Xalkori 50 mg oral pellets

Generic name:
Crizotinib - oral

Pronunciation
(kriz-OH-ti-nib)

Brand name(s)
Xalkori

Crizotinib is used to treat certain types of cancer (such as lung cancer, anaplastic large cell lymphoma-ALCL). It is also used to treat a certain type of tumor (inflammatory myofibroblastic tumor-IMT). Crizotinib works by slowing or stopping the growth of cancer or tumor cells. It belongs to a class of drugs known as kinase inhibitors.

Read the Medication Guide and, if available, the Instructions for Use provided by your pharmacist before you start taking crizotinib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once or twice daily. This medication comes in 2 dosage forms: a capsule to swallow or a capsule that must be opened that contains pellets.

If you are using the capsules to swallow, swallow the capsule(s) whole. Do not chew, crush, or split the capsules.

If you are using the capsules that contain pellets, do not swallow the capsule(s) whole. You must first open the capsule(s), then directly pour or spoon all of the pellets into your mouth. Do not chew or crush the pellets before swallowing. Drink water after taking to make sure the entire dose is taken. Repeat these steps if the dose is for more than one capsule. Throw away the empty capsule shell(s) in the trash.

If you vomit after taking your dose of the medication, do not take an extra dose. Take the next dose of your medication at the regular time.

The dosage is based on your medical condition, lab tests, response to treatment, and other medications you may be taking. Children's dosage is also based on body size. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

To decrease the risk of side effects, your doctor may prescribe other medications to take along with this medication. Carefully follow your doctor's directions for all your medications.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

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 last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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 right away 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/decreased 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:

• symptoms of lung problems (such as trouble breathing, cough)
• eye pain/swelling/redness
• fast/slow/irregular heartbeat
• severe dizziness
• fainting
• easy bleeding/bruising
• symptoms of liver problems (such as nausea/vomiting that doesn't stop, dark urine, stomach/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. Tell your doctor right away 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 or at www.fda.gov/medwatch.

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:

• kidney problems
• liver problems

Crizotinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause 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 cause QT prolongation. 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 make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using crizotinib before having any immunizations/vaccinations. 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. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

This medication can affect fertility in both males and females. Ask your doctor for more details.

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the capsules.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using crizotinib. Crizotinib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for some time after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for 90 days after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 45 days after the last dose. Consult your doctor before breastfeeding.

See also How to Use section.

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:

• drugs that may slow the heartbeat (including digoxin, clonidine, beta-blockers such as atenolol/metoprolol, calcium channel blockers such as diltiazem/verapamil)

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, asunaprevir, elacestrant, ergots (such as ergotamine), fentanyl, flibanserin, lomitapide, lonafarnib, 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 someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver/kidney function, EKG, complete blood counts, eye exams, blood pressure, heart rate) will be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.

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. Take your next dose at the regular time. Do not double the dose to catch up.

Store in the original container at room temperature 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.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.