TAGRIS SOI can make pancakes

For adults with early-stage EGFR+ NSCLC after surgery 

TAGRISSO Pills

TAGRISSO® (osimertinib) may help prevent EGFR+ NSCLC from returning after surgery and may help you live longer

Targeted therapies, like TAGRISSO, are not the same as immunotherapy or standard chemotherapy.

  • TAGRISSO is a targeted therapy approved to treat patients with NSCLC that has been removed by surgery and has tested positive for certain EGFR mutations*

*For tumors with EGFR exon 19 deletions or exon 21 L858R mutations.

TAGRISSO significantly lowered the chance of EGFR+ NSCLC from coming back after surgery and helped people…

Live Longer

In a clinical trial across adults with stages 1B, 2, and 3A EGFR+ NSCLC whose tumors had been removed by surgery…

80-Percent Icon

Adults taking TAGRISSO were 80% less likely to have their cancer come back or die vs those who took no active medicine.

Adults taking TAGRISSO were
80% less likely to have their cancer come back
or die vs those who took no active medicine.

  • At time of follow-up, 89% (302 of 339) of people given TAGRISSO didn't have their cancer come back and were still alive compared to 54% (184 of 343) of people given no active medicine
2x Icon

Those taking TAGRISSO were twice as likely to survive than those who took no active medicine (51% less likely to die).

Those taking TAGRISSO were
twice as likely to survive
than those who took no active medicine (51% less likely to die).

  • When patients were followed up for overall survival, 88% (297 of 339) of people given TAGRISSO were still alive compared to 76% (261 of 343) of people given no active medicine

Remember to always take TAGRISSO exactly as directed by your doctor. In this clinical trial, all adults treated with TAGRISSO took it for 3 years or until their disease returned or their doctor stopped treatment.

The clinical trial included 682 adults with stage 1B, 2, and 3A EGFR+ NSCLC who had surgery to remove their tumor—some of these adults may have had chemotherapy after their surgery. They were then treated with either TAGRISSO (339 people) or placebo (no active medicine) (343 people). The treatment was given for 3 years or until their cancer returned, or until their doctor stopped treatment.

The main goal of the trial was disease-free survival (DFS), which is the length of time people remain cancer free after starting treatment. A secondary goal of the trial was overall survival (OS), which is the length of time people are alive after starting treatment.

 

Ask your doctor if TAGRISSO may be right for you 

How to take TAGRISSO

Dosing that may conveniently fit into your daily routine

80-mg Tablet Icon

once-a-day pill
(80-mg tablet)

Without Food Icon

with or without food

Home Icon

may be taken at home

What if I miss a dose?

Calendar Icon

What if I miss a dose?

If you miss a dose of TAGRISSO, do not make up for the missed dose. Take your next dose at your regular time.

Your doctor may change your dose, temporarily stop, or permanently stop treatment with TAGRISSO if you have side effects.

It’s important to follow your doctor’s instructions for staying on track with your treatment. Always take TAGRISSO exactly as directed by your doctor.

“Inspirational patient quote to come”

—Name X.

What if I’m having trouble swallowing TAGRISSO whole?

Glass Icon

Place your TAGRISSO pill in a glass or container. Pour in 2 ounces (approximately 60 mL) of water. Don’t use carbonated water or other liquids

Drinking Water Icon

Drink the mixture right away

Container Icon

Stir until the pill is in small pieces. The pill will not completely dissolve. Do not crush, heat, or use ultrasound on the pill

Pitcher Icon

Add 4 to 8 more ounces (approximately 120 mL to 240 mL) of water to the glass or container, and drink it to make sure you take your full dose of TAGRISSO

Take TAGRISSO once a day every day for 3 years or as prescribed

You may experience side effects with TAGRISSO

If you experience side effects, remember to talk to your healthcare team right away. They may be able to help you manage side effects and continue on treatment. Your doctor may change your dose, temporarily stop, or permanently stop treatment with TAGRISSO if you have side effects.

