Sepiapterin
- Part D specialty tier in 75% of formularies (2026Q3)
- Sephience
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
Sepiapterin: storage and handling
- Refrigerate
- Yes, as the label states
Label statement
Store SEPHIENCE liquid or soft food mixture either refrigerated or at controlled room temperature [see Dosage and Administration ( 2.4 )] .
- Freezing
- Not addressed
- Room temperature
- at or below 30°C (86°F)
Label statement
Store SEPHIENCE at room temperature between 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
- Room temperature
- at or below 25°C (77°F)
Label statement
Storing SEPHIENCE: Store SEPHIENCE oral powder packet(s) at room temperature between 68°F to 77°F (20°C to 25°C).
- Room temperature
- up to 6 hours at or below 25°C (77°F)
Label statement
For SEPHIENCE oral powder that is mixed with water, apple juice, strawberry jam, or applesauce: If the SEPHIENCE mixture is not taken or given right away, cover and store the mixture at room temperature between 68°F to 77°F (20°C to 25°C) for up to 6 hours or in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 24 hours.
- Room temperature
- up to 6 hours
Label statement
Throw away (discard) unused SEPHIENCE mixture after 6 hours at room temperature or after 24 hours if refrigerated.
- Room temperature
- at or below 25°C (77°F)
Label statement
Store SEPHIENCE oral powder packets at room temperature between 68°F to 77°F (20°C to 25°C).
- Room temperature
- up to 6 hours at or below 25°C (77°F)
Label statement
For SEPHIENCE oral powder that is mixed with water, apple juice, strawberry jam, or applesauce: If the SEPHIENCE mixture is not taken or given right away, cover and store the mixture at room temperature between 68°F to 77°F (20°C to 25°C) for up to 6 hours or refrigerate between 36°F to 46°F (2°C to 8°C) for no more than 24 hours.
- Back into the refrigerator
- Not addressed
- Light
- Not addressed
- Shaking
- Not addressed
All storage statements on the label (11)
- Store SEPHIENCE at room temperature between 20°C to 25°C (68°F to 77°F); excursion permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
- Store SEPHIENCE liquid or soft food mixture either refrigerated or at controlled room temperature [see Dosage and Administration ( 2.4 )] .
- Storing SEPHIENCE: Store SEPHIENCE oral powder packet(s) at room temperature between 68°F to 77°F (20°C to 25°C).
- For SEPHIENCE oral powder that is mixed with water, apple juice, strawberry jam, or applesauce: If the SEPHIENCE mixture is not taken or given right away, cover and store the mixture at room temperature between 68°F to 77°F (20°C to 25°C) for up to 6 hours or in the refrigerator between 36°F to 46°F (2°C to 8°C) for up to 24 hours.
- If the stored SEPHIENCE mixture was prepared with water or apple juice , stir the mixture for 30 seconds or more before taking or giving the dose.
- If the stored SEPHIENCE mixture was prepared with strawberry jam or applesauce , stir the mixture for 60 seconds or more before taking or giving the dose.
- Throw away (discard) unused SEPHIENCE mixture after 6 hours at room temperature or after 24 hours if refrigerated.
- Store SEPHIENCE oral powder packets at room temperature between 68°F to 77°F (20°C to 25°C).
- For SEPHIENCE oral powder that is mixed with water, apple juice, strawberry jam, or applesauce: If the SEPHIENCE mixture is not taken or given right away, cover and store the mixture at room temperature between 68°F to 77°F (20°C to 25°C) for up to 6 hours or refrigerate between 36°F to 46°F (2°C to 8°C) for no more than 24 hours.
- If the stored SEPHIENCE mixture was prepared with water or apple juice, stir the mixture for 30 seconds or more before taking or giving the dose.
- If the stored SEPHIENCE mixture was prepared with strawberry jam or applesauce, stir the mixture for 60 seconds or more before taking or giving the dose.
FDA label version 6, effective April 24, 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
2%of plans list it
13%of those: prior authorization
0%step therapy
0%quantity limit
98%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.