Evrysdi▼ and Food
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
This article responds to your request for information on the administration of Evrysdi® (risdiplam) with food.
Last updated September 05, 2023
Administration of Evrysdi after food or drink
Effect of food on risdiplam
Food, in the form of high-fat, high calorie meals, has no relevant effect on the exposure of risdiplam.[1]
Timing of Evrysdi with food in Roche clinical trials
In the clinical trials, Evrysdi was administered with a morning meal or after breastfeeding. Following drug administration, patients rinsed their mouth water and swallowed to ensure the drug was completely swallowed. For those unable to swallow or who had a feeding tube, the drug was administered by bolus via a feeding tube. The tube was then flushed with water.[2,3]
The rationale for administering Evrysdi after food or milk was to help prevent a dose being forgotten or taken twice in error by linking the dose to a meal.[1]
Precaution against mixing Evrysdi with food or drink
Mixing Evrysdi with food or drink has not been studied and therefore is not recommended.[4] In addition, if mixed with food or drink, there is no guarantee that the full dose will be taken if the patient does not finish the meal or drink.
References
- Roche Internal Regulatory Report (Accessed on 8 August 2023).
- Mercuri E, Deconinck N, Mazzone E, et al. Safety and efficacy of once-daily risdiplam in type 2 and non-ambulant type 3 spinal muscular atrophy (SUNFISH part 2): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Neurol 2022;21:42-52. https://www.ncbi.nlm.nih.gov/pubmed/34942136
- Masson R, Mazurkiewicz-Bełdzińska M, Rose K, et al. Safety and efficacy of risdiplam in patients with type 1 spinal muscular atrophy (FIREFISH part 2): secondary analyses from an open-label trial. Lancet Neurol 2022;21:1110-1119. https://www.ncbi.nlm.nih.gov/pubmed/36244364
- Roche Internal Clinical Report (Accessed on 8 August 2023).
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