Xalkori

Generic Name: crizotinib (kriz OH ti nib)
Brand Names: Xalkori

What is Xalkori?

Xalkori (crizotinib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Xalkori is used to treat non-small cell lung cancer that has spread to other parts of the body.

Xalkori may also be used for purposes not listed in this medication guide.

Important information

Xalkori can cause serious heart or liver problems. Call your doctor at once if you have: headache with chest pain and severe dizziness, fast or pounding heartbeats, upper stomach pain, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Slideshow: Flashback: FDA Drug Approvals 2013

Do not use Xalkori if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medicine and for at least 3 months after your treatment ends, whether you are a man or a woman.

Before you take Xalkori, tell your doctor if you have liver or kidney disease, a heart rhythm disorder, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or a personal or family history of Long QT syndrome.

Before taking this medicine

You should not use Xalkori if you are allergic to crizotinib.

To make sure Xalkori is safe for you, tell your doctor if you have:

  • liver or kidney disease;

  • a heart rhythm disorder;

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  • a personal or family history of Long QT syndrome; or

  • if you take any heart or blood pressure medicines.

FDA pregnancy category D. Xalkori can harm an unborn baby.

See also: Pregnancy and breastfeeding warnings (in more detail)

  • If you are a woman, do not take Xalkori if you are pregnant.

  • If you are a man, use effective birth control if your sexual partner is able to get pregnant. An unborn baby can be harmed if a man fathers the child while he is taking this medicine.

  • Use birth control to prevent pregnancy while you are receiving Xalkori, whether you are a man or a woman. Keep using birth control for at least 3 months after treatment ends.

  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking Xalkori.

It is not known whether crizotinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Xalkori.

How should I take Xalkori?

Take Xalkori exactly as prescribed by your doctor. Before you start treatment, your doctor may perform tests to make sure Xalkori is the best treatment for your type of lung cancer.

Xalkori is usually taken twice per day. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

You may take Xalkori with or without food.

Do not crush, chew, dissolve, or open a capsule. Swallow it whole.

While using Xalkori, your heart rate and blood pressure will need to be checked often. You will also need frequent blood tests to check your liver function. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG). Your cancer treatments may be delayed based on the results of these tests.

You should not stop taking Xalkori without your doctor's advice.

Store at room temperature away from moisture and heat.

Xalkori dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

250 mg orally twice a day.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 6 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Xalkori?

Grapefruit and grapefruit juice may interact with crizotinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking Xalkori.

This medicine may cause blurred vision and may impair your reactions. Be careful if you drive or do anything that requires you to be able to see clearly.

Xalkori side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Xalkori: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;

  • very slow heart rate;

  • a light-headed feeling, like you might pass out;

  • sudden chest pain or discomfort, wheezing, dry cough or cough with mucus, feeling short of breath;

  • fever, swollen gums, painful mouth sores, pain when swallowing, cold or flu symptoms;

  • easy bruising or bleeding (nosebleeds, bleeding gums); or

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Xalkori side effects may include:

  • nausea, vomiting;

  • diarrhea, constipation;

  • swelling in your hands or feet;

  • tired feeling; or

  • vision problems such as blurred vision, increased sensitivity of your eyes to light, or seeing flashes of light or "floaters."

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Xalkori?

Other drugs may interact with crizotinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Xalkori.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xalkori only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2014 Cerner Multum, Inc. Version: 2.02. Revision Date: 2014-02-17, 9:38:22 AM.

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