Trofinetide

  • Part D specialty tier in 79% of formularies (2026Q3)
  • Daybue

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

Trofinetide: storage and handling

Refrigerate
Yes, as the label states
Label statement
DAYBUE Oral Solution Store DAYBUE in an upright position refrigerated at 2°C to 8°C (36°F to 46°F).
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
at or below 30°C (86°F)
Label statement
DAYBUE STIX for Oral Solution Store DAYBUE STIX packets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Room temperature
at or below 25°C (77°F)
Label statement
DAYBUE STIX for oral solution : Store DAYBUE STIX for oral solution powder packets at room temperature between 68°F to 77°F (20°C to 25°C).
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).

DAYBUE STIX for Oral Solution Store DAYBUE STIX packets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Discard any unused DAYBUE oral solution after 14 days of first opening the bottle.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-844-422-2342 (the number printed on the label) about this product.

Where the label prints this number
For more information, go to www.daybue.com or call 1-844-422-2342.
All storage statements on the label (8)
  • DAYBUE Oral Solution Store DAYBUE in an upright position refrigerated at 2°C to 8°C (36°F to 46°F).
  • Do not freeze.
  • Discard any unused DAYBUE oral solution after 14 days of first opening the bottle.
  • DAYBUE STIX for Oral Solution Store DAYBUE STIX packets at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
  • DAYBUE oral solution : Store DAYBUE oral solution bottle in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • DAYBUE STIX for oral solution : Store DAYBUE STIX for oral solution powder packets at room temperature between 68°F to 77°F (20°C to 25°C).
  • DAYBUE Oral Solution Keep bottles of DAYBUE upright and refrigerated before and after opening.
  • Do not freeze [see How Supplied/Storage and Handling (16.2) ] .

FDA label version 12, effective September 4, 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

5%of plans list it
61%of those: prior authorization
0%step therapy
46%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.