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

What is Tagrisso?

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. This medicine is used only if your tumor has a specific genetic marker, for which your doctor will test.

Tagrisso is usually given after other cancer medicines have been tried without success.

Tagrisso was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, tumors responded to this medicine. However, further studies are needed to determine if this medicine can lengthen survival time.

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 Tagrisso 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:

  • a breathing disorder;

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

  • a heart rhythm disorder; or

  • a personal or family history of long QT syndrome.

Tagrisso can harm an unborn baby or cause birth defects. Do not use if you are pregnant, and tell your doctor right away if you become pregnant. Use effective birth control while you are using this medicine and for at least 6 weeks after your last dose.

It is not known whether osimertinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 2 weeks after your last dose.

If a man fathers a baby while using Tagrisso, the baby may have birth defects. Use a condom to prevent pregnancy during your treatment, and for at least 4 months after your treatment ends.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman. However, you should use birth control as recommended during and after treatment with Tagrisso.

How should I take Tagrisso?

Take Tagrisso exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Tagrisso is usually given once per day.

You may take Tagrisso 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. To make sure you get the entire dose, add 4 to 8 ounces of water to the same glass, swirl gently and drink right away.

While using Tagrisso, 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.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Tagrisso dosing information

Usual Adult Dose of Tagrisso 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

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.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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; or

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

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

Common Tagrisso side effects may include:

  • diarrhea;

  • 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.

See also: Side effects (in more detail)

What other drugs will affect Tagrisso?

Many drugs can interact with osimertinib. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antidepressant;

  • cancer medicine;

  • an antibiotic or antifungal medicine;

  • antiviral medicine to treat hepatitis or HIV/AIDS;

  • heart or blood pressure medicine;

  • medicine to treat a psychiatric disorder;

  • seizure medicine; or

  • tuberculosis medicine.

This list is not complete and many other drugs can interact with Tagrisso. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about Tagrisso.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 1.01. Revision Date: 2016-01-13, 12:13:16 PM.