EVRYSDI

Negara: Indonesia

Bahasa: Bahasa Indonesia

Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Bahan aktif:

RISDIPLAM

Tersedia dari:

MENARINI INDRIA LABORATORIES - Indonesia

INN (Nama Internasional):

RISDIPLAM

Dosis:

60 MG

Bentuk farmasi:

SIRUP KERING

Unit dalam paket:

BOX OF 1 BOTTLE OF 2 G POWDER FOR ORAL SOLUTION + 1 PRESS-IN BOTT...

Diproduksi oleh:

F. HOFFMANN-LA ROCHE LTD - Switzerland

Tanggal Otorisasi:

2021-12-20

Karakteristik produk

_Draft_Evrysdi_PI_MAT_CDS3.0_EN_v1 _
_Page 1 of 23_
EVRYSDI
®
Risdiplam
Information as set forth in this label only applies to Evrysdi
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: mannitol, isomalt, strawberry flavor, tartaric acid,
sodium benzoate, polyethylene
glycol, sucralose, ascorbic acid, and disodium edetate dihydrate.
Evrysdi is supplied as a powder in an amber glass bottle. Each bottle
is filled with 2.0 g of powder
contains 60 mg risdiplam.
The powder is constituted with purified water or sterile 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.
DISETUJUI OLEH BPOM: 28/10/2021
EREG100364VR12100158
_Draft_Evrysdi_PI_MAT_CDS3.0_EN_v1 _
_Page 2 of 23_
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 AND BODY WEIGHT
RECOMMENDED DAILY DOSE
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
Dose changes must be made under the supervision of a HCP. Treatment
with a daily dose above 5
mg has not been studied. No data are available in infants below