
Tagrisso
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.
What is Tagrisso (osimertinib)?
What is Tagrisso (osimertinib) used for?
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
How Tagrisso (osimertinib) works
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.
Drug facts
| Common Brands | Tagrisso |
|---|---|
| Drug Class | EGFR inhibitor |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
More on Tagrisso (osimertinib) essentials
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 platelet count (53%)
- Low red blood cell count (52%)
- Diarrhea (47%)
- Skin rash (46%)
- Muscle pain (38%)
- Nail changes (34%)
- Dry skin (32%)
- Mouth sores (24%)
- Tiredness (21%)
Less Common Side Effects
- Stomach pain
- Nausea
- Vomiting
- Constipation
- Itchy skin
- Cough
- Fever
- Shortness of breath
- Headache
- Reduced appetite
- Dizziness
- Back pain
Tagrisso (osimertinib) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Lung problems: trouble breathing, shortness of breath, cough, fever
- Heart problems: heart pounding or racing, shortness of breath, swelling of your ankles and feet, dizziness, lightheadedness, feeling faint
- Eye problems: watery eyes, sensitivity to light, eye pain, eye redness, vision changes
- Skin problems: rash or spots that look like rings, severe blistering, peeling of the skin
- Inflammation of the blood vessels in your skin: purple or red spots, large hives that don’t go away, hives that look bruised
- Blood and bone marrow problems: fever, easy bruising or bleeding, pale skin, infection, tiredness, weakness
More on Tagrisso (osimertinib) side effects
The following Tagrisso (osimertinib) 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 of Tagrisso (osimertinib)
Pros
- 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
Cons
- Requires EGFR testing before use
- Can cause skin and stomach-related side effects
- Not recommended during pregnancy or breastfeeding
Pharmacist tips for Tagrisso (osimertinib)
- 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.
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.
Lung problems
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.
Heart rhythm problem (QT prolongation)
- 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.
Heart problems
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.
Eye problems
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.
Skin problems
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.
Inflammation of the blood vessels in your skin
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.
Blood and bone marrow problems
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.
Harm to unborn baby
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.
Tagrisso (osimertinib) dosage
Typical dosage for Tagrisso (osimertinib)
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).
What are alternatives to Tagrisso (osimertinib)?
Non-small-cell lung cancer (NSCLC) in adults with specific EGFR mutations, including:
News about Tagrisso (osimertinib)



