Skip to Content

Osimertinib

Generic Name: osimertinib (OH sim ER ti nib)
Brand Name: Tagrisso

Medically reviewed on Oct 1, 2018

What is osimertinib?

See also: Alunbrig

Osimertinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Osimertinib is used to treat a certain type of non-small cell lung cancer. Osimertinib is used only if your tumor has a specific genetic marker, for which your doctor will test.

Osimertinib is usually given after other treatments have failed.

Osimertinib may also be used for purposes not listed in this medication guide.

Important Information

Osimertinib can cause serious side effects on your heart, lungs, or vision.

Call your doctor at once if you have fast or pounding heartbeats, swelling in your lower legs, a cough, fever, shortness of breath, vision changes, eye pain, increased sensitivity to light, or if you feel light-headed.

Before taking this medicine

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

Tell your doctor if you have ever had:

  • a breathing disorder;

  • an electrolyte imbalance (such as high or low levels of calcium, potassium, or magnesium in your blood);

  • eye problems; or

  • long QT syndrome (in you or a family member).

Osimertinib can harm an unborn baby if the mother or the father is using osimertinib.

  • If you are a woman, do not use osimertinib if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 weeks 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 4 months after your last dose.

  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is using osimertinib.

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 osimertinib can harm an unborn baby.

You should not breast-feed while using this medicine and for at least 2 weeks after your last dose.

How should I take osimertinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Osimertinib is usually given once per day.

You may take osimertinib with or without food.

To make swallowing easier, you may place the tablet in a glass with about 4 tablespoons of water. Stir until the tablet is mostly dissolved and drink this mixture right away. Add 4 to 8 ounces more water to the glass, swirl gently and drink right away.

You may need frequent blood tests. Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Osimertinib is usually given until your body no longer responds to the medication.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. 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 should I avoid while taking osimertinib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Osimertinib side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • shortness of breath even with mild exertion;

  • fast or pounding heartbeats;

  • a light-headed feeling, like you might pass out;

  • swelling, rapid weight gain;

  • new or worsening lung symptoms--sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath; or

  • eye problems--vision changes, watery eyes, increased sensitivity to light, eye pain or redness.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • mouth sores, loss of appetite;

  • diarrhea;

  • feeling tired;

  • dry skin, rash; or

  • tenderness, discoloration, infection, or other problems with your fingernails or toenails.

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.

Osimertinib dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

80 mg orally once a day until disease progression or unacceptable toxicity

Comments:
-Take at the same time each day with a full glass of water.
-This drug can be taken with or without food.
-The tablet should not be crushed, split or chewed; however, it may be dissolved in water if the patient cannot swallow it.
-If a dose missed, it should be made up unless the next dose is due within 12 hours.

Uses:
-For first-line treatment of EGFR mutation-positive metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
-For previously treated EGFR T790M mutation-positive metastatic NSCLC, as detected by an FDA-approved test, in patients whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

What other drugs will affect osimertinib?

Many drugs can affect osimertinib. 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.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide