Ceritinib, Oral

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KEY POINTS

• This medicine is taken by mouth to treat non-small cell lung cancer. Take 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: antineoplastic (anticancer); kinase inhibitor

Generic and brand names: ceritinib, oral; Zykadia

What is this medicine used for?

This medicine is taken by mouth to treat non-small cell lung cancer that is advanced or that has spread to other parts of the body.

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
• Any other lung disease (such as pulmonary fibrosis)
• Diabetes
• Heart disease or a heart attack
• 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: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Use an effective method of birth control while taking this medicine and for at least 2 weeks after treatment. 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 taking this medicine.

How do I use it?

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 or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

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

Do not break, crush, or chew the capsules. Swallow them whole. Do not touch or handle crushed or broken capsules.

Take this medicine on an empty stomach, at least 2 hours before or after a meal.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is within 12 hours of the next dose. In that case, skip that dose and take the next regular dose. 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 have not been reported.

What should I watch out for?

This medicine may cause changes in your heartbeat. Tell your healthcare provider right away if you faint, feel dizzy, feel new chest pain, or have abnormal heartbeats. Also tell your provider if you start or stop taking heart or blood pressure medicines.

You need to have blood tests and checkups regularly to see how this medicine affects you. Keep all appointments.

Rarely, this medicine may cause pancreatitis. If you have stomach pain that is severe and will not go away, with or without vomiting, or severe back pain, contact your healthcare provider right away.

This medicine is likely to cause nausea, vomiting, diarrhea, and stomach pain. Contact your healthcare provider if these symptoms are severe or do not go away.

This medicine may make you drowsy or dizzy or cause vision problems. Do not drive or operate machinery unless you are fully alert and can see clearly.

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

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking 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.): Shortness of breath; chest pain; fast, slow, or irregular heartbeat; severe dizziness or fainting; unexplained cough, sore throat, or fever; runny or stuffy nose; trouble swallowing; unusual tiredness or weakness; eye pain or vision problems; unusual bruising or bleeding; severe stomach pain, diarrhea, nausea, or vomiting; increased thirst or hunger; increased drowsiness; fruity-smelling breath; trouble thinking or concentrating; flushing; increased urination; loss of appetite; yellowing of the skin or eyes; dark urine; light-colored bowel movements; unusual bruising or bleeding; numbness or tingling.

Other: Mild rash, diarrhea, constipation, nausea, vomiting, mild dizziness or tiredness, decreased appetite.

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) and tamsulosin (Flomax)
• Anagrelide (Agrylin)
• Antacids
• Antianxiety medicines such as alprazolam (Xanax), buspirone, clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), 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), 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), thioridazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Apomorphine (Apokyn)
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bosentan (Tracleer)
• Cancer medicines such as abiraterone (Zytiga), arsenic trioxide (Trisenox), enzalutamide (Xtandi), idelalisib (Zydelig), imatinib (Gleevec), mitotane (Lysodren), nilotinib (Tasigna), sorafenib (Nexavar), sunitinib (Sutent), toremifene (Fareston), vandetanib (Caprelsa), and vemurafenib (Zelboraf)
• Cholesterol-lowering medicines such as atorvastatin (Lipitor) and lomitapide (Juxtapid)
• Clonidine (Catapres, Kapvay)
• Colchicine (Colcrys)
• Conivaptan (Vaprisol)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Dexamethasone
• Diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), and glyburide (Glynase)
• Donepezil (Aricept)
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Erectile dysfunction medicines such as avanafil (Stendra), sildenafil (Viagra), tadalafil (Cialis), and vardenafil (Levitra, Staxyn)
• Fingolimod (Gilenya)
• Galantamine (Razadyne)
• Heart medicines such as amiodarone (Cordarone, Pacerone), digoxin (Lanoxin), diltiazem (Cardizem, Cartia, Tiazac), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide, nicardipine (Cardene), procainamide, propafenone (Rythmol), quinidine, 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)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), esomeprazole (Nexium), famotidine (Pepcid), lansoprazole (Prevacid), and omeprazole (Prilosec)
• Medicines to treat breathing or lung problems such as arformoterol (Brovana), formoterol (Perforomist), salmeterol (Serevent), and vilanterol (Breo Ellipta)
• Medicines to treat or prevent blood clots such as apixaban (Eliquis), cilostazol (Pletal), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Mifepristone (Korlym, Mifeprex)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal) and ergotamine (Ergomar)
• Naloxegol (Movantik)
• Narcotic pain medicines such as fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), methadone (Dolophine, Methadose), and oxycodone (OxyContin, Roxicodone)
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), and ondansetron (Zofran)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pasireotide (Signifor)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rivastigmine (Exelon)
• Simeprevir (Olysio)
• St. John's wort
• 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.

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.