Brand Name

Tagrisso

Generic Name
Osimertinib
View Brand Information
FDA approval date: November 13, 2015
Classification: Kinase Inhibitor
Form: Tablet

What is Tagrisso (Osimertinib)?

Receiving a lung cancer diagnosis can be overwhelming, filled with uncertainty and questions about treatment options and survival. For many people with specific genetic forms of non-small cell lung cancer (NSCLC), Tagrisso (osimertinib) represents a major step forward in precision cancer therapy. This medication offers patients not just longer survival, but also a better quality of life, helping them breathe easier and live more fully during treatment. 

Tagrisso is a targeted therapy used to treat certain types of lung cancer driven by mutations in the epidermal growth factor receptor (EGFR) gene. It belongs to a class of medications known as tyrosine kinase inhibitors (TKIs), which work by blocking abnormal signals that cause cancer cells to grow and spread. Approved by the U.S. Food and Drug Administration (FDA) in 2015, Tagrisso is now considered a first-line treatment for patients with EGFR-mutated NSCLC. It can also be used when the cancer has progressed after earlier EGFR-targeted treatments or when it has spread to the brain. 

What does Tagrisso do? 

Tagrisso is prescribed to treat non-small cell lung cancer (NSCLC) in adults whose tumors have specific EGFR gene mutations, such as exon 19 deletions or exon 21 (L858R) substitutions. These mutations cause cancer cells to grow uncontrollably, and Tagrisso is designed to block the signals driving this growth. 

Doctors may prescribe Tagrisso in several settings: 

  • As a first-line therapy for newly diagnosed EGFR-mutated NSCLC. 
     
  • After previous EGFR therapy if the cancer develops a T790M resistance mutation. 
     
  • As adjuvant treatment after surgery to reduce the risk of cancer returning. 

Clinical studies have shown that Tagrisso can extend overall survival and delay disease progression more effectively than earlier EGFR inhibitors. In the pivotal FLAURA trial, patients taking Tagrisso lived a median of nearly 39 months, compared with about 31 months for those taking older EGFR-targeted drugs (FDA, 2024). 

Many patients also experience improved control of cancer that has spread to the brain or spinal cord, since Tagrisso can cross the blood-brain barrier, something earlier drugs in its class often cannot do. 

How does Tagrisso work? 

Tagrisso (osimertinib) targets and blocks abnormal EGFR proteins found on the surface of cancer cells. These proteins send continuous “grow and divide” signals that cause uncontrolled tumor growth. 

By binding to the mutated EGFR receptor, Tagrisso stops the cancer’s internal signaling pathway, slowing or stopping cell growth. It also works against tumors with the T790M mutation, a common cause of resistance to older EGFR inhibitors such as erlotinib or gefitinib. 

In simpler terms, Tagrisso helps turn off the “growth switch” in cancer cells while sparing most normal cells. This selective action often results in fewer severe side effects than traditional chemotherapy, allowing many patients to continue normal daily activities during treatment. 

Clinically, this mechanism is vital because it helps control tumor growth, delay progression, and improve survival outcomes for patients with specific genetic profiles, making Tagrisso a cornerstone in personalized cancer medicine. 

Tagrisso side effects 

While Tagrisso is generally well-tolerated, it can cause side effects. Most are mild to moderate, but some require close monitoring or medical attention. 

Common side effects include: 

  • Diarrhea 
     
  • Rash or dry skin 
     
  • Fatigue 
     
  • Nail changes or mild hair thinning 
     
  • Cough or mild shortness of breath 

These effects are usually manageable and tend to improve over time with supportive care. 

Serious side effects (less common) include: 

  • Heart rhythm problems (QT prolongation): This can cause irregular heartbeat or fainting. Doctors often monitor heart function during treatment. 
     
  • Interstitial lung disease (ILD): A rare but potentially serious inflammation of lung tissue. Patients should contact their doctor if they develop sudden worsening cough, fever, or breathing difficulty. 
     
  • Eye or vision changes: Blurred vision, eye pain, or swelling should be reported immediately. 
     
  • Low blood cell counts: Routine blood tests help ensure healthy levels of red and white cells and platelets. 

Patients with heart disease, lung conditions, or electrolyte imbalances should inform their doctor before starting Tagrisso. 

