Crizotinib (kriz-OH-ti-nib)

Treats cancer, including non-small cell lung cancer (NSCLC), systemic anaplastic large cell lymphoma (ALCL), and inflammatory myofibroblastic tumor (IMT).

Brand Name(s):

Xalkori

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Pellet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Do not crush, chew, or split it.
• If you are not able to swallow the capsule whole. You may use the oral pellets. Do not chew or crush the oral pellets, or swallow the shell containing the oral pellets.
• Oral pellets: Open the shell and empty the contents directly into the mouth. You may also empty the pellets into a medicine cup or dry spoon and then pour them into the mouth. Drink enough water to make sure all oral pellets are swallowed.
• You may also receive medicines to help prevent nausea and vomiting. Drink plenty of fluids to help prevent dehydration.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If your next dose is more than 6 hours away, take the missed dose as soon as you can. If your next dose is less than 6 hours away, wait until then to use the medicine and skip the missed dose. Do not take extra medicine to make up for the missed dose. If you vomit after you take a dose, do not take an extra dose. Take the next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how crizotinib works. Tell your doctor if you are using any of the following:
  • Alfentanil, arsenic trioxide, cisapride, clonidine, cyclosporine, digoxin, dofetilide, fentanyl, pimozide, quinidine, sirolimus, St John's wort, tacrolimus
  • Blood pressure medicine
  • Ergot medicine
  • Medicine to treat HIV/AIDS
  • Medicine to treat an infection
  • Medicine to treat seizures
  • Medicine to treat depression or mental illness
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control during treatment with this medicine and for at least 45 days after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 90 days after the last dose.
• Do not breastfeed during treatment with this medicine and for 45 days after the last dose.
• Tell your doctor if you have kidney disease, liver disease, congestive heart failure, heart rhythm problems (including QT prolongation), or a mineral imbalance.
• This medicine may cause the following problems:
  • Liver problems
  • Lung or breathing problems (including interstitial lung disease or pneumonitis), which may be life-threatening
  • Heart rhythm problems
  • Slow heartbeat
  • Serious stomach or bowel problems
• This medicine may cause dizziness, tiredness, or vision problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred or changes in vision
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Diarrhea, constipation
• Fast, slow, pounding, or uneven heartbeat
• Fainting, dizziness, or lightheadedness
• Rapid weight gain, swelling in your hands, ankles, or feet
• Trouble breathing, chest pain, fever, chills, cough

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste
• Pain in the arms or legs, muscle or joint pain
• Runny or stuffy nose, sore throat
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088