Amikacin (inhaled)

  • Part D specialty tier in 78% of formularies (2026Q3)
  • ARIKAYCE

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

Amikacin (inhaled): storage and handling

Refrigerate
Yes, as the label states
Label statement
Store ARIKAYCE vials refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date on vial.
Freezing
Do not freeze
Label statement
Do not freeze.
Room temperature
up to 28 days at or below 25°C (77°F)
Label statement
ARIKAYCE can be stored at room temperature up to 25°C (77°F) for up to 4 weeks.
Room temperature
up to 28 days
Label statement
Once at room temperature, any unused drug must be discarded at the end of 4 weeks.
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 (up to 28 days 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).

ARIKAYCE can be stored at room temperature up to 25°C (77°F) for up to 4 weeks.
Once expired, discard any unused drug.
Once at room temperature, any unused drug must be discarded at the end of 4 weeks.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-833-LIGHT-00 (1-833-544-4800) (the number printed on the label) about this product.

Where the label prints this number
If you do not understand any part of the instructions, contact Insmed inLighten™ Patient Support at 1-833-LIGHT-00 (1-833-544-4800) before using the Lamira Nebulizer System.
All storage statements on the label (5)
  • Store ARIKAYCE vials refrigerated at 2°C to 8°C (36°F to 46°F) until expiration date on vial.
  • Do not freeze.
  • Once expired, discard any unused drug.
  • ARIKAYCE can be stored at room temperature up to 25°C (77°F) for up to 4 weeks.
  • Once at room temperature, any unused drug must be discarded at the end of 4 weeks.

FDA label version 17, effective August 4, 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
94%of those: prior authorization
0%step therapy
29%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.