Medication Guide App

Xalkori

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

Xalkori is used for:

Treating certain types of lung cancer. It may also be used for other conditions as determined by your doctor.

Xalkori is a tyrosine kinase inhibitor. It works by preventing the growth of cancer cells.

Do NOT use Xalkori if:

  • you are allergic to any ingredient in Xalkori
  • you have previously developed a certain lung problem (pneumonitis) from taking Xalkori
  • you have a history of certain types of irregular heartbeat (eg, QT prolongation, long QT syndrome)
  • you are taking alfentanil, asenapine, certain azole antifungals (eg, itraconazole, ketoconazole, voriconazole), carbamazepine, cyclosporine, an ergot derivative (eg, ergotamine), fentanyl, a hydantoin (eg, phenytoin), certain macrolide antibiotics (eg, clarithromycin, troleandomycin), mifepristone, nefazodone, phenobarbital, pimozide, primidone, certain protease inhibitors (eg, ritonavir), quinidine, a rifamycin (eg, rifampin), sirolimus, St. John's wort, tacrolimus, or telithromycin

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Xalkori:

Some medical conditions may interact with Xalkori. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of kidney or liver problems, eye or vision problems, heart problems (eg, congestive heart failure; fast, slow, or irregular heartbeat), high blood pressure, or abnormal blood electrolyte levels (eg, calcium, potassium, magnesium)
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval). Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of this type of irregular heartbeat

Some MEDICINES MAY INTERACT with Xalkori. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, antiarrhythmics (eg, disopyramide, dofetilide, dronedarone, sotalol), arsenic, asenapine, astemizole, bepridil, chloroquine, cisapride, citalopram, clozapine, dolasetron, domperidone, doxepin, droperidol, fluoroquinolone antibiotics (eg, levofloxacin), haloperidol, ibutilide, maprotiline, methadone, nortriptyline, ondansetron, paliperidone, pentamidine, certain phenothiazines (eg, chlorpromazine, thioridazine), quetiapine, terfenadine, tetrabenazine, toremifene, tyrosine kinase inhibitors (eg, dasatinib, lapatinib, nilotinib, sunitinib), vandetanib, or ziprasidone because the risk of a certain type of irregular heartbeat (prolonged QT interval) may be increased
  • Azole antifungals (eg, itraconazole, ketoconazole, voriconazole), beta-blockers (eg, propranolol), calcium channel blockers (eg, verapamil), clonidine, digoxin, macrolide antibiotics (eg, clarithromycin, erythromycin, troleandomycin), mifepristone, nefazodone, protease inhibitors (eg, ritonavir), or telithromycin because they may increase the risk of Xalkori's side effects
  • Carbamazepine, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease Xalkori's effectiveness
  • Alfentanil, cyclosporine, ergot derivatives (eg, ergotamine), fentanyl, pimozide, quinidine, sirolimus, or tacrolimus because the risk of their side effects may be increased by Xalkori

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xalkori may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xalkori:

Use Xalkori as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Xalkori. Talk to your pharmacist if you have questions about this information.
  • Take Xalkori by mouth with or without food.
  • Swallow Xalkori whole. Do not break, crush, dissolve, open, or chew before swallowing.
  • Do not eat grapefruit or drink grapefruit juice while you use Xalkori.
  • Take Xalkori on a regular schedule to get the most benefit from it.
  • Continue to take Xalkori even if you feel well. Do not miss any doses.
  • If you miss a dose of Xalkori, take it as soon as possible. If it is within 6 hours of your next dose, skip the missed dose and go back to your regular dosing schedule. If you vomit after taking a dose of Xalkori, do not take an extra dose. Take the next dose at the regular time. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Xalkori.

Important safety information:

  • Xalkori may cause dizziness, tiredness, or vision changes. These effects may be worse if you take it with alcohol or certain medicines. Use Xalkori with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not change your dose or stop taking Xalkori without first checking with your doctor.
  • Xalkori may cause vision changes such as blurred vision, flashes of light, floaters in your vision, or sensitivity to light. If this occurs, it usually begins within 1 week after starting Xalkori. Tell your doctor right away if you develop any of these symptoms.
  • Serious and sometimes fatal liver problems have occurred in patients taking Xalkori. Your doctor should perform lab tests to check your liver function while taking Xalkori. Contact your doctor right away if you develop dark urine; persistent loss of appetite; right-sided stomach pain; severe or persistent tiredness, nausea, or vomiting; or yellowing of the skin or eyes.
  • Serious and sometimes fatal inflammation of the lungs (pneumonitis) has occurred in some patients taking Xalkori. These cases occurred within 2 months after Xalkori was started. Contact your doctor right away if you develop trouble breathing, shortness of breath, cough with or without mucus, or fever.
  • If you experience nausea, vomiting, diarrhea, or constipation, talk with your doctor about ways to lessen these effects.
  • Xalkori may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Tell your doctor or dentist that you take Xalkori before you receive any medical or dental care, emergency care, or surgery.
  • Women who may become pregnant should use effective birth control while taking Xalkori and for at least 90 days after stopping it. Check with your doctor if you have questions about effective birth control.
  • Men who take Xalkori should always use effective birth control when having sex with a woman who may become pregnant. Do this for as long as you take Xalkori and for at least 90 days after you stop taking it. Check with your doctor if you have questions about effective birth control. If you think that your sexual partner may be pregnant, contact your doctor right away.
  • Lab tests, including liver and heart function, blood pressure, blood electrolytes, eye exams, and complete blood cell counts, may be performed while you use Xalkori. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Xalkori should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Xalkori may cause harm to the fetus. Avoid becoming pregnant while you are taking it and for 90 days after you stop taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Xalkori is found in breast milk. Do not breast-feed while taking Xalkori.

Possible side effects of Xalkori:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; indigestion; light-headedness; loss of appetite; mild cough or sore throat; mild swelling; nausea; runny or stuffy nose; taste changes; tiredness; upset stomach; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); burning, numbness, or tingling; changes in sense of touch; chest pain; coughing up blood; fainting; fast, slow, or irregular heartbeat; mouth or tongue sores or swelling; new or worsening breathing problems (eg, shortness of breath, trouble breathing); severe or persistent dizziness or light-headedness; severe or unusual swelling; symptoms of infection (eg, fever, chills, persistent sore throat or cough); symptoms of liver problems (eg, dark urine; pale stools; persistent loss of appetite; stomach pain; severe or persistent tiredness, nausea, or vomiting; yellowing of the skin or eyes); vision changes (eg, blurred vision, floaters, light flashes, light hurting your eyes).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Xalkori:

Store Xalkori at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Keep Xalkori tightly closed in its original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xalkori out of the reach of children and away from pets.

General information:

  • If you have any questions about Xalkori, please talk with your doctor, pharmacist, or other health care provider.
  • Xalkori is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Xalkori or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Xalkori. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Xalkori. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Xalkori.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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