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What is <strong>XALKORI®?</strong>

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XALKORI (crizotinib) 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.

XALKORI for ALK+ or ROS1+ metastatic non-small cell lung cancer (NSCLC)

In 2011, XALKORI became the first medication for people who test ALK-positive (ALK+) and have NSCLC that has spread to other parts of the body (metastatic). Today, it also treats those who test ROS1-positive (ROS1+).

Learn more about the ALK and ROS1 genes

About XALKORI® (crizotinib) | Safety Info
Read about Rx XALKORI® (crizotinib), a medicine used to treat people with metastatic NSCLC whose tumors test ALK-positive or ROS1-positive. See risks & benefits

How XALKORI <strong>Works</strong>

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XALKORI® (crizotinib) and the ALK or the ROS1 genes
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There are many kinds of lung cancer, and the same medication is not used to treat each kind. XALKORI is only used for certain types of lung cancer. It’s for non-small
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 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. These types of lung cancer are called ALK-positive (ALK+) or ROS1-positive (ROS1+), depending on which gene is abnormal.

XALKORI treats ALK+ or ROS1+ NSCLC that has spread to other parts of the body (metastatic). For many patients in clinical studies, XALKORI shrank or slowed tumor growth for a certain length of time. For some of these patients, that meant their cancer did not get worse during this time. In clinical studies, XALKORI did not make the cancer go away. But in the majority of people with ALK+ or ROS1+ metastatic NSCLC, XALKORI was able to shrink or slow the growth of patients’ tumors for a period of time.

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How XALKORI may be able to help

ALK+ Study Results

ROS1+ Study Results

XALKORI was tested in 3 clinical studies of people with ALK+ NSCLC that had spread to other parts of their bodies. A total of 1,669 people received XALKORI in these studies.

Length of time during which ALK+ cancer did not get worse

In one study, 172 people took XALKORI and 171 people were given chemotherapy. In the group of people taking XALKORI, the length of time during which their cancer did not get worse was longer than for those in the group receiving chemotherapy.

In people taking XALKORI, the tumors did not grow or spread for a median time period of 10.9 months. Median time period means that half the people went longer than 10.9 months with no tumor growth or spread, and the other half went less than 10.9 months with no tumor growth or spread.

For people treated with chemotherapy, the median time period was 7 months for no tumor growth or spread.

Length of time during which cancer did not get worse

7.0 MONTHS
 
CHEMOTHERAPY INFUSIONS
 
 
10.9 MONTHS
XALKORI CAPSULES
 

How did ALK+ tumors respond to XALKORI?

  • The Objective Response Rate (ORR) measures tumor response to treatment, including tumor shrinkage.
  • The results showed that the ORR of patients taking XALKORI was 74% — meaning 74% of patients saw their tumors respond to XALKORI — compared to 45% of patients taking chemotherapy.
    • Three patients in the XALKORI group had all signs of cancer disappear (known as a complete response, but this does not mean that the cancer is cured). Two of the patients in the chemotherapy group had a complete response.
    • 125 of the 172 patients in the XALKORI group had the spread of cancer lessened, or had tumors that shrank (known as a partial response). In the chemotherapy group, 75 of the 171 patients had a partial response.
  • The length of time these partial and complete responses lasted before the tumors resumed growing or spreading was a median time period of 11.3 months for people who took XALKORI and a median of 5.3 months for people who had chemotherapy.
  • This study also measured the total time patients lived after starting each treatment. This measure is still ongoing. So far, no significant difference has been shown in overall survival between patients taking XALKORI and chemotherapy.

Study description: The 343 people in this study with ALK+ NSCLC that had spread to other parts of their bodies were split into 2 groups and given different treatments. One group took XALKORI capsules twice a day, and the other group received chemotherapy infusions every 21 days. None of these people had received previous systemic treatment for their non-small cell lung cancer that had spread to other parts of the body.

The ability of XALKORI to treat ROS1+ tumors was tested in a clinical study that included 50 people with ROS1+ NSCLC that had spread to other parts of their bodies. This study did not compare XALKORI to another medication such as chemotherapy.

