Xalkori Capsules - Crizotinib Capsules

What is this medication?

CRIZOTINIB (kriz OH ti nib) treats some types of cancer. It works by blocking a protein that causes cancer cells to grow and multiply. This helps to slow or stop the spread 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:

• Irregular heartbeat or rhythm
• Kidney disease
• Liver disease
• Lung disease
• Slow heartbeat
• Vision problems
• An unusual or allergic reaction to crizotinib, other medications, foods, dyes, or preservatives
• If you or your partner are pregnant or trying to get pregnant
• Breastfeeding

How should I use this medication?

Take this medication 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 medication. Swallow the capsules whole. You can take it with or without food. If it upsets your stomach, take it with food. Your care team may change your dose or tell you stop taking this medication if you get side effects. Do not change your dose or stop taking it unless your care team tells you to.

Do not take this medication 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 care team about the use of this medication 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 unless it is less than 6 hours before the next dose. If it is less than 6 hours before the next dose, skip the missed dose. Take the next dose at the normal time.

If you vomit after taking your dose, do not take another dose. Take your next dose at your usual scheduled time.

What may interact with this medication?

Do not take this medication with any of the following:

• Certain medications for fungal infections, such as fluconazole, itraconazole, ketoconazole, posaconazole
• Cisapride
• Dronedarone
• Flibanserin
• Levoketoconazole
• Lomitapide
• Lonafarnib
• Pacritinib
• Pimozide
• Saquinavir
• Thioridazine

This medication may also interact with the following:

• Grapefruit Juice
• Medications that lower your heart rate, such as clonidine, diltiazem, digoxin, metoprolol, propranolol
• Other medications that cause heart rhythm changes

This medication may affect how other medications work, and other medications may affect the way this medication works. Talk with your care team about all of the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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 care team for regular checks on your progress. It may be some time before you see the benefit from this medication.

This medication 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 care team tells you to stop.

You may need blood work done while you are taking this medication.

Your vision may be tested before and during use of this medication. Tell your care team right away if you have any change in your eyesight.

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

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

This medication 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, tanning beds, or tanning booths.

Talk to your care team if you or your partner may be pregnant. Serious birth defects can occur if you take this medication during pregnancy and for 45 days after the last dose. A negative pregnancy test is required before starting this medication. Contraception is recommended while taking this medication and for 45 days after the last dose. Your care team can help you find the option that works for you.

If your partner can get pregnant, use a condom during sex while taking this medication and for 90 days after the last dose.

Do not breastfeed while taking this medication and for 45 days after the last dose.

This medication may cause infertility. Talk to your care team if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in vision such as blurry vision, seeing halos around lights, vision loss
• Dry cough, shortness of breath or trouble breathing
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Pain, redness, or swelling with sores inside the mouth or throat
• Sensitivity to light
• Severe or prolonged diarrhea
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue

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

• Diarrhea
• Fatigue
• Nausea
• Pain, tingling, or numbness in the hands or feet
• Skin reactions on sun-exposed areas
• Swelling of the ankles, hands, or feet
• Vomiting

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 medication after the expiration date.

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

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

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.