Vosoritide

What it is used for

VOXZOGO is indicated to increase linear growth in pediatric patients with achondroplasia with open epiphyses. This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Risk of Low Blood Pressure

Who should not take it

None

Storing it

Storage

Refrigerate VOXZOGO vials and prefilled diluent syringes at 2°C to 8°C (36°F to 46°F). Do not freeze.

VOXZOGO can be stored at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) for 90 days. Do not return VOXZOGO to the refrigerator once stored at room temperature.

After reconstitution, VOXZOGO can be held in the vial at room temperature 20°C to 25°C (68°F to 77°F) for a maximum of 3 hours.

Record the starting date of room-temperature storage clearly on the unopened product carton.

Do not use beyond expiration date on the label.

Store in the original package to protect from light.