Adalimumab

  • Part D specialty tier in 76% of formularies (2026Q3)
  • Biologic
  • Humira

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

Adalimumab: storage and handling

Refrigerate
Yes, as the label states
Label statement
HUMIRA must be refrigerated at 36°F to 46°F (2°C to 8°C).
Freezing
Do not freeze
Label statement
DO NOT FREEZE.
Room temperature
up to 14 days at or below 25°C (77°F)
Label statement
If needed, for example when traveling, HUMIRA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light.
Room temperature
up to 14 days at or below 25°C (77°F)
Label statement
Do not freeze Refrigerated HUMIRA may be used until the expiration date printed on the HUMIRA carton, dose tray or Pen If needed, for example when you are traveling, you may also store HUMIRA at room temperature up to 77°F (25°C) for up to 14 days.
Room temperature
up to 14 days
Label statement
Throw away HUMIRA if it has been kept at room temperature and not used within 14 days.
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Store in original carton until time of administration to protect from light.
Shaking
Not addressed
Travel
Stated
Label statement
If needed, for example when traveling, HUMIRA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light.
Travel
Stated
Label statement
Do not freeze Refrigerated HUMIRA may be used until the expiration date printed on the HUMIRA carton, dose tray or Pen If needed, for example when you are traveling, you may also store HUMIRA at room temperature up to 77°F (25°C) for up to 14 days.

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 14 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).

If needed, for example when traveling, HUMIRA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light.
HUMIRA should be discarded if not used within the 14-day period.
Throw away HUMIRA if it has been kept at room temperature and not used within 14 days.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-800-4HUMIRA (1-800-448-6472) (the number printed on the label) about this product.

Where the label prints this number
Call your healthcare provider or 1-800-4HUMIRA (1-800-448-6472) if you need help.
All storage statements on the label (20)
  • Do not use beyond the expiration date on the container.
  • HUMIRA must be refrigerated at 36°F to 46°F (2°C to 8°C).
  • DO NOT FREEZE.
  • Do not use if frozen even if it has been thawed.
  • Store in original carton until time of administration to protect from light.
  • If needed, for example when traveling, HUMIRA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light.
  • HUMIRA should be discarded if not used within the 14-day period.
  • Record the date when HUMIRA is first removed from the refrigerator in the spaces provided on the carton and dose tray.
  • Do not store HUMIRA in extreme heat or cold.
  • Store HUMIRA in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Store HUMIRA in the original carton until use to protect it from light.
  • Do not freeze Refrigerated HUMIRA may be used until the expiration date printed on the HUMIRA carton, dose tray or Pen If needed, for example when you are traveling, you may also store HUMIRA at room temperature up to 77°F (25°C) for up to 14 days.
  • Throw away HUMIRA if it has been kept at room temperature and not used within 14 days.
  • Record the date you first remove HUMIRA from the refrigerator in the spaces provided on the carton and dose tray.
  • Read Instructions on All Pages Before Using the HUMIRA Pen Take HUMIRA out of the refrigerator.
  • Leave HUMIRA at room temperature for 15 to 30 minutes before injecting.
  • Do not remove the Gray Cap #1 or Plum-colored Cap #2 while allowing HUMIRA to reach room temperature Do not warm HUMIRA in any other way.
  • For example, do not warm it in a microwave or in hot water.
  • Do not use the Pen if liquid has been frozen (even if thawed) Check expiration date on the Pen label.
  • Do not use the Pen if expiration date has passed.

FDA label version 2154, effective December 23, 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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Biosimilars

Humira: 10 licensed biosimilar products, 9 interchangeable (FDA Purple Book). Compare presentations and dates

Medicare Part D coverage

100%of plans list it
98%of those: prior authorization
0%step therapy
94%quantity limit
94%specialty tier

5,496 Part D plans, CMS formulary files 2026Q3. Look up tier, PA, step therapy and quantity limits by plan

Patient assistance

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.