Pasireotide, Injection

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KEY POINTS

• This medicine is given by injection to treat Cushing’s syndrome.
• This medicine may cause serious problems with low levels of the adrenal gland hormone cortisol in your blood. It can also cause problems with the electrical system of your heart, and affect your blood sugar level.
• 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: somatostatin analog

Generic and brand names: pasireotide, injection; Signifor

What is this medicine used for?

This medicine is given by injection (shots) to treat Cushing’s syndrome in people who cannot benefit from pituitary surgery.

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
• Gallstones
• Heart problems such as heart attack, heart failure, unstable angina, or a slow heartbeat
• Liver disease
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Problems with low levels of potassium or magnesium in your blood

Females of childbearing age: Talk with your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

This medicine is given as a shot under the skin. You can give yourself these shots or have someone at home give them to you.

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

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.

What if I miss a dose?

If you miss a dose, use it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and use the next one as directed. Do not use double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

This medicine may cause serious problems with low levels of the adrenal gland hormone cortisol in your blood. Contact your healthcare provider right away if you have these symptoms:

• Unusual tiredness or weakness
• Loss of appetite
• Nausea and vomiting
• Dizziness or fainting
• Confusion
• Shaking
• Cold sweats
• Vision problems

This medicine can slow your heartbeat or cause problems with the electrical system of your heart. Call your healthcare provider right away if you have an irregular or slow heartbeat, severe dizziness, weakness, or fainting spells.

This medicine may cause high blood sugar, even if you do not have diabetes. Contact your provider if you have:

• Unusual thirst
• Increased urination
• Increased appetite with weight loss

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.

You may need regular lab tests to show how you are responding to the medicine. Keep all appointments for these tests.

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

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; fainting; severe dizziness; yellowing of your skin or eyes; dark urine; light-colored bowel movements; chest pain; fast, irregular, or slow heartbeat; increased urination; shaking; cold sweats; strong hunger; unusual thirst; severe headache; sudden or severe stomach pain; severe nausea or vomiting; severe diarrhea; swelling in arms or legs; unexplained weight loss; unexplained loss of appetite; unusual tiredness or weakness; fever; pain in the upper right belly, right shoulder, or between the shoulder blades.

Other: Constipation; mild diarrhea; mild stomach pain; joint or muscle pain; mild headache; pain at the spot of the injection; hair loss; stuffy or runny nose; cough.

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:

• Antibiotics such as 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), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• Antifungal medicines such as fluconazole (Diflucan), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antipsychotic medicines such as asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Artemether/lumefantrine (Coartem)
• Beta blockers such as atenolol (Tenormin), bisoprolol (Zebeta), labetalol (Trandate), metoprolol (Lopressor, Toprol), and pindolol
• 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), ceritinib (Zykadia), crizotinib (Xalkori), lapatinib (Tykerb), nilotinib (Tasigna), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cyclosporine (Gengraf, Neoral, Sandimmune)
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as acarbose (Precose), canagliflozin (Invokana), dapagliflozin (Farxiga), exenatide (Bydureon, Byetta), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), rosiglitazone (Avandia), saxagliptin (Onglyza), and sitagliptin (Januvia)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), torsemide (Demadex), and triamterene (Dyrenium)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), and sotalol (Betapace, Sorine)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as dolasetron (Anzemet) and ondansetron (Zofran)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine

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 at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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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.