Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Alecensa

Alecensa 150 mg hard capsules · Abschnitt 4.8 · PDF-Seite 9–10

HOS-135887 · Präparat HOS-097784

9  System organ class Alecensa ADRs (MedDRA) N = 533 Frequency category Frequency category (all grades) (grades 3-4) Musculoskeletal and connective tissues disorders Myalgia10) Very common Uncommon Increased blood creatine Very common Common phosphokinase Renal and urinary disorders Blood creatinine increased Very common Uncommon** Acute kidney injury Common Uncommon** General disorders and administration site conditions Oedema11) Very common Uncommon Investigations Weight increased Very common Uncommon Metabolism and Nutrition Disorders Hyperuricaemia12) Common -* *No Grade 3-4 ADRs were observed. **Includes one Grade 5 event (observed in the advanced NSCLC setting). 1) includes cases of anaemia, haemoglobin decreased and normochromic normocytic anaemia. 2) cases reported in study BO40336 (N = 128). 3) includes cases of dysgeusia, hypogeusia, and taste disorder. 4) includes cases of blurred vision, visual impairment, vitreous floaters, reduced visual acuity, asthenopia, diplopia, photophobia, and photopsia. 5) includes cases of bradycardia and sinus bradycardia. 6) includes cases of stomatitis and mouth ulceration. 7) includes cases of blood bilirubin increased, hyperbilirubinaemia, bilirubin conjugated increased, and blood bilirubin unconjugated increased. 8) includes two patients with reported MedDRA term of drug-induced liver injury as well as one patient with reported Grade 4 increased AST and ALT who had documented drug-induced liver injury by liver biopsy. 9) includes cases of rash, rash maculopapular, dermatitis, dermatitis acneiform, erythema, rash papular, rash pruritic, rash macular, exfoliative rash, and rash erythematous. 10) includes cases of myalgia, musculoskeletal pain, and arthralgia. 11) includes cases of oedema peripheral, oedema, generalised oedema, eyelid oedema, periorbital oedema, face oedema, localised oedema, peripheral swelling, face swelling, lip swelling, swelling, joint swelling and eyelid swelling. 12) includes cases of hyperuricaemia and increased blood uric acid.

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