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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 one month after stopping
treatment. To prevent pregnancy, females of
reproductive potential must use effective forms
of contraception during treatment and for one
month after stopping treatment. For all female
patients, Adempas is available only through a
restricted program called the Adempas Risk
Evaluation and Mitigation Strategy (REMS)
Program...
Continue
reading below.
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Do You Know 3 Critical Parameters for
Managing CTEPH (WHO Group
4)?
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Dear {% if
contact.first_name == "Healthcare Practitioner"
%}HCP{% else%}{{contact.first_name |
capitalize}} {{contact.last_name |
capitalize}}{% endif %},
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Adempas is for adult patients 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.
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Adempas is the first and only
treatment approved for adults with
inoperable or persistent/recurrent CTEPH (WHO Group
4). Consider Adempas for your adult CTEPH patients*
who aren't at goal. Adempas demonstrated efficacy
for CTEPH patients in both WHO Functional Class II
and III.1,2
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| * |
In adults with inoperable or
persistent/recurrent CTEPH after
surgery. |
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Improvement in
6MWD
46 m mean improvement compared
to placebo (95% Cl, 25 m-67 m;
p<0.0001)
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Improvement in
WHO FC
33% vs 15% on placebo
(p=0.0026)
Stable: 62% for
Adempas vs 78% for
placebo
Deteriorated: 5%
for
Adempas vs 7% for placebo
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Improvement in PVR and NT-proBNP
PVR decreased -246 dyn.sec.cm-5
(95% Cl, -303 to -190;
p<0.001) NT-proBNP decreased
-444 ng/L (95% Cl, -843 to -45;
p<0.001)
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6MWD = 6-minute walking distance; CTEPH = chronic
thromboembolic pulmonary hypertension; NT-proBNP =
N-terminal pro-brain natriuretic peptide; PVR =
pulmonary vascular resistance; WHO FC = World Health
Organization Functional Class.
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Important
Safety Information
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WARNING:
EMBRYO-FETAL
TOXICITY
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Do not
administer
Adempas
(riociguat)
tablets
to a
pregnant
female
because
it may
cause
fetal
harm.
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Females
of
reproductive
potential:
Exclude
pregnancy
before
the
start of
treatment,
monthly
during
treatment,
and one
month
after
stopping
treatment.
To
prevent
pregnancy,
females
of
reproductive
potential
must use
effective
forms of
contraception
during
treatment
and for
one
month
after
stopping
treatment.
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For all
female
patients,
Adempas
is
available
only
through
a
restricted
program
called
the
Adempas
Risk
Evaluation
and
Mitigation
Strategy
(REMS)
Program.
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Contraindications
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Adempas is contraindicated in:
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Pregnancy.
Based on data from
animal reproduction
studies, Adempas may
cause fetal harm when
administered to a
pregnant woman and 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. |
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Co-administration with
nitrates or nitric oxide
donors (such as amyl
nitrite) in any form.
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Concomitant
administration with
specific
phosphodiesterase
(PDE)-5 inhibitors (such
as sildenafil,
tadalafil, or
vardenafil) or
nonspecific PDE
inhibitors (such as
dipyridamole or
theophylline) is
contraindicated. Do not
administer within 24
hours of sildenafil. Do
not administer 24 hours
before or within 48
hours after tadalafil.
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Patients
with concomitant use of
other soluble guanylate
cyclase (sGC)
stimulators. |
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Patients
with Pulmonary
Hypertension associated
with Idiopathic
Interstitial
Pneumonias
(PH-IIP).
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Warnings and
Precautions
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Embryo-Fetal Toxicity.
Based on data from animal reproduction
studies, Adempas may cause embryo-fetal
toxicity when administered to a pregnant
female and is contraindicated in females
who are pregnant. Advise females of
reproductive potential of the potential
risk to a fetus. Obtain a pregnancy test
before the start of treatment, monthly
during treatment, and for one month
after stopping treatment. Advise females
of reproductive potential to use
effective contraception during treatment
with Adempas and for at least one month
after the last dose.
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For females, Adempas is only available
through a restricted program under the
Adempas REMS Program. |
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Adempas REMS Program.
Females can only receive Adempas through
the Adempas REMS Program, a restricted
distribution program.
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Important requirements of the Adempas
REMS Program include the following: |
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Prescribers
must be certified with
the program by enrolling
and completing training.
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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.
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Female
patients of reproductive
potential must comply
with the pregnancy
testing and
contraception
requirements. |
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Pharmacies
must be certified with
the program and must
only dispense to
patients who are
authorized to receive
Adempas. |
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Further information, including a list of
certified pharmacies, is available at www.AdempasREMS.com
or 1-855-4ADEMPAS.
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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 reduction if patient
develops signs or symptoms of
hypotension.
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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.
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Pulmonary Veno-Occlusive
Disease. Pulmonary
vasodilators may significantly worsen
the cardiovascular status of patients
with pulmonary veno-occlusive disease
(PVOD). Therefore, administration of
Adempas to such patients is not
recommended. Should signs of pulmonary
edema occur, the possibility of
associated PVOD should be considered and
if confirmed, discontinue treatment with
Adempas.
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Most Common Adverse
Reactions
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| The most common adverse
reactions occurring more frequently
(≥3%) on Adempas than placebo were
headache (27% vs 18%),
dyspepsia/gastritis (21% vs 8%),
dizziness (20% vs 13%), nausea (14% vs
11%), diarrhea (12% vs 8%), hypotension
(10% vs 4%), vomiting (10% vs 7%),
anemia (7% vs 2%), gastroesophageal
reflux disease (5% vs 2%), and
constipation (5% vs 1%). |
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| Other events that were seen
more frequently in Adempas compared to
placebo and potentially related to
treatment were palpitations, nasal
congestion, epistaxis, dysphagia,
abdominal distension, and peripheral
edema. |
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Indication
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| • |
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Adempas
(riociguat) tablets 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.
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For important risk and use
information, please see the full Prescribing
Information, including Boxed
Warning.
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You are encouraged to report side
effects or quality complaints
of products to the FDA by visiting www.fda.gov/medwatch
or calling 1-800-FDA-1088. For Bayer
products, you can
report these directly to Bayer by clicking
here.
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References:
1. Adempas Prescribing
Information. Whippany, NJ. Bayer
Pharmaceuticals Inc., 2021. 2.
Ghofrani H-A, D'Armini AM,
Grimminger F, et al. Riociguat for the
treatment of chronic thromboembolic
pulmonary hypertension. N Engl J
Med. 2013;369(4):319-329.
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BAYER, the Bayer Cross, and Adempas are
registered trademarks of Bayer.
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All other trademarks are property of
their respective owners. These trademark
owners are
not affiliated with Bayer
and do not sponsor or endorse Bayer or
this product. |
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©2022 Bayer. All rights reserved.
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100 Bayer Blvd. Whippany, NJ 07981
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PP-ADE-US-2584-1 May 2022
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