SUMMARY

• Johnson & Johnson cannot recommend any practices, procedures, or storage conditions that deviate from the approved product labeling. Stability is not guaranteed for ERLEADA 240 mg when stored outside of its original packaging.
• A study of ERLEADA 240 mg film-coated tablets stored in open, high density polyethylene (HDPE) bottles was conducted. The product met study specifications for 3 months. This study was not conducted to assess open bottle stability for longer periods of time. It is recommended to keep the desiccant in the original commercial packaging.¹
  • Based on available stability data, a refill or dispensing of ERLEADA tablets into another pharmacy container (ie, amber vials) can be allowed; however, it is strongly recommended to minimize exposure of the ERLEADA tablets to open air.
  • A refill or dispensing of ERLEADA tablets into another pharmacy container is allowed for a maximum period of 2 months, when stored at the temperature conditions described in the approved labeling for ERLEADA.
  • The tablets remaining in the original commercial packaging after refilling or dispensing can also be stored for a maximum period of 3 months prior to subsequent use. It is recommended to keep the desiccant in the original commercial packaging.
• ERLEADA tablets may be stored in pill boxes for daily use. During daily use of ERLEADA, the tablets inside the pill boxes are exposed to open air.¹
  • Based on available stability data, filling into pill boxes can be allowed for a maximum period of 10 days, when stored at the temperature conditions described in the approved labeling for ERLEADA.
• No data are available regarding repacking of ERLEADA tablets in blister packs.¹