Agalsidase beta

  • Biologic
  • Fabrazyme

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.

Loading the therapy management checklist…

Storage and cold chain

Agalsidase beta: storage and handling

Refrigerate
Yes, as the label states
Label statement
Refrigerate vials of FABRAZYME at 2°C to 8°C (36°F to 46°F).
Freezing
Not addressed
Room temperature
No allowance stated
Back into the refrigerator
Not addressed
Light
Not addressed
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.

The label does not state a room-temperature allowance for this product.

Entered: 1 day at up to 77°F (25°C).

Refrigerate vials of FABRAZYME at 2°C to 8°C (36°F to 46°F).

Contact the manufacturer at 1-800-745-4447 (the number printed on the label) about this product.

Where the label prints this number
registrynxt.com or by calling 1-800-745-4447, extension 15500.
All storage statements on the label (3)
  • Refrigerate vials of FABRAZYME at 2°C to 8°C (36°F to 46°F).
  • Do not use FABRAZYME after the expiration date on the vial.
  • If immediate use is not possible, the reconstituted and diluted solution may be stored for up to 24 hours at 2°C to 8°C (36°F to 46°F) [see Dosage and Administration (2.2) ] .

FDA label version 35, effective August 22, 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.

Loading dosing schedules…

Medicare Part D coverage

No Part D formulary in the CMS files (2026Q3) lists this drug. It may be covered under Part B or not covered.

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.