How ROS1+ tumors responded to XALKORI

  • The Objective Response Rate (ORR) measures tumor response to treatment, including tumor shrinkage.
  • The results showed that the ORR of patients taking XALKORI was 66%, meaning 66% of patients saw their tumors respond to XALKORI.
    • One patient had all signs of cancer disappear (known as a complete response, but this does not mean that the cancer is cured).
    • 32 of 50 patients had the spread of cancer lessened, or had tumors that shrank (known as a partial response).
  • The length of time these partial and complete responses lasted before the tumors resumed growing or spreading was a median time period of 18.3 months.
    • This means that after the tumors responded, half of the patients went longer than 18.3 months before their tumor grew or spread, and half went less than 18.3 months before their tumor grew or spread.

Study description: The 50 people in this study with ROS1+ NSCLC that had spread to other parts of their bodies were treated with XALKORI capsules twice a day. All of the people in the study took XALKORI; the results were not compared to results with another medication. Most of the people in the study had received previous systemic treatment for their NSCLC that had spread to other parts of the body.

50 PATIENTS TOOK XALKORI TO TREAT THEIR ROS1-POSITIVE METASTATIC NSCLC.

Objective Response Rate 
66%

of patients taking XALKORI had their tumor respond

 

  • 1 patient’s tumor was not detectable after XALKORI treatment. (This does not mean that the cancer is cured.)
  • 32 patients’ tumors shrank over 30%.
 
Time without tumor growth or spread 
66%

months was the median time period that patients went before their tumors grew or spread, after the tumors initially shrank or their spread lessened.

 

 

ALK+ Study Results

XALKORI was tested in 3 clinical studies of people with ALK+ NSCLC that had spread to other parts of their bodies. A total of 1,669 people received XALKORI in these studies.

Length of time during which ALK+ cancer did not get worse

In one study, 172 people took XALKORI and 171 people were given chemotherapy. In the group of people taking XALKORI, the length of time during which their cancer did not get worse was longer than for those in the group receiving chemotherapy.

In people taking XALKORI, the tumors did not grow or spread for a median time period of 10.9 months. Median time period means that half the people went longer than 10.9 months with no tumor growth or spread, and the other half went less than 10.9 months with no tumor growth or spread.

For people treated with chemotherapy, the median time period was 7 months for no tumor growth or spread.

Length of time during which cancer did not get worse

7.0 MONTHS
 
CHEMOTHERAPY INFUSIONS
 
 
10.9 MONTHS
XALKORI CAPSULES
 

How did ALK+ tumors respond to XALKORI?

  • The Objective Response Rate (ORR) measures tumor response to treatment, including tumor shrinkage.
  • The results showed that the ORR of patients taking XALKORI was 74% — meaning 74% of patients saw their tumors respond to XALKORI — compared to 45% of patients taking chemotherapy.
    • Three patients in the XALKORI group had all signs of cancer disappear (known as a complete response, but this does not mean that the cancer is cured). Two of the patients in the chemotherapy group had a complete response.
    • 125 of the 172 patients in the XALKORI group had the spread of cancer lessened, or had tumors that shrank (known as a partial response). In the chemotherapy group, 75 of the 171 patients had a partial response.
  • The length of time these partial and complete responses lasted before the tumors resumed growing or spreading was a median time period of 11.3 months for people who took XALKORI and a median of 5.3 months for people who had chemotherapy.
  • This study also measured the total time patients lived after starting each treatment. This measure is still ongoing. So far, no significant difference has been shown in overall survival between patients taking XALKORI and chemotherapy.

Study description: The 343 people in this study with ALK+ NSCLC that had spread to other parts of their bodies were split into 2 groups and given different treatments. One group took XALKORI capsules twice a day, and the other group received chemotherapy infusions every 21 days. None of these people had received previous systemic treatment for their non-small cell lung cancer that had spread to other parts of the body.

ROS1+ Study Results

The ability of XALKORI to treat ROS1+ tumors was tested in a clinical study that included 50 people with ROS1+ NSCLC that had spread to other parts of their bodies. This study did not compare XALKORI to another medication such as chemotherapy.

How ROS1+ tumors responded to XALKORI

  • The Objective Response Rate (ORR) measures tumor response to treatment, including tumor shrinkage.
  • The results showed that the ORR of patients taking XALKORI was 66%, meaning 66% of patients saw their tumors respond to XALKORI.
    • One patient had all signs of cancer disappear (known as a complete response, but this does not mean that the cancer is cured).
    • 32 of 50 patients had the spread of cancer lessened, or had tumors that shrank (known as a partial response).
  • The length of time these partial and complete responses lasted before the tumors resumed growing or spreading was a median time period of 18.3 months.
    • This means that after the tumors responded, half of the patients went longer than 18.3 months before their tumor grew or spread, and half went less than 18.3 months before their tumor grew or spread.

