SUMMARY  

• Johnson & Johnson cannot recommend any practices, procedures, or storage conditions that deviate from approved product labeling. Please refer to local product labeling for information regarding storage and handling of AKEEGA 50 mg/500 mg and AKEEGA 100 mg/500 mg oral film-coated tablets.
• AKEEGA may be provided in commercial packaging as high-density polyethylene (HDPE) bottles and/or polyvinylidene chloride (PVdC) blister packaging based on regional availability. Please refer to local labeling for how supplied, storage, and handling recommendations.¹
• Stability studies for storage and handling of AKEEGA have been conducted.¹
  • Approved commercial packaging:
    • Studies of AKEEGA tablets stored in HDPE bottles and PVdC blister packaging were conducted. The product met study specifications for 30 months at 25°C/60% relative humidity (RH) and 30°C/75% RH.
    • Once opened, remaining tablets in commercial packaging can be stored for a maximum period of 3 months prior to use.
  • Repackaging:
    • No data are available regarding repackaging stability for AKEEGA tablets. AKEEGA tablets may be dispensed in another pharmacy container (eg, amber vials or pill boxes) for daily use. Refill or dispensing of AKEEGA tablets into another pharmacy container is allowed for a maximum period of 3 months, when stored at the temperature conditions described in the approved labeling for AKEEGA.
  • Light exposure:
    • A light stability study demonstrated AKEEGA does not require protection from light when the tablets are removed from the packaging.
  • Other:
    • No desiccants should be used.