Sandostatin

Sandostatin is a prescription medication used to treat the symptoms of acromegaly, carcinoid tumors, and vasoactive intestinal peptide adenomas. Sandostatin belongs to a class of drugs called octapeptides, which work by decreasing the amounts of certain natural substances. These substances may be made in excessive amounts by the body because of certain conditions like tumors.

Sandostatin is available in an injectable form to be given directly into a vein (IV) by a healthcare professional. It is also available in an injectable form to be given directly under the skin (subcutaneously) that may be done by the patient after proper training.

A long-acting form of Sandostatin is available in an injectable form to be given directly into a muscle (IM) by a healthcare professional.

The immediate-release injection (Sandostatin) is usually injected 2 to 4 times a day. The ong-acting injection (Sandostatin LAR Depot) is usually injected once every 4 weeks.

Common side effects of Sandostatin include bile duct abnormalities, fatigue, headache, and abdominal pain. Sandostatin can cause dizziness. Do not drive or operate heavy machinery until you know how Sandostatin affects you.

Sandostatin is a prescription medication used to treat symptoms of the following conditions:

• acromegaly. This is a condition in which the body makes too much growth hormone. This causes an enlargement of the hands, feet, and facial features. It can also lead to joint pain and other symptoms.
• carcinoid tumors. Carcinoid tumors are slow-growing tumors that release natural substances that can cause diarrhea and flushing.
• vasoactive intestinal peptide secreting adenomas (VIP-omas). These are tumors that form in the pancreas and release natural substances that can cause many negative symptoms including diarrhea.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported with Sandostatin. See the “Drug Precautions” section.

Common side effects of Sandostatin include:

• bile duct abnormalities. Bile ducts are small tubes that carry bile between the liver and the gallbladder and from the gallbladder to the small intestine. Bile helps you digest food.
• fatigue
• headache
• abdominal (stomach area) pain
• diarrhea
• dizziness
• gallstones
• flatulence (gas)
• flu-like symptoms (fever, muscle aches, nausea, chills)
• constipation
• injection site pain
• vomiting

This is not a complete list of Sandostatin side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• insulin
• medications that treat high blood sugar such as glyburide (Micronase, Diabeta), pioglitazone (Actos), and metformin (Glucophage)
• beta blockers such as propranolol (Inderal), carvedilol (Coreg), metoprolol (Lopressor, Toprol XL), and nadolol (Corgard)
• bromocriptine (Parlodel)
• medications that use the enzyme CYP3A4 such as alfentanil (Alfenta), astemizole (Hismanal), cisapride (Propuslid) cyclosporine (Neoral, Gengraf, Sandimmune), dihydroergotamine (Migranal, DHE-45), ergotamine (Ergostat, Medihaler Ergotamine), fentanyl (Abstral, Actiq, Fentora, Onsolis), pimozide (Orap), quinidine (Quinact, Quinalan), sirolimus (Rapamune, Rapamycin), tacrolimus (Prograf)

This is not a complete list of Sandostatin drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Sandostatin including:

• bile duct abnormalities. Tell your healthcare provider right away if you have any or all of the following symptoms of bile duct abnormality:
  • yellowing of the skin or eyes
  • itching
  • weight loss
  • a decreased appetite
  • fatigue
  • fever or night sweats
  • light brown urine
  • abdominal (stomach area) pain
  • clay-colored or greasy stools
• low or high blood sugars. Blood glucose levels should be monitored when Sandostatin is started or when the dose is changed. If you are on medication(s) for diabetes, your doses may be changed.
• hypothyroidism. Assessment of thyroid function is recommended. Tell your healthcare provider right away if you have any or all of the following symptoms of hypothyroidism:
  • fatigue
  • weight gain
  • feel cold
  • feel sluggish
  • dry skin
  • constipated
• heart irregularities. Bradycardia (a slow heart rate), arrhythmia (an irregular heart rate), conduction abnormalities, and other changes may occur. Use with caution if you have heart problems.
• nutritional imbalances. Sandostatin may change the absorption of dietary fats. Monitoring of vitamin B12 levels is recommended during therapy with Sandostatin. Those needing total parenteral nutrition (TPN) and Sandostatin should have periodic monitoring of zinc levels.

