Etanercept

  • Part D specialty tier in 80% of formularies (2026Q3)
  • Biologic
  • ENBREL

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

Etanercept: storage and handling

Refrigerate
Yes, as the label states
Label statement
Enbrel should be refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light or physical damage.
Freezing
Do not freeze
Label statement
DO NOT FREEZE.
Room temperature
up to 30 days at or below 25°C (77°F)
Label statement
For convenience, storage of individual single-dose prefilled syringes, SureClick autoinjectors, single-dose vials, or Enbrel Mini cartridges at room temperature at 68°F to 77°F (20°C to 25°C) for a maximum single period of 30 days is permissible, with protection from light and sources of heat.
Room temperature
up to 30 days
Label statement
If not used within 30 days at room temperature, the single-dose prefilled syringe, SureClick autoinjector, single-dose vial, or Enbrel Mini cartridge should be discarded.
Room temperature
up to 14 days at or below 25°C (77°F)
Label statement
For convenience, storage of an individual dose tray containing Enbrel multiple-dose vial and diluent syringe at room temperature at 68°F to 77°F (20°C to 25°C) for a maximum single period of 14 days is permissible, with protection from light, sources of heat, and humidity.
Room temperature
up to 14 days
Label statement
If not used within 14 days at room temperature, the dose tray should be discarded.
Room temperature
up to 30 days at or below 25°C (77°F)
Label statement
If needed, you may store your Enbrel prefilled syringe at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days.
Room temperature
up to 30 days
Label statement
Throw away any Enbrel prefilled syringe that has been stored at room temperature after 30 days.
Back into the refrigerator
Not allowed
Label statement
Once a single-dose prefilled syringe, SureClick autoinjector, single-dose vial, or Enbrel Mini cartridge has been stored at room temperature, it should not be placed back into the refrigerator.
Light
Protect from light
Label statement
Enbrel should be refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light or physical damage.
Shaking
Do not shake
Label statement
DO NOT SHAKE.

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 30 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).

For convenience, storage of individual single-dose prefilled syringes, SureClick autoinjectors, single-dose vials, or Enbrel Mini cartridges at room temperature at 68°F to 77°F (20°C to 25°C) for a maximum single period of 30 days is permissible, with protection from light and sources of heat.
Once a single-dose prefilled syringe, SureClick autoinjector, single-dose vial, or Enbrel Mini cartridge has been stored at room temperature, it should not be placed back into the refrigerator.
If not used within 30 days at room temperature, the single-dose prefilled syringe, SureClick autoinjector, single-dose vial, or Enbrel Mini cartridge should be discarded.
If not used within 14 days at room temperature, the dose tray should be discarded.
Throw away any Enbrel prefilled syringe that has been stored at room temperature after 30 days.

If anything else happened to the product, or you are unsure, Contact the manufacturer at 1-888-4ENBREL (1-888-436-2735) (the number printed on the label) about this product.

Where the label prints this number
Use a new autoinjector, and call 1-888-4ENBREL (1-888-436-2735).
All storage statements on the label (22)
  • Enbrel should be refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light or physical damage.
  • Do not store Enbrel in extreme heat or cold.
  • DO NOT SHAKE.
  • DO NOT FREEZE.
  • For convenience, storage of individual single-dose prefilled syringes, SureClick autoinjectors, single-dose vials, or Enbrel Mini cartridges at room temperature at 68°F to 77°F (20°C to 25°C) for a maximum single period of 30 days is permissible, with protection from light and sources of heat.
  • Once a single-dose prefilled syringe, SureClick autoinjector, single-dose vial, or Enbrel Mini cartridge has been stored at room temperature, it should not be placed back into the refrigerator.
  • If not used within 30 days at room temperature, the single-dose prefilled syringe, SureClick autoinjector, single-dose vial, or Enbrel Mini cartridge should be discarded.
  • Do not use Enbrel beyond the expiration date stamped on the carton or barrel/cartridge label.
  • The AutoTouch reusable autoinjector should be stored at room temperature.
  • Do not refrigerate the AutoTouch reusable autoinjector.
  • For convenience, storage of an individual dose tray containing Enbrel multiple-dose vial and diluent syringe at room temperature at 68°F to 77°F (20°C to 25°C) for a maximum single period of 14 days is permissible, with protection from light, sources of heat, and humidity.
  • Once the dose tray has been stored at room temperature, it should not be placed back into the refrigerator.
  • If not used within 14 days at room temperature, the dose tray should be discarded.
  • Once a vial has been reconstituted, the solution must be used immediately or may be refrigerated for up to 14 days.
  • Do not use Enbrel beyond the expiration date stamped on the dose tray.
  • Storage of your Enbrel prefilled syringe Store the Enbrel prefilled syringe in the refrigerator at 36°F to 46°F (2°C to 8°C).
  • Store the Enbrel prefilled syringe in the original carton to protect from light or physical damage.
  • If needed, you may store your Enbrel prefilled syringe at room temperature between 68°F to 77°F (20°C to 25°C) for up to 30 days.
  • Once the Enbrel prefilled syringe has reached room temperature, do not put it back in the refrigerator.
  • Throw away any Enbrel prefilled syringe that has been stored at room temperature after 30 days.
  • Do not store the Enbrel prefilled syringe in extreme heat or cold.
  • Take the Enbrel carton containing the prefilled syringes out of the refrigerator and place it on your flat work surface.

FDA label version 218, effective May 11, 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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Biosimilars

Enbrel: 3 licensed biosimilar products, 0 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
95%quantity limit
97%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.