IMAAVY – Stability of Final Vialed Product for Intravenous Infusion

SUMMARY  

• The company cannot recommend any practices, procedures, or usage of IMAAVY that deviate from the approved labeling.
• Please refer to local labeling for storage, stability, and handling information for IMAAVY 300 mg and 1200 mg (185 mg/mL) single-dose vials for intravenous use.

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 IMAAVY 300 mg and 1200 mg (185 mg/mL) single-dose vials 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 IMAAVY
  300 mg and 1200 mg (185 mg/mL) single-dose vials for intravenous use are defined in Table: Proven Limits for Temperature Excursions.¹ 
• Additional stability analyses are ongoing and the information provided in the table may change as data becomes available.