Emergency medical attention is required for symptoms like chest pain, severe shortness of breath, swelling, or severe skin reactions. Despite these potential risks, most patients tolerate the medication well, especially compared to conventional chemotherapy. 

Tagrisso dosage 

Tagrisso is an oral tablet taken once daily, with or without food, offering convenient at-home treatment. Consistency is vital; take it at the same time daily to maintain stable drug levels. Do not crush or chew unless directed by a healthcare professional. 

Doctors regularly monitor patients using blood tests (liver/kidney function), ECGs (heart rhythm), and scans (tumor response). Severe side effects may lead to temporary dose adjustments. Caution is needed for older adults or those with existing heart/lung conditions due to potential medication processing influences. 

Does Tagrisso have a generic version? 

As of 2025, Tagrisso (osimertinib) does not have a generic version available in the United States or most other countries. It is currently manufactured exclusively by AstraZeneca. However, international versions may exist in other markets. 

Tagrisso’s patent is active, so generics aren’t expected soon. International access programs and patient assistance may offer cost relief. Approved generics will be FDA-certified as equivalent. Discuss financial support and insurance with your oncologist or pharmacist. 

Conclusion 

Tagrisso (osimertinib) has transformed the outlook for many people living with EGFR-mutated non-small cell lung cancer. By precisely targeting the molecular drivers of tumor growth, it offers an effective, well-tolerated, and convenient treatment that can significantly extend survival and maintain quality of life. 

Under medical supervision, Tagrisso is a safe and effective option for most eligible patients. With consistent use and open communication, it offers hope for longer, easier breathing and renewed strength. 

References 

  1. U.S. Food and Drug Administration (FDA). (2024). Tagrisso (osimertinib) prescribing information. Retrieved from https://www.accessdata.fda.gov 
     
  1. Mayo Clinic. (2024). Osimertinib (oral route) description and precautions. Retrieved from https://www.mayoclinic.org 
     
  1. MedlinePlus. (2024). Osimertinib: Uses, side effects, and warnings. National Library of Medicine. Retrieved from https://medlineplus.gov 
     
  1. National Institutes of Health (NIH). (2024). Targeted therapy for non-small cell lung cancer (NSCLC). Retrieved from https://www.nih.gov 
     

Save this treatment for later
Sign Up
Not sure about your diagnosis?
Check Your Symptoms

Related Clinical Trials

Phase II Study of Osimertinib (AZD9291) in Advanced NSCLC Patients With Exon 20 Insertion Mutations in EGFR

Summary: This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Phase III Prospective Randomized Trial of Primary Lung Tumor Stereotactic Body Radiation Therapy Followed by Concurrent Mediastinal Chemoradiation for Locally-Advanced Non-Small Cell Lung Cancer

Summary: This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to the usual treatment (conventional image guided radiation therapy \[IGRT\] and chemotherapy followed by immunotherapy with durvalumab or targeted therapy with osimertinib) versus the usual treatment alone in treating patients with non-small cell lung cancer that has spread to nearby tissue or lymph node...

A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) Combinations in Adult Participants With Advanced Solid Tumors

Summary: The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.

