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Evrysdi

Evrysdi

Manufacturer:

Roche

Distributor:

DKSH

Marketer:

Roche
Concise Prescribing Info
Contents
Risdiplam
Indications/Uses
Spinal muscular atrophy (SMA) in patients ≥2 mth w/ clinical diagnosis of Type 1, Type 2, Type 3 SMA or 1-4 survival of motor neuron 2 (SMN2) copies.
Dosage/Direction for Use
Patients ≥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. Max daily dose: 5 mg once daily.
Administration
Should be taken with food: Take after meal at approx the same time each day. For breastfeeding infants, take after breastfeeding. Do not mix w/ food/liqd/formula/milk. Consume immediately (w/in 5 min) after drawing into oral syringe then drink water to ensure complete swallowing. For patients w/ difficulty swallowing, may be administered via nasogastric or gastrostomy tube then flush tube w/ water.
Contraindications
Special Precautions
Patients who previously received SMN1 gene therapy. Retinal toxicity. Rare hereditary problems of fructose intolerance. Confirm pregnancy status of women prior to treatment. Women of childbearing potential should use highly effective contraception during treatment & for at least 1 mth after last dose. Male patients should not donate sperm during treatment & for 4 mth after last dose. Not recommended in pregnancy & lactation. Increased jaundice in newborn infants up to 4 wk old.
Adverse Reactions
Diarrhoea; rash including maculopapular, erythematous & papular rash, erythema, dermatitis, allergic dermatitis, folliculitis; headache; pyrexia (including hyperpyrexia). Nausea; mouth ulcerations & aphthous ulcers; UTI including cystitis; arthralgia.
Drug Interactions
Increased plasma conc of drug eliminated via MATE1 or MATE2-K eg, metformin. Potential synergistic effects w/ retinotoxic drugs.
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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