EVRYSDI Oral solution Ref.[10192] Active ingredients: Risdiplam

2.1 Important Administration Instructions

Dose Preparation

It is recommended that a healthcare provider discuss with the patient or caregiver how to prepare the prescribed daily dose prior to administration of the first dose [see Instructions for Use].

Instruct patients or caregivers to prepare the dose using the reusable oral syringe provided.

EVRYSDI must be taken immediately after it is drawn up into the oral syringe. If EVRYSDI is not taken within 5 minutes, EVRYSDI should be discarded from the oral syringe, and a new dose should be prepared.

Dose Administration

EVRYSDI is taken orally once daily after a meal at approximately the same time each day.

In infants who are breastfed, EVRYSDI should be administered after breastfeeding. EVRYSDI cannot be mixed with formula or milk.

Instruct patients to drink water after taking EVRYSDI to ensure the drug has been completely swallowed.

If the patient is unable to swallow and has a nasogastric or gastrostomy tube, EVRYSDI can be administered via the tube. The tube should be flushed with water after delivering EVRYSDI [see Instructions for Use].

2.2 Dosing Information

EVRYSDI is administered orally once daily. The recommended dosage is determined by age and body weight (see Table 1).

Table 1. Adult and Pediatric Dosing Regimen by Age and Body Weight:

2.3 Missed Dose

If a dose of EVRYSDI is missed, EVRYSDI should be administered as soon as possible if still within 6 hours of the missed dose, and the usual dosing schedule can be resumed on the next day. Otherwise, the missed dose should be skipped, and the next dose should be taken at the regularly scheduled time on the next day.

If a dose is not fully swallowed or vomiting occurs after taking a dose of EVRYSDI, another dose should not be administered to make up for the lost dose. The patient should wait until the next day to take the next dose at the regularly scheduled time.

2.4 Preparation of Oral Solution by Pharmacists

EVRYSDI powder must be constituted to the oral solution by a pharmacist prior to dispensing to the patient.

Preparation of the EVRYSDI Oral Solution 0.75 mg/mL

The EVRYSDI “Instructions for Constitution” booklet contains more detailed instructions on the preparation of the oral solution [see Instructions for Constitution].

Caution should be exercised in the handling of EVRYSDI powder for oral solution. Avoid inhalation and direct contact with skin or mucous membranes with the dry powder and the constituted solution. If such contact occurs, wash thoroughly with soap and water; rinse eyes with water. Wear disposable gloves during the preparation and cleanup procedure.

• Gently tap the bottom of the closed glass bottle to loosen the powder.
• Remove the cap. Do not throw away the cap.
• Carefully pour 79 mL of Purified Water into the EVRYSDI bottle to yield the 0.75 mg/mL oral solution. Do not mix EVRYSDI with formula or milk.
• Insert the Press-In bottle adapter into the bottle opening by pushing it down against the bottle lip. Ensure it is completely pressed against the bottle lip.
• Re-cap the bottle tightly and shake well for 15 seconds. Wait for 10 minutes. You should have obtained a clear solution. If not, shake well again for another 15 seconds.
• Write the date of expiration of the constituted oral solution (calculated as 64 days after constitution) and the lot number on the bottle label. Peel off the part of the bottle label that has the expiration date of the powder.
• Put the bottle back in its original carton.
• Select the appropriate oral syringes (6 mL or 12 mL) based on the patient’s dosage and remove the other oral syringes from the carton.
• Dispense with the “Instructions for Use” and FDA-approved patient labeling. Alert patients to read the important handling information described in the Instructions for Use.

Keep the constituted oral solution of EVRYSDI in the original amber bottle to protect from light. Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Discard any unused portion 64 days after constitution. Keep the bottle in an upright position with the cap tightly closed.

Store the dry powder at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature]. Keep in the original carton.

Keep the constituted oral solution of EVRYSDI in the original amber bottle to protect from light. Store in a refrigerator at 2°C to 8°C (36°F to 46°F) [see Dosage and Administration (2.4)].