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What is XALKORI?

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

Taking XALKORI

Taking XALKORI

If your doctor prescribes XALKORI, there are some things you should know about how to take it and what to expect.

Before you start XALKORI

Before you start XALKORI, it’s important to talk with your healthcare provider about all your health issues and the other medications you are taking, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

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

Always tell your healthcare provider right away about any side effects. They may change the dose of XALKORI or some of your other medicines, choose different medicines while you are taking XALKORI, or stop your treatment.

Be sure to tell your healthcare provider if you:

  • have heart problems, including a condition called long QT syndrome

  • have liver or kidney problems

  • have vision or eye 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 birth control during treatment with XALKORI and for at least 45 days after the final dose of XALKORI.
    • Males who have female partners who can become pregnant should use condoms during treatment with XALKORI and for at least 90 days after the final dose of XALKORI.
    • Talk to your healthcare provider about the birth control methods that may be right for you.
    • If you or your partner becomes pregnant, tell your healthcare provider 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.

Before You Start | How to Take | What to Expect

How to take XALKORI

XALKORI is a pill you take twice a day, with or without food. If your healthcare provider prescribes XALKORI, make sure you:

  • take XALKORI exactly as your healthcare provider tells you.

  • swallow XALKORI capsules whole.

  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with XALKORI if you have certain side effects. Do not change your dose or stop taking XALKORI unless your healthcare provider tells you.

  • do not take more than 1 dose of XALKORI at a time.

  • do not drink grapefruit juice or eat grapefruit as long as you are taking XALKORI. It may increase the amount of XALKORI in your blood to a harmful level.

XALKORI should be taken twice a day, without interruption. In other words, there are no "cycles" or scheduled times when you should stop taking XALKORI and then begin taking it again. Your healthcare provider will regularly check your blood and heart during treatment.

What if you miss a dose?

If you miss a dose of XALKORI, take it as soon as you remember EXCEPT if your next scheduled dose is in less than 6 hours. In that case, just take the next pill at your regular time. But be sure to tell your healthcare provider about your missed dose at your next visit. If you vomit after taking a dose of XALKORI, do not take an extra dose, just take your next dose at your regular time.

Before You Start | How to Take | What to Expect

How will you know if XALKORI is working?

It’s important to keep taking XALKORI exactly as directed until your healthcare provider tells you to stop. Regular scans by your cancer-care team will reveal whether your tumor is responding to treatment with XALKORI. Your healthcare provider will determine when those scans should be scheduled. Your healthcare provider will also order blood tests at least every month to check for liver problems.

What about side effects?

XALKORI has side effects you should know about before you start taking it. Some are serious and occur rarely, while others are more common.

Serious side effects of XALKORI include life-threatening liver injury and lung problems (pneumonitis) that may lead to death; very slow and very fast or abnormal heartbeats; and partial or complete loss of vision in one or both eyes.

The most common side effect is vision problems. This could include double vision, seeing flashes of light, blurry vision, light hurting your eyes, or new or increased floaters. These problems usually happened within one week of starting XALKORI. Tell your healthcare provider right away if you have any change in vision. Your healthcare provider may stop XALKORI and refer you to an eye healthcare provider if you develop severe vision problems during treatment with XALKORI.

Other common side effects include nausea, diarrhea, vomiting, swelling of your hands, feet, face, and eyes, constipation, increased liver function blood test results, tiredness, decreased appetite, upper respiratory infection, dizziness, and feeling of numbness or tingling in the extremities.

These are not all of the possible side effects of XALKORI. For more information, please see the Full Prescribing and Patient Information or ask your healthcare provider or pharmacist.

As always, it’s important to keep your cancer-care team aware of how you’re feeling. But it’s even more important when you’re starting a new treatment like XALKORI. Always tell your healthcare provider right away about any side effects. Your healthcare provider may change the dose of XALKORI or some of your other medicines, choose different medicines while you are taking XALKORI, or stop your treatment.

Before You Start | How to Take | What to Expect

 

XALKORI is available through certain specialty pharmacies. On the next page, we’ll discuss how to get XALKORI and how to get help paying for it if you are eligible.

> NEXT, LET’S TALK:GETING XALKORI

 

Indications

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

Important Safety Information

XALKORI® (crizotinib) may cause serious side effects, some of which may include:

Liver problems — XALKORI may cause life-threatening liver injury that may lead to death. Your healthcare provider should do blood tests at least every month to check your liver during treatment with XALKORI. Tell your healthcare provider right away if you get 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 heart 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.

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 stop XALKORI and refer you to an eye healthcare provider if you develop severe vision problems during treatment with XALKORI. Tell your healthcare provider right away if you have any loss of vision or any change in vision, including:

  • double vision
  • seeing flashes of light
  • blurry vision
  • light hurting your eyes
  • new or increased floaters

Before you take XALKORI, tell your healthcare provider if you:

  • have heart problems, including a condition called long QT syndrome
  • have liver or kidney problems
  • have vision or eye 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 birth control during treatment with XALKORI and for at least 45 days after the final dose of XALKORI.
    • > Males who have female partners who can become pregnant should use condoms during treatment with XALKORI and for at least 90 days after the final dose of XALKORI.
    • > Talk to your healthcare provider about birth control methods that may be right for you.
    • > If you or your partner becomes pregnant, tell your healthcare provider 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.

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

You should not drink grapefruit juice or eat grapefruit during treatment with XALKORI. It may increase the amount of XALKORI in your blood to a harmful level.

The most common side effects of XALKORI include:

  • vision problems
  • nausea
  • diarrhea
  • vomiting
  • swelling of your hands, feet, face, and eyes
  • constipation
  • increased liver function blood test results
  • tiredness
  • decreased appetite
  • upper respiratory infection
  • dizziness
  • feeling of numbness or tingling in the extremities

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.

XALKORI may cause decreased fertility. In females, this could affect your ability to become pregnant. In males, this could affect your ability to father a child.

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

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

 

Indications

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

If you are uninsured or don’t have sufficient coverage for XALKORI, call 1-877-744-5675 to talk to a counselor at Pfizer RxPathways®. They are available Monday through Friday, 8 AM to 8 PM ET and can help verify whether you are eligible for patient assistance.

The product information provided in this site is intended for residents of the United States. The products discussed herein may have different product labeling in different countries.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.