Dornase alfa

  • Part D specialty tier in 80% of formularies (2026Q3)
  • Biologic
  • Pulmozyme

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

Dornase alfa: storage and handling

Refrigerate
Yes, as the label states
Label statement
Store PULMOZYME ampules at a refrigerated temperature between 2°C to 8°C (36°F to 46°F) in their protective foil to protect from light and heat.
Freezing
Not addressed
Room temperature
up to 60 hours at or below 28°C (82°F)
Label statement
Do not use if the ampules are exposed to room temperature (22°C to 28°C [72°F to 82°F]) for more than a total of 60 hours.
Room temperature
up to 60 hours at or below 28°C (82°F)
Label statement
Do not use Pulmozyme if the ampules have been exposed to room temperature at 72°F to 82°F (22°C to 28°C) for more than a total of 60 hours or if the solution has turned cloudy or discolored.
Room temperature
up to 60 hours at or below 28°C (82°F)
Label statement
Do not use Pulmozyme if the ampules have been exposed to room temperature 72°F to 82°F (22°C to 28°C) for more than a total of 60 hours or if the solution has turned cloudy or discolored.
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Store PULMOZYME ampules at a refrigerated temperature between 2°C to 8°C (36°F to 46°F) in their protective foil to protect from light and heat.
Shaking
Not addressed
Travel
Stated
Label statement
When traveling, Pulmozyme ampules should be kept refrigerated in their protective foil pouch to protect from light and heat.

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 60 hours at up to 28°C (82°F)). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

Do not use if the ampules are exposed to room temperature (22°C to 28°C [72°F to 82°F]) for more than a total of 60 hours.

If anything else happened to the product, or you are unsure, Contact the manufacturer about this product; the label text ClinDose has does not print a phone number for it.

All storage statements on the label (14)
  • Store PULMOZYME ampules at a refrigerated temperature between 2°C to 8°C (36°F to 46°F) in their protective foil to protect from light and heat.
  • Once the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from light and heat.
  • Do not use beyond the expiration date stamped on the ampule.
  • During transport, keep the ampules refrigerated in their protective foil pouch to protect from light and heat.
  • Do not use if the ampules are exposed to room temperature (22°C to 28°C [72°F to 82°F]) for more than a total of 60 hours.
  • Avoid excessive heat and light.
  • Store Pulmozyme ampules at a refrigerated temperature between 36°F to 46°F (2°C to 8°C) in their protective foil pouch to protect from light and heat until you are ready to use them.
  • When the protective foil pouch is opened, the unused ampules must be kept refrigerated in the protective foil pouch to protect from light and heat.
  • When traveling, Pulmozyme ampules should be kept refrigerated in their protective foil pouch to protect from light and heat.
  • Protect Pulmozyme from excessive heat and light.
  • Do not use Pulmozyme if the ampules have been exposed to room temperature at 72°F to 82°F (22°C to 28°C) for more than a total of 60 hours or if the solution has turned cloudy or discolored.
  • Do not use Pulmozyme past the expiration date printed on the ampule.
  • Do not use Pulmozyme if the ampules have been exposed to room temperature 72°F to 82°F (22°C to 28°C) for more than a total of 60 hours or if the solution has turned cloudy or discolored.
  • Instruct patients on the proper techniques to store and handle PULMOZYME [see How Supplied/Storage and Handling (16) ].

FDA label version 24, effective December 17, 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.

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Medicare Part D coverage

100%of plans list it
100%of those: prior authorization
0%step therapy
24%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.