Study description: The 50 people in this study with ROS1+ NSCLC that had spread to other parts of their bodies were treated with XALKORI capsules twice a day. All of the people in the study took XALKORI; the results were not compared to results with another medication. Most of the people in the study had received previous systemic treatment for their NSCLC that had spread to other parts of the body.

50 PATIENTS TOOK XALKORI TO TREAT THEIR ROS1-POSITIVE METASTATIC NSCLC.

Objective Response Rate 
66%

of patients taking XALKORI had their tumor respond

 

  • 1 patient’s tumor was not detectable after XALKORI treatment. (This does not mean that the cancer is cured.)
  • 32 patients’ tumors shrank over 30%.
 
Time without tumor growth or spread 
66%

months was the median time period that patients went before their tumors grew or spread, after the tumors initially shrank or their spread lessened.

 

 

How XALKORI® (crizotinib) Works | Safety Info
Read how Rx XALKORI® (crizotinib) works to help treat ALK+ or ROS1+ NSCLC that has spread to other parts of the body. See risks & benefits.

Side Effects

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XALKORI® (crizotinib) side effects
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XALKORI has side effects you should know about before you start taking it. Tell your healthcare provider right away if you have any side effect that bothers you or that does not go away.

XALKORI has been known to cause serious side effects, including:

  • Liver problems XALKORI may cause a 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

Risks related to pregnancy

If you 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.

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Common side effects
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The most common side effect of XALKORI is vision problems.

A majority of people in two XALKORI studies reported visual changes that happened about 4 to 7 times per week. These visual changes usually lasted up to 1 minute and had mild or no impact on their daily activities, according to a questionnaire that patients had responded to.

If you have any loss of vision or change in vision, tell your doctor right away. You can also use these images to provide your doctor with a more specific description of your vision changes.

  • Normal Vision Changes In Vision Examples
  • Double Vision Changes In Vision Examples
  • Flashes of Light Changes In Vision Examples
  • Blurry Vision Changes In Vision Examples
  • New or
    Increased Floaters     Changes In Vision Examples

Other common side effects of XALKORI 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
  • 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, please ask your healthcare provider or pharmacist. You can also review the full Patient Prescribing Information.

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 treatment such as XALKORI. Always tell your healthcare provider if you have any side effect that bothers you or does not go away. Your healthcare provider may change the dose of XALKORI or some of your other medications, choose different medicines while you are taking XALKORI, or stop your treatment.

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

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Tips to help manage common side effects:
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You and your doctor may be able to manage some side effects. Other side effects, however, may not be manageable. In some cases, your doctor may adjust your dose or stop your treatment.

Nausea / Vomiting

Diarrhea

Constipation

Swelling of your hands, feet, face, and eyes

It is best to call your doctor or nurse at the first sign of nausea or vomiting. This is especially important if these symptoms keep you from taking your oral medications. Your doctor may prescribe a medicine for these symptoms.
  • Eat small meals
  • Avoid foods that are sweet, fried, or fatty
  • Drink lots of fluids, but in small amounts
If you vomit, start with small amounts of water, broth, or other clear liquids when you are ready to eat again. If that stays down, then try soft foods. Some examples include gelatin, yogurt, strained soup, or cream of wheat. Slowly work up to eating solid food. Make sure that you do not eat any food that you are allergic to.
Diarrhea is defined as 3 or more loose or watery stools/bowel movements in one day. If you have these symptoms, call your doctor or nurse. It is important for you and your doctor to try to manage diarrhea as soon as it begins. Ask your doctor or nurse if you can be treated with over-the-counter medications.
  • Avoid spicy foods, fatty foods, caffeine, and fruit
  • Eat only mild foods
  • Drink water often — but only in small sips
Some people taking your treatment experience constipation.
  • Drink plenty of fluids
  • Ask your doctor before taking a stool softener and laxative, or before getting an enema
  • Add fiber to your diet
  • Increase physical activity
Swelling, or edema, occurs in some patients on treatment. If you have swelling of your face or mouth while taking treatment, it may be a sign of a serious side effect. Ask your doctor to perform a full evaluation. Here are some tips to possibly address edema:
  • Taking a prescribed diuretic may help. This decreases the amount of water in your body through urination
  • Maintain a balanced diet, while cutting down on salt
  • Walking and other exercises can help increase circulation and reduce swelling
  • Wearing compression socks or elastic sleeves can help with your circulation
  • Elevating your arms and legs when sitting or lying down can help
Don’t stop drinking water and other fluids without talking to your doctor first.
Nausea / Vomiting

It is best to call your doctor or nurse at the first sign of nausea or vomiting. This is especially important if these symptoms keep you from taking your oral medications. Your doctor may prescribe a medicine for these symptoms.