Brand Information

TAGRISSO (osimertinib)
1DOSAGE FORMS AND STRENGTHS
80 mg tablets: beige, oval and biconvex tablet marked with “AZ 80” on one side and plain on the reverse.
40 mg tablets: beige, round and biconvex tablet marked with “AZ 40” on one side and plain on the reverse.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
  • Interstitial Lung Disease/Pneumonitis
  • QTc Interval Prolongation
  • Cardiomyopathy
  • Keratitis
  • Erythema multiforme, Stevens-Johnson syndrome, and Toxic epidermal necrolysis
  • Cutaneous Vasculitis
  • Aplastic Anemia
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data in the WARNINGS AND PRECAUTIONS section reflect exposure to TAGRISSO in 1813 patients with EGFR mutation-positive NSCLC who received TAGRISSO monotherapy at the recommended dose of 80 mg orally once daily until disease progression or unacceptable toxicity in four randomized, controlled trials [ADAURA (n=337), FLAURA (n=338), FLAURA2 (monotherapy arm; n=275), and AURA3 (n=279)]
The data described below reflect exposure to TAGRISSO (80 mg daily) in 337 patients with EGFR mutation-positive resectable NSCLC, 143 patients with EGFR mutation-positive locally advanced, unresectable (stage III) NSCLC, and 833 patients with EGFR mutation-positive locally advanced or metastatic NSCLC in five randomized, controlled trials [ADAURA (n=337), LAURA (n=143), FLAURA (n=279), FLAURA2 (monotherapy arm; n=275), and AURA3 (n=279)]. The data also reflect exposure to TAGRISSO at the recommended dose of 80 mg daily given in combination with pemetrexed and platinum-based chemotherapy in 276 patients with EGFR mutation-positive locally advanced or metastatic NSCLC in one randomized controlled trial [FLAURA2 (n=276)]. Patients with a history of interstitial lung disease, drug induced interstitial disease or radiation pneumonitis that required steroid treatment, serious arrhythmia or baseline QTc interval greater than 470 msec on electrocardiogram were excluded from enrollment in these studies.
Adjuvant Treatment of EGFR Mutation-Positive NSCLC - Monotherapy
The safety of TAGRISSO was evaluated in ADAURA, a randomized, double-blind, placebo-controlled trial for the adjuvant treatment of patients with EGFR exon 19 deletions or exon 21 L858R mutation-positive NSCLC who had complete tumor resection, with or without prior adjuvant chemotherapy. At time of DFS analysis, the median duration of exposure to TAGRISSO was 22.5 months.
Serious adverse reactions were reported in 16% of patients treated with TAGRISSO. The most common serious adverse reaction (≥1%) was pneumonia (1.5%). Adverse reactions leading to dose reductions occurred in 9% of patients treated with TAGRISSO. The most frequent adverse reactions leading to dose reductions or interruptions were diarrhea (4.5%), stomatitis (3.9%), nail toxicity (1.8%) and rash (1.8%). Adverse reactions leading to permanent discontinuation occurred in 11% of patients treated with TAGRISSO. The most frequent adverse reactions leading to discontinuation of TAGRISSO were interstitial lung disease (2.7%), and rash (1.2%).
Tables 4 and 5 summarize common adverse reactions and laboratory abnormalities which occurred in ADAURA.
Clinically relevant adverse reactions in ADAURA in <10% of patients receiving TAGRISSO were alopecia (6%), epistaxis (6%), interstitial lung disease (3%), palmar-plantar erythrodysesthesia syndrome (1.8%), skin hyperpigmentation (1.8%), urticaria (1.5%), keratitis (0.6%), QTc interval prolongation (0.6%), and erythema multiforme (0.3%). QTc interval prolongation represents the incidence of patients who had a QTcF prolongation >500 msec.
Laboratory abnormalities in ADAURA that occurred in <20% of patients receiving TAGRISSO was increased blood creatinine (10%).
Locally Advanced, Unresectable (Stage III) EGFR Mutation Positive NSCLC
The safety of TAGRISSO was evaluated in LAURA, a double blind, randomized (2:1), placebo controlled study conducted in 216 patients with EGFR exon 19 deletions or exon 21 L858R mutation positive, locally advanced, unresectable (stage III) NSCLC, who had not progressed during or following definitive platinum based chemoradiation therapy. Among patients who received TAGRISSO, 81% were exposed for 6 months or longer and 74% were exposed for one year or longer.
Serious adverse reactions were reported in 38% of patients treated with TAGRISSO. The most common serious adverse reactions (≥1%) included ILD/pneumonitis (13%), pneumonia (6%) and gastroenteritis (1.4%). Fatal adverse reactions occurred in 1.4% of patients who received TAGRISSO due to pneumonia (0.7%) and ILD/pneumonitis (0.7%).
