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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 was 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.

The ALK fusion gene

The ALK fusion gene

A particular genetic defect

Advances in genetics have revealed a number of genetic alterations or defects that are believed to cause some cancers to grow.

One of these, the anaplastic lymphoma kinase (ALK) fusion gene, was identified in non-small cell lung cancer (NSCLC) in 2007. The ALK fusion gene is an alteration or defect in a normal gene called ALK and is thought to play a critical role in the growth of some NSCLCs.

About 3% to 5% of people with NSCLC may test positive for the ALK fusion gene (ALK+). This number may seem small, but not if you are one of them. While some people may be more likely to have the ALK fusion gene in their tumors, there is no true way to know without getting tested. Men and women with NSCLC who tested ALK+ for clinical trials were of various races and ranged in age from their 20s up to 82. There were smokers, former smokers, and a majority who had never smoked.

Why it's important to know

More and more we are discovering that knowing what drives the cancer helps to select the treatment of choice. XALKORI blocks the action of the ALK fusion gene. If you test ALK+ and your NSCLC has spread to other parts of your body, it may respond to XALKORI.

XALKORI is a prescription medicine. It treats NSCLC that has spread to other parts of the body and was caused by a defect in a gene. This gene is called ALK. It is not known if XALKORI is safe and effective in children.

Getting tested is the only way to know

Experts have made specific recommendations about who should be tested for the ALK fusion gene. Ask your doctor if this is an appropriate test for you.

How to start the conversation

If you have been diagnosed with lung cancer, here are some questions you may want to ask your doctor:

  • Are any biomarker tests available for my type of tumor?

  • Should I be tested for the ALK fusion gene?

  • When is it appropriate to test me for biomarkers like the ALK fusion gene?

  • What can biomarker testing tell me about my cancer?

  • Will I need another biopsy?

If your doctor recommends testing you for biomarkers such as the ALK fusion gene, you may also want to ask:

  • How could it affect my course of treatment?

In the next section, you’ll learn more about XALKORI — what it is, how it works, and what it could mean for your cancer treatment plan.

> NEXT, LET’S TALK: ABOUT 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.

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 may harm your unborn baby.
    • >Women who are able to become pregnant and men who take XALKORI should use birth control during treatment and for 3 months 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. You and your doctor should decide if you will take XALKORI or breastfeed. You should not do both.

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.
  • nausea
  • diarrhea
  • vomiting
  • constipation
  • swelling of your hands or feet
  • feeling tired

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 1-866-706-2400 to talk to a counselor at Pfizer RxPathwaysTM. They are available Monday through Friday, 9 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.