EVRYSDI POWDER FOR ORAL SOLUTION 0.75 MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Risdiplam

Available from:

ROCHE SINGAPORE PTE. LTD.

ATC code:

M09AX10

Pharmaceutical form:

POWDER, FOR SOLUTION

Composition:

Risdiplam 60 mg

Administration route:

ORAL, ENTERAL

Prescription type:

Prescription Only

Manufactured by:

F. Hoffmann-La Roche Ltd

Authorization status:

ACTIVE

Authorization date:

2021-10-20

Summary of Product characteristics

Please visit www.roche.com.sg/pharma/evrysdi for a printable version
of this leaflet.
POWSOL-EVR-2023 06
EVRYSDI
®
Risdiplam
____________________________________________
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Pharmacotherapeutic group: Other drugs for disorders of the
musculo-skeletal system
ATC code: M09AX10
1.2
TYPE OF DOSAGE FORM
Powder for oral solution
1.3
ROUTE OF ADMINISTRATION
Oral or enteral
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: risdiplam
Excipients:
Ascorbic
Acid,
Disodium
Edetate
Dihydrate,
Isomalt,
Macrogol/Polyethylene Glycol 6000, Mannitol, Sodium Benzoate,
Strawberry Flavor,
Sucralose, Tartaric Acid
Evrysdi is supplied as a powder in a 100 mL, Type III amber glass
bottle. Each bottle
is filled with 2.0 g of powder containing 60 mg of risdiplam.
The powder is constituted with purified water or water for injection
to yield an oral
solution containing 0.75 mg/mL of risdiplam (see section
_4.2 Special Instructions for _
_Use, Handling and Disposal_
).
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Evrysdi is indicated for the treatment of spinal muscular atrophy
(SMA).
2.2
DOSAGE AND ADMINISTRATION
Evrysdi oral solution must be constituted by a health care provider
(HCP) prior to being
dispensed.
GENERAL
SMA treatment should be initiated as early as possible after
diagnosis.
Evrysdi is taken orally once daily using the oral syringe provided, at
approximately the
same time each day.
The recommended once daily dose of Evrysdi for SMA patients is
determined by age
and body weight (see Table 1).
TABLE 1
DOSING REGIMEN BY AGE AND BODY WEIGHT
AGE
A AND BODY WEIGHT
RECOMMENDED DAILY DOSE
16 days to < 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
a
based on corrected age for preterm infants
Dose changes must be made under the supervision of a HCP. Treatment
with a daily
dose above 5 mg has not been studied. No