For the treatment of metastatic EGFRm NSCLC

First-line safety profile of TAGRISSO in FLAURA

ADVERSE REACTIONS OCCURRING IN ≥10% OF PATIENTS ON TAGRISSO1*

ADVERSE REACTION TAGRISSO (n=279) EGFR TKI Comparator (n=277)
Any grade (%) Grade 3 or higher (%) Any grade (%) Grade 3 or higher (%)
Gastrointestinal Disorders
Diarrhea 58 2.2 57 2.5
Stomatitis 29 0.7 20 0.4
Nausea 14 0 19 0
Constipation 15 0 13 0
Vomiting 11 0 11 1.4
Skin Disorders
Rash 58 1.1 78 6.9
Dry skin§ 36 0.4 36 1.1
Nail toxicity|| 35 0.4 33 0.7
Pruritus 17 0.4 17 0
Metabolism and Nutrition Disorders
Decreased appetite 20 2.5 19 1.8
Respiratory, Thoracic, and Mediastinal Disorders
Cough 17 0 15 0.4
Dyspnea 13 0.4 7 1.4
Neurologic Disorders
Headache 12 0.4 7 0
Cardiac Disorders
Prolonged QT interval# 10 2.2 4 0.7
General Disorders and Administration Site Conditions
Fatigue** 21 1.4 15 1.4
Pyrexia 10 0 4 0.4
Infection and Infestation Disorders
Upper RTI 10 0 7 0
ADVERSE REACTION TAGRISSO (n=279)
Any grade (%) Grade 3
or higher (%)
Gastrointestinal Disorders
Diarrhea 58 2.2
Stomatitis 29 0.7
Nausea 14 0
Constipation 15 0
Vomiting 11 0
Skin Disorders
Rash 58 1.1
Dry skin§ 36 0.4
Nail toxicity|| 35 0.4
Pruritus 17 0.4
Metabolism and Nutrition Disorders
Decreased appetite 20 2.5
Respiratory, Thoracic, and Mediastinal Disorders
Cough 17 0
Dyspnea 13 0.4
Neurologic Disorders
Headache 12 0.4
Cardiac Disorders
Prolonged QT interval# 10 2.2
General Disorders and Administration Site Conditions
Fatigue** 21 1.4
Pyrexia 10 0
Infection and Infestation Disorders
Upper RTI 10 0
ADVERSE REACTION EGFR TKI Comparator (n=277)
Any grade
(%)
Grade 3
or higher (%)
Gastrointestinal Disorders
Diarrhea 57 2.5
Stomatitis 20 0.4
Nausea 19 0
Constipation 13 0
Vomiting 11 1.4
Skin Disorders
Rash 78 6.9
Dry skin§ 36 1.1
Nail toxicity|| 33 0.7
Pruritus 17 0
Metabolism and Nutrition Disorders
Decreased appetite 19 1.8
Respiratory, Thoracic, and Mediastinal Disorders
Cough 15 0.4
Dyspnea 7 1.4
Neurologic Disorders
Headache 7 0
Cardiac Disorders
Prolonged QT interval# 4 0.7
General Disorders and Administration Site Conditions
Fatigue** 15 1.4
Pyrexia 4 0.4
Infection and Infestation Disorders
Upper RTI 7 0
  • In FLAURA, 2.9% of patients treated with once-daily TAGRISSO had a dose reduction1

*NCI CTCAE v4.0.

One grade 5 (fatal) event was reported (diarrhea) for EGFR TKI comparator.

Includes rash, rash generalized, rash erythematous, rash macular, rash maculopapular, rash papular, rash pustular, rash pruritic, rash vesicular, rash follicular, erythema, folliculitis, acne, dermatitis, dermatitis acneiform, drug eruption, skin erosion.

§Includes dry skin, skin fissures, xerosis, eczema, xeroderma.

||Includes nail bed disorder, nail bed inflammation, nail bed infection, nail discoloration, nail pigmentation, nail disorder, nail toxicity, nail dystrophy, nail infection, nail ridging, onychoclasis, onycholysis, onychomadesis, onychomalacia, paronychia.

Includes pruritus, pruritus generalized, eyelid pruritus.

#The frequency of “Prolonged QT interval” represents reported adverse events in the FLAURA study. Frequencies of QTc intervals of >500 ms or >60 ms are presented in Section 5.2 of the Prescribing Information.

**Includes fatigue, asthenia.

RTI, respiratory tract infection.

Reference: 1. TAGRISSO [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2018.

Important Safety Information Expand

  • There are no contraindications for TAGRISSO

  • Interstitial lung disease (ILD)/pneumonitis occurred in 3.9% of the 1142 TAGRISSO-treated patients; 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 is confirmed

  • Heart rate-corrected QT (QTc) interval prolongation occurred in TAGRISSO-treated patients. Of the 1142 TAGRISSO-treated patients in clinical trials, 0.9% were found to have a QTc > 500 msec, and 3.6% 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 2.6% of the 1142 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were fatal. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 3.9% of 908 patients who had baseline and at least one follow-up LVEF assessment. Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors. 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 0.7% of 1142 patients treated with TAGRISSO 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

  • 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

  • Most common adverse reactions (≥20%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue and decreased appetite

Indications

  • TAGRISSO is indicated for the first-line treatment of patients with metastatic 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

  • TAGRISSO is indicated for the treatment of 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


Please see complete Prescribing Information including Patient Information.

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