Xalkori (Crizotinib)

Crizotinib



(kriz oh' ti nib)

Xalkori®

Crizotinib is used to treat certain types of non-small cell lung cancer that has spread to nearby tissues or to other parts of the body. Crizotinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.

Crizotinib comes as a capsule to take by mouth. It is usually taken with or without food twice a day. Take crizotinib at around the same times every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any part you do not understand. Take crizotinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules whole; do not split, chew, or crush them. Do not touch capsules that are broken or crushed.
Your doctor may temporarily or permanently stop your treatment, decrease the dose, or tell you take your medication less often if you experience serious side effects of crizotinib. Tell your doctor how you are feeling during your treatment.
Continue to take crizotinib even if you feel well. Do not stop taking crizotinib without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before taking crizotinib,

tell your doctor and pharmacist if you are allergic to crizotinib, any other medications, or any of the ingredients in crizotinib capsules. Ask your pharmacist or check the manufacturer's patient information for a list of the ingredients.

tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); certain antibiotics such as clarithromycin (Biaxin); certain antifungal medications such as itraconaozole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); chloroquine (Aralen); chlorpromazine (Thorazine); citalopram (Celexa); cyclosporine (Gengraf, Neoral, Sandimmune); dihydroergotamine (D.H.E. 45, Migranal); disopyramide (Norpace); dofetilide (Tikosyn); droperidol (Inapsine); ergotamine (Ergomar, in Cafergot, in Migergot); erythromycin (E.E.S., Erythrocin); fentanyl (Abstral, Actiq, Fentora, Lazanda, Onsolis); flecainide (Tambocor); certain medications for human immunodeficiency virus (HIV) such as atazanavir (Reyataz), indinavir (Crixivan), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); certain medications for seizures such as carbamazepine (Carbatrol, Equetro, Tegretol), phenobarbital, and phenytoin (Dilantin); mesoridazine (Serentil); methadone (Dolophine); moxifloxacin (Avelox); nefazodone; pentamidine (NebuPent, Pentam); pimozide (Orap); procainamide (Pronestyl); quinidine (in Nuedexta); rifabutin (Mycobutin), rifampin (Rimactane, Rifadin, in Rifater); sirolimus (Rapamune); sotalol (Betapace); tacrolimus (Prograf); telithromycin (Ketek); thioridazine (Mellaril); and vandetanib (Caprelsa). Many other medications may also interact with crizotinib, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

tell your doctor what herbal products you are taking, especially St. John's wort.

tell your doctor if you have or have ever had long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), a slow heartbeat, heart failure, or liver or kidney disease.

tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should use birth control so that you or your partner will not become pregnant during your treatment with crizotinib and for 90 days after your treatment. Talk to your doctor about which method of birth control you should use. If you become pregnant while taking crizotinib, call your doctor immediately.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking crizotinib.

you should know that crizotinib may cause vision problems, dizziness, and excessive tiredness. Do not drive a car or operate machinery until you know how this medication affects you.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Take the missed dose as soon as you remember it. However, if it is less than 6 hours before you are scheduled to take your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Crizotinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:



diarrhea

constipation

stomach pain

sores in the mouth

change in ability to taste food

heartburn

headache

numbness, burning, or tingling in the hands or feet

difficulty falling asleep or staying asleep

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:



shortness of breath

cough

fever

swelling of the arms, hands, feet, ankles, or lower legs

chest pain

slow heartbeat

rash

weakness

excessive tiredness

pain in the right upper part of the stomach

nausea

vomiting

yellowing of the skin or eyes

dark urine

itching

fever

unusual bleeding or bruising

double vision

blurred vision

sensitivity to light

seeing sudden flashes of light

seeing new or increased floaters (spots in your vision)
Crizotinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them.  However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community.  See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with crizotinib and will also order certain lab tests during your treatment to check your body's response to crizotinib.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.