Evrysdi Adverse Reactions

Summary of the safety profile: In infantile-onset SMA patients, the most common adverse reactions observed in Evrysdi clinical studies were pyrexia (54.8%), rash (29.0%) and diarrhoea (19.4%).
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.
Based on interim safety data in a limited number of patients in RAINBOWFISH (see Dosage & Administration), the safety profile of Evrysdi in pre-symptomatic patients appears to be consistent with the safety profile of symptomatic infantile-onset and later-onset SMA patients. At the time of interim analysis, the RAINBOWFISH study had enrolled 18 patients with pre-symptomatic SMA between 16 and 40 days of age at the time of the first dose (weight range 3.1 to 5.7 kg). The median exposure duration was 8.7 months (range: 0.5 to 22.8 months). Limited post-marketing data are available in neonates <20 days of age.
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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Post-marketing experience: Cutaneous vasculitis was reported during post-marketing experience. Symptoms recovered after permenant discontinuation of Evrysdi. The frequency cannot be estimated based on available data.
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 thailand.drug_safety@roche.com.