Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Roche Registration GmbH, Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Germany
Evrysdi is indicated for the treatment of 5q spinal muscular atrophy (SMA) in patients with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.
Treatment with Evrysdi should be initiated by a physician with experience in the management of SMA.
The recommended once daily dose of Evrysdi is determined by age and body weight (see Table 1). Evrysdi is taken orally once a day after a meal at approximately the same time each day.
Table 1. Dosing regimen by age and body weight:
| Age* and body weight | Recommended daily dose |
|---|---|
| <2 months of age | 0.15 mg/kg |
| 2 months to <2 years of age | 0.20 mg/kg |
| ≥2 years of age (<20 kg) | 0.25 mg/kg |
| ≥2 years of age (≥20 kg) | 5 mg |
* based on corrected age for preterm infants
Treatment with a daily dose above 5 mg has not been studied.
If a planned dose is missed, it should be administered as soon as possible if still within 6 hours of the scheduled dose. Otherwise, the missed dose should be skipped and the next dose should be administered at the regularly scheduled time 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 incomplete dose. The next dose should be administered at the regularly scheduled time.
No dose adjustment is required in elderly patients based on limited data in subjects aged 65 years and older (see section 5.2).
Risdiplam has not been studied in this population. No dose adjustment is expected to be required in patients with renal impairment (see section 5.2).
No dose adjustment is required in patients with mild or moderate hepatic impairment. Patients with severe hepatic impairment have not been studied and may have increased risdiplam exposure (see sections 5.1 and 5.2).
Use of Evrysdi for SMA in patients 2 months of age and younger is supported by pharmacokinetic and safety data from paediatric patients 16 days and older (see sections 4.8, 5.1 and 5.2). No data on risdiplam pharmacokinetics are available in patients less than 16 days of age.
Oral use.
Evrysdi must be constituted by a healthcare professional (e.g. pharmacist) prior to being dispensed. It is recommended that a healthcare professional (HCP) discuss with the patient or caregiver how to prepare the prescribed daily dose prior to administration of the first dose.
Evrysdi is taken orally once a day after a meal at approximately the same time each day, using the re-usable oral syringe provided. In infants who are breastfed, Evrysdi should be administered after breastfeeding. Evrysdi should not be mixed with milk or formula milk.
Evrysdi should be taken immediately after it is drawn up into the oral syringe. If it is not taken within 5 minutes, it should be discarded from the oral syringe and a new dose be prepared. If Evrysdi spills or gets on the skin, the area should be washed with soap and water.
The patient should drink water after taking Evrysdi to ensure the medicinal product has been completely swallowed. If the patient is unable to swallow and has a nasogastric or gastrostomy tube in situ, Evrysdi can be administered via the tube. The tube should be flushed with water after delivering Evrysdi.
Selection of the oral syringe for the prescribed daily dose:
| Syringe size | Dosing volume | Syringe markings |
|---|---|---|
| 1 mL | 0.3 mL to 1 mL | 0.01 mL |
| 6 mL | 1 mL to 6 mL | 0.1 mL |
| 12 mL | 6.2 mL to 6.6 mL | 0.2 mL |
For the calculation of dosing volume, the syringe markings need to be considered. The dose volume should be rounded to the nearest graduation mark on the selected oral syringe.
There is no known antidote for overdosage of Evrysdi. In the event of an overdose, the patient should be closely supervised and supportive care instituted.
Powder for oral solution:
2 years.
Constituted oral solution:
64 days stored in a refrigerator (2 to 8°C).
If necessary, the patient or their caregiver may store the oral solution at room temperature (below 40˚C) for no more than a total of 120 hours (5 days). The oral solution should be returned to the refrigerator when it is no longer necessary to keep the bottle at room temperature. The total time outside the refrigerator (below 40˚C) should be monitored.
The oral solution should be discarded if it has been stored at room temperature (below 40°C) for more than a total of 120 hours (5 days), or for any period of time kept above 40°C.
Keep in the original amber glass bottle to protect from light.
For storage conditions after constitution of the medicinal product, see section 6.3. Keep the oral solution in the original amber glass bottle to protect from light and keep the bottle always in an upright position with the cap tightly closed.
Amber type III glass bottle with a tamper-evident child resistant screw cap.
Each carton contains; one bottle, 1 press-in bottle adaptor, two re-usable 1 mL, two re-usable 6 mL and one re-usable 12 mL graduated amber oral syringes.
Evrysdi powder must be constituted to the oral solution by a HCP (eg. pharmacist) prior to being dispensed.
Caution should be exercised in the handling of Evrysdi powder for oral solution (see section 4.4). 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:
Discard any unused portion 64 days after constitution.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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