Metreleptin

  • Part D specialty tier in 93% of formularies (2026Q3)
  • Biologic
  • Myalept

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

Metreleptin: storage and handling

Refrigerate
Yes, as the label states
Label statement
MYALEPT should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) and protected from light until preparing for use.
Freezing
Do not freeze
Label statement
Do not freeze MYALEPT.
Room temperature
up to 4 hours
Label statement
A A vial of powder or MYALEPT mixed with bacteriostatic water for injection can be left at room temperature for up to 4 hours.
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
MYALEPT should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) and protected from light until preparing for use.
Shaking
Not addressed
Travel
Stated
Label statement
A To take a dose of MYALEPT if you are away from home or traveling, you must take all of your supplies with you.

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).

A A vial of powder or MYALEPT mixed with bacteriostatic water for injection can be left at room temperature for up to 4 hours.
Unused reconstituted solution cannot be saved for later use and should be discarded.

Contact the manufacturer at 1-855-669-2537 (the number printed on the label) about this product.

Where the label prints this number
3: Preparing MYALEPT Step 4: Filling the syringe used for injecting MYALEPT Step 5: Injecting MYALEPT Step 6: Disposing of used needles and syringes If at any time during these steps you have questions: See the "Common Questions" tab Call 1-855-669-2537 Visit www.MYALEPT.com Supplies you will need to give your MYALEPT (see Figure A).
All storage statements on the label (9)
  • MYALEPT should be stored in the refrigerator at 36°F to 46°F (2°C to 8°C) and protected from light until preparing for use.
  • MYALEPT should not be used past the expiration date.
  • Do not freeze MYALEPT.
  • Use with BWFI: when MYALEPT is reconstituted with BWFI, the vial can be used for multiple doses within 3 days when stored in the refrigerator at 36°F to 46°F (2°C to 8°C) and protected from light.
  • Unused reconstituted solution cannot be saved for later use and should be discarded.
  • After reconstitution, the vials should not be frozen (below 0°C) or shaken vigorously.
  • If the reconstituted product is inadvertently frozen, it should be thrown away.
  • A A vial of powder or MYALEPT mixed with bacteriostatic water for injection can be left at room temperature for up to 4 hours.
  • A To take a dose of MYALEPT if you are away from home or traveling, you must take all of your supplies with you.

FDA label version 18, effective March 25, 2024. 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

2%of plans list it
100%of those: prior authorization
0%step therapy
30%quantity limit
99%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.