAR Depot) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking octreotide:

• Abdominal or stomach pain
• blurred vision
• constipation
• depressed mood
• dizziness
• dry mouth
• dry skin and hair
• fainting
• fast, slow, or irregular heartbeat
• feeling cold
• flushed, dry skin
• fruit-like breath odor
• hair loss
• hoarseness or husky voice
• increased hunger
• increased thirst
• increased urination
• muscle cramps and stiffness
• nausea
• severe stomach pain with nausea and vomiting
• sweating
• troubled breathing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• weight gain

• Abdominal or stomach bloating
• anxious feeling
• behavior change similar to drunkenness
• changes in menstrual periods
• cold sweats
• confusion
• convulsions (seizures)
• cool, pale skin
• decreased sexual ability in males
• difficulty with concentrating
• drowsiness
• headache
• loss of appetite
• muscle cramps and stiffness
• nightmares
• restless sleep
• shakiness
• slurred speech
• swelling of the front part of the neck
• tiredness
• troubled breathing (rapid and deep)
• unconsciousness
• unusual thirst

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• chills
• darkened urine
• fever
• indigestion
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pinpoint red spots on the skin
• severe constipation
• unusual bleeding or bruising
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking octreotide:

• Abdominal or stomach discomfort
• decreased appetite
• diarrhea
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, shallow breathing
• feeling of warmth
• general feeling of discomfort
• light-colored stools
• muscle pain or cramping
• no blood pressure or pulse
• redness of the face, neck, arms, and occasionally, upper chest
• shortness of breath
• sleepiness
• stopping of heart
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• upper right abdominal or stomach pain
• weakness
• weight loss

Some side effects of octreotide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Pain, redness, stinging, swelling, tingling, or burning sensation at the injection site
• passing of gas

• Backache
• bladder pain
• cloudy urine
• cough
• difficult, burning, or painful urination
• disturbed color perception
• double vision
• frequent urge to urinate
• frequent urination usually with very small amounts of urine
• general feeling of discomfort or illness
• halos around lights
• itching skin
• joint pain
• lack of appetite
• loss of vision
• lower back or side pain
• muscle aches and pains
• night blindness
• overbright appearance of lights
• runny nose
• shivering
• sore throat
• stools that float, are foul smelling, and fatty in appearance
• trouble concentrating
• trouble sleeping
• tunnel vision