TAGRISSO osimertinib 80 mg Tablet, Film Coated, 10-count

1 INDICATIONS AND USAGE TAGRISSO is a kinase inhibitor indicated for: • adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. ( 1.1 , 2.2 ) • the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

( 1.2 , 2.2 ) • the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. ( 1.3 , 2.2 ) • in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. ( 1.4 , 2.2 ) • the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.

( 1.5 , 2.2 )

1.1Adjuvant Treatment of EGFR Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ] .

1.2Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC TAGRISSO is indicated for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2)].

1.3First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC TAGRISSO is indicated for the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ].

1.4First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC TAGRISSO in combination with pemetrexed and platinum-based chemotherapy is indicated for the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test [see Dosage and Administration (2.2) ].

1.5Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC TAGRISSO is indicated for the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy [see Dosage and Administration (2.2) ] .

2 DOSAGE AND ADMINISTRATION Adjuvant treatment of early-stage NSCLC: 80 mg orally once daily, with or without food, until disease recurrence, or unacceptable toxicity, or for up to 3 years. ( 2.3 ) Locally advanced, unresectable (stage III) NSCLC: Following platinum-based chemoradiation therapy, 80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. ( 2.3 ) Metastatic NSCLC: 80 mg orally once daily, with or without food, until disease progression or unacceptable toxicity.

( 2.3 ) Locally advanced or metastatic NSCLC: 80 mg orally once daily administered in combination with pemetrexed and platinum-based chemotherapy, with or without food, until disease progression or unacceptable toxicity due to TAGRISSO. ( 2.3 )

2.1Recommended Evaluation and Testing Before Initiating TAGRISSO TAGRISSO Monotherapy • Before initiating TAGRISSO monotherapy in patients with cardiac risk factors, conduct cardiac monitoring, including assessment of left ventricular ejection fraction (LVEF) [see Warnings and Precautions (5.3) ] . • Before initiating TAGRISSO, perform complete blood count with differential [see Warnings and Precautions (5.7) ] . TAGRISSO in Combination with Pemetrexed and Platinum-based Chemotherapy • Before initiating TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of left ventricular ejection fraction (LVEF) [see Warnings and Precautions (5.3) ] . • Before initiating TAGRISSO, perform complete blood count with differential [see Warnings and Precautions (5.7) ] .

2.2Patient Selection Table 1 below presents the patient selection criteria for treatment with TAGRISSO. Table 1: Patient Selection Select patients for treatment with TAGRISSO based on the presence of a mutation as detected by an FDA-approved test. Indication Treatment Regimen Required Mutation Source for Testing Adjuvant Treatment of EGFR Mutation-Positive NSCLC [see Indications and Usage (1.1) ] TAGRISSO monotherapy EGFR exon 19 deletions or exon 21 L858R mutations Tumor Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC [see Indications and Usage (1.2) ] Following completion of platinum-based chemoradiation therapy, TAGRISSO monotherapy EGFR exon 19 deletions or exon 21 L858R mutations Tumor First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC [see Indications and Usage (1.3) ] TAGRISSO monotherapy EGFR exon 19 deletions or exon 21 L858R mutations Plasma or tumor First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC [see Indications and Usage (1.4) ] TAGRISSO in combination with pemetrexed and platinum-based chemotherapy EGFR exon 19 deletions or exon 21 L858R mutations Plasma or tumor Previously Treated EGFR T790M Mutation-Positive Metastatic NSCLC [see Indications and Usage (1.5) ] TAGRISSO monotherapy EGFR T790M Mutation Plasma or tumor Information on FDA-approved tests for the detection of EGFR mutations is available at http://www.fda.gov/companiondiagnostics .

2.3Recommended Dosage and Administration Recommended Dosage Table 2 provides the recommended dosage of TAGRISSO by indication. Table 2: Recommended Dosage of TAGRISSO Indication Recommended Dosage of TAGRISSO Duration of Treatment Adjuvant Treatment of EGFR Mutation-Positive NSCLC 80 mg tablet orally once daily with or without food For a total of 3 years or until disease recurrence or unacceptable toxicity Locally Advanced, Unresectable (Stage III) EGFR Mutation-Positive NSCLC Following platinum-based chemoradiation therapy, 80 mg tablet orally once daily with or without food Until disease progression or unacceptable toxicity First-line Treatment of EGFR Mutation-Positive Metastatic NSCLC 80 mg tablet orally once daily with or without food Until disease progression or unacceptable toxicity First-line Treatment of EGFR Mutation-Positive Locally Advanced or Metastatic NSCLC 80 mg tablet orally once daily with or withou…

3 DOSAGE 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. Tablets: 80 mg and 40 mg. ( 3 )

17 PATIENT 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 [see Warnings and Precautions (5.1 )] .

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 [see Warnings and Precautions (5.2) ] . Cardiomyopathy • Inform patients that TAGRISSO can cause cardiomyopathy.

Advise patients to immediately report any signs or symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.3) ] . 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) [see Warnings and Precautions (5.4) ] . 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 [see Warnings and Precautions (5.5) ] . 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 [see Warnings and Precautions (5.6) ] .

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 [see Warnings and Precautions (5.7) ] . 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 [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1) ] . 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 [see Use in Specific Populations (8.3) ] . • Advise males to use effective contraception during treatment and for 4 months after the last dose of TAGRISSO [see Use in Specific Populations (8.3) ] .

Lactation • Advise women not to breastfeed during treatment with TAGRISSO and for 2 weeks after the last dose [see Use in Specific Populations (8.2) ] . Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 TAGRISSO is a registered trademark of the AstraZeneca group of companies. ©AstraZeneca 2024 Patient Medication Information PATIENT INFORMATION TAGRISSO ® (tuh-GRISS-oh) (osimertinib) tablets What is the most important information I should know about TAGRISSO? 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…

Patient Medication Information PATIENT INFORMATION TAGRISSO ® (tuh-GRISS-oh) (osimertinib) tablets What is the most important information I should know about TAGRISSO? 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 or symptoms of blood and bone marrow problems, including: o a new fever or fever that does not go away (temperature 100.4°F or higher) o easy bruising or bleeding that will not stop o unusually pale skin o infection o tiredness o weakness See “What are the possible side effects of TAGRISSO?” for more information about side effects. 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). • 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. 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…