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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.

Biomarker testing & NSCLC treatment

Biomarker testing & NSCLC treatment

How genetics is changing the fight against non-small cell lung cancer (NSCLC)

Advances in genetics are changing the way doctors treat some people with NSCLC. These discoveries are unlocking the secrets behind what makes some cancers grow, and giving doctors the ability to devise treatment plans based on the genetic makeup of the person’s cancer.

Biomarker testing and biomarker-driven treatments

Many cancer cells look the same under the microscope. But as scientists study these cells at the molecular level, they are finding genetic alterations or defects that are common to certain types of cancer. In some cases, these defects are what make the cells grow and multiply abnormally.

Biomarkers are the molecular fingerprints of these genetic defects. By testing a sample of your tumor for biomarkers, doctors can learn if your cancer has one of these defects, and that may point to a specific treatment choice. Biomarker-driven therapies are believed to work by blocking the activity of the defective gene that is making the cancer grow.

That's why it's important for people with NSCLC that has spread to other parts of the body to ask their doctor if biomarker testing is appropriate for them. Testing your tumor for a range of biomarkers results in a molecular profile of your tumor. A biomarker test can tell your doctor which of the known genetic defects may be driving your NSCLC, and also which ones are not.

About half of NSCLCs are linked to known biomarkers, and scientists continue to search for new genetic defects and their biomarkers. Their hope is that these discoveries will yield more, and even better, treatment options in the future.

On the next page, we’ll discuss a particular genetic defect that is linked to NSCLC.

> NEXT, LET’S TALK: THE ALK FUSION GENE

Biomarker-driven therapy:

A type of treatment that is designed to block the action of cancer-causing genes or proteins.

 

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.