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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.

Molecular profiling & NSCLC treatment

Molecular profiling & 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.

Molecular profiling 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 molecular profile 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.

 

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.