Sandostatin 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.

Sandostatin is used to treat acromegaly.

Sandostatin is also used to reduce flushing episodes and watery diarrhea caused by cancerous tumors (carcinoid syndrome) or tumors called vasoactive intestinal peptide tumors (VIPomas).

Use Sandostatin exactly as prescribed by your doctor. Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before using Sandostatin, tell your doctor if you have diabetes, gallbladder disease, heart disease, high blood pressure, a heart rhythm disorder, thyroid problems, pancreatitis, kidney disease, or liver disease.

You may be shown how to use an IV at home. Do not self-inject Sandostatin 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 Sandostatin your doctor has prescribed for you.

To be sure Sandostatin is helping your condition and not causing harmful effects, your blood cells, kidney function, and liver function may need to be tested often. Do not miss any follow up visits to your doctor for blood or urine tests. Call your doctor at once if you have a serious side effect such as easy bruising or bleeding, slow heart rate, or severe pain in your upper stomach spreading to your back.

Before using this medicine

You should not use Sandostatin if you are allergic to octreotide.

To make sure Sandostatin is safe for you, tell your doctor if you have ever had:

• diabetes;

• gallbladder disease;

• heart disease, high blood pressure, or heart rhythm disorder;

• thyroid problems;

• pancreatitis;

• liver disease; or

• kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

Using Sandostatin 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.

Sandostatin is not approved for use by anyone younger than 18 years old.

Use Sandostatin exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Sandostatin injection is injected under the skin, into a muscle, or as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine.

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

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

You will need frequent medical tests.

If you need radiation treatment, you may need to stop using Sandostatin for a short time. Follow your doctor's instructions very carefully.

Store unopened Sandostatin in the original carton in the refrigerator. Protect from light. Do not freeze.

Take the ampul out of the refrigerator and let it reach room temperature before injecting your dose. Do not heat the ampul. Each ampul is for one use only. Throw it away after one use, even if there is still medicine left inside.

You may also store an unopened ampul at room temperature for up to 14 days. Throw away the ampul if not used within 14 days.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.

Usual Adult Dose for Carcinoid Tumor:

Initial dose: 100 to 600 mcg per day, IV or subcutaneously, in 2 to 4 divided doses

Comments:
-The median daily dose was 450 mcg; mean daily dose was 300 mcg.
-Benefits were seen in doses from 50 mcg to 1500 mcg per day.
-Experience with doses above 750 mcg per day is limited.


Long-Acting depot formulation (Establish tolerability with short acting product for at least 2 weeks before using this formulation):
Initial dose: 20 mg, IM (intragluteally), at 4 week intervals, for 2 months; continue with dose of regular octreotide for at least 2 weeks (at same dose patient was on before the switch)
After 2 months:
-If symptoms are controlled, consider reducing dose to 10 mg every 4 weeks
-If symptoms are not adequately controlled, increase to 30 mg every 4 weeks
Maximum dose: 30 mg every 4 weeks

Comments:
-Failure to continue dosing of regular octreotide during a switch to the long acting formulation may exacerbate symptoms; some patients require 3 to 4 weeks of concomitant dosing.

Use: Symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.

Usual Adult Dose for Vasoactive Intestinal Peptide Tumor:

Initial dose: 200 to 300 mcg per day, IV or subcutaneously, in 2 to 4 divided doses
Maintenance dose: 150 to 750 mcg per day
-Doses above 450 mcg per day are not usually required.


Long-Acting depot formulation (Establish tolerability with short acting product for at least 2 weeks before using this formulation):
Initial dose: 20 mg, IM (intragluteally), at 4 week intervals, for 2 months; continue with dose of regular octreotide for at least 2 weeks (at same dose patient was on before the switch)
After 2 months:
-If symptoms are controlled, consider reducing dose to 10 mg every 4 weeks
-If symptoms are not adequately controlled, increase to 30 mg every 4 weeks

Comments:
-Adjust dose for therapeutic response.

Use: Long term treatment of the profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP) secreting tumors.

Usual Adult Dose for Acromegaly:

Initial dose: 50 mcg, IV or subcutaneously, 3 times a day
Maintenance dose: Usually 100 mcg, 3 times a day
Maximum dose: 500 mcg, 3 times a day

Comments:
-Starting at a low dose may help patients adapt to gastrointestinal adverse events.
-Use IGF-1 (somatomedin C) levels, every 2 weeks, to guide titration.
-Multiple growth hormone levels, zero to 8 hours after dosing, may permit more rapid dose titration.
-Doses over 300 mcg per day seldom provide additional biochemical benefit.


Long-Acting depot formulation (Establish tolerability with short acting product for at least 2 weeks before using this formulation):
Initial dose: 20 mg, IM (intragluteally), at 4 week intervals, for 3 months
After 3 months:
-If GH is 1 ng/mL or less, IGF-1 normal, and clinical symptoms controlled: 10 mg, IM, every 4 weeks
-If GH is 2.5 ng/mL or less and clinical symptoms controlled: 20 mg, IM, every 4 weeks
-If GH is higher than 2.5 ng/mL and/or clinical symptoms uncontrolled: 30 mg, IM, every 4 weeks
-If GH, IGF-1, or symptoms are not adequately controlled at 30 mg, may increase dose to 40 mg IM every 4 weeks
Maximum dose: 40 mg, every 4 weeks

Comments:
-The goal is growth hormone (GH) levels under 5 ng/mL, or IGF-1 levels under 1.9 U/mL (male) or 2.2 U/mL (female).
-If increased doses do not provide additional benefit, reduce dose.
-Check IGF-1 or growth hormone levels every 6 months.
-For patients who have received irradiation: withdraw medication yearly for about 4 weeks (8 weeks for long-acting formulation) to assess disease activity; if growth hormone or IGF-1 increase and symptoms recur, resume therapy.

Use: To reduce blood levels of growth hormone and IGF-1 (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection or radiotherapy.

You should not use Sandostatin if you are allergic to octreotide.

To make sure Sandostatin is safe for you, tell your doctor if you have ever had:

• diabetes;

• gallbladder disease;

• heart disease, high blood pressure, or heart rhythm disorder;

• thyroid problems;

• pancreatitis;

• liver disease; or

• kidney disease (or if you are on dialysis).

Tell your doctor if you are pregnant or breastfeeding.

Using Sandostatin 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.

Sandostatin is not approved for use by anyone younger than 18 years old.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe upper stomach pain, diarrhea, weight loss, warmth or tingling, numbness or cold feeling, unexplained muscle pain, weakness, weak pulse, fainting, or slow breathing (breathing may stop).

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Call your doctor at once if you have:

• severe constipation;

• slow or uneven heartbeats;

• signs of gallstones - fever, chills, nausea, vomiting, severe pain in your upper stomach spreading to your back, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;

• low blood sugar - headache, hunger, sweating, irritability, dizziness, fast heart rate, and feeling anxious or shaky; 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 Sandostatin side effects may include:

• gallstones;

• nausea, vomiting, diarrhea, stomach pain, gas;

• headache, back pain; or

• dizziness, tiredness.

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 your other medicines, especially:

• bromocriptine (Cycloset, Parlodel);

• cyclosporine;

• insulin or oral diabetes medicine; or

• heart or blood pressure medication.

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 drug interactions are listed here.