Miscellaneous musculoskeletal disorders:

Indications for EVRYSDI:

Spinal muscular atrophy (SMA) in patients ≥2 months of age.

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: not established. 2months–<2yrs: 0.2mg/kg. ≥2yrs (<20kg): 0.25mg/kg; (≥20kg): 5mg. Breastfed infants: administer after breastfeeding; do not mix with formula or milk.

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.

Pharmacologic Class:

Survival motor neuron 2 (SMN2) splicing modifier.

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.

Generic Availability:

NO

How Supplied:

Pwd—80mL (w. bottle adapter, oral syringes)