Vedolizumab

What it is used for

ENTYVIO is indicated in adults for the treatment of:

• moderately to severely active ulcerative colitis (UC).
• moderately to severely active Crohn's disease (CD).

Side effects, and when to stop

The following topics are also discussed in detail in the Warnings and Precautions section:

• Infusion-Related Reactions and Hypersensitivity Reactions
• Infections
• Progressive Multifocal Leukoencephalopathy
• Liver Injury

Who should not take it

ENTYVIO is contraindicated in patients who have had a known serious or severe hypersensitivity reaction to ENTYVIO or any of its excipients (such as dyspnea, bronchospasm, urticaria, flushing, rash and increased heart rate).

Storing it

Storage and Handling

• 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.