The goals of the Adempas REMS are:

1. To inform prescribers, patients, and pharmacists about the serious risk of teratogenicity and safe-use conditions for Adempas

2. To minimize the risk of fetal exposure and adverse fetal outcomes in Females of Reproductive Potential (FRP) prescribed Adempas:

  a. Females who are pregnant must not be prescribed Adempas

  b. Females taking Adempas must not become pregnant