Evrysdi

Evrysdi

risdiplam

Manufacturer:

Roche

Distributor:

DKSH

Marketer:

Roche
Concise Prescribing Info
Contents
Risdiplam
Indications/Uses
Spinal muscular atrophy (SMA) in patients w/ clinical diagnosis of Type 1, 2, or 3 SMA, or w/ 1-4 survival of motor neuron 2 (SMN2) copies.
Dosage/Direction for Use
Patient ≥2 yr weighing ≥20 kg 5 mg once daily, <20 kg 0.25 mg/kg once daily; 2 mth to <2 yr 0.20 mg/kg once daily; <2 mth 0.15 mg/kg once daily. Max: 5 mg daily.
Administration
Should be taken with food: Do not mix w/ formula/milk. Consume immediately. May be administered via feeding tube.
Contraindications
Special Precautions
Patients who previously received SMN1 gene therapy. Retinal toxicity. Not to be taken by patients w/ rare hereditary problems of fructose intolerance. Patients of reproductive potential should use highly effective contraception during treatment & until at least 1 mth after last dose in female patients & 4 mth after last dose in male patients w/ female partners of childbearing potential. Male patients should not donate sperm during treatment & for 4 mth after last dose. Not recommended during pregnancy & lactation. Increased jaundice in newborn infants up to 4 wk old.
Adverse Reactions
Diarrhoea; rash including maculopapular, erythematous & papular rash, dermatitis, acneiform & allergic dermatitis, erythema, folliculitis; 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. Potential synergistic effects w/ retinotoxic drugs.
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
1's
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