TAGRISSO may cause serious side effects, including: 

  • Lung problems. TAGRISSO may cause severe lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever
  • Heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your healthcare provider 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, dizziness, feeling lightheaded, or feeling faint
  • Eye problems. TAGRISSO may cause eye problems. Tell your healthcare provider right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO
  • Skin problems. TAGRISSO may cause skin problems. Tell your healthcare provider right away if you develop skin reactions that look like rings (target lesions), severe blistering or peeling of the skin
  • Inflammation of the blood vessels in your skin. TAGRISSO may cause blood vessel problems in your skin. Tell your healthcare provider right away if you develop purple spots or redness of the skin that does not fade in color when pressed (non-blanching) on your lower arms, lower legs, or buttocks or large hives on the main part of your body (trunk) that do not go away within 24 hours and look bruised
  • Blood and bone marrow problems. TAGRISSO may cause a condition where your bone marrow cannot make enough new blood cells (aplastic anemia), and which may lead to death. Your healthcare provider will monitor your blood cell counts before you start and during treatment with TAGRISSO. Tell your healthcare provider right away if you develop any signs and symptoms of blood and bone marrow problems, including a new fever or fever that does not go away (100.4 °F), easy bruising or bleeding that will not stop, unusually pale skin, infection, tiredness, or weakness

Before taking TAGRISSO, tell your healthcare provider about all of your medical conditions, including if you:

  • have lung or breathing problems other than your lung cancer
  • have heart problems, including a condition called long QTc syndrome
  • have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
  • have a history of eye problems
  • are pregnant or plan to become pregnant. TAGRISSO can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant
  • Females who are able to become pregnant should have a pregnancy test before starting treatment with TAGRISSO. You should use effective birth control (contraception) during treatment with TAGRISSO and for 6 weeks after the last dose of TAGRISSO
  • Males who have female partners that are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 4 months after the last dose of TAGRISSO
  • females who are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during treatment with TAGRISSO and for 2 weeks after your last dose of TAGRISSO. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your healthcare provider if you take a heart or blood pressure medicine

The most common side effects of TAGRISSO when given alone include:

  • low white blood cell counts
  • low platelet counts
  • low red blood cell counts (anemia)
  • diarrhea
  • rash
  • muscle, bone, or joint pain
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • dry skin
  • mouth sores
  • tiredness
  • low white blood cell counts
  • low platelet counts
  • low red blood cell counts (anemia)
  • diarrhea
  • rash
  • muscle, bone, or joint pain
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • dry skin
  • mouth sores
  • tiredness

The most common side effects of TAGRISSO when given alone after treatment with platinum-based chemotherapy and radiation treatment include:

  • low white blood cell counts
  • lung problems
  • low platelet counts
  • rash
  • diarrhea
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • cough
  • COVID-19
  • low white blood cell counts
  • lung problems
  • low platelet counts
  • rash
  • diarrhea
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • cough
  • COVID-19

The most common side effects of TAGRISSO in combination with pemetrexed and platinum-based chemotherapy include:

  • low white blood cell counts
  • low platelet counts
  • rash
  • diarrhea
  • mouth sores
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • dry skin
  • increase of a substance in the blood called creatinine
  • low white blood cell counts
  • low platelet counts
  • rash
  • diarrhea
  • mouth sores
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • dry skin
  • increase of a substance in the blood called creatinine

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TAGRISSO. For more information, ask your healthcare provider or pharmacist.

What is TAGRISSO?

TAGRISSO is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has certain abnormal epidermal growth factor receptor (EGFR) gene(s):

 

  • to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery, or
  • when your lung cancer has spread to nearby tissues (locally advanced) that is unable to be removed (unresectable) by surgery and has responded or stabilized following chemotherapy and radiation treatment, or
  • as your first treatment when your lung cancer has spread to other parts of the body (metastatic), or
  • in combination with pemetrexed and platinum-based chemotherapy, as your first treatment when your lung cancer has spread to nearby tissues (locally advanced) or to other parts of the body (metastatic), or
  • when your lung cancer has spread to other parts of the body (metastatic), and you have had previous treatment with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working.

