Aplastic anemia has been reported in patients treated with TAGRISSO in clinical trials (0.07% of 1479) and postmarketing.If no other etiology can be identified, consider permanent discontinuation of TAGRISSO based on severity Withhold TAGRISSO if cutaneous vasculitis is suspected, evaluate for systemic involvement, and consider dermatology consultation. Postmarketing cases of cutaneous vasculitis including leukocytoclastic vasculitis, urticarial vasculitis, and IgA vasculitis have been reported in patients receiving TAGRISSO.Withhold TAGRISSO if SJS or EMM is suspected and permanently discontinue if confirmed Postmarketing cases consistent with Stevens-Johnson syndrome (SJS) and erythema multiforme major (EMM) have been reported in patients receiving TAGRISSO.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 Keratitis was reported in 0.7% of 1479 patients treated with TAGRISSO in clinical trials.For symptomatic congestive heart failure, permanently discontinue TAGRISSO Assess LVEF in patients who develop relevant cardiac signs or symptoms during treatment. Conduct cardiac monitoring, including assessment of LVEF at baseline and during treatment, in patients with cardiac risk factors. In the ADAURA study, 1.5% (5/325) of TAGRISSO-treated patients experienced LVEF decreases ≥10% from baseline and a drop to <50%. A decline in left ventricular ejection fraction (LVEF) ≥10% from baseline and to <50% LVEF occurred in 3.2% of 1233 patients who had baseline and at least one follow-up LVEF assessment. Cardiomyopathy occurred in 3% of the 1479 TAGRISSO-treated patients 0.1% of cardiomyopathy cases were fatal.Permanently discontinue TAGRISSO in patients who develop QTc interval prolongation with signs/symptoms of life-threatening arrhythmia 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. No QTc-related arrhythmias were reported. Of the 1479 TAGRISSO-treated patients in clinical trials, 0.8% were found to have a QTc >500 msec, and 3.1% of patients had an increase from baseline QTc >60 msec. ![]() Heart rate-corrected QT (QTc) interval prolongation occurs in TAGRISSO-treated patients.Permanently discontinue TAGRISSO if ILD is confirmed 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). Interstitial lung disease (ILD)/pneumonitis occurred in 3.7% of the 1479 TAGRISSO-treated patients 0.3% of cases were fatal.There are no contraindications for TAGRISSO.The majority of laboratory abnormalities were Grade 1 or 2 1ĬOMMON LABORATORY ABNORMALITIES (≥20% FOR ALL GRADES) IN AURA3 1*Ĭhemotherapy (pemetrexed/ cisplatin or pemetrexed/ carboplatin ) #Includes pruritus, pruritus generalized, eyelid pruritus.Ĭlinically relevant adverse reactions in AURA3 in 500 msec. ![]() ¶Includes nail disorders, nail bed disorders, nail bed inflammation, nail bed tenderness, nail discoloration, nail disorder, nail dystrophy, nail infection, nail ridging, nail toxicity, onychalgia, onychoclasis, onycholysis, onychomadesis, paronychia. ||Includes dry skin, eczema, skin fissures, xerosis. §Includes rash, rash generalized, rash erythematous, rash macular, rash maculopapular, rash papular, rash pustular, erythema, folliculitis, acne, dermatitis, acneiform dermatitis, pustule. ‡Includes stomatitis and mouth ulceration. In patients treated with TAGRISSO once daily in AURA3, 2.9% had a dose reduction. Musculoskeletal and connective tissue disorders Respiratory, thoracic, and mediastinal disorders General disorders and administration site conditions
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