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  • FDA Date: 01/25/2017

    Xiaflex (collagenase clostridium histolyticum) Injection REMS

    Goals of the Xiaflex (collagenase clostridium histolyticum) Injection REMS Program

    The goal of the XIAFLEX REMS is to mitigate the risks of corporal rupture (penile fracture) and other serious penile injuries associated with the use of XIAFLEX for Peyronie's disease by:

    • Training healthcare providers in how to properly administer XIAFLEX. 

    • Informing healthcare providers about the risks of corporal rupture (penile fracture) and other serious injuries to the penis. 

    • Informing healthcare providers about the need to counsel patients to communicate that risks of corporal rupture and other serious penile injuries are associated with the use of XIAFLEX in treating Peyronie's disease and that patient adherence to post-injection instructions is important for the drug's safety and effectiveness. 

    • Ensuring that XIAFLEX is dispensed only in certified pharmacies or healthcare settings for the treatment of Peyronie's disease.

    • Informing patients about the risks of corporal rupture and other serious penile injuries associated with the use of XIAFLEX in treating Peyronie's disease and that adherence to post-injection instructions is important for the drug's safety and effectiveness.

    REMS Elements

    • Elements to Assure Safe Use

    • Implementation System