Your healthcare provider will perform a test to make sure that TAGRISSO is right for you.
It is not known if TAGRISSO is safe and effective in children.

Please see complete Prescribing Information, including Patient Information for TAGRISSO.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

  • Take TAGRISSO exactly as your healthcare provider tells you to take it
  • Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TAGRISSO if you have side effects
  • Take TAGRISSO 1 time each day
  • You can take TAGRISSO with or without food
  • If you miss a dose of TAGRISSO, do not make up for the missed dose. Take your next dose at your regular time
  • If you cannot swallow TAGRISSO tablets whole:
    • place your dose of TAGRISSO in a container that contains 60 mL (2 ounces) of water. Do not use carbonated water or any other liquids
    • stir the TAGRISSO tablet and water until the TAGRISSO tablet is in small pieces (the tablet will not completely dissolve). Do not crush, heat, or use ultrasound to prepare the mixture
    • drink the TAGRISSO and water mixture right away
    • add 120 mL to 240 mL (4 to 8 ounces) of water into the container and drink to make sure that you take your full dose of TAGRISSO

 

Be sure to revisit How to take TAGRISSO for more information
FAQs Icon

How to discuss side effects 
with your doctor

  • Store TAGRISSO at room temperature between 68 °F and 77 °F (20 °C to 25 °C)
  • Safely throw away medicine that is out of date or that you no longer need
  • Keep TAGRISSO and all medicines out of the reach of children

General information about the safe and effective use of TAGRISSO.

  • Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use TAGRISSO for a condition for which it was not prescribed. Do not give TAGRISSO to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about TAGRISSO that is written for a healthcare professional

 

  • Active ingredient: osimertinib
  • Inactive ingredients: mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and sodium stearyl fumarate. Tablet coating contains: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, ferric oxide yellow, ferric oxide red and ferric oxide black

 

Before your next office visit, see common questions regarding early-stage EGFR+ NSCLC and TAGRISSO

Support is available for patients who may need help accessing TAGRISSO

IMPORTANT SAFETY INFORMATION

TAGRISSO may cause serious side effects, including:

  • Lung problems. TAGRISSO may cause severe lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your healthcare provider right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever
  • Heart problems, including heart failure. TAGRISSO may cause heart problems that may lead to death. Your healthcare provider should check your heart function before you start taking TAGRISSO and during treatment as needed. Tell your healthcare provider 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, dizziness, feeling lightheaded, or feeling faint
  • Eye problems. TAGRISSO may cause eye problems. Tell your healthcare provider right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your healthcare provider may send you to see an eye specialist (ophthalmologist) if you get eye problems with TAGRISSO
  • Skin problems. TAGRISSO may cause skin problems. Tell your healthcare provider right away if you develop skin reactions that look like rings (target lesions), severe blistering or peeling of the skin
  • Inflammation of the blood vessels in your skin. TAGRISSO may cause blood vessel problems in your skin. Tell your healthcare provider right away if you develop purple spots or redness of the skin that does not fade in color when pressed (non-blanching) on your lower arms, lower legs, or buttocks or large hives on the main part of your body (trunk) that do not go away within 24 hours and look bruised
  • Blood and bone marrow problems. TAGRISSO may cause a condition where your bone marrow cannot make enough new blood cells (aplastic anemia), and which may lead to death. Your healthcare provider will monitor your blood cell counts before you start and during treatment with TAGRISSO. Tell your healthcare provider right away if you develop any signs and symptoms of blood and bone marrow problems, including a new fever or fever that does not go away (100.4 °F), easy bruising or bleeding that will not stop, unusually pale skin, infection, tiredness, or weakness

