Short answer: Keep Voxzogo vials and diluent syringes in the fridge at 36°F to 46°F (2°C to 8°C), and do not freeze them. Before mixing, they may be kept at 68°F to 77°F (20°C to 25°C) for 90 days, then never returned to the fridge. Once mixed, use it within 3 hours. Keep it in the original package to protect from light. Source: Voxzogo label, section 16.
Section 16: “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.” “Store in the original package to protect from light.”
| Question | Label answer |
|---|---|
| Unmixed vials and diluent syringes | Refrigerate at 2°C to 8°C (36°F to 46°F) |
| Room temperature before mixing (section 16) | 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 |
| Room temperature before mixing (Patient Information) | 68°F to 77°F (20°C to 25°C) for 90 days; no excursion range given |
| Back into the fridge | No, once stored at room temperature |
| After mixing | In the vial at 20°C to 25°C (68°F to 77°F), maximum 3 hours |
| Freezing | Do not freeze |
| Light | Section 16: original package, to protect from light. Patient Information: out of direct sunlight |
| Pack | Co-pack of ten 0.4 mg, 0.56 mg or 1.2 mg single-dose vials, each with a diluent syringe |
The leaflets differ from section 16 on two points, shown as printed: they give no 59°F to 86°F excursion range, and they say “out of direct sunlight” where section 16 says to keep it in the original package. Patient Information: “Throw VOXZOGO away if unused within 90 days of storing at room temperature.”
Section 2.4, in order:
Section 2.4 also says: “Discard any unused portion. Do not pool unused portions from the vials. Do not administer more than 1 dose from a vial. Do not mix with other medications.” The Instructions for Use: “After mixing the VOXZOGO, use it right away. Do not use the mixed VOXZOGO if it has been sitting at room temperature for more than 3 hours.”
Dosing and side effects: Voxzogo dosing schedule, missed a Voxzogo dose and Voxzogo side effects. More on reconstitution.
Voxzogo may travel at room temperature within its 90 days. Write the start date on the carton, as the label asks, and do not put it back in the fridge afterwards. Keep it in its package and out of a hot car.
More in the travel guide.