Take your PAH and
CTEPH patients farther
with Adempas
In pulmonary arterial hypertension (PAH),
(WHO Group 1)
36m
improvement (mean) in 6-minute
walk distance (6MWD) over placebo
at Week 12 (95% Confidence Interval
(CI): 20m-52m; p<0.0001)
In inoperable and persistent/recurrent chronic
thromboembolic hypertension (CTEPH), (WHO Group 4)
46m
improvement (mean) in
6MWD over placebo at Week 16
(95% CI: 25m-67m; p<0.0001)
Randomized, multicenter, placebo-controlled clinical study of
443 adult PAH patients with predominantly WHO Functional
Class II-III. The primary endpoint was change from baseline
in 6MWD at 12 weeks.
Randomized, multicenter, placebo-controlled clinical study of
261 adult patients with persistent/recurrent CTEPH
after surgery or who were inoperable. The primary
endpoint was change from baseline in 6MWD at
16 weeks.
CONTRAINDICATIONS (continued)
Bleeding. In the placebo-controlled clinical trials, serious bleeding
occurred in 2.4% of patients taking Adempas compared to 0% of
placebo patients. Serious hemoptysis occurred in 5 (1%) patients
taking Adempas compared to 0 placebo patients, including
one event with fatal outcome. Serious hemorrhagic events also
included 2 patients with vaginal hemorrhage, 2 with catheter site
hemorrhage, and 1 each with subdural hematoma, hematemesis,
and intra-abdominal hemorrhage.
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity. Adempas may cause fetal harm when
administered during pregnancy and is contraindicated for use in
women who are pregnant. In females of reproductive potential,
exclude pregnancy prior to initiation of therapy, advise use of
acceptable contraception and obtain monthly pregnancy tests. For
females, Adempas is only available through a restricted program
under the Adempas REMS Program.
Adempas REMS Program. Females can only receive Adempas
through the Adempas REMS Program, a restricted distribution
program.
Important requirements of the Adempas REMS program include
the following:
• Prescribers must be certified with the program by enrolling and
completing training.
• All females, regardless of reproductive potential, must enroll in
the Adempas REMS Program prior to initiating Adempas. Male
patients are not enrolled in the Adempas REMS Program.
• Female patients of reproductive potential must comply with the
pregnancy testing and contraception requirements.
• Pharmacies must be certified with the program and must only
dispense to patients who are authorized to receive Adempas.
Further information, including a list of certified pharmacies, is
available at www.AdempasREMS.com or 1-855-4ADEMPAS.
Hypotension. Adempas reduces blood pressure. Consider the
potential for symptomatic hypotension or ischemia in patients with
hypovolemia, severe left ventricular outflow obstruction, resting
hypotension, autonomic dysfunction, or concomitant treatment with
antihypertensives or strong CYP and P-gp/BCRP inhibitors. Consider a
dose red V7F