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Tagrisso

Used for Lung Cancer
Used for Lung Cancer

Tagrisso (osimertinib) is taken by mouth to treat non-small cell lung cancer (NSCLC). It’s only used when the tumor has a specific change (mutation) in the EGFR gene, which can be detected with a certain test. It’s convenient to take because you take it by mouth, but it can have some side effects such as acne-like rash, diarrhea, and changes in heart rhythm.

Reviewed by:
reviewer
Allison Baxley, PharmD, BCOP
reviewer
Connie Zheng, PharmD
Last reviewed on June 4, 2023
BasicsSide effectsPros & consPharmacist tipsFAQsWarningsDosageAlternativesLatest newsReferencesPricesMedicare
basics-icon

What is Tagrisso (osimertinib)?

What is Tagrisso (osimertinib) used for?

  • Metastatic NSCLC with specific EGFR mutations as initial treatment or in those no longer responding to other oral EGFR inhibitors

  • NSCLC with specific EGFR mutations (given after surgery to remove the entire tumor)

How Tagrisso (osimertinib) works

Epidermal Growth Factor Receptor (EGFR) is a protein found in our body that's important for cell growth. People with certain non-small cell lung cancers have mutations in EGFR that make the cancer cells grow and spread more quickly. Tagrisso (osimertinib) is an EGFR inhibitor, meaning it blocks the activity of EGFR. More specifically, it targets and blocks the cells with the mutated EGFR (the cancer cells). As a result, the cancer cells can't grow and/or spread as well.

Tagrisso (osimertinib) is unique because sometimes it can still work in tumors that no longer respond well to treatment by other EGFR inhibitors.

Drug Facts

Common BrandsTagrisso
Drug ClassEpidermal Growth Factor Receptor (EGFR) inhibitor
Controlled Substance ClassificationNot a controlled medication
Generic StatusNo lower-cost generic available
AvailabilityPrescription only
basics-icon

What are the side effects of Tagrisso (osimertinib)?

The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.

Common Side Effects

  • Low white blood cell count (up to 65%)
  • Low platelets (53%)
  • Low red blood cells (47%)
  • Diarrhea (47%)
  • Acne-like rash (45%)
  • Muscle aches/pain (36%)
  • Nail changes (33%)
  • Dry skin (32%)
  • Mouth blisters and pain (26%)
  • Fatigue (21%)
  • Cough (20%)

Other Side Effects

  • Nausea
  • Vomiting
  • Constipation
  • Itchy skin
  • Headache

Serious Side Effects

Contact your healthcare provider immediately if you experience any of the following.
  • Serious lung problems: sudden cough, fever, trouble breathing, tightness in chest
  • Serious skin reactions: painful blisters, skin wounds, peeling skin, fever, muscle aches
  • Serious heart problems: heart failure, fluid in the lungs, trouble breathing, swelling in the legs, severe fatigue
  • Serious blood problems: sudden fatigue, bruising, bleeding, fever

Source: DailyMed

The following side effects have also been reported

Side effects that you should report to your care team as soon as possible:

  • Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
  • Aplastic anemia—unusual weakness or fatigue, dizziness, headache, trouble breathing, increased bleeding or bruising
  • Dry cough, shortness of breath or trouble breathing
  • Eye pain, redness, irritation, or discharge with blurry or decreased vision
  • Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
  • Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
  • Infection—fever, chills, cough, or sore throat
  • Redness, blistering, peeling, or loosening of the skin, including inside the mouth
  • Unusual weakness or fatigue, fever, headache, skin rash, muscle or joint pain, loss of appetite, pain, tingling, or numbness in the hands or feet

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

pros-and-cons

Pros and cons of Tagrisso (osimertinib)

thumbs-up

Pros

Works in a more specific, targeted way than traditional chemotherapy

Works on certain cancers after other medications don’t work anymore

Taken by mouth, so good for people who don’t like needles

thumbs-down

Cons

Often causes an itchy, acne-like rash on the face and upper body

Not recommended during pregnancy or breastfeeding

Often causes diarrhea, but usually mild

pharmacist-tips

Pharmacist tips for Tagrisso (osimertinib)

pharmacist

  • Though it’s rare, some people have developed a serious blood problem called aplastic anemia while taking Tagrisso (osimertinib). If you have new or sudden tiredness, bruising, bleeding, or fevers contact your provider right away.

    • If you have difficulty swallowing solids, let your provider know. They can give you instructions on how to make an oral solution from your Tagrisso (osimertinib) tablet. Typically, you can drop the Tagrisso (osimertinib) tablet in 2 ounces of water in a cup and stir until the tablet is in small pieces (it won’t dissolve completely). Immediately drink the liquid. Then, swirl the cup with another 4-8 ounces of water and drink again.

      • You might experience some diarrhea at the beginning of Tagrisso (osimertinib) treatment, but this should improve over time. Your provider might suggest an over-the-counter medication, like loperamide (Imodium A-D) to help manage diarrhea. If you experience diarrhea it’s important to drink a lot of fluids, but try to avoid sugary sports drinks because they can make diarrhea worse.

