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Tukysa · 4.8 · 10 professionals are asked to report any suspected adverse reactions via the national reporting system listed
Eintrag öffnenTukysa · 4.8 · 9 Table 4: Adverse reactions System organ class Frequency Adverse reaction Respiratory, thoracic and Very comm
Eintrag öffnenTukysa · 4.8 · Adverse reactions leading to discontinuation of TUKYSA occurred in 6% of patients; the most common adverse rea
Eintrag öffnenTukysa · 4.8 · Description of selected adverse reactions
Eintrag öffnenTukysa · 4.8 · Diarrhoea In HER2CLIMB, diarrhoea occurred in 82% of patients treated with tucatinib in combination with trast
Eintrag öffnenTukysa · 4.8 · Elderly In the HER2CLIMB study, 82 patients who received tucatinib were ≥ 65 years, of whom 8 patients were ≥
Eintrag öffnenTukysa · 4.8 · Increased ALT, AST, or bilirubin In HER2CLIMB, increased ALT, AST or bilirubin occurred in 41% of patients tre
Eintrag öffnenTukysa · 4.8 · Increased creatinine without impaired renal function Increase in serum creatinine has been observed in patient
Eintrag öffnenTukysa · 4.8 · Reporting of suspected adverse reactions
Eintrag öffnenTukysa · 4.8 · Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows con
Eintrag öffnenTukysa · 4.8 · Serious adverse reactions occurred in 29% of patients treated with tucatinib, and include diarrhoea (4%), vomi
Eintrag öffnenTukysa · 4.8 · Special populations
Eintrag öffnenTukysa · 4.8 · Summary of the safety profile
Eintrag öffnenTukysa · 4.8 · Tabulated list of adverse reactions
Eintrag öffnenTukysa · 4.8 · The adverse reactions observed during treatment are listed in this section by frequency category. Frequency ca
Eintrag öffnenTukysa · 4.8 · The data summarised in this section reflect exposure to TUKYSA in 431 patients with locally advanced unresecta
Eintrag öffnenTukysa · 4.8 · The most commonly reported Grade 3 and 4 adverse reactions (≥ 5%) during treatment are diarrhoea (13%), ALT in
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