Entyvio Storage at Room Temperature
Entyvio (vedolizumab) prefilled syringes and prefilled pens can be left out of the refrigerator at room temperature up to 25°C (77°F) for up to 7 days maximum. 1
Storage Requirements
Standard Storage
- Refrigerate at 2°C to 8°C (36°F to 46°F) for all Entyvio formulations (vials, prefilled syringes, and prefilled pens) 1
- Keep in original package to protect from light until time of use 1
Room Temperature Exception (Subcutaneous Formulations Only)
The FDA-approved drug label provides clear guidance for the subcutaneous formulations:
- Maximum time out of refrigerator: 7 days 1
- Maximum temperature: 25°C (77°F) 1
- Must remain in original package 1
- Example use case: traveling 1
After 7 days at room temperature, the medication must be discarded and cannot be used. 1
Critical Warnings
Do NOT:
- Use Entyvio if left out of refrigerator for more than 7 days 1
- Freeze Entyvio (any formulation) 1
- Use if it has been frozen 1
- Shake the prefilled syringe or pen 1
- Leave in direct sunlight 1
- Return to refrigerator after being at room temperature (no guidance supports refreezing or re-refrigeration) 1
Intravenous Formulation
The 7-day room temperature allowance applies specifically to the subcutaneous formulations (prefilled syringes and pens). The intravenous vial formulation should be kept refrigerated until reconstitution 1.
Practical Implications
This 7-day window provides flexibility for:
- Travel situations where refrigeration is temporarily unavailable 1
- Short-term storage needs
- Patient convenience during transport
If you accidentally leave Entyvio out of the refrigerator, mark the date and time immediately. Count 7 days from that point. If this period is exceeded, dispose of the medication in an FDA-cleared sharps container. 1
The research evidence supports that vedolizumab maintains physicochemical and biological stability when properly stored, with one study demonstrating stability for up to 30 days at 2-8°C for reconstituted intravenous preparations 2. However, the FDA-approved labeling for patient use of subcutaneous formulations at room temperature is limited to 7 days maximum 1.