Sotatercept

  • Part D specialty tier in 80% of formularies (2026Q3)
  • Biologic
  • WINREVAIR

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

Sotatercept: storage and handling

Refrigerate
Yes, as the label states
Label statement
Store vials refrigerated at 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 1 day at or below 25°C (77°F)
Label statement
The unused kit can be out of the refrigerator for (up to 25°C/77°F) up to 24 hours.
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in 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 1 day at up to 25°C (77°F)). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

The unused kit can be out of the refrigerator for (up to 25°C/77°F) up to 24 hours.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-800-672-6372 (the number printed on the label) about this product.

Where the label prints this number
For additional information on temperature excursions, call Merck Sharp & Dohme LLC at 1-800-672-6372.
All storage statements on the label (7)
  • Store vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton to protect from light.
  • Do not freeze.
  • The kit should remain in the refrigerator until ready for use.
  • The unused kit can be out of the refrigerator for (up to 25°C/77°F) up to 24 hours.
  • For additional information on temperature excursions, call Merck Sharp & Dohme LLC at 1-800-672-6372.
  • Store WINREVAIR in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Store in the original carton to protect from light.

FDA label version 12, effective August 12, 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

100%of plans list it
98%of those: prior authorization
0%step therapy
72%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.