Ceritinib tablets or capsules

What is this medication?

Ceritinib (se RI ti nib) is medicine that targets proteins in cancer cells and stops the cells from growing. It is used to treat non-small cell lung cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Zykadia

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• diabetes or high blood sugar
• heart disease
• history of irregular heartbeat
• history of pancreatitis
• liver disease
• low magnesium or potassium levels in the body
• lung or breathing disease, like asthma
• an unusual or allergic reaction to ceritinib, lactose, gelatin, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine with food. Do not take with grapefruit juice. Do not cut, crush, or chew this medicine. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If your next dose is to be taken in less than 12 hours, then do not take the missed dose. Take the next dose at your regular time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

• alfuzosin
• certain medicines for cholesterol like lovastatin and simvastatin
• certain medicines for fungal infections like fluconazole, isavuconazonium, posaconazole, or voriconazole
• cisapride
• dronedarone
• eletriptan
• eplerenone
• ergot alkaloids like dihydroergotamine and ergotamine
• flibanserin
• ivabradine
• lomitapide
• lurasidone
• naloxegol
• pimozide
• ranolazine
• saquinavir
• silodosin
• thioridazine
• tolvaptan
• triazolam
• ubrogepant
• venetoclax

This medicine may also interact with the following medications:

• alfentanil
• certain antiviral medicines for HIV or AIDS
• certain antibiotics like clarithromycin and telithromycin
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• cyclosporine
• dofetilide
• fentanyl
• grapefruit juice
• nefazodone
• other medicines that prolong the QT interval (cause an abnormal heart rhythm)
• quinidine
• rifampin
• sirolimus
• St. John's Wort
• tacrolimus
• warfarin
• ziprasidone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor for checks on your progress. You will need to have regular blood tests while on this medicine. Report any new symptoms promptly.

Call your doctor or health care professional for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This drug decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Avoid taking products that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your doctor. These medicines may hide a fever.

Do not become pregnant while taking this medicine or for 6 months after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 3 months after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for 2 weeks after the last dose.

This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

This drug may make you feel generally unwell. This is not uncommon, as chemotherapy can affect healthy cells as well as cancer cells. Report any side effects. Continue your course of treatment even though you feel ill unless your doctor tells you to stop.

This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and sunscreen. Do not use sun lamps or tanning beds/booths.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain or tightness
• cough
• fever or chills, sore throat
• severe nausea, vomiting
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
• signs and symptoms of high blood sugar such as dizziness; dry mouth; dry skin; fruity breath; nausea; stomach pain; increased hunger or thirst; increased urination
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• stomach pain
• unusual bleeding or bruising

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• dizziness
• headache
• nausea, vomiting
• unusually weak or tired

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.