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 thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4)
after surgical treatment, or inoperable CTEPH, to improve exercise capacity
and WHO functional class [see Clinical Studies (14.1)].
1.2 Pulmonary Arterial Hypertension
Adempas is indicated for the treatment of adults with pulmonary arterial
hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO
functional class and to delay clinical worsening.
Efficacy was shown in patients on Adempas monotherapy or in combination
with endothelin receptor antagonists or prostanoids. Studies establishing
effectiveness included predominately patients with WHO functional class
II–III and etiologies of idiopathic or heritable PAH (61%) or PAH associated
with connective tissue diseases (25%) [see Clinical Studies (14.2)].
4 CONTRAINDICATIONS
4.1 Pregnancy
Adempas may cause fetal harm when administered to a pregnant woman.
Adempas is contraindicated in females who are pregnant. Adempas was
consistently shown to have teratogenic effects when administered to animals.
If this drug is used during pregnancy, or if the patient becomes pregnant
while taking this drug, the patient should be apprised of the potential hazard
to the fetus [see Use in Specific Populations (8.1)].
4.2 Nitrates and Nitric Oxide Donors
Co-administration of Adempas with nitrates or nitric oxide donors (such as
amyl nitrite) in any form is contraindicated [see Drug Interactions (7.1) and
Clinical Pharmacology (12