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Tagrisso

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

Medically reviewed on Nov 1, 2018

What is Tagrisso?

See also: Alunbrig

Tagrisso (osimertinib) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Tagrisso 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.

Tagrisso is usually given after other treatments have failed.

Important Information

Tagrisso may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever.

Tagrisso may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking this medicine and during treatment. Call your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded.

Before taking this medicine

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

To make sure Tagrisso is safe for you, 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 this medicine.

  • If you are a woman, do not use Tagrisso 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 Tagrisso.

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 Tagrisso?

Take Tagrisso exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Tagrisso is usually given once per day.

You may take this medicine 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).

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

Store at room temperature away from moisture and heat.

Tagrisso dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

80 mg orally once a day

Duration of therapy: Until disease progression or unacceptable toxicity

Comments: The presence of a T790M epidermal growth factor receptor (EGFR) mutation in tumor specimens should be confirmed with an FDA-approved test prior to treatment initiation; information on FDA-approved tests available at http://www.fda.gov/companiondiagnostics.

Use: Treatment for patients with metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.

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 Tagrisso?

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

Tagrisso side effects

Get emergency medical help if you have signs of an allergic reaction to Tagrisso: 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 Tagrisso 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.

What other drugs will affect Tagrisso?

Many drugs can interact with 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 Tagrisso only for the indication prescribed.

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

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