Spesolimab
- Part D specialty tier in 82% of formularies (2026Q3)
- Biologic
- SPEVIGO
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
Spesolimab: storage and handling
- Refrigerate
- Yes, as the label states
Label statement
Prefilled syringes 300 mg/2 mL: Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
- Freezing
- Do not freeze
Label statement
Do not freeze.
- Room temperature
- up to 14 days at or below 25°C (77°F)
Label statement
If needed, SPEVIGO 300 mg/2 mL prefilled syringes may be stored at room temperature up to a maximum of 25°C (77°F) for up to 14 days in the original carton to protect from light.
- Room temperature
- up to 14 days at or below 8°C (46°F)
Label statement
Discard SPEVIGO 300 mg/2 mL prefilled syringes if kept at room temperature for more than 14 days. 150 mg/mL: Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
- Room temperature
- up to 1 day at or below 25°C (77°F)
Label statement
Prior to use, may store unopened SPEVIGO vials at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours in the original carton to protect from light.
- Back into the refrigerator
- Not addressed
- Light
- Protect from light
Label statement
Prefilled syringes 300 mg/2 mL: Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
- Shaking
- Not addressed
All storage statements on the label (11)
- Prefilled syringes 300 mg/2 mL: Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
- Do not freeze.
- Do not use if frozen even if it has been thawed.
- If needed, SPEVIGO 300 mg/2 mL prefilled syringes may be stored at room temperature up to a maximum of 25°C (77°F) for up to 14 days in the original carton to protect from light.
- Discard SPEVIGO 300 mg/2 mL prefilled syringes if kept at room temperature for more than 14 days. 150 mg/mL: Store SPEVIGO prefilled syringes refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
- Single-dose vials Store SPEVIGO vials refrigerated between 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
- Prior to use, may store unopened SPEVIGO vials at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours in the original carton to protect from light.
- Storing SPEVIGO: Store SPEVIGO prefilled syringes in the refrigerator between 36°F to 46°F (2°C to 8°C).
- Do not freeze SPEVIGO.
- Do not use SPEVIGO if frozen, even if it has been thawed.
- Store SPEVIGO in the original carton until use to protect from light.
FDA label version 7, effective April 8, 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.