Incompatibilities: Not applicable.
Special precautions for disposal and other handling: Evrysdi powder must be constituted to the oral solution by a HCP (eg. pharmacist) prior to being dispensed.
Preparation: Caution should be exercised in the handling of Evrysdi powder for oral solution (see Precautions). Avoid inhalation and direct contact with skin or mucous membranes with the dry powder and the constituted solution.
Wear disposable gloves during constitution and while wiping the outer surface of the bottle/cap and cleaning the working surface after constitution. If contact occurs, wash thoroughly with soap and water; rinse eyes with water.
Instructions for constitution: 1. Gently tap the bottom of the closed glass bottle to loosen the powder.
2. Remove the cap. Do not throw away the cap.
3. Carefully pour 79 mL of purified water or water for injection into the Evrysdi bottle to yield the 0.75 mg/mL oral solution.
4. Hold the medicine bottle on the table with one hand. Insert the press-in bottle adapter into the opening by pushing it down with the other hand. Ensure the adapter is completely pressed against the bottle lip.
5. Put the cap back on the bottle and close the bottle tightly. Ensure it is completely closed and then shake well for 15 seconds. Wait for 10 minutes. Patient should have obtained a clear solution. Afterwards, shake well again for another 15 seconds.
6. Write the "Discard after" date of the solution on the bottle label and carton. (The "Discard after" date is calculated as 64 days after constitution, the day of constitution is counted as day 0). Put the bottle back in its original carton with syringes (in pouches), Package Leaflet, and Instructions for Use booklet.
Discard any unused portion 64 days after constitution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.