EVRYSDI Film-coated tablet Ref.[116429] Active ingredients: Risdiplam

Treatment with risdiplam should be initiated by a physician with experience in the management of SMA.

Posology

The recommended once daily dose of risdiplam film-coated tablet for patients ≥2 years of age with ≥20 kg body weight is 5 mg.

There is an alternative oral solution available for patients of all age groups. Refer to the Evrysdi powder for oral solution SmPC.

The physician should prescribe the appropriate pharmaceutical form according to the dose required and the patient's needs, including the patient's ability to swallow. For patients with difficulty swallowing a whole tablet or who require administration via a nasogastric or gastrostomy tube, the film-coated tablet can be dispersed in water, or the powder for oral solution can be prescribed.

Treatment with a daily dose above 5 mg has not been studied.

Delayed or missed doses

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 risdiplam, another dose should not be administered to make up for the incomplete dose. The next dose should be administered at the regularly scheduled time.

Elderly

No dose adjustment is required in elderly patients based on limited data in subjects aged 65 years and older (see section 5.2).

Renal impairment

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).

Hepatic impairment

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).

Paediatric population

There is no relevant use of risdiplam film-coated tablets in children <2 years of age and <20 kg.

Method of administration

Oral use.

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 with or without food at approximately the same time each day.

The film‑coated tablets should be swallowed whole or dispersed in a small amount of room temperature water (see Section 6.6). Do not chew, cut, or crush the tablets.

If Evrysdi is dispersed in water, take it immediately. Evrysdi must not be dispersed in any liquid other than water. Discard the prepared mixture if it is not used within 10 minutes of adding water. Do not expose the prepared mixture to sunlight.

If the prepared mixture of Evrysdi spills or gets on the skin, the area should be washed with soap and water.

If administration through a nasogastric or gastrostomy tube is required, a tube that is 8 French or higher should be used to administer the prepared Evrysdi mixture after the dispersion is complete. After the administration of the Evrysdi mixture, the tube should be flushed with the water (at least 15 mL) used to rinse the dispersion cup.

Detailed instructions on the administration of the tablet prepared as a mixture are given in the Instructions for Use (IFU) at the end of the package insert.

There is no known antidote for overdosage of risdiplam. In the event of an overdose, the patient should be closely supervised and supportive care instituted.

3 years.

Film-coated tablets:

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.

Evrysdi film-coated tablets are available in aluminium/aluminium perforated unit-dose blisters containing 7 film-coated tablets. Pack size of 28 x 1 film-coated tablets (4 blisters of 7 x 1 tablets).

Refer to the Instructions for Use at the end of the package leaflet for full details on preparation and administration of the Evrysdi film-coated tablets.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.