Pasireotide, Injection (for Acromegaly)

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KEY POINTS

• This medicine is given by injection to treat acromegaly.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine can cause problems with the electrical system of your heart, serious problems with low levels of pituitary hormones in your blood, or high blood sugar, even if you do not have diabetes. Tell your healthcare provider if you have any side effects that 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 for acromegaly; Signifor LAR

What is this medicine used for?

This medicine is given by injection (shots) to treat acromegaly in people who cannot benefit from 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
• Problems with pituitary hormones

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?

These injections are given by your healthcare provider. It is usually given once every 4 weeks. Keep all appointments. If you miss an appointment for an injection, contact your healthcare provider right away to reschedule.

What should I watch out for?

This medicine may cause serious problems with low levels of pituitary hormones in your blood. Contact your healthcare provider right away if you have these symptoms:

• Loss of appetite
• Nausea and vomiting
• Dizziness or fainting
• Tiredness
• Diarrhea
• Weight loss

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 will 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; sudden or severe stomach pain; severe nausea or vomiting; swelling in arms or legs; unexplained weight loss; unusual tiredness or weakness.

Other: Constipation; diarrhea; pain in the upper right belly, right shoulder, or between the shoulder blades; joint pain; 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:

• Alfuzosin (Uroxatral)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), 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), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), thioridazine, and ziprasidone (Geodon)
• Apomorphine (Apokyn)
• 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), degarelix (Firmagon), nilotinib (Tasigna), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Clonidine (Catapres, Kapvay)
• 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)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, methyldopa, procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), and sotalol (Betapace, Sorine)
• HIV medicines such as as atazanavir (Reyataz), lopinavir/ritonavir (Kaletra), and saquinavir (Invirase)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat breathing or lung problems such as arformoterol (Brovana) and formoterol (Perforomist)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as dolasetron (Anzemet) and ondansetron (Zofran)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Propranolol (Hemangeol, Inderal, InnoPran)
• 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.

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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.