Details of how to report adverse events are available at the bottom of the page.
For full information on a Roche medicine, please see the relevant Summary of Product Characteristics.
Evrysdi has two oral formulations, providing your eligible patients with more choice and flexibility
Designed to fit their lifestyles, so they have the flexibility in how they plan their day
- A SMN2-splicing modifier now in a tablet formulation
- Stable at room temperature
- Can be swallowed whole or dispersed in room temperature water
- The blister packs can be taken anywhere which may provide greater independence for people living with SMA
- Does not contain any sucralose or isomalt*
- Evrysdi tablets were shown to be bioequivalent to the liquid formulation, which has been used to treat 18,000+ people with SMA worldwide3
Dr James Lilleker provides his thoughts on the Evrysdi tablet formulation and potential impact for people with SMA
The recommended once daily dose of Evrysdi tablets for patients ≥ 2 years of age with ≥ 20 kg body weight is one 5mg tablet. There is the alternative liquid formulation available for patients of all age groups or for those requiring the use of a nasogastric or gastrostomy tube. For patients with difficulty swallowing a whole tablet, the tablet can be dispersed in room temperature water or the liquid formulation can be prescribed.
Summary of the safety profile, based on the liquid formulation:
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 above occurred without an identifiable clinical or time pattern and generally resolved despite ongoing treatment in infantile-onset and later-onset SMA patients.
*Evrysdi tablets contain mannitol.
References
1. Evrysdi 5 mg film‑coated tablets Summary of Product Characteristics
2. Evrysdi 0.75 mg/mL powder for oral solution Summary of Product Characteristics
3. Data taken from Evrysdi February 2025 Periodic Benefit Risk Evaluation Report data. Source: Roche data on file M-GB-00021920 March 2025.