Generic name: crizotinib (kriz OH ti nib)
Brand name: Xalkori
Drug class: Multikinase inhibitors
Xalkori (crizotinib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.
Xalkori is used to treat non-small cell lung cancer that has spread to other parts of the body.
Xalkori may also be used for purposes not listed in this medication guide.
Warnings
Xalkori can cause serious heart or liver problems. Call your doctor at once if you have: fast or pounding heartbeats, sudden dizziness, shortness of breath, tiredness, itching, upper stomach pain, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Do not use Xalkori if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medicine and for at least 3 months after your treatment ends, whether you are a man or a woman.
Before you take Xalkori, tell your doctor if you have liver or kidney disease, a heart rhythm disorder, an electrolyte imbalance (such as low levels of potassium or magnesium in your blood), or a personal or family history of Long QT syndrome.
Before taking this medicine
You should not use Xalkori if you are allergic to crizotinib.
To make sure Xalkori is safe for you, tell your doctor if you have:
- liver or kidney disease;
- a heart rhythm disorder;
- an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
- long QT syndrome (in you or a family member); or
- if you take any heart or blood pressure medicines.
Crizotinib can harm an unborn baby or cause birth defects if the mother or the father is using this medicine.
You may need to have a negative pregnancy test before starting this treatment.
- If you are a woman, do not use Xalkori if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 45 days after your last dose.
- If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 90 days after your last dose.
- Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Xalkori.
This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because crizotinib can harm an unborn baby.
You should not breastfeed while you are taking Xalkori and for at least 45 days after your last dose.
How should I take Xalkori?
Take Xalkori exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Before you start treatment, your doctor may perform tests to make sure Xalkori is the best treatment for your type of lung cancer.
Xalkori is usually taken twice per day, with or without food.
Swallow the capsule whole and do not crush, chew, break, or open it.
You may need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results.
You should not stop taking Xalkori without your doctor's advice.
Store at room temperature away from moisture and heat.
Dosing information
Usual Adult Dose for Non-Small Cell Lung Cancer:
250 mg orally twice a day until disease progression or unacceptable toxicity
Use: For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 6 hours. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Grapefruit may interact with crizotinib and lead to unwanted side effects. Avoid the use of grapefruit products.
This medicine may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.
Crizotinib can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.
Xalkori side effects
Get emergency medical help if you have signs of an allergic reaction to Xalkori: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- increased sensitivity of your eyes to light, seeing flashes of light or "floaters";
- blurred vision, double vision, or vision loss;
- fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);
- very slow heartbeats;
- a light-headed feeling, like you might pass out;
- sudden chest pain or discomfort, wheezing, dry cough or cough with mucus, feeling short of breath;
- fever, swollen gums, painful mouth sores, pain when swallowing, cold or flu symptoms;
- easy bruising or bleeding (nosebleeds, bleeding gums); or
- liver problems - nausea, upper stomach pain, itching, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Xalkori side effects may include:
- nausea, vomiting, decreased appetite;
- diarrhea, constipation;
- abnormal liver function tests;
- swelling in your hands, feet, or eyes;
- numbness or tingling in your hands or feet;
- muscle weakness, trouble walking;
- cold symptoms such as stuffy nose, sneezing, sore throat;
- dizziness, tiredness; or
- vision problems.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Xalkori?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Crizotinib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.
Many drugs can interact with crizotinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
How long does it take for Xalkori to work?
In clinical studies, the length of time during which ALK+ lung cancer did not worsen was 10.9 months for patients receiving Xalkori capsules, and 7 months for patients receiving chemotherapy infusions. Xalkori is approved to treat certain types of non-small cell lung cancer that has spread to other parts of the body. It will not make your cancer go away.