Permanent discontinuation of TAGRISSO due to an adverse reaction occurred in 13% of patients. The adverse reactions resulting in permanent discontinuation of TAGRISSO in > 1 patient were ILD/pneumonitis (7%) and pneumonia (1.4%).
Dosage interruptions of TAGRISSO due to an adverse reaction occurred in 56% of patients. The adverse reactions requiring dosage interruption in ≥2% of patients were ILD/pneumonitis (35%), pneumonia (6%), COVID-19 (4.2%), neutropenia (2.1%), and QTc interval prolongation (2.1%).
Dose reductions of TAGRISSO due to an adverse reaction occurred in 8% of patients.
The most common adverse reactions, including laboratory abnormalities worsening from baseline, were lymphopenia, leukopenia, ILD/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19.
Tables 6 and 7 summarize common adverse reactions and laboratory abnormalities which occurred in LAURA.
Clinically relevant adverse reactions in LAURA in <10% of patients receiving TAGRISSO were dyspnea (8%), urinary tract infection (8%), alopecia (1.4%), urticaria (1.4%), epistaxis (0.7%), keratitis (0.7%), and QTc interval prolongation (0.7%). QTc interval prolongation represents the incidence of patients who had a QTc prolongation >500 msec.
A clinically relevant laboratory abnormality in LAURA that occurred in <20% of patients receiving TAGRISSO was increased blood creatinine (19%).
Previously Untreated EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer - Monotherapy
The safety of TAGRISSO was evaluated in FLAURA, a multicenter international double-blind randomized (1:1) active‑controlled trial conducted in 556 patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive, unresectable or metastatic NSCLC who had not received previous systemic treatment for advanced disease. The median duration of exposure to TAGRISSO was 16.2 months.
Serious adverse reactions were reported in 4% of patients treated with TAGRISSO; the most common serious adverse reactions (≥1%) were pneumonia (2.9%), ILD/pneumonitis (2.1%), and pulmonary embolism (1.8%). Dose reductions occurred in 2.9% of patients treated with TAGRISSO. The most frequent adverse reactions leading to dose reductions or interruptions were prolongation of the QT interval as assessed by ECG (4.3%), diarrhea (2.5%), and lymphopenia (1.1%). Adverse reactions leading to permanent discontinuation occurred in 13% of patients treated with TAGRISSO. The most frequent adverse reaction leading to discontinuation of TAGRISSO was ILD/pneumonitis (3.9%).
Tables 8 and 9 summarize common adverse reactions and laboratory abnormalities which occurred in FLAURA.
Clinically relevant adverse reactions in FLAURA in <10% of patients receiving TAGRISSO were alopecia (7%), epistaxis (6%), interstitial lung disease (3.9%), urticaria (2.2%), palmar-plantar erythrodysesthesia syndrome (1.4%), QTc interval prolongation (1.1%), keratitis (0.4%), and skin hyperpigmentation (0.4%). QTc interval prolongation represents the incidence of patients who had a QTcF prolongation >500 msec.
A clinically relevant laboratory abnormality in FLAURA that occurred in <20% of patients receiving TAGRISSO was increased blood creatinine (9%).
Previously Untreated EGFR Mutation-Positive Locally Advanced or Metastatic Non-Small Cell Lung Cancer – TAGRISSO in Combination with Pemetrexed and Platinum-based Chemotherapy
The safety of TAGRISSO in combination with pemetrexed and platinum-based chemotherapy was evaluated in FLAURA2, a multicenter international open-label, randomized (1:1), active-controlled trial conducted in 557 patients with EGFR exon 19 deletion or exon 21 L858R mutation-positive, locally advanced or metastatic NSCLC who had not received previous systemic treatment for advanced disease. The median duration of exposure to TAGRISSO in combination with pemetrexed and platinum-based chemotherapy was 22.3 months and the median duration of exposure to TAGRISSO monotherapy was 19.3 months.
Serious adverse reactions were reported in 38% of patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; the most frequently reported serious adverse reactions (≥2%) in the combination arm were anemia (3.3%), COVID-19 (2.5%), pneumonia (2.5%), febrile neutropenia (2.2%), thrombocytopenia (2.2%), and pulmonary embolism (2.2%). Fatal adverse reactions occurred in 7% of patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy including pulmonary embolism (1.1%), pneumonia (1.1%) and cardiomyopathy (1.1%).
