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Prescribing Information | Important Safety Information

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Introducing Isembyld

ACT NOW Before More Motor Function is Lost

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The first and only treatment to directly target muscle, the principal organ affected by SMA 

to calculate dose, vials needed, volume to withdraw, saline volume, and infusion volume.

The recommended dosage of ISEMBYLD is 10 mg/kg administered once every 4 weeks as an intravenous infusion over approximately 60 minutes to 120 minutes at an infusion rate no greater than 150 mL/hour. Vials are single-dose only. Unused ISEMBYLD should be discarded. Dose calculations based on 10 mg/kg.

Administration instructions

Full Prescribing Information
  • If necessary, remove the diluted ISEMBYLD solution from the refrigerator and allow the diluted solution to warm to room temperature. Do not use external heat sources to warm ISEMBYLD diluted solution because heat may damage the product.
  • Visually inspect the diluted ISEMBYLD solution for particles or discoloration prior to administration [see Dosage Forms and Strengths (3)]. Do not use if it is discolored, opaque, or foreign particles are seen.
  • Use a dedicated line with an infusion set containing a 0.2 or 0.22 micron low protein binding polyethersulfone (PES) in-line infusion filter. Use infusion sets and lines that are di(2-ethylhexyl)phthalate (DEHP)-free.
  • Infuse the diluted solution of ISEMBYLD intravenously over approximately 60 minutes to 120 minutes at an infusion rate no greater than 150 mL/hour.
  • After completion of the infusion, flush the infusion line with 0.9% Sodium Chloride Injection to ensure that all the ISEMBYLD has been administered.
  • If a planned dose is missed, it is recommended to administer ISEMBYLD as soon as possible and then restart the dosing schedule 4 weeks after the missed dose is administered.
  • Alternatively, if a planned dose is missed, dosing may be resumed on the next scheduled dose to maintain the original dosing schedule.