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Overview: Tagrisso is used to treat certain types of lung cancer. It works by turning off a protein, which prevents signals from being sent that tell cells to grow and multiply. Common side effects may include blood disorders, diarrhea, rash, muscle or bone pain, mouth sores, tiredness, and skin or nail changes. Tell your health care provider right away if you have changes in your heart rate or rhythm, any new or worsening trouble breathing, or swelling in your feet, ankles, or legs. Tagrisso is a tablet that is taken by mouth. 

Uses

What is Tagrisso used for?

Tagrisso (osimertinib) is commonly used for treating different kinds of epidermal growth factor receptor (EGFR) mutated lung cancer. EGFR is a protein on the surface of cells and helps cells to grow and multiply. When there is a mutation in EGFR, cancer cells can grow and multiply nonstop. Tagrisso may be used by itself or in combination with other medicines to treat certain EGFR mutated non-small cell lung cancer (NSCLC). 

Learn more about How Tagrisso Works for Lung Cancer.

Tagrisso may also be used for other conditions as determined by your health care provider.

How does Tagrisso work (mechanism of action)?

Tagrisso is a type of medicine called a kinase inhibitor. It attaches itself to the mutant EGFR protein and turns the protein off. When EGFR is turned off, it quits sending the signal to cells to grow and multiply. This causes the cells to die and can cause tumors to shrink in size. 

How is Tagrisso supplied (dosage forms)?

Brands and other names

  • Tagrisso

Dosage forms and strengths

  • 40 mg oral tablets
  • 80 mg oral tablets

How should I store Tagrisso?

Tagrisso should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Tagrisso?

The most common side effects of Tagrisso are listed below. These side effects may vary depending on the condition being treated. Tell your health care provider if you have any of these side effects that bother you.

  • Blood disorders (see below)
  • Diarrhea
  • Rash
  • Muscle or bone pain
  • Nail changes
  • Dry skin
  • Mouth sores
  • Tiredness
  • Lung inflammation (see below)
  • Cough

There may be other side effects of Tagrisso that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Tagrisso?

While less common, the most serious side effects of Tagrisso are described below, along with what to do if they happen.

Severe Allergic Reactions. Tagrisso may cause allergic reactions, which can be serious. Stop taking Tagrisso and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Lung Inflammation. Tagrisso can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Tell your health care provider right away if you have new or worsening trouble breathing, shortness of breath, wheezing, or chest tightness. You may also have a cough and/or fever.

Heart Rhythm Changes. Tagrisso may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Heart Failure. Tagrisso may increase your risk of heart failure. Tell your health care provider right away if you have any of the following symptoms of heart failure.

  • Shortness of breath or trouble breathing, especially while lying down
  • Swelling in your feet, ankles, or legs
  • Unusually fast weight gain
  • Unusual tiredness

Eye Issues. Tagrisso can cause eye problems, including swelling or an ulcer in the eye. Tell your health care provider right away if you have any of the following symptoms of eye issues.

  • Swelling or redness in the eye
  • Watery eyes
  • Sensitivity to light
  • Blurry vision
  • Eye pain

Severe Skin Reactions. Tagrisso can cause severe skin reactions, such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), that can lead to death if not treated. If you get a rash, call your health care provider right away. Get emergency help right away if you have any of the following symptoms of SJS or TEN.

  • Painful red or purple skin that looks burned and peels off
  • Flat red rash or blisters on your skin, mouth, nose, and genitals
  • Red, painful, watery eyes

Immune System Reactions. Tagrisso can cause inflammation of your liver, blood vessels, or lymph vessels, and cause symptoms that look like a condition called lupus. This is known as cutaneous vasculitis. Some people taking Tagrisso had specific types of vasculitis, called leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis. Stop taking Tagrisso and call your health care provider right away if you have any of the following symptoms.

  • Purple spots, redness, or discoloration of your skin that does not fade when you press on it
  • Large hives on the main part of your body (torso)
  • Rash
  • Joint pain
  • Fever
  • Weakness or unusual tiredness

Blood Disorders. Tagrisso can cause blood disorders, such as aplastic anemia, low platelet levels (thrombocytopenia), and low white blood cell levels (leukopenia). Stop taking Tagrisso and get help right away if you have an infection or any of the following symptoms of blood disorders.

  • Fever
  • Shortness of breath
  • Pale or yellowish skin
  • Easy bruising or bleeding
  • Frequent infection
  • Unusual weakness or tiredness
  • Dizziness, lightheadedness, or feeling like you are about to pass out
  • Headache
  • Fast or abnormal heartbeat

Warnings & Precautions

Who should not use Tagrisso?

Allergies to Ingredients. People who are allergic to any of the following should not take Tagrisso.

  • Osimertinib
  • Tagrisso
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Tagrisso.

What should I know about Tagrisso before using it?

Do not take Tagrisso unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share Tagrisso with other people, even if they have the same condition as you. It may harm them.

If you are unable to swallow Tagrisso, ask your pharmacist or other health care provider about options to take the medicine. They can give you instructions about how to mix the tablets in water to make it easier to swallow. It is important to not crush or chew Tagrisso tablets. 

Keep Tagrisso out of the reach of children.

What should I tell my health care provider before using Tagrisso?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Tagrisso is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have or have had any of the following.

Other Medicines and Supplements. Tagrisso may interact with other medicines and supplements. Before taking Tagrisso, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Tagrisso may cause harm to a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. You must not be pregnant before starting Tagrisso. If you can become pregnant, use effective birth control during treatment with Tagrisso and for 6 weeks after your last dose. If you have a partner that can become pregnant, use effective birth control (such as condoms) during treatment with Tagrisso and for 4 months after your last dose.

Breastfeeding. Do not undergo treatment with Tagrisso while you are breastfeeding and for 2 weeks after your last dose. It is not known if Tagrisso passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Tagrisso?

For more information about Tagrisso, you can visit the drugmaker’s website at www.tagrisso.com or call them at 800-236-9933.

Interactions

Does Tagrisso interact with foods or drinks?

There are no known interactions between Tagrisso and foods or drinks.

It is unknown if drinking alcohol will affect Tagrisso.

Does Tagrisso interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Tagrisso.

  • Medicines that can cause QT prolongation, which is a potentially dangerous heart rhythm problem

Some other medicines may alter the blood levels of Tagrisso, and vice versa. Tell your health care provider about all medicines that you take or have recently taken. 

This may not be a complete list of medicines that can interact with Tagrisso. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Tagrisso?

If you or someone else has used too much Tagrisso, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Tagrisso?

If you miss a dose, do not take the missed dose. Take your next dose at your regular time.