February 12, 2016
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"Another targeted agent for non-small-cell lung cancer (NSCLC) that is positive for the ALK rearrangement (found in about 5% of NSCLC patients) has just been approved by the US Food and Drug Administration (FDA). The new drug, alectinib ("...




(crizotinib) Capsules

Read this patient information leaflet before you start taking XALKORI and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your condition or treatment.

What is the most important information I should know about XALKORI?

XALKORI may cause serious side effects, including:

Liver problems. XALKORI may cause life-threatening or fatal liver injury. Your doctor should do blood tests at least every month to check your liver while you are taking XALKORI. Tell your doctor right away if you get any of the following:

  • your skin or the whites of your eyes turn yellow
  • you feel tired
  • your urine turns dark or brown (tea color)
  • you have nausea or vomiting
  • you have a decreased appetite
  • you have pain on the right side of your stomach
  • you bleed or bruise more easily than normal
  • you have itching

Lung problems (pneumonitis). XALKORI may cause life-threatening or fatal swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening symptoms, including:

  • trouble breathing or shortness of breath
  • cough with or without mucous
  • fever

Heart problems. XALKORI may cause very slow, very fast or abnormal heartbeats. Your doctor may check your heart during treatment with XALKORI. Tell your doctor right away if you feel dizzy or faint or have abnormal heartbeats. Tell your doctor if you take any heart or blood pressure medicines.

Vision problems. XALKORI may cause partial or complete loss of vision in one or both eyes. Tell your doctor right away if you have any loss of vision or tell your doctor if you have any change in vision such as difficulty seeing out of one or both eyes. Your doctor may stop XALKORI treatment and refer you to an eye doctor if you develop severe vision problems while taking XALKORI.

See “What are possible side effects of XALKORI?” for more information about side effects.

What is XALKORI?

XALKORI is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK (anaplastic lymphoma kinase).

It is not known if XALKORI is safe and effective in children.

What should I tell my doctor before taking XALKORI?

Before you take XALKORI, tell your doctor if you:

  • have heart problems, including a condition called long QT syndrome
  • have liver or kidney problems
  • have any other medical conditions
  • are pregnant, or plan to become pregnant. XALKORI can harm your unborn baby.
    • Females who are able to become pregnant should use effective methods of birth control during treatment with XALKORI and for at least 45 days after the last dose of XALKORI. Men who take XALKORI, who have a female partner who can get pregnant, should use birth control during treatment and for at least 90 days after stopping XALKORI.
    • Talk to your doctor about the birth control methods that may be right for you.
    • If you or your partner becomes pregnant, tell your doctor right away.
  • are breastfeeding or plan to breastfeed. It is not known if XALKORI passes into your breast milk. Do not breastfeed during treatment with XALKORI and for 45 days after the final dose. Talk to your healthcare provider about the best way to feed your baby during this time. You and your doctor should decide if you will take XALKORI or stop breastfeeding.

Tell your doctor about the medicines you take, including prescription medicines, over-thecounter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor or pharmacist when you get a new medicine.

How should I take XALKORI?

  • Take XALKORI exactly as your doctor tells you.
  • Swallow XALKORI capsules whole.
  • You may take XALKORI with or without food.
  • Do not change your dose or stop XALKORI unless your doctor tells you.
  • If you miss a dose, take it as soon as you remember. If it is close to your next dose (within 6 hours), just take your next dose at your regular time.
  • If you vomit after taking a dose of XALKORI, do not take an extra dose, just take your next dose at your regular time.
  • Call your doctor right away if you take too much XALKORI.
  • Your doctor will check your blood and heart while you are taking XALKORI.

What should I avoid while taking XALKORI?

  • You should not drink grapefruit juice or eat grapefruit during your treatment with XALKORI. It may make the amount of XALKORI in your blood increase to a harmful level.
  • XALKORI can cause changes in your vision, dizziness, and tiredness. If you have these symptoms avoid driving a car, using machinery, or doing anything that needs you to be alert.

What are the possible side effects of XALKORI?

XALKORI may cause serious side effects, including:

  • See “What is the most important information I should know about XALKORI?”

The most common side effects of XALKORI include:

  • Vision problems. These problems usually happen within 1 week of starting XALKORI. Tell your doctor right away if you have any change in vision, such as double vision, flashes of light, blurred vision, light hurting your eyes, new or increased floaters.
  • diarrhea
  • nausea
  • vomiting
  • constipation
  • swelling of your hands and feet
  • increase in liver enzymes that may indicate liver injury
  • upper respiratory infection
  • loss of appetite
  • taste alteration

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all of the possible side effects of XALKORI. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store XALKORI?

  • Store XALKORI at room temperature between 68°F to 77°F (20°C to 25°C).

Keep XALKORI and all medicines out of the reach of children.

General information about XALKORI

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use XALKORI for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them. This leaflet provides the most important information about XALKORI. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for more information about

XALKORI that is written for health professionals. For more information, go to www.XALKORI.com.

What are the ingredients in XALKORI?

Active ingredient: crizotinib

Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycolate, and magnesium stearate

Pink opaque capsule shell contains: gelatin, titanium dioxide, and red iron oxide White opaque capsule shell contains: gelatin and titanium dioxide

Printing ink contains: shellac, propylene glycol, strong ammonia solution, potassium hydroxide, and black iron oxide

This Patient Information has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 10/3/2015
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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