Evrysdi

Evrysdi

risdiplam

Manufacturer:

Roche

Distributor:

DKSH
Concise Prescribing Info
Contents
Risdiplam
Indications/Uses
5q spinal muscular atrophy (SMA) in patients w/ clinical diagnosis of SMA type 1, 2 or 3, or w/ 1-4 SMN2 copies.
Dosage/Direction for Use
Patient ≥2 yr weighing ≥20 kg 5 mg daily, ≥2 yr weighing <20 kg 0.25 mg/kg daily, 2 mth to <2 yr 0.2 mg/kg daily, <2 mth 0.15 mg/kg daily.
Administration
Should be taken with food: Take after meals & immediately after it is drawn up into the oral syringe. Drink water after intake to ensure it has been completely swallowed. Can be administered via tube if patient is unable to swallow & has nasogastric or gastrostomy tube in situ. Administer after breastfeeding in breastfed infants. Do not mix w/ milk or formula milk.
Contraindications
Special Precautions
Treatment w/ daily dose >5 mg has not been studied. Wash w/ soap & water if Evrysdi spills or gets on the skin. Contains isomalt. Should not be taken by patients w/ rare hereditary problems of fructose intolerance. Contains Na benzoate, which may increase jaundice in newborn babies (up to 4 wk old). Patients w/ severe hepatic impairment may have increased exposure. Potential embryo-foetal toxicity. Not recommended during pregnancy & in women of childbearing potential not using contraception. Female patients of childbearing potential should use highly effective contraception during treatment & for at least 1 mth after the last dose. Male patients & their female partners of childbearing potential should use highly effective contraception during treatment & for at least 4 mth after the last dose. Do not breastfeed during treatment. Male fertility may be compromised while on treatment. Male patients should not donate sperm while on treatment & for 4 mth after the last dose. No available data on pharmacokinetics in patients <16 days of age.
Adverse Reactions
Infantile-onset SMA (type 1): Diarrhoea; rash; pyrexia (including hyperpyrexia). Mouth ulcerations & aphthous ulcers; UTI (including cystitis). Later-onset SMA (type 2 & 3): Diarrhoea; rash; headache; pyrexia (including hyperpyrexia). Nausea, mouth ulcerations & aphthous ulcers; UTI (including cystitis); arthralgia.
Drug Interactions
May increase plasma conc of medicinal products eliminated via MATE1 or MATE2-K eg, metformin. No efficacy or safety data to support concomitant use w/ nusinersen.
MIMS Class
Other Drugs Acting on Musculo-Skeletal System
ATC Classification
M09AX10 - risdiplam ; Belongs to the class of other drugs for disorders of the musculo-skeletal system.
Presentation/Packing
Form
Evrysdi powd for oral soln 0.75 mg/mL
Packing/Price
((strawberry flavour)) 80 mL x 1's
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