Nilotinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat Philadelphia chromosome-positive chronic myelogenous leukemia. Take it exactly as directed.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause a severe or life-threatening heart problem called QT prolongation or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• This medicine may interact with many other medicines. 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); chemotherapy

Generic and brand names: nilotinib, oral; Tasigna

What is this medicine used for?

This medicine is taken by mouth to treat a type of leukemia called Philadelphia chromosome positive chronic myelogenous leukemia (CML).

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 heart attack
• A stroke
• Bleeding problems or problems with decreased blood flow to your brain or to your legs
• Chemotherapy or radiation therapy
• Imbalances of calcium, magnesium, potassium, phosphate, or sodium in your blood
• Lactose intolerance or severe lactase deficiency
• Liver or kidney disease
• Heart problems, including an irregular heartbeat
• Long QT syndrome (problems with electrical activity in the heart muscle)
• Pancreatitis
• Surgery to remove your stomach

This medicine interacts with many other medicines, and increases your risk for serious and life-threatening side effects. Tell your healthcare provider all prescription and nonprescription medicines you take. Do not start or stop any medicine unless you check with your healthcare provider or pharmacist first.

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. Talk with your healthcare provider about effective birth control. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

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.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more of it or for longer than prescribed. Taking too much increases the risk of serious side effects. Do not stop taking this medicine without your healthcare provider's approval. Ask your healthcare provider anything you do not understand.

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

Take this medicine on an empty stomach. Do not eat food for at least 2 hours before or 1 hour after you take this medicine. Take the medicine with a full glass of water. Swallow the capsules whole. Do not open, break, or chew them.

What if I miss a dose?

If you miss a dose, skip the dose and take the next dose at the regular time. 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: severe muscle cramps, vomiting, drowsiness.

What should I watch out for?

This medicine may cause a life-threatening heartbeat problem called QT prolongation. Your healthcare provider will check your heart regularly while you are taking this medicine. You also need to have blood tests regularly to see how this medicine affects you. Keep all appointments for tests.

This medicine may lower the number of certain types of blood cells in your body. You may get infections or bleed more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Do not have any vaccines without getting your healthcare provider's approval first. If you develop a fever or other signs of infection, or have any unusual bruising or bleeding, contact your healthcare provider right away.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

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; 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; confusion; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Shortness of breath; unexplained cough, sore throat, or fever; severe diarrhea, nausea, or vomiting; ongoing loss of appetite; severe stomach pain; yellowing of the skin or eyes; dark urine; light-colored bowel movements; unusual bruising or bleeding; chest pain; fast or irregular heartbeat; severe dizziness or fainting; leg pain or your leg feels cold; change in skin color of your leg; blood in your urine or bowel movement; unusual tiredness or weakness; unexplained swelling in the hands, ankles, feet or face; changes in urination; increased hunger or thirst.

Other: Rash, dry skin, constipation, mild diarrhea, mild tiredness, trouble sleeping, mild headache, mild dizziness, mild nausea or vomiting, flushing, muscle or joint pain, hair loss, night sweats, runny or stuffy nose.

What products might interact with this medicine?

Do not take any other medicines unless they are approved by the healthcare provider who prescribed 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), silodosin (Rapaflo), and tamsulosin (Flomax)
• Anagrelide (Agrylin)
• Antacids that contain aluminum, calcium, magnesium, or simethicone such as Gaviscon, Maalox, Mylanta, and TUMS (Take antacids at least 2 hours before or 2 hours after you take this medicine.)
• Antianxiety medicines such as alprazolam (Xanax), buspirone, chlordiazepoxide, and diazepam (Valium)
• Antibiotics such as azithromycin (Zithromax, Zmax), bedaquiline (Sirturo), ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), metronidazole, moxifloxacin (Avelox), pentamidine (NebuPent, Pentam), rifabutin (Mycobutin), rifampin (Rifadin), rifapentine (Priftin), and telithromycin (Ketek)
• Antidepressants such as amitriptyline, citalopram (Celexa), desipramine (Norpramin), escitalopram (Lexapro), fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), sertraline (Zoloft), and trazodone
• 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 (Clozaril, FazaClo), haloperidol (Haldol), iloperidone (Fanapt), paliperidone (Invega), pimozide (Orap), quetiapine (Seroquel), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Apomorphine (Apokyn)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Bosentan (Tracleer)
• Buprenorphine (Buprenex, Butrans) and buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), axitinib (Inlyta), bosutinib (Bosulif), ceritinib (Zykadia), crizotinib (Xalkori), dasatinib (Sprycel), degarelix (Firmagon), doxorubicin (Doxil), enzalutamide (Xtandi), eribulin (Halaven), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), sorafenib (Nexavar), tamoxifen, toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor), lomitapide (Juxtapid), lovastatin (Altoprev), and pravastatin (Pravachol)
• Cinacalcet (Sensipar)
• Colchicine (Colcrys)
• Conivaptan (Vaprisol)
• Dexamethasone
• Dextromethorphan, an ingredient in many cough and cold medicines such as Robitussin-DM
• Dextromethorphan/quinidine (Nuedexta)
• Diabetes medicines such as nateglinide (Starlix), pioglitazone (Actos), saxagliptin (Onglyza), and sitagliptin (Januvia)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Fingolimod (Gilenya)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), eplerenone (Inspra), flecainide, metoprolol (Toprol), nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, ranolazine (Ranexa), sotalol (Betapace, Sorine), and verapamil (Calan, Covera, Verelan)
• HIV medicines such as atazanavir (Reyataz), cobicistat (Tybost), darunavir (Prezista), delavirdine (Rescriptor), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Astagraf, Prograf, Protopic)
• Lithium (Lithobid)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to block or prevent stomach acid such as dexlansoprazole (Dexilant), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), and rabeprazole (AcipHex) (Take these medicines about 10 hours before or about 2 hours after you take this medicine.)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), budesonide (Entocort, Rhinocort, Uceris), fluticasone (Flonase, Flovent, Veramyst), fluticasone/salmeterol (Advair), fluticasone/vilanterol (Breo Ellipta), formoterol (Perforomist), salmeterol (Serevent), and theophylline
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), rivaroxaban (Xarelto), ticagrelor (Brilinta), and warfarin (Coumadin)
• Midazolam (Versed)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), and ergotamine (Ergomar)
• Naloxegol (Movantik)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), ondansetron (Zofran), prochlorperazine (Compro), and promethazine
• Octreotide (Sandostatin)
• Pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone, methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), and tramadol (ConZip, Ultram)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Simeprevir (Olysio)
• Sleeping pills such as flurazepam, secobarbital (Seconal), triazolam (Halcion), and zolpidem (Ambien, Edluar, Intermezzo)
• St. John's wort
• Stimulants such as armodafinil (Nuvigil), atomoxetine (Strattera), and modafinil (Provigil)
• Tetrabenazine (Xenazine)
• Tolvaptan (Samsca)

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.

Do not have any vaccines without getting your healthcare provider's approval first.

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.