Anifrolumab
- Part D specialty tier in 100% of formularies (2026Q3)
- Biologic
- SAPHNELO
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
Anifrolumab: storage and handling
- Refrigerate
- Yes, as the label states
Label statement
Store SAPHNELO in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. .
- Freezing
- Do not freeze
Label statement
Do not freeze.
- Room temperature
- up to 7 days at or below 25°C (77°F)
Label statement
If needed, SAPHNELO prefilled syringe or autoinjector can be stored at room temperature 68°F to 77°F (20°C to 25°C) for up to 7 days in the original carton to protect from light.
- Room temperature
- up to 7 days
Label statement
Discard SAPHNELO prefilled syringe or autoinjector if not used within 7 days at room temperature storage.
- Room temperature
- up to 7 days at or below 25°C (77°F)
Label statement
If needed, the SAPHNELO prefilled syringe or autoinjector (SAPHNELO PEN) can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days in the original carton to protect from light.
- Room temperature
- up to 7 days
Label statement
Throw away SAPHNELO prefilled syringe or autoinjector if not used within 7 days at room temperature storage. .
- Back into the refrigerator
- Not allowed
Label statement
After the SAPHNELO prefilled syringe or autoinjector has reached room temperature, do not return to the refrigerator.
- Light
- Protect from light
Label statement
Store SAPHNELO in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. .
- Shaking
- Do not shake
Label statement
Do not shake.
All storage statements on the label (16)
- Store SAPHNELO in a refrigerator at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. .
- Do not freeze.
- Do not shake.
- Do not expose to heat.
- Do not use SAPHNELO past the expiration date.
- If needed, SAPHNELO prefilled syringe or autoinjector can be stored at room temperature 68°F to 77°F (20°C to 25°C) for up to 7 days in the original carton to protect from light.
- After the SAPHNELO prefilled syringe or autoinjector has reached room temperature, do not return to the refrigerator.
- Discard SAPHNELO prefilled syringe or autoinjector if not used within 7 days at room temperature storage.
- How should I store SAPHNELO? .
- Store SAPHNELO prefilled syringe and autoinjector in a refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. .
- If needed, the SAPHNELO prefilled syringe or autoinjector (SAPHNELO PEN) can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days in the original carton to protect from light.
- Throw away SAPHNELO prefilled syringe or autoinjector if not used within 7 days at room temperature storage. .
- Do not shake SAPHNELO. .
- Do not freeze SAPHNELO. .
- Do not expose SAPHNELO to heat. .
- Do not use SAPHNELO past the expiration date. .
FDA label version 15, 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
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.