        • Ask your provider about the best way to handle and throw away Tagrisso (osimertinib) safely. Anticancer medications can be harmful to people who handle or come in contact with them. You should store the medication up and away, so children and pets won’t be able to reach it.

          faqs

          Frequently asked questions about Tagrisso (osimertinib)

          How is Tagrisso (osimertinib) different from other oral EGFR inhibitors for lung cancer?
          There are multiple oral EGFR inhibitors, including Tagrisso (osimertinib), that are approved to treat lung cancers with some EGFR gene mutations. But sometimes when people start treatment for their NSCLC with an EGFR inhibitor, their tumor can eventually outsmart that medication by creating a new change (mutation) called the T790M mutation. When someone develops the T790M mutation, most oral EGFR inhibitors won’t work as well anymore. Tagrisso (osimertinib) binds to the EGFR receptor a little differently, so it might still work in someone with a T790M mutation. Tagrisso (osimertinib) is the only oral EGFR inhibitor recommended if you have the T790M mutation. Talk with your provider if you’ve more questions about Tagrisso (osimertinib) and lung cancer.
          Will I get a rash if I take Tagrisso (osimertinib)?
          Rash is a common side effect of Tagrisso (osimertinib). For most people, it starts out as an acne-like rash on their face, upper chest, and back and dry, flaky skin on their scalp. Your provider might give you creams or other medications to help treat the rash. The rash usually starts within the first month of taking Tagrisso (osimertinib), and begins improving around 2 months after starting the medication. This acne-like rash is common and usually not life threatening, and is different from another skin rash that is rare but dangerous called Stevens-Johnson syndrome. But if you start to see severe blisters or large parts of your skin start peeling, get medical help right away.
          Can I take Tagrisso (osimertinib) if I have heart problems?
          If you have a history of heart problems, talk to your provider before starting Tagrisso (osimertinib). If you were born with heart rhythm problems (e.g, long QT syndrome) or have heart failure, you might still be able to take Tagrisso (osimertinib) but your doctor might need to monitor you more closely with tests like an electrocardiogram (EKG) or echocardiogram.
          How long should I take Tagrisso (osimertinib) for?
          You should take Tagrisso (osimertinib) as instructed by your provider. In general, how long you take this medication depends on whether you’re taking it after surgery (after your surgeon has already removed the entire tumor) or whether you’re taking it to treat NSCLC that has already spread to other parts of the body (metastatic). 1) If you’re taking Tagrisso (osimertinib) after surgery for early-stage NSCLC, your provider will likely recommend you take Tagrisso (osimertinib) for three years after surgery. In some cases, your provider might recommend chemotherapy first, then Tagrisso (osimertinib). 2) If you’re taking it for metastatic NSCLC, your provider will typically have you continue taking this medication as long as it’s working well to treat your cancer (based on your symptoms and scan results) and if you’re not experiencing any serious side effects. Many of the common side effects from Tagrisso (osimertinib), like rash and diarrhea, can be managed with other medications. But your provider might consider stopping or pausing Tagrisso (osimertinib) if you experience rare but serious side effects such as lung inflammation. Don’t stop taking Tagrisso (osimertinib) without first discussing it with your provider.
          Is Tagrisso (osimertinib) safe during pregnancy?
          Talk with your provider if you’re pregnant or thinking about becoming pregnant. Tagrisso (osimertinib) hasn’t been well studied in human pregnancies, but animal studies show that Tagrisso (osimertinib) might cause harm to an unborn baby. Because of this risk, your provider will order a pregnancy test before the start of treatment if you’re a female able to have babies. In addition, you should use birth control while taking Tagrisso (osimertinib) and for at least 6 weeks after the last dose. If you’re a male with a partner who is able to have babies, you should use effective birth control like condoms while taking Tagrisso (osimertinib) and for at least 4 months after the last dose.
          Are there any medications I shouldn’t take while I’m taking Tagrisso (osimertinib)?
          There are some medications that should be avoided if possible if you’re taking Tagrisso (osimertinib). For example, because Tagrisso (osimertinib) can change your heart rhythm (long QT), you usually shouldn’t take it with other medications that can also do the same, like amiodarone (Pacerone) or levofloxacin (Levaquin). But if the benefit is greater than the risk of harm, your provider might have you take these medications together but monitor you more closely during treatment. Another example is that medications like carbamazepine (Tegretol) might make Tagrisso (osimertinib) not work as well, so your doctor might raise your Tagrisso (osimertinib) dose if you have to take both medications together. Your provider or pharmacist will review all the medications that you’re taking before you start Tagrisso (osimertinib) to make sure there aren’t any interactions.
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          warings-icon

          What are the risks and warnings for Tagrisso (osimertinib)?

