Prescribing Information | Indication | Important Safety Information


	Dear Healthcare Professional,


	In resectable EGFRm NSCLC
	Healthcare professionals: You have the power and opportunity to set duration of therapy expectations at the start of treatment. In the ADAURA trial, patients with resected stage IB-IIIA EGFRm NSCLC were treated for a median of approximately 3 years (35.8 months)¹

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.²

Treat eligible patients with TAGRISSO until disease recurrence or unacceptable toxicity or for up to 3 years* in the adjuvant setting²

TAGRISSO: Convenient, once-daily dosing2

If a dose of TAGRISSO is missed, do not make up the missed dose and take the next dose as scheduled.

Select patients for treatment with TAGRISSO based on the presence of EGFR exon 19 deletions or exon 21 L858R mutations.²

Dosage modification2

•	Some situations may require dose interruption, discontinuation, or adjustment. For dose modifications, please see the complete Prescribing Information

•	TAGRISSO is also available as a 40-mg tablet

In a survey of patients with resectable stage I, II, or III NSCLC and/or caregivers, the majority were willing to stay on oral daily therapy for 3 years to keep their cancer from coming back^3†

†

An online survey was conducted from March to April 2‌0‌2‌1 in 7‌5 patients or caregivers caring for a patient who was diagnosed in the last 6 years with stage I-III NSCLC and had surgery or were planning to have surgery. These 7‌5 participants were asked the following question: “How likely would you/your loved one take an oral drug daily, for 3 years, post-surgery, to keep your/your loved one’s early stage, resectable lung cancer from coming back?” On a 7-point scale, where 1=“Not At All Likely” and 7=“Extremely Likely,” 1‌2% of participants chose 5, 2‌9% of participants chose 6, and 4‌0% of participants chose 7.³

ADAURA: A phase III, double-blind trial of patients with completely resected stage IB-IIIA EGFRm NSCLC2

ADAURA study design: Phase III, double-blind, randomized, placebo-controlled trial in
6‌8‌2 patients with completely resected AJCC 7‌th edition–defined stage IB, II, and IIIA EGFRm (exon 1‌9 deletion or exon 2‌1 L‌8‌5‌8‌R mutation) NSCLC with or without adjuvant chemotherapy. Patients were randomized 1:1 to either TAGRISSO (n=3‌3‌9; 8‌0 mg orally, once daily) or placebo (n=3‌4‌3); the planned treatment duration was 3 years or until disease recurrence/unacceptable toxicity.²

LEARN MORE ABOUT THE ADAURA CLINICAL TRIAL

IMPORTANT SAFETY INFORMATION

•

There are no contraindications for TAGRISSO

•

Interstitial lung disease (ILD)/pneumonitis occurred in 4% of the 1813 TAGRISSO-treated patients; 0.4% of cases were fatal. In the FLAURA2 study, ILD/pneumonitis occurred in 3.3% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 0.4% of cases were fatal. Withhold TAGRISSO and promptly investigate for ILD in patients who present with worsening of respiratory symptoms which may be indicative of ILD (eg, dyspnea, cough and fever). Permanently discontinue TAGRISSO if ILD/pneumonitis is confirmed

•

Heart rate-corrected QT (QTc) interval prolongation occurs in TAGRISSO-treated patients. Of the 1813 TAGRISSO monotherapy-treated patients in clinical trials, 1.1% were found to have a QTc >500 msec, and 4.3% of patients had an increase from baseline QTc >60 msec. Of the 276 patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy in the FLAURA2 study, 1.8% were found to have a QTc >500 msec, and 10.5% of patients had an increase from baseline QTc >60 msec. No QTc-related arrhythmias were reported. Conduct periodic monitoring with ECGs and electrolytes in patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or those who are taking medications known to prolong the QTc interval. Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia

•

Cardiomyopathy occurred in 3.8% of the 1813 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. In the FLAURA2 study, cardiomyopathy occurred in 9% of the 276 patients who received TAGRISSO in combination with pemetrexed and platinum-based chemotherapy; 1.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 4.2% of 1557 patients who had baseline and at least one follow-up LVEF assessment. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. In the FLAURA2 study, 8% (21/262) of patients treated with TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, who had baseline and at least one follow-up LVEF assessment, experienced LVEF decreases ≥10% and a drop to less than 50%. For patients receiving TAGRISSO monotherapy, conduct cardiac monitoring in patients with cardiac risk factors, including assessment of LVEF at baseline and during treatment. For patients receiving TAGRISSO in combination with pemetrexed and platinum-based chemotherapy, conduct cardiac monitoring in all patients, including assessment of LVEF at baseline and during treatment. Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. For symptomatic congestive heart failure, permanently discontinue TAGRISSO

•

Keratitis was reported in 0.6% of 1813 patients treated with TAGRISSO monotherapy in clinical trials. Promptly refer patients with signs and symptoms suggestive of keratitis (such as eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye) to an ophthalmologist

•

Postmarketing cases consistent with erythema multiforme major (EMM), Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if EMM, SJS, or TEN is suspected and permanently discontinue if confirmed

•

Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO. Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity

•

Aplastic anemia has been reported in patients treated with TAGRISSO in clinical trials (0.06% of 1813) and postmarketing. Some cases had a fatal outcome. Inform patients of the signs and symptoms of aplastic anemia including but not limited to, new or persistent fevers, bruising, bleeding, and pallor. If aplastic anemia is suspected, withhold TAGRISSO and obtain a hematology consultation. If aplastic anemia is confirmed, permanently discontinue TAGRISSO. Perform complete blood count with differential before starting TAGRISSO, periodically throughout treatment, and more frequently if indicated

•

Verify pregnancy status of females of reproductive potential prior to initiating TAGRISSO. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TAGRISSO and for 6 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception for 4 months after the final dose

•

Because of the potential for serious adverse reactions in breastfed infants from TAGRISSO, women should not breastfeed during treatment with TAGRISSO and for 2 weeks after the final dose

•

Most common (≥20%) adverse reactions, including laboratory abnormalities, were:


o	TAGRISSO monotherapy: leukopenia, lymphopenia, thrombocytopenia, anemia, diarrhea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin, stomatitis, and fatigue

INDICATION

•	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

Please see complete Prescribing Information, including Patient Information for TAGRISSO.

You may report side effects related to AstraZeneca products (opens new window).

AJCC, American Joint Committee on Cancer; EGFR, epidermal growth factor receptor; EGFRm, epidermal growth factor receptor mutation; FDA, US Food and Drug Administration; L858R, exon 21 leucine 858 arginine substitution; NSCLC, non-small cell lung cancer.

References: 1. Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. N Engl J Med. 2‌0‌2‌3‌;‌3‌8‌9‌(‌2‌)‌:1‌3‌7‌-1‌4‌7. 2. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2‌0‌2‌4. 3. Data on File. US-5‌5‌5‌7‌8. AstraZeneca Pharmaceuticals LP.



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