Pegvaliase

  • Part D specialty tier in 73% of formularies (2026Q3)
  • Biologic
  • Palynziq

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

Pegvaliase: storage and handling

Refrigerate
Yes, as the label states
Label statement
Store in refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton to protect from light.
Freezing
Do not freeze
Label statement
Do not freeze or shake.
Room temperature
up to 30 days at or below 25°C (77°F)
Label statement
For patients : If needed, store PALYNZIQ in the original carton at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days.
Room temperature
up to 30 days
Label statement
The shelf-life expires after storage at room temperature for 30 days, or after the expiration date on the product carton, whichever is earlier.
Back into the refrigerator
Not allowed
Label statement
Once stored at room temperature, do not return the product to the refrigerator.
Light
Protect from light
Label statement
Store in refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton 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 30 days at up to 25°C (77°F)). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

For patients : If needed, store PALYNZIQ in the original carton at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days.
Once stored at room temperature, do not return the product to the refrigerator.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-866-906-6100 (the number printed on the label) about this product.

Where the label prints this number
Call BioMarin at 1-866-906-6100 or your healthcare provider for help with PALYNZIQ.
All storage statements on the label (6)
  • Store in refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton to protect from light.
  • Do not freeze or shake.
  • For patients : If needed, store PALYNZIQ in the original carton at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days.
  • Record the date removed from refrigeration on the carton.
  • Once stored at room temperature, do not return the product to the refrigerator.
  • The shelf-life expires after storage at room temperature for 30 days, or after the expiration date on the product carton, whichever is earlier.

FDA label version 36, effective March 2, 2026. 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

4%of plans list it
51%of those: prior authorization
0%step therapy
14%quantity limit
96%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.