Source: FDA, National Drug Code (US) Revision Year: 2020
EVRYSDI for oral solution contains risdiplam, which is a survival of motor neuron 2 (SMN2)-directed RNA splicing modifier.
The chemical name of risdiplam is 7-(4,7-diazaspiro[2.5]octan-7-yl)2(2,8 dimethylimidazo[1,2-b]pyridazin-6-yl)pyrido-4H-[1,2-a]pyrimidin-4-one. Risdiplam has a molecular weight of 401.46 g/mol.
The molecular formula of risdiplam is C22H23N7O and the chemical structure is shown below.
EVRYSDI is supplied as a powder in an amber glass bottle. Each bottle contains 60 mg of risdiplam. The inactive ingredients of EVRYSDI are: ascorbic acid, disodium edetate dihydrate, isomalt, mannitol, polyethylene glycol 6000, sodium benzoate, strawberry flavor, sucralose, and tartaric acid.
The powder is constituted with purified water to yield 60 mg/80 mL (0.75 mg/mL) of risdiplam after constitution [see Dosage and Administration (2.4)].
| Dosage Forms and Strengths |
|---|
|
EVRYSDI for oral solution: 60 mg as a light yellow, yellow, greyish yellow, greenish yellow, or light green powder for constitution. Following constitution, the volume of the greenish yellow to yellow solution is 80 mL, providing 60 mg/80 mL (0.75 mg/mL) risdiplam. |
| How Supplied |
|---|
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Each amber glass bottle of EVRYSDI is packaged with a bottle adapter, two 6 mL reusable oral syringes, and two 12 mL reusable oral syringes. EVRYSDI for oral solution is a light yellow, yellow, greyish yellow, greenish yellow, or light green powder. Each bottle contains 60 mg of risdiplam (NDC 50242-175-07). |
| Drug | Countries | |
|---|---|---|
| EVRYSDI | Brazil, Ecuador, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, New Zealand, Poland, Romania, United Kingdom, United States |
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