Summary of the safety profile: In infantile-onset SMA patients, the most common adverse reactions observed in Evrysdi clinical studies were pyrexia (48.4%), rash (27.4%) and diarrhoea (16.1%).
In later-onset SMA patients, the most common adverse reactions observed in Evrysdi clinical studies were pyrexia (21.7%), headache (20.0%), diarrhoea (16.7%), and rash (16.7%).
The adverse reactions listed previously occurred without an identifiable clinical or time pattern and generally resolved despite ongoing treatment in infantile-onset and later-onset SMA patients.
See also Pharmacology: Toxicology: Preclinical safety data under Actions for the effects of Evrysdi observed in nonclinical studies.
Tabulated list of adverse reactions: The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000). Adverse drug reactions from clinical studies (Table 5) are listed by MedDRA system organ class. (See Table 5.)
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Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to Roche Thailand Local Safety Unit at firstname.lastname@example.org.