Crizotinib oral capsules

What is this medicine?

CRIZOTINIB (kriz OH ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat non-small cell lung cancer.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. You can take it with or without food. If it upsets your stomach, take it with food. If you vomit after taking your medicine, take your next dose at the regular time and do not take an extra dose. Take the doses about 12 hours apart. 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.

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

• low blood counts - this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding

• signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine

• signs of decreased platelets or bleeding - bruising, pinpoint red spots on the skin, black, tarry stools, blood in the urine, nosebleeds

• breathing problems

• changes in vision

• chest pain or chest tightness

• cough with or without mucous

• dark urine

• fast or irregular heartbeat

• feeling faint or lightheaded, falls

• general ill feeling or flu-like symptoms

• light-colored stools

• loss of appetite

• pain, tingling, numbness in the hands or feet

• right upper belly pain

• sores or white patches in your mouth or throat

• unusually weak or tired

• vomiting

• yellowing of the eyes or skin

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

• changes in taste

• constipation

• decreased appetite

• diarrhea

• dizziness

• headache

• joint pain

• nausea

• swelling of the ankles, feet, hands

• tired

• trouble sleeping

• upset stomach

What may interact with this medicine?

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

• cisapride

• dronedarone

• flibanserin

• fluconazole

• lomitapide

• pimozide

• posaconazole

• saquinavir

• thioridazine

This medicine may also interact with the following medications:

• certain antiviral medicines for HIV or AIDS

• certain antibiotics like erythromycin and clarithromycin

• certain medicines for fungal infections like itraconazole, ketoconazole, and voriconazole

• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin

• dofetilide

• grapefruit juice

• midazolam

• narcotic medicines for pain

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

• rifampin

• St. John's wort, Hypericum perforatum

• ziprasidone

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is less than 6 hours before your next dose, do not make up for the missed dose and just take your next dose at your regular time. Do not take double or extra doses.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

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

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

• heart disease

• history of irregular heartbeat

• history of low levels of calcium, magnesium, or potassium in the blood

• kidney disease

• liver disease

• an unusual or allergic reaction to crizotinib, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Tell your doctor or healthcare professional if your symptoms do not start to get better or if they get worse. Tell your doctor about any unusual symptoms.

Tell your doctor or health care professional right away if you have any change in your eyesight. Do not drive or use machinery if you have a change in your eyesight.

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

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.

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.

Women should not become pregnant while taking this medicine and for at least 45 days after the last dose. Men should use condoms during treatment and for at least 90 days after the last dose. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is 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 and for 45 days after the last dose. This medicine may interfere with the ability to have a child. Talk with your doctor or health care professional if you are concerned about your fertility.