Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Balversa

Balversa 3 mg film-coated tablets Balversa 4 mg film-coated tablets Balversa 5 mg film-coated tablets · Abschnitt 4.8 · PDF-Seite 11

HOS-151083 · Präparat HOS-100442

Summary of the safety profile The most common adverse reactions were hyperphosphataemia (78.5%), diarrhoea (55.5%), stomatitis (52.8%), dry mouth (39.9%), decreased appetite (31.7%), anaemia (28.2%), dry skin (28.0%), central serous retinopathy (28.0%), constipation (27.3%), dysgeusia (26.3%), palmar-plantar erythrodysaesthesia syndrome (PPES) (25.5%), alopecia (23.2%), asthenia (23.0%), alanine aminotransferase increased (21.7%), onycholysis (21.7%), fatigue (20.3%), nausea (18.6%), weight decreased (18.4%), aspartate aminotransferase increased (18.0%), dry eye (16.7%), nail discolouration (15.9%), vomiting (13.8%), blood creatinine increased (13.8%), hyponatraemia (13.4%), paronychia (12.5%), nail dystrophy (11.9%), onychomadesis (11.5%), epistaxis (10.6%), nail disorder (10.2%) and abdominal pain (10.0%). Most common Grade 3 or higher ADRs were stomatitis (10.6%), hyponatraemia (8.8%), palmar-plantar erythrodysaesthesia syndrome (7.9%), onycholysis (4.8%), diarrhoea (4.0%), hyperphosphataemia (2.9%), decreased appetite (2.5%), and nail dystrophy (2.5%). Grade 3 or 4 related TEAEs (47.6% vs 43.5%) and related serious adverse events (14.6% vs 10.5%) were reported more frequently for patients 65 years and older versus patients <65 years.

Originalpassage; keine automatisch abgeleitete Schwere, Häufigkeit oder Kausalität. Auch verneinte Befunde und nicht untersuchte Kombinationen bleiben sichtbar.