How long can Stalara (brand name) stay unrefrigerated?

Storage Guidelines for Stelara (Ustekinumab) Outside of Refrigeration

Stelara can be stored at room temperature up to 30°C (86°F) for a maximum single period of up to 30 days in the original carton to protect from light.

Proper Storage Requirements for Stelara

According to the FDA drug label for Stelara, the following storage guidelines should be followed:

Primary Storage Conditions

• Store Stelara prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C)
• Keep in the original carton to protect from light
• Store vials in an upright position

Room Temperature Storage Allowance

• Individual Stelara prefilled syringes may be stored at room temperature up to 30°C (86°F)
• This room temperature storage is permitted for a maximum single period of up to 30 days
• The medication must remain in the original carton during this time to protect from light 1

Important Handling Notes

• Record the date when the prefilled syringe is first removed from the refrigerator
• Once stored at room temperature, the syringe should not be returned to the refrigerator
• Discard the syringe if not used within 30 days of room temperature storage
• Do not freeze Stelara
• Do not shake the medication 1

Clinical Implications of Temperature Excursions

Temperature excursions can potentially affect medication stability and efficacy. For biologic medications like Stelara:

• Proteins in biologics may denature when exposed to temperatures outside the recommended range
• Extended exposure to higher temperatures may reduce potency
• The 30-day room temperature allowance provides flexibility for patients while maintaining medication integrity 2

Best Practices for Handling

• Always check the expiration date before use
• Inspect the medication visually before administration - do not use if discolored or contains particulate matter
• If the medication has been stored at room temperature for longer than 30 days, do not use it
• If the medication has been exposed to temperatures above 30°C (86°F), contact your healthcare provider 1

Documentation Recommendations

When removing Stelara from refrigeration:

• Mark the date of removal on the carton
• Calculate the 30-day expiration date
• Store at consistent room temperature, avoiding temperature fluctuations
• Keep away from direct sunlight and heat sources

This 30-day room temperature storage allowance provides convenience for patients while traveling or in situations where refrigeration may not be immediately available, while still maintaining the medication's safety and efficacy profile.