  • Eat small meals
  • Avoid foods that are sweet, fried, or fatty
  • Drink lots of fluids, but in small amounts

If you vomit, start with small amounts of water, broth, or other clear liquids when you are ready to eat again. If that stays down, then try soft foods. Some examples include gelatin, yogurt, strained soup, or cream of wheat. Slowly work up to eating solid food. Make sure that you do not eat any food that you are allergic to.

Diarrhea

Diarrhea is defined as 3 or more loose or watery stools/bowel movements in one day. If you have these symptoms, call your doctor or nurse. It is important for you and your doctor to try to manage diarrhea as soon as it begins. Ask your doctor or nurse if you can be treated with over-the-counter medications.

  • Avoid spicy foods, fatty foods, caffeine, and fruit
  • Eat only mild foods
  • Drink water often — but only in small sips
Constipation

Some people taking your treatment experience constipation.

  • Drink plenty of fluids
  • Ask your doctor before taking a stool softener and laxative, or before getting an enema
  • Add fiber to your diet
  • Increase physical activity
Swelling of your hands, feet, face, and eyes

Swelling, or edema, occurs in some patients on treatment. If you have swelling of your face or mouth while taking treatment, it may be a sign of a serious side effect. Ask your doctor to perform a full evaluation. Here are some tips to possibly address edema:

  • Taking a prescribed diuretic may help. This decreases the amount of water in your body through urination
  • Maintain a balanced diet, while cutting down on salt
  • Walking and other exercises can help increase circulation and reduce swelling
  • Wearing compression socks or elastic sleeves can help with your circulation
  • Elevating your arms and legs when sitting or lying down can help

Don’t stop drinking water and other fluids without talking to your doctor first.

Side Effects of XALKORI® (crizotinib) | Safety Info
Read about the side effects and benefits of XALKORI® (crizotinib), an Rx for treatment of ALK+ or ROS1+ metastatic NSCLC. See risks & benefits.

Taking <strong>XALKORI</strong>

Title: 
TAKING XALKORI® (crizotinib)
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If your doctor prescribes XALKORI, there are some things you should know about how to take it and what to expect.

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Before you start XALKORI
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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.

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.

Tell your healthcare provider about the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements. Keep a list of them to show to your doctor or pharmacist, and tell them when you get a new medicine.

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.

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How to take XALKORI
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XALKORI is a pill you take twice a day, with or without food — without interruption. In other words, there are no "cycles" or scheduled times when you should stop taking XALKORI and then begin taking it again.

If your doctor prescribes XALKORI, make sure you:

  • take XALKORI exactly as your healthcare provider tells you.
  • swallow XALKORI capsules whole.
  • know that 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.

EASY WAYS TO REMEMBER EACH DOSE:

There are some simple ways to remember to take XALKORI twice each day. Here are a few ideas you can try:

Calendar Icon

Use a calendar.

Record your dosage times on a calendar or planner. You can then check off each dose as you take it.

Weekly Pill Caddy Icon

Use a weekly pill caddy.

It can help you to organize your capsules in separate compartments. Refer back to the pill caddy to make sure you’ve taken XALKORI twice each day.

Notebook Icon

Use a diary or journal.

It can help you keep track of how much medicine to take and when. You can also use it to track symptoms and side effects for doctor visits.

Reminder Icon

Ask for a reminder.

A caregiver, friend, or family member can be helpful in reminding you to take each dose of your medicine.

Pill Bottle Icon

Place your pill bottle in plain sight.

Keep your medicine where you will see it, such as on your nightstand. Just make sure it is out of the reach of children and pets.

WHAT TO DO 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.

If you vomit after taking a dose of XALKORI, do not take an extra dose; just take your next dose at your regular time.

 

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How will you know if XALKORI is working?
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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.

Taking XALKORI® (crizotinib) For mNSCLC Treatment | Safety Info
Find instructions for taking Rx XALKORI® (crizotinib) for ALK+ or ROS1+ metastatic NSCLC, & learn what you can expect. See risks and benefits.