Sunitinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat certain types of cancer. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause a skin problem, high blood pressure, severe liver problems, or severe heart problems. This medicine may cause other 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: antineoplastic (anticancer)

Generic and brand names: sunitinib, oral; Sutent

What is this medicine used for?

This medicine is taken by mouth to treat:

• Advanced kidney cancer
• Gastrointestinal stromal tumors (GIST)
• Advanced pancreatic neuroendocrine tumors (pNET)

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
• A bleeding problem
• Diabetes
• Heart failure, an irregular heartbeat, or any other heart problem
• High blood pressure
• Kidney or liver problems
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Problems with the levels of magnesium or potassium in your blood
• Seizures
• Thyroid problems

Tell your healthcare provider if you have recently been sick or injured, had surgery, or if you are scheduled to have surgery.

Tell your provider if you have any dental problems, or if you are scheduled for dental surgery. Also tell your healthcare provider the date of your last dental exam. You may be at risk of a disease called osteonecrosis of the jaw if you have any dental problems or surgery while taking this medicine.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I take it?

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

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Treatment will be continued for as long as you continue to benefit and can tolerate the side effects.

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

This medicine may be taken with or without food.

Do not open, crush, or chew the capsules. Swallow them whole.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take 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?

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: weakness, shaking chills, stomach pain.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine can cause severe liver problems. Contact your healthcare provider right away if you develop severe tiredness, nausea, vomiting, loss of appetite, dark urine, fever, headache, muscle or joint pain, or yellowing of your skin or the whites of your eyes. These are signs of possible liver damage.

This medicine may cause heart problems such as heart failure, high blood pressure, or an irregular heartbeat. Tell your healthcare provider if you feel very tired, are short of breath, have swollen feet and ankles, feel dizzy, faint or have abnormal heartbeats while you are taking this medicine.

This medicine may cause a rare, but serious disease called osteonecrosis of the jaw. You may be at an increased risk for this problem if you have any dental problems or dental surgery, have cancer, anemia, or blood clotting problems, or you are receiving chemotherapy or corticosteroids (such as prednisone). Talk with your healthcare provider about this. You should brush your teeth and clean your mouth properly while taking this medicine. If you have any jaw pain, swelling, numbness, or loose teeth, contact your healthcare provider right away.

This medicine may cause low blood sugar, especially if you take medicines for diabetes. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. Contact your healthcare provider right away if you have these symptoms.

This medicine may cause changes in your skin or hair color. This is not harmful. Talk with your healthcare provider about this.

This medicine may cause a problem called tumor lysis syndrome. Report side effects such as nausea, shortness of breath, irregular heartbeat, cloudy urine, or tiredness to your provider immediately.

This medicine may make your mouth sore. Use a soft bristle brush or mouth swab to brush your teeth.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking 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; chest pain or tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness); yellowing of the eyes and skin, dark urine, severe nausea or vomiting, or pain in the right upper stomach area; decreased urination; unusual bruising or bleeding; bloody or black bowel movements; painful or swollen stomach; vomiting blood; bloody urine; any signs of infection such as sore throat or fever; unusual tiredness or weakness; swelling of hands, feet or ankles; unexplained weight changes; trouble breathing; severe dizziness or fainting; chest pain; fast or irregular heartbeat; seizures; numbness or tingling in hands or feet; blisters, rash, or peeling skin; unusual mood or behavior changes; jaw pain, swelling, numbness.

Other: Mild nausea or vomiting, diarrhea, mild stomach pain, gas, constipation, headache, dizziness, dry, thick or cracking skin; muscle or joint pain, change in sense of taste, loss of appetite, dry mouth, hair or skin color changes, hair loss, back pain, trouble sleeping.

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:

• Alpha blockers such as alfuzosin (Uroxatral), doxazosin (Cardura), prazosin (Minipress), silodosin (Rapaflo), tamsulosin (Flomax), and terazosin
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), chloramphenicol, ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), nafcillin, pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), nefazodone, sertraline (Zoloft), trazodone, venlafaxine (Effexor), vilazodone (Viibryd), and vortioxetine (Trintellix)
• Antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antipsychotic medicines such as aripiprazole (Abilify), asenapine (Saphris), chlorpromazine, clozapine, haloperidol (Haldol), iloperidone (Fanapt), olanzapine (Zyprexa), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, thiothixene (Navane), and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), primidone (Mysoline), topiramate (Qudexy, Topamax, Trokendi), and valproic acid (Depacon, Depakene, Depakote)
• Apomorphine (Apokyn)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), axitinib (Inlyta), bevacizumab (Avastin), ceritinib (Zykadia), crizotinib (Xalkori), dabrafenib (Tafinlar), dasatinib (Sprycel), degarelix (Firmagon), enzalutamide (Xtandi), erlotinib (Tarceva), idelalisib (Zydelig), imatinib (Gleevec), lapatinib (Tykerb), mitotane (Lysodren), nilotinib (Tasigna), pazopanib (Votrient), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Colchicine (Colcrys)
• Corticosteroids such as betamethasone (Celestone), dexamethasone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Everolimus (Afinitor, Zortress)
• Heart medicines such as amiodarone (Cordarone, Pacerone), amlodipine (Norvasc), amlodipine/atorvastatin (Caduet), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), felodipine, flecainide, isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat CC, Procardia), nisoldipine (Sular), procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), sotalol (Betapace, Sorine), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), etravirine (Intelence), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), nevirapine (Viramune), rilpivirine (Edurant), ritonavir (Norvir), saquinavir (Invirase), and zidovudine (Retrovir)
• Immunosuppressants such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), tacrolimus (Astagraf, Prograf, Protopic), and temsirolimus (Torisel)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to treat bone loss such as alendronate (Binosto, Fosamax), etidronate (Didronel), ibandronate (Boniva), pamidronate, risedronate (Actonel, Atelvia), and zoledronic acid (Reclast, Zometa)
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Medicines to treat pulmonary hypertension such as bosentan (Tracleer) and macitentan (Opsumit)
• Methadone (Dolophine, Methadose)
• Mifepristone (Korlym, Mifeprex)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), and ondansetron (Zofran)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• St. John's wort
• Warfarin (Coumadin)

Do NOT eat or drink products that contain grapefruit, Seville oranges, and tangelos at any time while you are taking this medicine. These fruits and juices affect the way this medicine works and increase your risk of serious side effects. Talk with your healthcare provider or pharmacist about this.

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 medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.