Crizotinib oral capsules

What is this medication?

CRIZOTINIB (kriz OH ti nib) treats non-small cell lung cancer. It may also treat anaplastic large-cell lymphoma. It can also be used to treat inflammatory myofibroblastic tumor. It works by slowing down the growth of cancer cells.

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

COMMON BRAND NAME(S): XALKORI

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

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

• blurred vision
• irregular heartbeat or rhythm
• kidney disease
• liver disease
• lung disease
• slow heartbeat
• vision problems
• an unusual or allergic reaction to crizotinib, 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 water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medicine. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Keep taking it unless your health care provider tells you to stop.

Do not take this medicine with grapefruit juice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. While it may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

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 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.

What may interact with this medication?

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

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?

This medicine 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 health care provider tells you to stop.

Your vision may be tested before and during use of this medicine.

Tell your doctor or health care provider right away if you have any change in your eyesight.

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

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills or sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for 45 days after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 90 days after stopping it. There is potential for serious harm to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine and for 45 days after stopping it.

This medicine may make it more difficult to get pregnant or father a child. Talk with your health care provider if you are concerned about your fertility.

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 (skin rash, itching or hives, swelling of the face, lips, or tongue)
• blurred vision OR changes in vision
• diarrhea
• heartbeat rhythm changes (trouble breathing; chest pain; dizziness; fast, irregular heartbeat; feeling faint or lightheaded, falls)
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; usually weak or tired, yellowing of the eyes or skin)
• mouth sores
• slow heartbeat (trouble breathing; chest pain; dizziness; feeling faint or lightheaded; falls; unusually weak or tired)
• trouble breathing
• unusual bleeding or bruising
• severe nausea, vomiting

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

• constipation
• decreased appetite
• edema (sudden weight gain; swelling of the ankles, feet, hands, or other unusual swelling; trouble breathing)
• pain, tingling, numbness in the hands or feet

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 and pets.

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

To get rid of medicines that are no longer needed or have expired:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.