Belimumab
- Part D specialty tier in 80% of formularies (2026Q3)
- Biologic
- BENLYSTA
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
Belimumab: storage and handling
- Refrigerate
- Yes, as the label states
Label statement
Prior to Dispensing Refrigerate prefilled autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C).
- Freezing
- Do not freeze
Label statement
Do not freeze.
- Room temperature
- up to 12 hours at or below 30°C (86°F)
Label statement
BENLYSTA may be stored outside of the refrigerator up to 86°F (30°C) for up to 12 hours if protected from sunlight.
- Back into the refrigerator
- Not allowed
Label statement
Do not use and do not place back in refrigerator if left out for more than 12 hours.
- Light
- Protect from light
Label statement
Store vials in the original carton until use to protect from light.
- Shaking
- Do not shake
Label statement
Do not shake.
All storage statements on the label (16)
- Store vials in the original carton until use to protect from light.
- Do not freeze.
- Avoid exposure to heat.
- Prior to Dispensing Refrigerate prefilled autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C).
- Keep the product in the original carton to protect from light until the time of use.
- Do not shake.
- Following Dispensing Refrigerate prefilled autoinjectors and prefilled syringes at 36°F to 46°F (2°C to 8°C).
- BENLYSTA may be stored outside of the refrigerator up to 86°F (30°C) for up to 12 hours if protected from sunlight.
- Do not use and do not place back in refrigerator if left out for more than 12 hours.
- Keep refrigerated until 30 minutes before use. .
- Keep in the original package until time of use to protect from light. .
- Do not freeze BENLYSTA.
- If the prefilled syringe has been frozen, do not use the prefilled syringe even if it is thawed. .
- Keep away from heat and sunlight. .
- Do not use and do not place back in the refrigerator if BENLYSTA is left out for more than 12 hours. .
- You may give other people a serious infection or get a serious infection from them. ○Do not shake the prefilled syringe. ○Do not use if dropped onto a hard surface. ○Do not remove the Needle Cap until right before the injection. ○Do not use in children less than 18 years of age.
FDA label version 38, effective August 21, 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.