Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Evrysdi Generic Name & Formulations
Legal Class
Rx
General Description
Risdiplam 60mg; pwd for oral soln (providing 0.75mg/mL) after constitution; contains mannitol, sucralose; strawberry flavor.
Pharmacological Class
Survival motor neuron 2 (SMN2) splicing modifier.
How Supplied
Bottle (80mL)—1 (w. adapter, oral syringes)
Manufacturer
Generic Availability
NO
Mechanism of Action
Risdiplam has been shown to increase exon 7 inclusion in SMN2 messenger ribonucleic acid (mRNA) transcripts and production of full-length SMN protein in the brain using in vitro assays and studies in transgenic animal models of SMA. Based on in vitro and in vivo data, risdiplam may cause alternative splicing of additional genes, including FOXM1 and MADD.
Evrysdi Indications
Indications
Spinal muscular atrophy (SMA).
Evrysdi Dosage and Administration
Adults and Children
Must be administered immediately after drawn up into the oral syringe. Take once daily after a meal at same time each day. May be given via nasogastric or gastrostomy tube if unable to swallow. <2months: 0.15mg/kg. 2months–<2yrs: 0.2mg/kg. ≥2yrs (<20kg): 0.25mg/kg; (≥20kg): 5mg. Breastfed infants: administer after breastfeeding; do not mix with formula or milk.
Evrysdi Contraindications
Not Applicable
Evrysdi Boxed Warnings
Not Applicable
Evrysdi Warnings/Precautions
Warnings/Precautions
Avoid inhalation and direct contact with skin or mucous membranes with dry powder and constituted solution. Hepatic impairment: avoid. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥1 month after the last dose. Possible male infertility. Nursing mothers.
Evrysdi Pharmacokinetics
Absorption
Time to reach maximum plasma concentration (Tmax): 1–4 hours.
Distribution
Apparent volume of distribution at steady state: 190 L (for a 31.3 kg patient).
Risdiplam is predominantly bound to serum albumin with a free fraction of 11%.
Elimination
Fecal (53%), renal (28%).
Apparent clearance: 2.45 L/h (for a 31.3 kg patient).
Half–life: 50 hours.
Evrysdi Interactions
Interactions
Avoid concomitant with MATE substrates (eg, metformin); if unavoidable, monitor for drug-related toxicities; consider dose reduction of substrate.
Evrysdi Adverse Reactions
Adverse Reactions
Late-onset: fever, diarrhea, rash; Infantile-onset: also upper respiratory tract infection, pneumonia, constipation, vomiting.
Evrysdi Clinical Trials
See Literature
Evrysdi Note
Not Applicable
Evrysdi Patient Counseling
See Literature
Images
