Ceritinib Oral capsule

What is this medicine?

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.

What should I tell my health care provider before I take this medicine?

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

• QT prolongation

• 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 medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food or with grapefruit juice. Take H2-blockers at least 10 hours before or 2 hours after this medicine. Avoid taking antacids within 2 hours of taking this medicine. Do not cut, crush, or chew this medicine. If you cannot swallow the capsules whole, you may open the capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce. Immediately swallow the mixture. Do not store for future use.

If you vomit after taking this medicine, do not take an extra dose, but continue with the next scheduled dose.

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, do not make up the missing dose. Take your next dose as scheduled. Do not take double or extra doses.

What may interact with this medicine?

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

• astemizole

• bretylium

• certain medicines for fungal infections like fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole

• certain medicines for seizures like carbamazepine, fosphenytoin, phenobarbital, phenytoin, primidone

• certain medicines for stomach problems like dexlansoprazole, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole

• cisapride

• dofetilide

• dronedarone

• grepafloxacin

• pimozide

• rifampin

• sparfloxacin

• St. John's Wort, hypericum perforatum

• terfenadine

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• alfentanil

• antacids

• antiviral medicines for HIV or AIDS

• certain antibiotics like clarithromycin, erythromycin, telithromycin

• certain medicines for blood pressure, heart disease, irregular heart beat

• certain medicines for depression, anxiety, or psychotic disturbances

• certain medicines for stomach problems like famotidine

• certain medicines that treat or prevent blood clots like warfarin

• cyclosporine

• ergot alkaloids like dihydroergotamine, ergotamine

• fentanyl

• grapefruit juice

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

• quinidine

• sirolimus

• tacrolimus

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 medicine?

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 at least 2 weeks after the last dose. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. 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.

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.

What side effects may I notice from receiving this medicine?

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 these 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 medicine?

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.