Elamipretide

  • Part D specialty tier in 67% of formularies (2026Q3)
  • FORZINITY

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

Elamipretide: storage and handling

Refrigerate
Yes, as the label states
Label statement
Store refrigerated at 2°C to 8°C (36°F to 46°F).
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
at or below 25°C (77°F)
Label statement
Following the first dose, the opened vial can be stored either refrigerated 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F).
Room temperature
at or below 25°C (77°F)
Label statement
After the first dose, store opened vials in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature between 68°F to 77°F (20°C to 25°C).
Back into the refrigerator
Not addressed
Light
Not addressed
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 (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).

Following the first dose, the opened vial can be stored either refrigerated 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F).
Discard vials 8 days after first opening.
Write the "Discard After" date on the vial.

If anything else happened to the product, or you are unsure, Contact the manufacturer about this product; the label text ClinDose has does not print a phone number for it.

All storage statements on the label (12)
  • Store refrigerated at 2°C to 8°C (36°F to 46°F).
  • Do not freeze.
  • Following the first dose, the opened vial can be stored either refrigerated 2°C to 8°C (36°F to 46°F) or at room temperature between 20°C to 25°C (68°F to 77°F).
  • Discard vials 8 days after first opening.
  • Storing FORZINITY Store unused vials of FORZINITY in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • After the first dose, store opened vials in the refrigerator between 36°F to 46°F (2°C to 8°C) or at room temperature between 68°F to 77°F (20°C to 25°C).
  • Do not freeze FORZINITY vials.
  • When using a new vial of FORZINITY: Remove the carton from the refrigerator.
  • Allow the vial to sit at room temperature for at least 10 minutes.
  • Write the "Discard After" date on the vial.
  • Return the carton containing unused vials to the refrigerator.
  • If using an opened vial stored in a refrigerator, allow the opened vial to sit at room temperature for

FDA label version 10, effective December 10, 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

1%of plans list it
100%of those: prior authorization
0%step therapy
81%quantity limit
83%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.