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Generic Name: Osimertinib
Trade Name: Tagrisso®

For what conditions is Tagrisso used? Tagrisso is FDA approved for the treatment of adults with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation-positive tumors as:

  • Adjuvant therapy after surgery in patients with EGFR exon 19 deletions or exon 21 L858R mutations
  • First-line therapy in patients with metastatic EGFR exon 19 deletions or exon 21 L858R mutations
  • Second-line therapy in patients with metastatic EGFR T790M mutations who have progressed on or after prior EGFR therapy.

What is the mechanism of action? Tagrisso is classified as an epidermal growth factor receptor inhibitor tyrosine kinase inhibitor. The epidermal growth factor receptor pathway is involved in regulating growth and replication of a cell. In many cancer cells, this pathway is abnormal and provides continual growth stimulation of a cell. Tagrisso blocks part of the epidermal growth factor receptor pathway so that the cellular growth signals are inhibited.

How is Tagrisso given (administered)? Tagrisso is given in the form of a pill and is taken orally, typically once per day with or without food.

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while being treated with Tagrisso. Physical examinations, scans or other measures may be performed to assess side effects and response to therapy. Blood may be drawn to monitor functions of some organs, such as the liver. In addition, patients will have their lungs monitored, as a rare but serious side effect affecting the lungs may occur. Patients will also have their heart function monitored.

What are the common side effects of treatment with Tagrisso?

  • Low blood cell counts (red, white, and/or platelets)
  • Diarrhea
  • Rash
  • Muscle, bone or joint pain
  • Changes in your nails
  • Dry skin
  • Mouth sores
  • Tiredness
  • Cough

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to the physician’s instructions and inform the physician of any side effects.
  • Wear sunscreen and protective clothing; try to minimize sun exposure.
  • Drink plenty of fluid. Patients should ask their physician about the amount of liquid to consume during a day.
  • Maintain adequate rest and nutrition.

Are there any special precautions patients should be aware of before starting treatment?

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  • It is important that patients inform their physician of any pre-existing conditions (lung or breathing problems, heart problems, eye problems or problems with your electrolytes) as they may worsen with this drug.
  • Patients should let their physician know of any other medication they are taking (whether prescription or over the counter, including vitamins, herbs, etc.) as they may interfere with treatment.
  • Talk to your doctor if your partner is pregnant or planning to become pregnant. If a man’s sexual partner is not pregnant but could become pregnant, effective birth control should be used during treatment and for 4 months after treatment ends. Females should use an effective method of birth control during treatment and for 6 weeks after the last does of Tagrisso.
  • Do not breastfeed during treatment or for 2 weeks after the last dose of Tagrisso.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Tell your healthcare provider right away if you experience symptoms of:

  • Lung problems: trouble breathing, shortness of breath, cough or fever
  • Heart problems including heart failure: feeling your heart pounding or racing, shortness of breath, swelling of your ankles and feet, lightheadedness
  • Eye problems: watery eyes, sensitivity to light, eye pain, eye redness or vision changes
  • Skin problems: skin reactions, severe blistering or peeling of the skin
  • Inflammation of the blood vessels in your skin: purpose spots or redness of the skin

What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated 04/21

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.