Berotralstat

  • Part D specialty tier in 88% of formularies (2026Q3)
  • Orladeyo

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

Berotralstat: storage and handling

Freezing
Not addressed
Room temperature
at or below 30°C (86°F)
Label statement
Excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .
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.

Within the label's stated room-temperature allowance (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).

Excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-833-633-2279 (the number printed on the label) about this product.

Where the label prints this number
ORL:2PPI For more information, visit www.ORLADEYO.com or call 1-833-633-2279.
All storage statements on the label (4)
  • Store at 20°C to 25°C (68°F to 77°F).
  • Excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .
  • Do not use if tamper-evident seal is broken or missing. 72769-111-02 96 mg 72769-112-02 108 mg 72769-113-02 132 mg 72769-114-02 Store at 20°C to 25°C (68°F to 77°F).
  • Store ORLADEYO at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

FDA label version 10, effective August 20, 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

3%of plans list it
100%of those: prior authorization
0%step therapy
81%quantity limit
97%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.