Xalkori Oral

Nausea, diarrhea, vomiting, dizziness, tiredness, headache, heartburn, change in taste, loss of appetite, mouth sores, joint pain, trouble sleeping, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (such as cough, sore throat, fever, chills).
Tell your doctor right away if you have any serious side effects, including: vision changes (such as blurred vision, flashes of light, sensitivity to light, floaters), swelling of the legs/feet/hands.
Get medical help right away if you have any very serious side effects, including: trouble breathing, cough with or without phlegm, eye pain/swelling/redness, fast/irregular heartbeat, severe dizziness, fainting, easy bleeding/bruising, dark urine, severe abdominal pain, yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Crizotinib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Therefore, tell your doctor immediately if you develop any rash.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems.
Crizotinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using crizotinib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).
Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/\"water pills\") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using crizotinib safely.
Crizotinib can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
This drug may make you dizzy or cause vision changes. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication is not recommended for use during pregnancy. It may harm an unborn baby. To avoid pregnancy, both males and females using crizotinib and their partners must use reliable form(s) of birth control during treatment and for at least 3 months after stopping this drug. Consult your doctor for more details. If you become pregnant, think you may be pregnant, or cause a pregnancy, contact your doctor immediately.
It is unknown if this drug passes into breast milk. Because of possible harm to a nursing infant, breast-feeding is not recommended while using this medication. Consult your doctor before breast-feeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval.
Some products that may interact with this drug include: natalizumab.
Other medications can affect the removal of crizotinib from your body, which may affect how crizotinib works. Examples include azole antifungals (such as itraconazole), macrolide antibiotics (such as erythromycin), rifamycins (such as rifabutin), drugs for seizures (such as carbamazepine, phenytoin), St. John\'s wort, among others.
This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include alfentanil, cyclosporine, ergots (such as ergotamine), fentanyl, sirolimus, tacrolimus, among others.
Many drugs besides crizotinib may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, quinidine, procainamide, sotalol, and certain antipsychotic medications (such as pimozide, thioridazine, ziprasidone), among others.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES:
Do not share this medication with others.
Laboratory and/or medical tests (such as ALK testing, liver function tests, EKG, complete blood counts, eye exams) will be performed before starting and while you are taking this medication to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE:
If you miss a dose, take it as soon as you remember. If it is less than 6 hours before the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature. Keep this medication in the original container away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised November 2011. Copyright(c) 2011 First Databank, Inc.