Dosage interruptions of TAGRISSO, when given with pemetrexed and platinum-based chemotherapy, due to an adverse reaction occurred in 44% of patients. Adverse reactions which required dosage interruption in ≥ 2% of patients included anemia (4.7%), neutropenia (4.3%), diarrhea (3.6%), febrile neutropenia (3.3%) and thrombocytopenia (2.9%).
Permanent discontinuation of TAGRISSO when given in combination with pemetrexed and platinum-based chemotherapy due to an adverse reaction occurred in 11% of patients. Adverse reactions which resulted in permanent discontinuation of TAGRISSO in ≥1% of patients included ILD/pneumonitis (2.9%), pneumonia (1.4%), and decreased ejection fraction (1.1%).
Adverse reactions leading to dose reduction of TAGRISSO occurred in 10% of patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy. The most frequently reported adverse reactions leading to dose reduction of TAGRISSO in the combination arm in ≥1% of patients were diarrhea (1.1%) and rash (1.1%).
Tables 10 and 11 summarize common adverse reactions and laboratory abnormalities which occurred in FLAURA2.
Clinically relevant adverse reactions in FLAURA2 in <10% of patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy were alopecia (9%), epistaxis (7%), palmar-plantar erythrodysesthesia syndrome (5%), interstitial lung disease (3.3%), skin hyperpigmentation (2.5%), QTc interval prolongation (1.8%), erythema multiforme (1.4%), urticaria (1.4%), and keratitis (0.7%). QTc interval prolongation represents the incidence of patients who had a QTcF prolongation >500 msec.
Previously Treated EGFR T790M Mutation-Positive Metastatic Non-Small Cell Lung Cancer – Monotherapy
The safety of TAGRISSO was evaluated in AURA3, a multicenter international open label randomized (2:1) controlled trial conducted in 419 patients with unresectable or metastatic EGFR T790M mutation-positive NSCLC who had progressive disease following first line EGFR TKI treatment. A total of 279 patients received TAGRISSO 80 mg orally once daily until intolerance to therapy, disease progression, or investigator determination that the patient was no longer benefiting from treatment. A total of 136 patients received pemetrexed plus either carboplatin or cisplatin every three weeks for up to 6 cycles; patients without disease progression after 4 cycles of chemotherapy could continue maintenance pemetrexed until disease progression, unacceptable toxicity, or investigator determination that the patient was no longer benefiting from treatment. Left Ventricular Ejection Fraction (LVEF) was evaluated at screening and every 12 weeks. The median duration of treatment was 8.1 months for patients treated with TAGRISSO and 4.2 months for chemotherapy-treated patients. The trial population characteristics were: median age 62 years, age less than 65 (58%), female (64%), Asian (65%), never smokers (68%), and ECOG PS 0 or 1 (100%).
Serious adverse reactions were reported in 18% of patients treated with TAGRISSO and 26% in the chemotherapy group. No single serious adverse reaction was reported in 2% or more patients treated with TAGRISSO. One patient (0.4%) treated with TAGRISSO experienced a fatal adverse reaction (ILD/pneumonitis).
Dose reductions occurred in 2.9% of patients treated with TAGRISSO. The most frequent adverse reactions leading to dose reductions or interruptions were prolongation of the QT interval as assessed by ECG (1.8%), neutropenia (1.1%), and diarrhea (1.1%). Adverse reactions resulting in permanent discontinuation of TAGRISSO occurred in 7% of patients treated with TAGRISSO. The most frequent adverse reaction leading to discontinuation of TAGRISSO was ILD/pneumonitis (3%).
Tables 12 and 13 summarize common adverse reactions and laboratory abnormalities which occurred in TAGRISSO-treated patients in AURA3.
Clinically relevant adverse reactions in AURA3 in <10% of patients receiving TAGRISSO were epistaxis (5%), interstitial lung disease (3.9%), alopecia (3.6%), urticaria (2.9%), palmar-plantar erythrodysesthesia syndrome (1.8%), QTc interval prolongation (1.4%), keratitis (1.1%), and erythema multiforme (0.7%), and skin hyperpigmentation (0.4%). QTc interval prolongation represents the incidence of patients who had a QTcF prolongation >500 msec.
Clinically relevant laboratory abnormalities in AURA3 that occurred in <20% of patients receiving TAGRISSO included increased blood creatinine (7%).
Other Clinical Trials Experience
The following adverse reaction has been reported following administration of TAGRISSO: increased blood creatine phosphokinase.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of TAGRISSO. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
