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What is XALKORI?

XALKORI is a prescription medicine. It treats non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene. This gene is called anaplastic lymphoma kinase (ALK). 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 doctor 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 doctor about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.

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

Always tell your doctor or nurse 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 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.

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 doctor prescribes XALKORI, make sure you:

  • take XALKORI exactly as your doctor tells you.

  • swallow XALKORI capsules whole.

  • do not change your dose or stop taking XALKORI unless your doctor 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 make the amount of XALKORI in your blood increase to a harmful level.

  • call your doctor right away if you take too much XALKORI.

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 doctor 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 doctor or nurse 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 doctor tells you to stop. Regular scans by your cancer-care team will reveal whether your tumor is responding to treatment with XALKORI. Your doctor will determine when those scans should be scheduled. Your doctor 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 liver problems and lung problems (pneumonitis), which can be life-threatening or fatal; very slow and very fast or abnormal heartbeats; and partial or complete loss of vision in one or both eyes.

The most common side effects with XALKORI are 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.

Other common side effects can include 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, and taste alteration.

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 doctor 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 doctor or nurse right away about any side effects. Your doctor 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

 

Indication

XALKORI is a prescription medicine used to treat 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.

Important Safety Information

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

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 medications.

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.

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-the-counter 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.

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

The most common side effects of XALKORI include:

  • vision problems — these problems usually happen soon after 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 or feet
  • increase in liver enzymes that may indicate liver injury
  • upper respiratory infection
  • loss of appetite
  • taste alteration

XALKORI may cause changes in your vision or make you feel tired or dizzy. If you have these symptoms avoid driving a car, using machinery or doing anything that needs you to be alert.

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 the FDA at 1-800-FDA-1088 (1-800-332-1088).

 

Indication

XALKORI is a prescription medicine used to treat 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.

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.