Table 3.

Summary of Riociguat Rems Program Requirements.

Requirement	Female of reproductive potential	Pre-pubertal	Post-menopausal or other medical reasons for permanent irreversible infertility
Prescriber enrolls female patients into the riociguat (Adempas) REMS program	X	X	X
Counseling with the Adempas REMS Guide for Females Who Can Get Pregnant	X
Counseling with the Riociguat (Adempas) Medication Guide, including the risk of teratogenicity	X	X
Prescriber must order and review pregnancy tests before starting treatment, monthly during treatment, and for 1 month after stopping treatment	X
Prescriber must verify reproductive status annually by completing the “Riociguat (Adempas) REMS Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form” for females who are at least 8 years of age		X
Prescriber must complete the “Riociguat (Adempas) REMS Change in Reproductive Potential Status and Pre-pubertal Annual Verification Form” upon becoming aware of any changes or misclassification in reproductive status	X	X	X

Abbreviation: REMS, risk evaluation and mitigation strategy.

Source: Adempas [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2018. ⁴³