May 26, 2017
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"The US Food and Drug Administration (FDA) today granted accelerated approval for osimertinib (Tagrisso, AstraZeneca), previously known as AZD9291, for the treatment of a specific type of advanced non-small-cell lung cancer.




Xalkori Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking crizotinib (Xalkori)?

You should not use crizotinib if you are allergic to it.

To make sure you can safely use crizotinib, tell your doctor if you have any of these other conditions:

  • liver or kidney disease;
  • a heart rhythm disorder;
  • a personal or family history of Long QT syndrome; or
  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

FDA pregnancy category D. Do not use crizotinib if you are pregnant. It could harm the unborn baby. Use effective birth control while you are using this medication and for at least 3 months after your treatment ends.

If a man fathers a child while using this medicine, the baby may have birth defects. Use a condom to prevent pregnancy while you are using this medication and for at least 3 months after your treatment ends.

It is not known whether crizotinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using crizotinib.

How should I take crizotinib (Xalkori)?

Before you start treatment, your doctor may perform tests to make sure crizotinib is the best treatment for your type of lung cancer.

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Crizotinib is usually taken twice per day. Follow your doctor's instructions.

You may take crizotinib with or without food.

Do not crush, chew, dissolve, or open a crizotinib capsule. Swallow it whole.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood cells and liver function may need to be tested often. Your heart function may need to be tested with an electrocardiogram (ECG or EKG). Your cancer treatments may be delayed based on the results of these tests. Do not miss any follow-up visits to your doctor.

Do not stop taking this medication without first talking to your doctor.

Store in the original container at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Side Effects Centers

Additional Xalkori Information

Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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