Vosoritide

  • Part D specialty tier in 75% of formularies (2026Q3)
  • VOXZOGO 0.4mg

Therapy management checklist

Screening, baseline and ongoing monitoring with the label's stated frequency, hold and discontinue criteria, and counseling points, each quoted from the FDA label.

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Storage and cold chain

Vosoritide: storage and handling

Refrigerate
Yes, as the label states
Label statement
Refrigerate VOXZOGO vials and prefilled diluent syringes at 2°C to 8°C (36°F to 46°F).
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
up to 90 days at or below 30°C (86°F)
Label statement
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.
Room temperature
up to 3 hours at or below 25°C (77°F)
Label statement
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 [see Dosage and Administration (2.4) ] .
Room temperature
up to 90 days at or below 25°C (77°F)
Label statement
You may store VOXZOGO (before mixing) at room temperature between 68°F to 77°F (20°C to 25°C) for 90 days.
Room temperature
up to 90 days
Label statement
Record the date you started storing VOXZOGO at room temperature on the carton to keep track of the 90 days.
Room temperature
up to 90 days
Label statement
Throw VOXZOGO away if unused within 90 days of storing at room temperature.
Back into the refrigerator
Not allowed
Label statement
Do not return VOXZOGO to the refrigerator once stored at room temperature.
Light
Protect from light
Label statement
Store in the original package to protect from light.
Shaking
Not addressed

Temperature excursion helper

Answers only from this label's storage statements. It does not judge whether a product is still usable beyond what the label states.

Within the label's stated room-temperature allowance (up to 90 days at up to 30°C (86°F)). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

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.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-800-123-4567 (the number printed on the label) about this product.

Where the label prints this number
For Help or More Information Call your healthcare provider Call BioMarin at 1-800-123-4567 Visit www.VOXZOGO.com Manufactured for: BioMarin Pharmaceutical Inc., Novato, CA 94949 REP-5233-C10 This Instructions for Use has been approved by the U.S.
All storage statements on the label (15)
  • 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 [see Dosage and Administration (2.4) ] .
  • Do not use beyond expiration date on the label.
  • Store in the original package to protect from light.
  • Store the VOXZOGO vial and prefilled diluent syringe in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • You may store VOXZOGO (before mixing) at room temperature between 68°F to 77°F (20°C to 25°C) for 90 days.
  • Record the date you started storing VOXZOGO at room temperature on the carton to keep track of the 90 days.
  • Do not return VOXZOGO to the refrigerator after it has been stored at room temperature.
  • Throw VOXZOGO away if unused within 90 days of storing at room temperature.
  • Do not use VOXZOGO past the expiration date.
  • Do not freeze VOXZOGO.
  • Store VOXZOGO out of direct sunlight.

FDA label version 16, effective November 25, 2025. DailyMed

Dosing and titration calendar

Built only from the schedules the label states (loading, titration, day schedules, cycles and weight bands). Steps the label states in words the calendar cannot place are shown, not guessed.

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Medicare Part D coverage

0%of plans list it
100%of those: prior authorization
0%step therapy
70%quantity limit
70%specialty tier

5,496 Part D plans, CMS formulary files 2026Q3. Look up tier, PA, step therapy and quantity limits by plan

Patient assistance

No manufacturer program page is listed for this drug yet.

Independent foundations and the full directory (checked 2026-11-06). Eligibility and amounts are set by each program; open its page for them.

For licensed clinicians. Use with clinical judgment. Statements are quoted from the FDA label; confirm against the label for the product you are using.