FDA Approves Xalkori


The U.S. Food and Drug Administration has approved Xalkori (crizotinib) to treat certain patients with late-stage (locally advanced or metastatic), non-small cell lung cancers (NSCLC) who express the abnormal anaplastic lymphoma kinase (ALK) gene.
Xalkori is being approved with a companion diagnostic test that will help determine if a patient has the abnormal ALK gene, a first-of-a-kind genetic test called the Vysis ALK Break Apart FISH Probe Kit.

This ALK gene abnormality causes cancer development and growth. About 1 percent to 7
percent of those with NSCLC have the ALK gene abnormality. Patients with this form of lung cancer are typically non-smokers. Xalkori works by blocking certain proteins called kinases, including the protein produced by the abnormal ALK gene. Xalkori is a pill taken twice a day as a single-agent treatment.

Xalkori Patient Information

Read this patient information leaflet before you start taking Xalkori and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your condition or treatment.

What is the most important for me to know about Xalkori?

Xalkori may cause serious side effects, such as:
  • Swelling of the lungs (pneumonitis) - Xalkori may cause life-threatening 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
  • Liver problems - 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
See Xalkori side effects for more information about side effects.

What is Xalkori?

Xalkori is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that is advanced or 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.

What should I tell my doctor before taking Xalkori?

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, nonprescription medicines, vitamins, and herbal supplements.
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.

How should I take Xalkori?

  • Take Xalkori exactly as your doctor tells you.
  • Swallow Xalkori capsules whole.
  • Do not crush, dissolve, or open capsules.
  • You may take Xalkori with or without food.
  • Do not change your dose or stop Xalkori unless your doctor tells you.
  • If you miss a dose, take it as soon as you remember. If it is close to your next dose (within 6 hours), just take your next dose at your regular time.
  • Do not take more than 1 dose of Xalkori at a time.
  • Call your doctor right away if you take too much Xalkori.
  • Your doctor will check your blood and heart while you are taking Xalkori.

What should I avoid while taking Xalkori?

  • You should not drink grapefruit juice or eat grapefruit during your treatment with Xalkori. It may make the amount of Xalkori in your blood increase to a harmful level.
  • Xalkori can cause changes in your vision, dizziness, and tiredness. If you have these symptoms, use caution when driving a car, using machinery, or doing anything that needs you to be alert.

Xalkori side effects

Xalkori may cause serious side effects:
  • See What is most important for me to know about Xalkori?
  • Changes in your 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.
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 and feet
  • constipation
Tell your doctor if you have any side effect that bothers you or that does not go away.
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 FDA at 1- 800-FDA-1088.

How do I store Xalkori?

Store Xalkori at room temperature between 68°F to 77°F (20°C to 25°C).
  • Keep Xalkori in the original container, and keep the container closed tightly.
  • Do not touch or handle crushed or broken Xalkori capsules. Xalkori is made with a capsule to prevent contact with the active ingredient.
Keep Xalkori and all medicines out of the reach of children.

General information about Xalkori

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Xalkori for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.
This leaflet provides the most important information about Xalkori. If you would like to know more about Xalkori talk with your doctor. You can ask your doctor or pharmacist for more information about Xalkori.
For more information, go to www.xalkori.com.

What are the ingredients in Xalkori?

Active ingredient: crizotinib.
Inactive ingredients: colloidal silicon dioxide, microcrystalline cellulose, anhydrous dibasic calcium phosphate, sodium starch glycolate, and magnesium stearate.

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