Rilonacept

  • Part D specialty tier in 78% of formularies (2026Q3)
  • Biologic
  • Arcalyst

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

Rilonacept: storage and handling

Refrigerate
Yes, as the label states
Label statement
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Freezing
Not addressed
Room temperature
up to 3 hours
Label statement
ARCALYST may be kept at room temperature after mixing with Sterile Water for Injection, USP, and should be used within 3 hours of mixing.
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
Shaking
Not addressed

Temperature excursion helper

Answers only from this label's storage statements. It does not judge whether a product is still usable beyond what the label states.

Beyond the room-temperature allowance the label states. The label does not state stability beyond it.

Entered: 1 day at up to 77°F (25°C).

ARCALYST may be kept at room temperature after mixing with Sterile Water for Injection, USP, and should be used within 3 hours of mixing.

Contact the manufacturer at 1-833-KINIKSA (1-833-546-4572) (the number printed on the label) about this product.

Where the label prints this number
For more information about ARCALYST, call 1-833-KINIKSA (1-833-546-4572), or visit www.ARCALYST.com.
All storage statements on the label (6)
  • Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
  • After reconstitution, ARCALYST may be kept at room temperature, protected from light [see Dosage and Administration (2.5) ].
  • Keep ARCALYST in the carton it comes in to protect from light.
  • Store ARCALYST in the refrigerator from 36°F to 46°F (2°C to 8°C).
  • Refrigerated ARCALYST can be used until the expiration date printed on the vial and carton.
  • ARCALYST may be kept at room temperature after mixing with Sterile Water for Injection, USP, and should be used within 3 hours of mixing.

FDA label version 16, effective December 16, 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

96%of plans list it
97%of those: prior authorization
0%step therapy
6%quantity limit
97%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.