Tagrisso (osimertinib) is a prescription tablet used to treat adults with certain types of non-small-cell lung cancer (NSCLC) with a specific mutation in the EGFR gene. It’s FDA approved for use in early-stage cases after surgery, as well as in advanced and metastatic stages. This medication is an EGFR inhibitor that helps slow the growth and spread of cancer cells. It’s typically taken once a day by mouth, with or without food. Common side effects include low blood cell counts, diarrhea, and rash.
Non-small-cell lung cancer (NSCLC) in adults with specific EGFR mutations, including:
Early-stage NSCLC after surgery to remove the tumor
Advanced NSCLC that can’t be removed by surgery, if the cancer hasn’t gotten worse with platinum-based chemotherapy and radiation therapy
Metastatic NSCLC as the first treatment
Advanced or metastatic NSCLC as a first treatment taken together with pemetrexed and platinum-based chemotherapy
Metastatic NSCLC that’s longer responding to other EGFR inhibitors
Tagrisso (osimertinib) is an epidermal growth factor receptor (EGFR) inhibitor. It works by blocking a protein called EGFR, which when mutated or changed can cause the cancer to grow and spread. By targeting this protein, the medication can help slow down or stop the cancer from getting worse.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
Oral tablet taken once a day
Can be used to treat early and advanced stages of NSCLC
Works in a more specific, targeted way than traditional chemotherapy
Requires EGFR testing before use
Can cause skin and stomach-related side effects
Not recommended during pregnancy or breastfeeding
Take Tagrisso (osimertinib) once a day at the same time each day.
If you have trouble swallowing, you can take Tagrisso (osimertinib) as a mixture. Drop the tablet in 2 oz of water and stir until it breaks into small pieces (it won’t fully dissolve). Drink the mixture right away, then add another 4 to 8 ounces of water to the same cup, swirl, and drink again.
Tagrisso (osimertinib) can cause serious or life-threatening lung problems. Call your oncology care team right away if you have new or worse breathing symptoms, like coughing or shortness of breath.
Tagrisso (osimertinib) can affect your heart rhythm. Call your oncologist if you feel dizzy, lightheaded, or faint.
Tagrisso (osimertinib) can cause a rare but serious condition called aplastic anemia. Tell your oncologist if you have a fever that won’t go away, feel very tired or weak, get infections often, or notice easy bruising or bleeding.
Some people have experienced serious skin problems from Tagrisso (osimertinib) like cutaneous vasculitis. Call your care team if you get red or purple spots on your skin that don’t go away, or have large hives that look bruised after 24 hours.
Tagrisso (osimertinib) can cause eye problems. Let your oncologist know right away if your eyes feel red, painful, sensitive to light, watery, or if your vision changes.
Some medications can interact with Tagrisso (osimertinib). Tell your oncologist or pharmacist about everything you take, including prescription and over-the-counter medications.
Tagrisso (osimertinib) can harm an unborn baby. If you can get pregnant, use birth control during treatment and for 6 weeks after your last dose. Let your oncologist know right away if you become pregnant.
Men taking Tagrisso (osimertinib) with sexual partners that can get pregnant should use effective birth control. Continue using it during treatment and for 4 months after your last dose.
Don’t breastfeed while taking Tagrisso (osimertinib). You should also avoid breastfeeding for 2 weeks after your last dose since it’s not known if the medication passes into breast milk or could harm your baby.
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.
Rarely, Tagrisso (osimertinib) can cause serious lung problems, like lung inflammation or a condition called interstitial lung disease (ILD). Tell your cancer care team right away if you have shortness of breath, a cough, fever, or any new or worsening breathing symptoms. Your oncologist might have you stop taking the medication while they check what’s causing the problem. If it turns out to be serious, you might need to stop treatment for good.
Risk factors: History of abnormal heart rhythm | Heart problems | Low electrolytes | Taking other medications that affect heart rhythm
Tagrisso (osimertinib) can affect how your heart beats by causing something called QT prolongation. This means your heartbeat could become abnormal, which might lead to serious problems if not checked closely.
If you have certain heart conditions, like heart failure or abnormal heart rhythm, your oncologist will likely check your heart more often with electrocardiogram (ECG or EKG) tests and blood work. Some medications can also raise your risk, so make sure your care team knows everything you take. If you start feeling dizzy, faint, or notice a fast or uneven heartbeat, tell your oncologist right away. You might need to stop Tagrisso (osimertinib) if these symptoms are serious.
Tagrisso (osimertinib) can cause a serious heart problem called cardiomyopathy, which means your heart doesn’t pump blood as well as it should. This can lead to heart failure, fluid in your lungs, or other heart problems. Your oncologist will likely check your heart before and during treatment to make sure it’s safe. Let your care team know right away if you have symptoms like shortness of breath, swelling in your legs or feet, or feeling extremely tired.
Rarely, Tagrisso (osimertinib) can cause keratitis, or inflammation of the eye. Tell your oncologist right away if you notice eye symptoms like redness, pain, tearing, light sensitivity, blurry vision, or swelling. If needed, your care team might refer you to an eye specialist for further care.
Mild rashes are common and usually not serious when taking Tagrisso (osimertinib). But in rare cases, this medication can cause life-threatening skin problems, including severe skin reactions or infections that can be life-threatening, like Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). Tell your oncologist right away if you get a painful rash, blisters, or peeling skin as these are signs of a serious skin reaction that need immediate medical attention.
In rare cases, Tagrisso (osimertinib) has been linked to inflammation of the small blood vessels in the skin, also known as cutaneous vasculitis. Let your care team know right away if you notice unusual skin changes, like red or purple spots, hives that look bruised, or a rash that doesn’t go away.
A rare but serious blood problem called aplastic anemia has been reported in people taking Tagrisso (osimertinib). This condition happens when your body doesn’t make enough healthy blood cells. Before and during treatment, your oncologist will check your blood counts regularly to watch for changes. Tell your care team right away if you have symptoms like fever that won’t go away, easy bruising, bleeding, or very pale skin, as these could be signs of aplastic anemia.
Tagrisso (osimertinib) might harm an unborn baby if taken during pregnancy. In animal studies, it caused pregnancy loss and other serious problems.
If you can get pregnant, use effective birth control while taking Tagrisso (osimertinib) and for 6 weeks after your last dose. If you’re a man with a partner who could get pregnant, use birth control during treatment and for 4 months after your last dose. Let your oncologist know right away if you or your partner becomes pregnant during treatment.
The typical dose is 80 mg by mouth once a day.
Your dose might differ if you have certain side effects or take other medications that interact with Tagrisso (osimertinib).
Non-small-cell lung cancer (NSCLC) in adults with specific EGFR mutations, including:
Early-stage NSCLC after surgery to remove the tumor
Advanced NSCLC that can’t be removed by surgery, if the cancer hasn’t gotten worse with platinum-based chemotherapy and radiation therapy
Metastatic NSCLC as the first treatment
Advanced or metastatic NSCLC as a first treatment taken together with pemetrexed and platinum-based chemotherapy
Metastatic NSCLC that’s longer responding to other EGFR inhibitors
Metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations
Metastatic NSCLC that have non-resistant mutations in the EGFR gene
Metastatic squamous NSCLC that’ve gotten worse after receiving platinum therapy
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Gesthalter, Y, et al. (2022). Treatment of Advanced-Stage Non–Small Cell Lung Cancer. American Journal of Respiratory and Critical Care Medicine.
MedlinePlus. (n.d.). Aplastic Anemia.
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National Cancer Institute. (n.d.). pneumonitis.
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.
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