Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Tagrisso

TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 12–13

HOS-135428 · Präparat HOS-097706

12 m Includes: acne, dermatitis, dermatitis acneiform, drug eruption, erythema, folliculitis, pustule, rash, rash erythematous, rash follicular, rash macular, rash maculo-papular, rash papular, rash pustular, rash pruritic, rash vesicular, skin erosion. n Includes: nail bed disorder, nail bed infection, nail bed inflammation, nail discolouration, nail disorder, nail dystrophy, nail infection, nail pigmentation, nail ridging, nail toxicity, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomalacia, paronychia. o Includes: dry skin, eczema, skin fissures, xeroderma, xerosis. p Includes: eyelid pruritus, pruritus. q Cases of erythema dyschromicum perstans have been reported in the post-marketing setting. r Six of the 1956 patients in the ADAURA, AURA, FLAURA, FLAURA2 (monotherapy arm), LAURA and AURA studies reported erythema multiforme. Post-marketing reports of erythema multiforme have also been received, including 7 reports from a post-marketing surveillance study (N=3578). s Estimated frequency. The upper limit of the 95% CI for the point estimate is 3/1956 (0.4%). t One event was reported in a post-marketing study, and the frequency has been derived from the ADAURA, FLAURA, FLAURA2 (monotherapy arm), LAURA and AURA studies and the post-marketing study (N=5534). u Represents the incidence of laboratory findings, not of reported adverse events. v Represents decreases greater than or equal to 10 percentage points and a drop to less than 50%. w Represents the incidence of patients who had a QTcF prolongation >500 msec.

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