  • Skin and subcutaneous tissue: Erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), cutaneous vasculitis, erythema dyschromicum perstans
  • Blood and lymphatic system disorders: Aplastic anemia
4DESCRIPTION
Osimertinib is a kinase inhibitor for oral use. The molecular formula for osimertinib mesylate is C
chem_structure
TAGRISSO tablets contain 40 or 80 mg of osimertinib, equivalent to 47.7 and 95.4 mg of osimertinib mesylate, respectively. Inactive ingredients in the tablet core are mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and sodium stearyl fumarate. The tablet coating consists of polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, ferric oxide yellow, ferric oxide red and ferric oxide black.
5HOW SUPPLIED/STORAGE AND HANDLING
80 mg tablets: beige, oval and biconvex tablet marked with “AZ 80” on one side and plain on the reverse and are available in bottles of 30 (NDC 0310-1350-30).
40 mg tablets: beige, round and biconvex tablet marked with “AZ 40” on one side and plain on the reverse and are available in bottles of 30 (NDC 0310-1349-30).
Store TAGRISSO bottles at 25°C (77°F). Excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
6PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Interstitial Lung Disease/Pneumonitis
  • Inform patients of the risks of severe or fatal ILD, including pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms
QTc Interval Prolongation
  • Inform patients of symptoms that may be indicative of significant QTc prolongation including dizziness, lightheadedness, and syncope. Advise patients to report these symptoms and to inform their physician about the use of any heart or blood pressure medications
Cardiomyopathy
  • Inform patients that TAGRISSO can cause cardiomyopathy. Advise patients to immediately report any signs or symptoms of heart failure to their healthcare provider
Keratitis
  • Advise patients to contact their healthcare provider immediately if they develop eye symptoms (eye inflammation, lacrimation, light sensitivity, eye pain, red eye or changes in vision)
Erythema Multiforme Major, Stevens-Johnson Syndrome, and Toxic Epidermal Necrolysis
  • Inform patients of signs and symptoms that may be indicative of EMM, SJS, or TEN. Advise patients to contact their healthcare provider immediately if they develop target lesions or severe blistering or peeling of skin
Cutaneous Vasculitis
  • Inform patients of signs and symptoms that may be indicative of cutaneous vasculitis. Advise patients to contact their healthcare provider immediately if they develop multiple, non-blanching red papules on their forearms, lower legs, or buttocks or large hives on their trunk that do not go away within 24 hours and develop a bruised appearance
Aplastic Anemia
  • Inform patients of signs and symptoms of aplastic anemia including but not limited to new or persistent fevers, bruising, bleeding, pallor, infection, tiredness or weakness. Advise patients to contact their healthcare provider immediately if signs and symptoms suggestive of aplastic anemia develop
Embryo-Fetal Toxicity
  • Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider if they become pregnant or if pregnancy is suspected, while taking TAGRISSO
Females and Males of Reproductive Potential
  • Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the last dose
  • Advise males to use effective contraception during treatment and for 4 months after the last dose of TAGRISSO
Lactation
  • Advise women not to breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose
Distributed by:
TAGRISSO is a registered trademark of the AstraZeneca group of companies.
This Patient Information has been approved by the U.S. Food and Drug Administration.                       Revised: 09/2024
©AstraZeneca 2024
6.1Patient Medication Information
This Patient Information has been approved by the U.S. Food and Drug Administration.                                                           Revised: 09/2024
7PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 40 mg
NDC 0310-
Tagrisso®
(osimertinib) tablets
40 mg per tablet

Rx only
AstraZeneca
Tagrisso_40_mg_tablet_bottle_label
8PACKAGE/LABEL PRINCIPAL DISPLAY PANEL – 80 mg
NDC 0310-
Tagrisso®
(osimertinib) tablets
80 mg per tablet

Rx only
AstraZeneca
Tagrisso 80 mg tablets bottle label
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0310-
Tagrisso®
(osimertinib) tablets
40 mg per tablet

Rx only
AstraZeneca
40_mg
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
NDC 0310-
Tagrisso®
(osimertinib) tablets
80 mg per tablet

Rx only
AstraZeneca
80_mg