Before taking TAGRISSO, tell your healthcare provider about all of your medical conditions, including if you:

  • have lung or breathing problems other than your lung cancer
  • have heart problems, including a condition called long QTc syndrome
  • have problems with your electrolytes, such as sodium, potassium, calcium or magnesium
  • have a history of eye problems
  • are pregnant or plan to become pregnant. TAGRISSO can harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with TAGRISSO or think you may be pregnant
  • Females who are able to become pregnant should have a pregnancy test before starting treatment with TAGRISSO. You should use effective birth control (contraception) during treatment with TAGRISSO and for 6 weeks after the last dose of TAGRISSO
  • Males who have female partners that are able to become pregnant should use effective birth control during treatment with TAGRISSO and for 4 months after the last dose of TAGRISSO
  • females who are breastfeeding or plan to breastfeed. It is not known if TAGRISSO passes into your breast milk. Do not breastfeed during treatment with TAGRISSO and for 2 weeks after your last dose of TAGRISSO. Talk to your healthcare provider about the best way to feed your baby during this time

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your healthcare provider if you take a heart or blood pressure medicine

The most common side effects of TAGRISSO when given alone include:

  • low white blood cell counts
  • low platelet counts
  • low red blood cell counts (anemia)
  • diarrhea
  • rash
  • muscle, bone, or joint pain
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • dry skin
  • mouth sores
  • tiredness
  • low white blood cell counts
  • low platelet counts
  • low red blood cell counts (anemia)
  • diarrhea
  • rash
  • muscle, bone, or joint pain
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • dry skin
  • mouth sores
  • tiredness

The most common side effects of TAGRISSO when given alone after treatment with platinum-based chemotherapy and radiation treatment include:

  • low white blood cell counts
  • lung problems
  • low platelet counts
  • rash
  • diarrhea
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • cough
  • COVID-19
  • low white blood cell counts
  • lung problems
  • low platelet counts
  • rash
  • diarrhea
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • cough
  • COVID-19

The most common side effects of TAGRISSO in combination with pemetrexed and platinum-based chemotherapy include:

  • low white blood cell counts
  • low platelet counts
  • rash
  • diarrhea
  • mouth sores
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • dry skin
  • increase of a substance in the blood called creatinine
  • low white blood cell counts
  • low platelet counts
  • rash
  • diarrhea
  • mouth sores
  • changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from the nailbed, and shedding of nail
  • dry skin
  • increase of a substance in the blood called creatinine

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of TAGRISSO. For more information, ask your healthcare provider or pharmacist.

What is TAGRISSO?

TAGRISSO is a prescription medicine used to treat adults with non-small cell lung cancer (NSCLC) that has certain abnormal epidermal growth factor receptor (EGFR) gene(s):

  • to help prevent your lung cancer from coming back after your tumor(s) has been removed by surgery, or
  • when your lung cancer has spread to nearby tissues (locally advanced), that is unable to be removed (unresectable) by surgery and has responded or stabilized following chemotherapy and radiation treatment, or
  • as your first treatment when your lung cancer has spread to other parts of the body (metastatic), or
  • in combination with pemetrexed and platinum-based chemotherapy, as your first treatment when your lung cancer has spread to nearby tissues (locally advanced) or to other parts of the body (metastatic), or
  • when your lung cancer has spread to other parts of the body (metastatic) and you have had previous treatment with an EGFR tyrosine kinase inhibitor (TKI) medicine that did not work or is no longer working.

Your healthcare provider will perform a test to make sure that TAGRISSO is right for you.
It is not known if TAGRISSO is safe and effective in children.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

EGFR is epidermal growth factor receptor; EGFR+ is epidermal growth factor receptor mutation-positive; NSCLC is non-small cell lung cancer.

EGFR+ is epidermal growth factor receptor mutation-positive; NSCLC is non-small cell lung cancer.

IMPORTANT SAFETY INFORMATION

see-more