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Evrysdi
risdiplam
Adult Dosing .
Dosage forms: TAB: 5 mg; SOLUTION: 0.75 mg per mL
spinal muscular atrophy
- [5 mg PO/NG/GT qd]
- Info: do not cut/crush/chew tab, but may disperse tab in filtered water
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Peds Dosing .
- Dosage forms: TAB: 5 mg; SOLUTION: 0.75 mg per mL
spinal muscular atrophy
- [oral solution form, <2 mo]
- Dose: 0.15 mg/kg/dose PO/NG/GT qd
- [oral solution form, 2-23 mo]
- Dose: 0.2 mg/kg/dose PO/NG/GT qd
- [oral solution form, 2 yo and older, <20 kg]
- Dose: 0.25 mg/kg/dose PO/NG/GT qd
- [tablet or oral solution form, 2 yo and older, >20 kg]
- Dose: 5 mg PO/NG/GT qd; Info: do not cut/crush/chew tab, but may disperse tab in filtered water
renal dosing
- [see below]
- renal impairment: no adjustment
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- caution: patients of childbearing potential
- caution: male patients of reproductive potential
Drug Interactions .
Overview
risdiplam
SMN2 splicing modifier
- MATE1 inhibitor
- MATE2-K inhibitor
Avoid/Use Alternative
Monitor/Modify Tx
Caution Advised
Adverse Reactions .
Serious Reactions
- male infertility (animal studies)
Common Reactions
- fever
- diarrhea
- rash
- URI
- pneumonia
- bronchitis
- constipation
- vomiting
- cough
- mouth ulceration
- arthralgia
- UTI
Safety/Monitoring .
Monitoring Parameters
pregnancy test at baseline
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available; risk of fetal harm, including malformations and decr. fetal wt, based on animal data at >1-2x MRHD
Pregnancy Registry
enroll patients or encourage patients to enroll in Evrysdi Pregnancy Registry at 1-833-760-1098 or www.evrysdipregnancyregistry.com
Individuals of Reproductive Potential
obtain negative pregnancy test before tx start; avoid pregnancy by using effective contraception during tx and for at least 1mo after D/C in patients of childbearing potential
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for risdiplam: liver, other; CYP450: 1A1, 2J2, 3A4, 3A7
Excretion: for risdiplam: feces 53% (14% unchanged), urine 28% (8% unchanged); Half-life: 50h
Subclass: Motor Neuron Diseases
Mechanism of Action
for risdiplam: incr. exon 7 inclusion in survival motor neuron-2 (SMN2) mRNA, producing full-length SMN protein (SMN2 splicing modifier)
Formulary .
No Formulary Selected
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