Sandostatin can cause dizziness. Do not drive or operate heavy machinery until you know how Sandostatin affects you.

Do not take Sandostatin if you are allergic to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Sandostatin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Sandostatin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to any ingredient in Sandostatin
• have liver problems
• have heart problems
• have kidney problems
• have thyroid problems
• have diabetes
• are being fed by total parenteral nutrition (TPN; feeding by giving a fluid containing nutrients directly into a vein)
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Sandostatin falls into category B. There are no well-done studies that have been done in humans with Sandostatin. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether Sandostatin passes into human milk. Because many drugs can pass into human milk, caution should be used when Sandostatin is given to a nursing woman.

Inject Sandostatin exactly as prescribed. 

This medication is available in an injectable immediate-release form (Sandostatin) to be given directly into a vein (IV) by a healthcare professional. It is also available in an injectable form to be given directly under the skin (subcutaneously) that may be done by the patient after proper training.

A long-acting injectable form (Sandostatin LAR Depot) is also available. It is given directly into a muscle (IM) by a healthcare provider.

Sandostatin immediate-release injection is usually injected 2 to 4 times a day. Inject Sandostatin immediate-release injection at around the same times every day.

Sandostatin LAR Depot (long-acting injection) is usually injected once every 4 weeks.

Treatment begins with the immediate-release injection for 2 weeks, during which time your doctor may gradually increase your dose.

After two weeks your doctor may give you the long-acting injection. In order to control your condition, you may need to continue to receive the immediate-release injection for 2 weeks or longer after you receive your first dose of the long-acting injection. 

If you are being treated for a carcinoid tumor or VIP-oma, you may experience worsening of your symptoms from time to time during your treatment. If this happens, your doctor may tell you to use the immediate-release injection for a few days until your symptoms are controlled.

If you have acromegaly and have been treated with radiation therapy, your doctor will probably tell you not to use Sandostatin immediate-release injection for 4 weeks every year or not to receive the Sandostatin LAR Depot (long-acting injection) for 8 weeks every year. This will allow your doctor to see how the radiation therapy has affected your condition and decide whether you should still be treated with Sandostatin.

Those with carcinoid tumors and VIP-omas should follow their return visit schedules closely for injections in order to keep symptoms under control.

Those with acromegaly should follow their return visit schedules closely to maintain control of certain hormone levels that are treated by this medication.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Sandostatin at the same time.

Inject Sandostatin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Sandostatin dose your doctor recommends will be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose range for Sandostatin (octreotide) is 100 to 750 micrograms (mcg), divided into equal doses and taken 2 to 4 times daily.

The recommended dose for Sandostatin LAR Depot (long-acting octreotide) is 20 mg every four weeks for three months (for acromegaly) or for two months (for carcinoid tumors or VIP-omas). It should be used only after response and tolerance has been shown with Sandostatin.

If you inject too much Sandostatin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Sandostatin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Sandostatin

• Store at refrigerated temperatures 2ºC-8ºC (36ºF-46ºF) and store in outer carton in order to protect from light.
• At room temperature, (20ºC-30ºC or 70ºF-86ºF), Sandostatin is stable for 14 days if protected from light.
• The solution can be allowed to come to room temperature before injection.
• Do not warm artificially (i.e. microwave, stove, oven).
• After initial use, multiple-dose vials should be discarded within 14 days.
• Ampuls should be opened just prior to administration and the unused portion discarded.
• Dispose unused product or waste properly.
• Keep this and all medications out of the reach of children.

Sandostatin LAR Depot

• Store at refrigerated temperatures between 2°C-8°C (36°F-46°F) and protect from light until the time of use.
• The product kit should remain at room temperature for 30-60 minutes before preparing the drug suspension.
• After preparation, the drug suspension must be given immediately.
• Keep this and all medications out of the reach of children.