Caplacizumab

  • Part D specialty tier in 81% of formularies (2026Q3)
  • Biologic
  • Cablivi

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

Caplacizumab: 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
Do not freeze
Label statement
Do not freeze.
Room temperature
up to 1460 hours at or below 30°C (86°F)
Label statement
Unopened vials may be stored in the original carton at room temperature up to 30°C (86°F) for a single period of up to 2 months.
Room temperature
up to 1460 hours at or below 30°C (86°F)
Label statement
Unopened CABLIVI vials may be stored at room temperature up to 86°F (30°C) in the original carton for a single period of up to two months.
Back into the refrigerator
Not allowed
Label statement
Do not return CABLIVI to the refrigerator after it has been stored at room temperature.
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.

Within the label's stated room-temperature allowance (up to 1460 hours at up to 30°C (86°F)). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

Unopened vials may be stored in the original carton at room temperature up to 30°C (86°F) for a single period of up to 2 months.
Do not return CABLIVI to the refrigerator after it has been stored at room temperature.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-800-745-4447 (the number printed on the label) about this product.

Where the label prints this number
Talk to your healthcare provider or call 1-800-745-4447 if you have any questions.
All storage statements on the label (10)
  • Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
  • Do not freeze.
  • Unopened vials may be stored in the original carton at room temperature up to 30°C (86°F) for a single period of up to 2 months.
  • Do not return CABLIVI to the refrigerator after it has been stored at room temperature.
  • Storing CABLIVI Store CABLIVI in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Store CABLIVI in the original carton to protect from light.
  • Do not freeze CABLIVI.
  • Unopened CABLIVI vials may be stored at room temperature up to 86°F (30°C) in the original carton for a single period of up to two months.
  • Write the date removed from the refrigerator in the space provided on the carton.
  • The mixed CABLIVI solution can be stored for up to 4 hours in the refrigerator at 36°F to 46°F (2°C to 8°C).

FDA label version 18, 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

25%of plans list it
88%of those: prior authorization
0%step therapy
78%quantity limit
96%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.