Efgartigimod alfa and hyaluronidase (human recombinant)

• Store VYVGART HYTRULO vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use.
• Do not freeze.
• Do not shake.
• If needed, unopened vials may be stored in the original carton for up to 3 days at room temperature at 20°C to 25°C (68°F to 77°F) for a single period before administration or returned to refrigeration.
• Do not store the vial at room temperature more than one time.
• Record the date removed from and the date returned to the refrigerator on the carton.
• Store VYVGART HYTRULO prefilled syringe refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use.
• If needed, prefilled syringes may be stored at room temperature at up to 30°C (86°F) in the original carton for a single period of up to 30 days after removing from refrigerator or until expiration date on the carton, whichever occurs first.
• Record the date removed from the refrigerator on the carton.
• Storing VYVGART HYTRULO Prefilled Syringe Store VYVGART HYTRULO in the refrigerator between 36°F to 46°F (2°C to 8°C) (see Figure A ).
• Keep the prefilled syringes in the original carton to protect them from light until ready to use.
• Do not freeze the prefilled syringes or store them in direct sunlight.
• Do not use a prefilled syringe that has been frozen or left in direct sunlight.
• Prefilled Syringe Parts Safety Needle (not provided with VYVGART HYTRULO prefilled syringe) that is 25G, 5/8 inch length, thin wall Gather and Check the Prefilled Syringe 1 Remove the carton from the refrigerator
• Remove the carton containing the prefilled syringe from the refrigerator (see Figure C ).
• Remove 1 prefilled syringe from the carton (see Figure D ) and place any remaining prefilled syringes back into the refrigerator for later use.
• Check the expiration date on the prefilled syringe label (see Figure F ).
• Do not use the prefilled syringe if the expiration date has passed.
• Refrigerated Store VYVGART HYTRULO in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Warm VYVGART HYTRULO by letting it sit on a flat surface for at least 30 minutes for the prefilled syringe and 15 minutes for the vial.
• Do not warm VYVGART HYTRULO any other way (e.g., with an external heat source).
• Store VYVGART HYTRULO in the original carton to protect from light until you are ready to use it.
• Do not freeze VYVGART HYTRULO.
• Do not shake VYVGART HYTRULO.
• Do not use VYVGART HYTRULO past the expiration date.
• Remove from the refrigerator only the dose you are preparing to inject.
• Future doses should remain refrigerated until ready to use.
• Room temperature If needed, VYVGART HYTRULO may be stored at room temperature.
• Record the date you removed VYVGART HYTRULO from the refrigerator.
• Single-dose prefilled syringe may be stored at room temperature (up to 86°F (30°C)) for up to 30 days.
• When removed from the refrigerator and brought to room temperature VYVGART HYTRULO must be used within 30 days or thrown away.
• Single-dose vial may be stored at room temperature (between 68°F to 77°F (20°C to 25°C)) for up to 3 days.
• When removed from the refrigerator and brought to room temperature, VYVGART HYTRULO must be used within 3 days or thrown away.
• Do not put VYVGART HYTRULO back into the refrigerator after it has warmed to room temperature.

FDA label version 13, effective July 15, 2026. DailyMed