Crizotinib, Oral krih-ZOH-ty-nib

What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: crizotinib, oral; Xalkori

What is this medicine used for?

This medicine is taken by mouth to treat non-small cell lung cancer that is advanced or that has spread to other parts of the body.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• any other lung disease (such as pulmonary fibrosis)
• heart disease or a heart attack
• liver or kidney disease
• long QT syndrome (problems with electrical activity in the heart muscle)
• problems with the levels of calcium, magnesium, or potassium in your blood

Males: Use an effective birth control method while you are taking this medicine and for 3 months after stopping it. Talk with your healthcare provider about effective birth control.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Use an effective method of birth control while taking this medicine and for at least 3 months after treatment. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are taking this medicine.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less than prescribed. Do not stop taking this medicine without your healthcare provider's approval.

Do not break, crush, or chew the capsules. Swallow them whole. Do not touch or handle crushed or broken capsules.

You may take this medicine with or without food.

What if I miss a dose?

If you miss a dose and it is within 6 hours of the next dose, skip that dose and take the regular dose. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose have not been reported.

What should I watch out for?

You need to have blood tests and checkups regularly to see how this medicine affects you. Keep all appointments.

This medicine may make you drowsy or dizzy or cause blurred vision. Do not drive or operate machinery unless you are fully alert and can see clearly.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Shortness of breath; chest pain; fast or irregular heartbeat; severe dizziness or fainting; unexplained cough, sore throat, or fever; runny or stuffy nose; mouth sores or trouble swallowing; unusual tiredness or weakness; eye pain or vision problems; blood in stool, urine or vomit; severe stomach pain, diarrhea, nausea, or vomiting; ongoing loss of appetite; yellowing of the skin or eyes; dark urine; pale-colored stools; unusual bruising or bleeding; numbness or tingling; swelling in your hands or feet.

Other: Mild rash, diarrhea, constipation, nausea, vomiting, dizziness, decreased appetite, trouble sleeping, headache, tiredness, back pain, muscle or joint pain, change in sense of taste.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• antibiotics such as ciprofloxacin (Cipro), clarithromycin (Biaxin), doxycycline (Adoxa, Doryx, Monodox, Vibramycin), erythromycin (Ery-Tabs, E.E.S.), isoniazid, levofloxacin (Levaquin), moxifloxacin (Avelox), pentamidine (NebuPent), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane), rifapentine (Priftin), and telithromycin (Ketek)
• antidepressants such as amitriptyline, doxepin, fluoxetine (Prozac), imipramine (Tofranil), nefazodone, nortriptyline (Pamelor), paroxetine (Paxil), and sertraline (Zoloft)
• antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), iloperidone (Fanapt), pimozide (Orap), thioridazine, and ziprasidone (Geodon)
• antiseizure medicines such as carbamazepine (Tegretol), phenobarbital, phenytoin (Dilantin), and primidone (Mysoline)
• antifungal medicines such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend)
• anti-HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), and saquinavir (Invirase)
• arsenic trioxide (Trisenox)
• bosentan (Tracleer)
• conivaptan (Vaprisol)
• dexamethasone
• heart medicines such as amiodarone (Cordarone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), dronedarone (Multaq), flecainide (Tambocor), propafenone (Rythmol), procainamide, diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene, Cardene SR), quinidine, and verapamil (Calan, Covera, Isoptin)
• imatinib (Gleevec)
• immunosuppressants such as cyclosporine (Sandimmune, Gengraf, Neoral), sirolimus (Rapamune), and tacrolimus (Prograf, Protopic)
• medicines to treat erectile dysfunction such as sildenafil (Viagra), tadalafil (Cialis), or vardenafil (Levitra)
• migraine medicines such as dihydroergotamine (Migranal, DHE 45) and ergotamine (Ergomar)
• narcotic pain medicines such as fentanyl (Duragesic, Actiq, Fentora) and methadone (Dolophine, Methadose)
• St. John's wort
• vandetanib (Caprelsa)

Do not eat grapefruit or drink grapefruit juice while taking this medicine. The effects of this medicine may be increased if you take it with grapefruit or grapefruit juice. Talk with your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.