Miscellaneous musculoskeletal disorders:

Indications for: EVRYSDI

Spinal muscular atrophy (SMA).

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 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 Classification:

Survival motor neuron 2 (SMN2) splicing modifier.

EVRYSDI Interactions:

Avoid concomitant with MATE substrates (eg, metformin); if unavoidable, monitor for drug-related toxicities; consider dose reduction of substrate.

Adverse Reactions:

Late-onset: fever, diarrhea, rash; Infantile-onset: also upper respiratory tract infection, pneumonia, constipation, vomiting.

Metabolism:

Hepatic (FMO1, FMO3, CYP1A1, CYP2J2, CYP3A4, CYP3A7).

Drug Elimination:

Fecal (53%), renal (28%). 

Apparent clearance: 2.45 L/h (for a 31.3 kg patient).

Half–life: 50 hours.

Generic Drug Availability:

NO

How Supplied:

Bottle (80mL)—1 (w. adapter, oral syringes)