Carglumic acid

  • Part D specialty tier in 79% of formularies (2026Q3)
  • Carbaglu

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

Carglumic acid: storage and handling

Refrigerate
Yes, as the label states
Label statement
Before opening, store CARBAGLU in a refrigerator between 36°F to 46°F (2°C to 8°C) in the bottle it comes in.
Freezing
Not addressed
Room temperature
at or below 30°C (86°F)
Label statement
After first opening of the bottle: Store at room temperature between 15°C and 30°C (59°F and 86°F).
Room temperature
at or below 30°C (86°F)
Label statement
After opening, store CARBAGLU at room temperature between 59°F to 86°F (15°C to 30°C).
Room temperature
at or below 30°C (86°F)
Label statement
After first opening of the bottle: do not refrigerate, store at room temperature between 15°C and 30°C (59°F and 86°F).
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 30°C (86°F)). Follow the label's instructions for what to do next.

Entered: 1 day at up to 77°F (25°C).

After first opening of the bottle: Store at room temperature between 15°C and 30°C (59°F and 86°F).
Discard bottle one month after first opening.

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 (10)
  • After first opening of the bottle: Store at room temperature between 15°C and 30°C (59°F and 86°F).
  • Do not refrigerate.
  • Do not use CARBAGLU after the expiration date stated on the bottle.
  • Discard bottle one month after first opening.
  • Before opening, store CARBAGLU in a refrigerator between 36°F to 46°F (2°C to 8°C) in the bottle it comes in.
  • After opening, store CARBAGLU at room temperature between 59°F to 86°F (15°C to 30°C).
  • Do not store CARBAGLU in a refrigerator after opening.
  • Do not use CARBAGLU tablets after the expiration date on the bottle.
  • Storage [see How Supplied/Storage and Handling ( 16 )] Store UNOPENED bottle in a refrigerator at 2°C to 8°C (36°F to 46°F).
  • After first opening of the bottle: do not refrigerate, store at room temperature between 15°C and 30°C (59°F and 86°F).

FDA label version 36, effective January 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

99%of plans list it
79%of those: prior authorization
0%step therapy
0%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.