          Tagrisso (osimertinib) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.

          risk-warning

          Serious lung problems

          Though rare, some people taking Tagrisso (osimertinib) have experienced a serious lung problem called interstitial lung disease (ILD). Talk to your provider right away if you experience sudden or worsening cough, trouble breathing , and fever. You might have to pause or stop Tagrisso (osimertinib) while your oncologist figures out the cause.

          risk-warning

          Serious heart problems

          • Risk factors: Heart rhythm problems (i.e., long QT) | heart failure | Taking medications that can change heart rhythm

            Some people taking Tagrisso (osimertinib) have changes in their heart rhythm, also called QTc prolongation. If you’re born with long QT syndrome or if you’re at risk for QTc prolongation for another reason, such as another medication you take, your oncologist might monitor you more closely with a test called an electrocardiogram (EKG). If the EKG shows heart rhythm problems and you experience symptoms, such as dizziness, chest pain, or weakness, your provider will likely switch you to a different medication.

            Rarely, some people taking Tagrisso (osimertinib) developed heart failure, which can be life-threatening. If you already have heart failure, your doctor will monitor you closely with a test called an echocardiogram. If you have any new chest pain, trouble breathing, or swelling in your legs, contact your provider right away because they might ask you to stop this medication.

            risk-warning

            Eye problems

            Rarely, Tagrisso (osimertinib) can cause swelling in part of your eye. If you notice eye pain, blurred vision, red eye(s), or are suddenly very sensitive to light, contact your provider. Your oncologist might refer you to see an ophthalmologist.

            risk-warning

            Serious skin problems

            Mild rashes are common and usually not serious for people taking Tagrisso (osimertinib). But rarely, this medication can also cause serious skin problems, including severe skin reactions or infections that can be life-threatening, such as Stevens-Johnson syndrome. Tell your provider right away if you develop painful blisters, skin wounds, or peeling skin as these are signs of a serious skin reaction that need immediate medical attention.

            If you experience a purple or reddish-brown rash on your legs, buttocks, or upper body, contact your provider. This could be a sign of a blood vessel-related condition called cutaneous vasculitis, which isn’t usually life-threatening but needs medical attention.

            risk-warning

            Serious blood problems

            Rarely, some people taking Tagrisso (osimertinib) developed a serious blood condition called aplastic anemia, which means your body can’t make blood cells as well. If you develop new bruises, bleeding, fevers, or pale skin contact your provider right away. You might have to pause or stop Tagrisso (osimertinib) while your provider figures out the cause.

            risk-warning

            Harm to unborn baby

            Based on animal studies, Tagrisso (osimertinib) might harm an unborn baby or raise the risk for miscarriage (pregnancy loss). Because of these risks, if you’re a female who can get pregnant, you should use birth control while taking Tagrisso (osimertinib) and for 6 weeks after the last dose. Your provider might ask for a negative pregnancy test before you start taking Tagrisso (osimertinib). Males taking Tagrisso (osimertinib) should use condoms while taking Tagrisso (osimertinib) and for 4 months after the last dose. Let your provider know right away if you become pregnant while taking Tagrisso (osimertinib).

            dosage

            Tagrisso (osimertinib) dosage forms

            Typical dosing for Tagrisso (osimertinib)

            • The usual dose of Tagrisso (osimertinib) is 80 mg by mouth once a day.

            alternatives

            What are alternatives to Tagrisso (osimertinib)?

            There are a number of medications that your doctor can prescribe in place of Tagrisso (osimertinib). Compare a few possible alternatives below.
            Tagrisso (osimertinib)
            Used for:

            • Metastatic NSCLC with specific EGFR mutations as initial treatment or in those no longer responding to other oral EGFR inhibitors

            • NSCLC with specific EGFR mutations (given after surgery to remove the entire tumor)

            View Prices
            Gefitinib (Iressa)
            Used for:

            • Metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations

            View Prices
            Gilotrif (afatinib)
            Used for:

            • Metastatic NSCLC that have non-resistant mutations in the EGFR gene

            • Metastatic squamous NSCLC that’ve gotten worse after receiving platinum therapy

            View Prices

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            References

            Best studies we found

            American Cancer Society. (2019). Chemotherapy safety.

            American Lung Association. (n.d.). Interstitial lung disease (ILD).

            AstraZeneca Pharmaceuticals LP. (2024). Tagrisso- osimertinib tablet, film coated [package insert]. DailyMed.

            View All References (10)

            Churchill, J., et al. (2022). What is an ophthalmologist? American Academy of Ophthalmology. 

            Lacouture, M. E. (2013). Prevention and treatment of acneiform rash caused by EGFR inhibitors. The Asco Post.

            Lacouture, M. E., et al. (2011). Clinical practice guidelines for the prevention and treatment of EGFR inhibitor-associated dermatologic toxicities. Supportive Care in Cancer. 

            National Cancer Institute. (n.d.). Drug resistance.

            National Cancer Institute. (n.d.). EGFR gene.

            National Comprehensive Cancer Network. (2023). Early and locally advanced non-small cell lung cancer.

            National Comprehensive Cancer Network. (2023). Metastatic non-small cell lung cancer.

            National Heart, Lung, and Blood Institute. (2022). Aplastic anemia.

            Suda, K., et al. (2009). EGFR T790M mutation: A double role in lung cancer cell survival?

            Vasculitis Foundation. (n.d.). Cutaneous small-vessel vasculitis.

            GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.
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