Ensifentrine
- Part D specialty tier in 80% of formularies (2026Q3)
- Ohtuvayre
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
Ensifentrine: storage and handling
- Freezing
- Do not freeze
Label statement
Do not freeze.
- Room temperature
- at or below 25°C (77°F)
Label statement
Store at controlled room temperature (68°F to 77°F [20°C to 25°C], excursions permitted from 59ºF to 86ºF [15ºC to 30ºC]) [See USP Controlled Room Temperature], maintaining the orientation indicated on the carton.
- Room temperature
- at or below 25°C (77°F)
Label statement
Store OHTUVAYRE ampules in the protective foil pouch in the carton at room temperature between 68°F to 77°F (20°C to 25°C) away from direct sunlight and excessive heat, in an upright position as indicated on the carton.
- Room temperature
- at or below 25°C (77°F)
Label statement
Store OHTUVAYRE at room temperature between 68°F to 77°F (20°C to 25°C).
- Back into the refrigerator
- Not addressed
- Light
- Protect from light
Label statement
Protect from direct sunlight and excessive heat.
- Shaking
- Not addressed
All storage statements on the label (14)
- Store OHTUVAYRE in the protective foil pouch.
- Once the foil pouch is opened, discard ampules if not used within 14 days.
- Store at controlled room temperature (68°F to 77°F [20°C to 25°C], excursions permitted from 59ºF to 86ºF [15ºC to 30ºC]) [See USP Controlled Room Temperature], maintaining the orientation indicated on the carton.
- Protect from direct sunlight and excessive heat.
- Do not freeze.
- The ampule containing OHTUVAYRE should be shaken vigorously to ensure complete resuspension of the active ingredient immediately prior to use.
- The used ampule and any residual content should be discarded after use.
- Storing OHTUVAYRE and Nebulizer Clean and store your nebulizer.
- See the manufacturer's instructions that come with your nebulizer for how to clean and store your nebulizer.
- Store OHTUVAYRE ampules in the protective foil pouch in the carton at room temperature between 68°F to 77°F (20°C to 25°C) away from direct sunlight and excessive heat, in an upright position as indicated on the carton.
- Store OHTUVAYRE at room temperature between 68°F to 77°F (20°C to 25°C).
- Keep OHTUVAYRE away from direct sunlight and excessive heat.
- Store OHTUVAYRE in the unopened protective foil pouch and only open the foil pouch immediately before using OHTUVAYRE .
- Do not use OHTUVAYRE after the expiration date provided on the foil pouch and ampule.
FDA label version 6, effective April 23, 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
5,496 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.