Octreotide Acetate, Injection

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KEY POINTS

• This medicine is given by injection to treat acromegaly. It is also used to treat severe diarrhea and flushing caused by certain types of tumors. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: growth hormone inhibitor; antidiarrheal

Generic and brand names: octreotide acetate, injection; Sandostatin

What is this medicine used for?

This medicine is given by injection (shots) to treat acromegaly when you can’t be treated with radiation or surgery, or when other treatments have not worked well enough. This condition happens when the body produces too much growth hormone, causing the head, face, hands, or feet to grow too large.

This medicine may also be given to treat certain tumors that cause severe flushing and watery diarrhea.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Gall bladder problems
• Heart problems such as heart failure
• Kidney or liver disease
• Thyroid problems

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. You may be able to become pregnant while taking this medicine, even if you were unable to get pregnant before starting this medicine. Talk with your healthcare provider about birth control methods while taking this medicine. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

This medicine is given as a shot under the skin or into a vein. It is usually given by your healthcare provider.

Sometimes you can give yourself these shots or have someone at home give them to you. Check the label on the medicine for directions about your specific dose. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Check with your healthcare provider before using this medicine in children under age 18.

Do not use this medicine if it is cloudy or has particles in it.

Ask your healthcare provider or pharmacist how to dispose of any used needles, syringes, or vials. Put used needles in rigid puncture-resistant containers with lids or caps, such as heavy plastic bleach bottles with screw caps. DO NOT throw needles directly into garbage cans or dumpsters. Never share needles or syringes with anyone else.

What if I miss a dose?

If you miss a dose, contact your healthcare provider right away.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: tremors, cold sweats, increased hunger, headache, drowsiness, restlessness, irritability, weakness, trouble concentrating, dizziness, fast or irregular, heartbeat, nausea, severe stomach pain.

What should I watch out for?

You may need regular lab tests to show how you are responding to the medicine and to check for side effects such as a decrease in thyroid function. Keep all appointments for these tests.

This medicine may affect the way your body absorbs dietary fat and vitamin B12. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are using this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Confusion, severe dizziness or fainting, blurred vision or eye pain, chest pain, cold sweats, fast heartbeat, increased thirst or hunger, increased urination, irregular or slow heartbeat, severe back or shoulder pain, severe headache, severe nausea or diarrhea that continues, shaking, strong hunger, sudden or severe stomach pain, swelling in arms or legs, unusual tiredness or weakness, unexplained weight loss, yellowing of the skin or eyes.

Other: Constipation; mild stomach cramps, nausea, or vomiting; bloating, dizziness; tiredness; muscle or joint pain; pain at the spot of the injection; mild headache; hair loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Alfuzosin (Uroxatral)
• Antiarrhythmic medicines (to treat irregular heartbeat) such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), quinidine, and sotalol (Betapace, Sorine)
• Antibiotics such as azithromycin (Zithromax, Zmax), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nortriptyline (Pamelor), and sertraline (Zoloft)
• Antifungal medicines such as fluconazole (Diflucan) and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, and ziprasidone (Geodon)
• Apomorphine (Apokyn)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), bisoprolol (Zebeta), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bromocriptine (Cycloset, Parlodel)
• Calcium channel blockers such as diltiazem (Cardizem, Cartia, Tiazac), felodipine, nifedipine (Adalat CC, Procardia), and verapamil (Calan, Covera, Verelan)
• Cancer medicines such as arsenic trioxide (Trisenox), crizotinib (Xalkori), degarelix (Firmagon), nilotinib (Tasigna), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as acarbose (Precose), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)
• Diuretics (water pills) such as bumetanide, furosemide (Lasix), hydrochlorothiazide (Microzide), and spironolactone (Aldactone)
• Doxepin (Silenor)
• Fingolimod (Gilenya)
• HIV medicines such as lopinavir/ritonavir (Kaletra) and saquinavir (Invirase)
• Magnesium, potassium, or phosphate supplements
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Natural remedies such as alfalfa, aloe, bilberry, burdock, celery, fenugreek, garcinia, garlic, ginger, ginseng, gymnema, and stinging nettle
• Nausea medicines such as dolasetron (Anzemet) and ondansetron (Zofran)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Tetrabenazine (Xenazine)

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the refrigerator. If protected from light, the medicine may be kept at room temperature for 14 days. Keep the container tightly closed. Protect it from heat, high humidity, and bright light. After you open the multi-dose vials, they may be kept at room temperature for 14 days. Open the single-use ampules just before you use them. Discard the unused medicine after 1 hour.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.