EVRYSDI

Treatment with Evrysdi should be initiated by a physician with experience in the management of SMA. Posology The recommended once daily dose of Evrysdi 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 or who may require the use of a nasogastric or gastrostomy tube. 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, the tablet can be dispersed 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 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. 2). Renal impairment Risdiplam has not been studied in this population. 2). Hepatic impairment No dose adjustment is required in patients with mild or moderate hepatic impairment.

2). Paediatric population There is no relevant use of Evrysdi 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. 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.

Do not administer the prepared mixture via a nasogastric or gastrostomy tube. If administration through a nasogastric or gastrostomy tube is required, Evrysdi powder for oral solution should be used.

4%). 7%). The adverse reactions listed above occurred without an identifiable clinical or time pattern and generally resolved despite ongoing treatment in infantile- onset and later-onset SMA patients. Based on the primary analysis of RAINBOWFISH, the safety profile of Evrysdi in pre-symptomatic patients is consistent with the safety profile of symptomatic infantile-onset and later-onset SMA patients.

7 kg). 9 months). Limited post marketing data are available in neonates <20 days of age. 3 for the effects of Evrysdi observed in nonclinical studies. Tabulated list of adverse reactions The corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).

Adverse drug reactions from clinical studies (Table 1) are listed by MedDRA system organ class. Table 1. 1). Post-marketing experience Cutaneous vasculitis was reported during post-marketing experience. Symptoms recovered after permanent discontinuation of Evrysdi.

The frequency cannot be estimated based on available data. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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3). Patients of reproductive potential should be informed of the risks and must use highly effective contraception during treatment and until at least 1 month after the last dose in female patients, and 4 months after the last dose in male patients.

6). Potential effects on male fertility Based on observations from animal studies, male patients should not donate sperm while on treatment and for 4 months after the last dose of Evrysdi. 3). The effects of Evrysdi on male fertility have not been investigated in humans.

e. is essentially ‘sodium-free’.

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