EVRYSDI FILM-COATED TABLET 5MG [SIN17484P]

Product Info

EVRYSDI FILM-COATED TABLET 5MG

[SIN17484P]

Indication

2.1 THERAPEUTIC INDICATION(S)
Evrysdi is indicated for the treatment of spinal muscular atrophy (SMA).

Dosing

2.2 DOSAGE AND ADMINISTRATION

General
SMA treatment should be initiated as early as possible after diagnosis.

Evrysdi is taken orally once daily, at approximately the same time each day, with or without food.

The recommended once daily dose of Evrysdi for SMA patients is determined by age and body weight (see Table 1).

Evrysdi Powder for Oral Solution
Evrysdi powder for oral solution must be constituted by a health care provide (HCP) prior to being dispensed.

Evrysdi powder for oral solution is available for all age groups.

Evrysdi Film-coated Tablets
The Evrysdi film-coated tablets are available for patients prescribed the 5 mg dose.

The physician should prescribe the appropriate pharmaceutical form according to the dose required, and the patient’s needs. For patients with difficulty swallowing a whole tablet, the tablet can be dispersed or the powder for oral solution can be prescribed.

Dose changes must be made under the supervision of an HCP. Treatment with a daily dose above 5 mg has not been studied. Limited post marketing data are available in infants below 16 days of age (see section 3.2.5 Pharmacokinetics in Special Populations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration
It is recommended a HCP discuss with the patient or caregiver how to prepare the prescribed daily dose prior to administration of the first dose (see section 4.2 Special Instruction for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Evrysdi Powder for oral solution:
Use the re-usable oral syringe provided to deliver the daily dose of Evrysdi powder for oral solution.

The patient should drink water after taking the constituted Evrysdi powder for oral solution to ensure the drug has been completely swallowed. If the patient is unable to swallow and has a nasogastric or gastrostomy tube, administer Evrysdi powder for oral solution via the tube. The tube should be flushed with water after delivering Evrysdi powder for oral solution (see section 4.2 Special Instructions for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Evrysdi Film-coated tablet:
The Evrysdi film-coated tablet should be swallowed whole with water or dispersed in a small amount of room temperature non-chlorinated drinking water (e.g. bottled water) (see section 4.2 Special Instruction for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Do not chew, cut or crush the tablets.

If Evrysdi film-coated tablet is dispersed in non-chlorinated drinking water (e.g. bottled water), take it immediately. Evrysdi film-coated tablets must not be dispersed in any liquid other than non-chlorinated drinking water (e.g. bottled water). Discard the prepared dispersion if it is not used within 10 minutes of adding water. Do not expose the prepared dispersion to sunlight.

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

Evrysdi film-coated tablets should not be administered via nasogastric or gastrostomy tube. If administration through a nasogastric or gastrostomy tube is required, the Evrysdi powder for oral solution should be used.

Delayed or Missed Doses
Evrysdi is taken orally once daily at approximately the same time each day. If a dose of Evrysdi is missed, administer as soon as possible if still within 6 hours of the scheduled dose. Otherwise, skip the missed dose and take the next dose at the regularly scheduled time the next day.

If a dose is not fully swallowed or vomiting occurs after taking a dose of Evrysdi, do not administer another dose to make up for the incomplete dose. Wait until the next day to administer the next dose at the regularly scheduled time.

2.2.1 Special Dosage Instructions
Pediatric use
The safety and efficacy of Evrysdi in pediatric patients < 16 days of age have not yet been established in clinical trials (see section 3.1.2 Clinical / Efficacy Studies – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Limited safety data are available from the post marketing setting from patients below 16 days of age treated with Evrysdi at the recommended dose. The safety and efficacy of Evrysdi in preterm infants before reaching the corrected age of 16 days have not been established.

Geriatric use
The pharmacokinetics (PK) and safety of Evrysdi have been assessed in subjects without SMA up to 69 years of age. Evrysdi has not been studied in patients with SMA above 60 years of age (see sections 3.2.5 Pharmacokinetics in Special Populations and 2.5.5 Geriatric Use – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal Impairment
The safety and efficacy of Evrysdi in patients with renal impairment have not been studied. No dose adjustment is expected to be required in patients with renal impairment (see sections 3.2.5 Pharmacokinetics in Special Populations and 2.5.6 Renal Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic Impairment
No dose adjustment is required in patients with mild or moderate hepatic impairment. Evrysdi has not been studied in patients with severe hepatic impairment (see sections 3.2.5 Pharmacokinetics in Special Populations and 2.5.7 Hepatic Impairment – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Contraindications

2.3 CONTRAINDICATIONS
Evrysdi is contraindicated in patients with a known hypersensitivity to risdiplam or any of the excipients.