Vedolizumab

  • Part D specialty tier in 86% of formularies (2026Q3)
  • Biologic
  • ENTYVIO

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

Vedolizumab: storage and handling

Refrigerate
Yes, as the label states
Label statement
Refrigerate ENTYVIO unopened vials, prefilled syringes, and prefilled pens at 2°C to 8°C (36° to 46°F).
Freezing
Do not freeze
Label statement
Do not freeze ENTYVIO vial, prefilled syringe, or prefilled pen.
Room temperature
up to 7 days at or below 25°C (77°F)
Label statement
If needed, the ENTYVIO prefilled syringe or ENTYVIO PEN can be left out of the refrigerator in the original package at room temperature up to 25°C (77°F) for up to 7 days (for example, when traveling).
Room temperature
up to 7 days
Label statement
Do not use ENTYVIO prefilled syringe or ENTYVIO PEN if left out of the refrigerator for more than 7 days.
Room temperature
up to 7 days at or below 25°C (77°F)
Label statement
Your prefilled pen can be left in its box at room temperature up to 77°F (25°C) for up to 7 days (for example, when traveling).
Room temperature
up to 7 days
Label statement
Do not use the prefilled pen if it is left out of the refrigerator for more than 7 days.
Room temperature
up to 7 days
Label statement
Throw away the prefilled pen in a FDA-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight.
Back into the refrigerator
Not addressed
Light
Protect from light
Label statement
Retain in original package to protect from light until the time of use.
Shaking
Do not shake
Label statement
Do not shake the ENTYVIO prefilled syringe or ENTYVIO PEN.
Travel
Stated
Label statement
If needed, the ENTYVIO prefilled syringe or ENTYVIO PEN can be left out of the refrigerator in the original package at room temperature up to 25°C (77°F) for up to 7 days (for example, when traveling).
Travel
Stated
Label statement
Your prefilled pen can be left in its box at room temperature up to 77°F (25°C) for up to 7 days (for example, when traveling).

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 7 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, the ENTYVIO prefilled syringe or ENTYVIO PEN can be left out of the refrigerator in the original package at room temperature up to 25°C (77°F) for up to 7 days (for example, when traveling).
Throw away the prefilled pen in a FDA-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight.

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 (14)
  • Refrigerate ENTYVIO unopened vials, prefilled syringes, and prefilled pens at 2°C to 8°C (36° to 46°F).
  • If needed, the ENTYVIO prefilled syringe or ENTYVIO PEN can be left out of the refrigerator in the original package at room temperature up to 25°C (77°F) for up to 7 days (for example, when traveling).
  • Do not use ENTYVIO prefilled syringe or ENTYVIO PEN if left out of the refrigerator for more than 7 days.
  • Do not freeze ENTYVIO vial, prefilled syringe, or prefilled pen.
  • Do not use ENTYVIO vial, prefilled syringe, or prefilled pen if it has been frozen.
  • Do not shake the ENTYVIO prefilled syringe or ENTYVIO PEN.
  • Retain in original package to protect from light until the time of use.
  • Storing ENTYVIO Store your prefilled pen in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Your prefilled pen can be left in its box at room temperature up to 77°F (25°C) for up to 7 days (for example, when traveling).
  • Do not use the prefilled pen if it is left out of the refrigerator for more than 7 days.
  • Do not freeze the prefilled pen.
  • Throw away the prefilled pen in a FDA-cleared sharps disposal container if it has been left out of the refrigerator for more than 7 days, frozen, or left in direct sunlight.
  • Remove the ENTYVIO PEN box from the refrigerator Take 1 prefilled pen box from the refrigerator and check the expiration date on the box (see Figure A ).
  • Do not use the prefilled pen if the expiration date on the box has passed.

FDA label version 26, effective April 29, 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

9%of plans list it
80%of those: prior authorization
0%step therapy
76%quantity limit
95%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.