Xalkori

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 either a gene called ALK (anaplastic lymphoma kinase) or a gene called ROS1.
• children 1 year of age and older and young adults with ALCL or children 1 year of age and older and adults with IMT when your ALCL or IMT with a defect in a gene called ALK has returned, or you have tried a treatment and it did not work or is no longer working, or specifically for IMT, when the tumor cannot be surgically removed.

It is not known if Xalkori is safe and effective in older adults with ALCL or in children younger than 1 year of age with ALCL or IMT.

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 liver injury that may lead to death. Your healthcare provider should do blood tests to check your liver every 2 weeks during the first 2 months of treatment with Xalkori, then once a month and as recommended by your healthcare provider during treatment. Tell your healthcare provider right away if you develop any of the following new or worsening symptoms:
  • yellowing of your skin or the white part of your eyes
  • severe tiredness
  • dark or brown (tea color) urine
  • nausea or vomiting
  • decreased appetite
  • pain on the right side of your stomach
  • bleed or bruise more easily than normal
  • itching
• Lung problems (pneumonitis). Xalkori may cause life-threatening lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider 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 healthcare provider may check your pulse rate and blood pressure regularly during treatment with Xalkori. Tell your healthcare provider right away if you feel dizzy or faint or have abnormal heartbeats. Tell your healthcare provider if you take any heart or blood pressure medicines.
• Severe vision problems. Vision problems are common with Xalkori. These problems usually happen within 1 week of starting treatment with Xalkori. Vision problems with Xalkori can be severe and may cause partial or complete loss of vision in one or both eyes. Your healthcare provider may hold or permanently stop your treatment with Xalkori and refer you to an eye specialist if any vision problems develop during treatment with Xalkori. Tell your healthcare provider right away if you have any new vision problems, loss of vision or any change in vision, including:
  • double vision
  • light hurting your eyes
  • seeing flashes of light
  • new or increased floaters
  • blurry vision

  In addition, for children or young adults taking Xalkori to treat anaplastic large cell lymphoma (ALCL) or children taking Xalkori to treat inflammatory myofibroblastic tumor (IMT):
  Your healthcare provider may refer you to an eye specialist before starting Xalkori, and within 1 month of starting Xalkori to check for vision problems. You should have an eye examination every 3 months during treatment with Xalkori and more often if there are any new vision problems.

• Severe stomach, intestine, and mouth (gastrointestinal) problems in children or young adults with ALCL or children with IMT. Xalkori may cause severe diarrhea, nausea, vomiting, or mouth sores. Tell your healthcare provider right away if problems with swallowing, vomiting, or diarrhea develop during treatment with Xalkori.
  • Your healthcare provider may give medicines as needed to prevent or treat diarrhea, nausea, and vomiting.
  • Your healthcare provider may recommend drinking more fluids or may prescribe electrolyte supplements or other kinds of nutritional support if severe symptoms develop.

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

What should I tell my healthcare provider before taking Xalkori?

Before taking Xalkori, tell your healthcare provider about all of your medical conditions, including if you:

• have liver or kidney problems
• have lung problems
• have heart problems, including a condition called long QT syndrome
• have vision or eye problems
• are pregnant, or plan to become pregnant. Xalkori can harm the unborn baby.
  • Females who are able to become pregnant:
    • Your healthcare provider will check to see if you are pregnant before starting treatment with Xalkori.
    • Effective birth control (contraception) should be used during treatment with Xalkori and for at least 45 days after the final dose of Xalkori.
    • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with Xalkori.
  • Males who have female partners who can become pregnant:
    • You should use condoms during treatment with Xalkori and for at least 90 days after the final dose of Xalkori.
• are breastfeeding or plan to breastfeed. It is not known if Xalkori passes into the 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 the baby during this time.

Tell your healthcare provider about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

How should I take Xalkori?

• Xalkori should be taken exactly as prescribed by your healthcare provider.
• Xalkori capsules should be swallowed whole.
• Xalkori may be taken with or without food.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Xalkori if you have certain side effects. Do not change the dose or stop treatment with Xalkori unless your healthcare provider tells you to.
• If a dose of Xalkori is missed, it should be taken as soon as you remember. If it is close to the time of the next dose (within 6 hours), the missed dose should be skipped, and the next dose should be taken at the regular time.
• If you vomit after taking a dose of Xalkori, do not take an extra dose. The next dose should be taken at the regular time.
• Xalkori should be given to children under adult supervision.

What should I avoid while taking Xalkori?

• Do not drink grapefruit juice, eat grapefruit or take supplements containing grapefruit extract during treatment with Xalkori. These may increase the amount of Xalkori in the blood.
• Xalkori can cause changes in vision, dizziness, and tiredness. Do not drive or operate machinery if you have any of these symptoms.
• Avoid spending prolonged time in sunlight. Xalkori can make your skin sensitive to the sun (photosensitivity), and you may burn more easily. You should use sunscreen and wear protective clothing that covers your skin to help protect against sunburn if you have to be in the sunlight during treatment with Xalkori.

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 in adults with NSCLC include:

• vision problems
• nausea, diarrhea, or vomiting
• swelling of your hands, feet, face, or eyes
• constipation
• increased liver function blood tests
• tiredness
• decreased appetite
• upper respiratory infection
• dizziness
• feeling of numbness or tingling in your arms or legs

The most common side effects of Xalkori in people with ALCL include:

• diarrhea, vomiting, or nausea
• vision problems
• headache
• muscle and joint pain
• mouth sores
• tiredness
• decreased appetite
• fever
• stomach-area (abdominal) pain
• cough
• itchy skin
• low blood counts

The most common side effects of Xalkori in adults with IMT include:

• vision problems
• nausea
• swelling of your hands, feet, face, or eyes

The most common side effects of Xalkori in children with IMT include:

• diarrhea, vomiting, or nausea
• stomach-area (abdominal) pain
• rash
• vision problems
• upper respiratory infection
• cough
• fever
• muscle and joint pain
• tiredness
• swelling of your hands, feet, face, or eyes
• constipation
• headache

Xalkori may cause fertility problems in females and males, which may affect the ability to have children. Talk to your healthcare provider if you have concerns about fertility.

These are not all of the possible side effects of Xalkori.

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

General information about the safe and effective use of Xalkori

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Xalkori for a condition for which it was not prescribed. Do not give Xalkori to other people, even if they have the same symptoms that you have. It may harm them. You can ask your healthcare provider or pharmacist for more information about Xalkori that is written for health professionals.

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.

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.

For more information, go to www.Pfizer.com or call 1-800-438-1985