What is the role of
nitric oxide (NO) in
PAH and CTEPH?
• PAH and CTEPH are associated with impaired
synthesis of NO, endothelial dysfunction,
and insufficient stimulation of the NO-sGCcGMP pathway
• Intracellular cyclic guanosine monophosphate
(cGMP) plays an important role in regulating
processes that influence vascular tone,
proliferation, fibrosis, and inflammation
Adempas stimulates sGC
regardless of NO level to
produce more cGMP
IN THE PRESENCE OF
• Adempas sensitizes soluble guanylate cyclase
(sGC) to endogenous NO by stabilizing sGC-NO
binding
• Adempas directly stimulates sGC independently
of NO via a different binding site
• Increased cGMP leads to vasodilation
N
O
sGC
sGC
Adempas
cGMP
cGMP
vasodilation
INDEPENDENTLY OF
INDICATIONS
• Adempas (riociguat) tablets are 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.
• 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 predominantly patients with
WHO functional class II–III and etiologies of idiopathic
or heritable PAH (61%) or PAH associated with connective
tissue diseases (25%).
*Time to clinical worsening was a combined endpoint
defined as death (all-cause mortality), heart/lung
transplantation, atrial septostomy, hospitalization due to
persistent worsening of pulmonary hypertension, start of
new PAH-specific treatment, persistent decrease in 6MWD
and persistent worsening of WHO functional class.
N
O
IMPORTANT SAFETY INFORMATION
WARNING: EMBRYO-FETAL TOXICITY
Do not administer Adempas (riociguat) tablets to a pregnant
female because it may cause fetal harm.
Females of reproductive potential: Exclude pregnancy before
the start of treatment, monthly during treatment, and 1 month
after stopping treatment. Prevent pregnancy during treatment
and for one month after stopping treatment by using acceptable
methods of contraception.
For all female patients, Adempas is available only through a
restricted program called the Adempas Risk Evaluation and
Mitigation Strategy (REMS) Program.
CONTRAINDICATIONS
Adempas is contraindicated in:
• Pregnancy. Adempas may cause fetal harm when administered
to a pregnant woman. 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
• Co-administration with nitrates or nitric oxide donors (such as amyl
nitrite) in any form.
Please see additional Important Safety Information, including Boxed Warning, throughout and Brief Summary of Prescribing Information
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