SUMMARY  

• Johnson & Johnson cannot recommend any practices, procedures, or storage conditions that deviate from the product labeling.
• Please refer to local labeling for storage, stability, and handling information for TREMFYA 200 mg/20mL (10 mg/mL) solution in a single-dose vial for intravenous infusion.

Stability and temperature excursion data

This information is provided in response to your unsolicited request.

• This data is based on analyses from a strictly controlled environment. Johnson & Johnson cannot support the return to the recommended storage condition after temperature excursion from the data listed below.
• Stability analyses were conducted with TREMFYA 200 mg/20 mL (10 mg/mL) final vialed product for intravenous use to provide the proven limits for temperature excursions that vary from the recommended storage condition of 2°C to 8°C (36°F to 46°F).¹
• Based on the stability data, the proven limits for temperature excursions for TREMFYA 200 mg/20 mL (10 mg/mL) final vialed product (for intravenous use) are defined in Table: Proven Limits for Temperature Excursions. Temperature excursions are permitted up to a maximum of 10 days cumulative with maximum of 5 temperature excursions at 48 hours each.¹