Nitisinone
- Part D specialty tier in 82% of formularies (2026Q3)
- ORFADIN
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
Nitisinone: storage and handling
- Refrigerate
- Yes, as the label states
Label statement
Remove the ORFADIN oral suspension bottle from the refrigerator 30 minutes to 1 hour before using it to allow it to reach room temperature.
- Freezing
- Do not freeze
Label statement
Do not freeze.
- Room temperature
- up to 45 days at or below 25°C (77°F)
Label statement
Alternatively, patients/caregivers may store ORFADIN capsules at room temperature up to 25°C (77°F) for up to 45 days.
- Room temperature
- up to 60 days at or below 25°C (77°F)
Label statement
After first opening, store the product at room temperature (up to 25°C (77°F)) for up to 60 days.
- Room temperature
- up to 60 days
Label statement
ORFADIN oral suspension should be thrown away (discarded) 60 days after it is removed from the refrigerator and the adapter is inserted in the bottle.
- Back into the refrigerator
- Not addressed
- Light
- Not addressed
- Shaking
- Not addressed
All storage statements on the label (14)
- Alternatively, patients/caregivers may store ORFADIN capsules at room temperature up to 25°C (77°F) for up to 45 days.
- If not used within 45 days, discard ORFADIN capsules.
- Do not freeze.
- Store upright.
- After first opening, store the product at room temperature (up to 25°C (77°F)) for up to 60 days.
- If not used within 60 days, discard unused portion.
- The discard after date should be noted on the bottle
- How should I store ORFADIN oral suspension? ” for instructions on how to store ORFADIN oral suspension if the adapter is not inserted.
- Remove the ORFADIN oral suspension bottle from the refrigerator 30 minutes to 1 hour before using it to allow it to reach room temperature.
- ORFADIN oral suspension should be thrown away (discarded) 60 days after it is removed from the refrigerator and the adapter is inserted in the bottle.
- Write the discard date on the bottle label.
- Shake the bottle well for at least 20 seconds until the solid cake of particles at the bottom of the bottle is dissolved (See Figure B ).
- Figure D Follow the instructions in “ How to prepare a dose of ORFADIN oral suspension after the adapter is inserted. ” How to prepare a dose of ORFADIN oral suspension after the adapter is inserted See “ How should I store ORFADIN oral suspension? ” for instructions on how to store ORFADIN oral suspension after the adapter is inserted.
- Shake the ORFADIN oral suspension bottle well for at least 5 seconds (See Figure E ).
FDA label version 12, effective December 18, 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
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.