ADEMPAS (riociguat) tablets, for oral use
Initial U.S. Approval: 2013
BRIEF SUMMARY of PRESCRIBING INFORMATION
For additional information, please see the full Prescribing Information at
www.adempas-us.com.
WARNING: EMBRYO-FETAL TOXICITY
See full prescribing information for complete boxed warning
• Do not administer Adempas to a pregnant female because it may cause
fetal harm. (4.1, 5.1, 8.1)
• Females of reproductive potential: Exclude pregnancy before start of
treatment, monthly during treatment, and 1 month after treatment
discontinuation. Prevent pregnancy during treatment and for one
month after treatment discontinuation by use of acceptable methods of
contraception. (2.3, 5.1, 5.2, 8.6)
• For females, Adempas is available only through a restricted program
called the Adempas REMS Program. (5.1, 5.2).
1 INDICATIONS AND USAGE
1.1 Chronic-Thromboembolic Pulmonary Hypertension
Adempas is indicated for the treatment of adults with persistent/recurrent
chronic thromb