Testing for ALK

Only testing can tell if your tumor is ALK+

Could XALKORI^® (crizotinib) be an option for you? The only way to know for sure is to get tested for the ALK fusion gene.

The ALK fusion gene, discovered in 2007, is an alteration or defect in a normal gene called Anaplastic Lymphoma Kinase (ALK). This defective gene is believed to play an essential role in the growth of some lung cancers.

Who should be tested?

There is no "one type" of person who is likely to have the ALK fusion gene. Men and women with advanced non-small cell lung cancer (NSCLC) who tested ALK+ for a clinical trial 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. 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.

What’s involved in ALK testing?

Your doctor needs a tissue sample. If there is enough tissue from a previous biopsy, your doctor can send this to be tested. Otherwise, another biopsy may be required. Once the tissue is sent to the lab, most results will come back within 2 weeks.

If you have any questions about testing for the ALK fusion gene or whether you may be ALK+, talk to your doctor. Getting tested is the only way to know for sure.

Want to learn more? The next page has helpful tools and resources to increase your knowledge about living with advanced NSCLC and getting the support you need.

Indication

XALKORI^® (crizotinib) is a prescription medicine used to treat non-small cell lung cancer (NSCLC) that is advanced or has spread to other parts of the body and is caused by a defect in a gene called ALK (anaplastic lymphoma kinase). XALKORI approval is based on the percentage of patients whose tumors responded to treatment.

It is not known whether XALKORI will improve symptoms or will help patients with this disease live longer. 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 and/or fatal liver injury. Your doctor should do blood tests 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

Swelling of the lungs (pneumonitis) — XALKORI may cause life-threatening and/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

Changes in heartbeat (called QT interval prolongation), very fast or abnormal heartbeats — Your doctor may check your heart during treatment with XALKORI. Tell your doctor right away if you have abnormal heartbeats, feel dizzy, or faint. These may be symptoms related to QT interval prolongation.

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® (crizotinib) passes into your breast milk. You and your doctor should decide if you will take XALKORI or breastfeed. You should not do both.

Especially tell your doctor if you take:

• St. John’s Wort (Hypericum perforatum)
• medicines for:
  • >depression (antidepressants)
  • >fungal infections (antifungals)
  • >bacterial infections (antibiotics)
  • >tuberculosis (TB)
  • >HIV-AIDS
  • >heart conditions
  • >seizures

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

Do 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 — these problems usually happen within 2 weeks of starting XALKORI. Tell your doctor right away if you have any change in vision, such as:
  • >flashes of light
  • >blurred vision
  • >light hurting your eyes
  • >new or increased floaters
• nausea
• diarrhea
• vomiting
• swelling of your hands or feet
• constipation

Use caution when driving or operating machinery as XALKORI may cause changes in vision or make you feel tired or dizzy.

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).

If you are uninsured or don’t have sufficient coverage for XALKORI, call 1-877-744-5675 to talk to a counselor at the Pfizer First Resource® Program. 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.

Copyright © 2012 Pfizer Inc. All rights reserved.

Pfizer, PO Box 29387, Mission, KS 66201.

Last Updated: December 2012
CRI512424-01