ADEMPAS- riociguat tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RIOCIGUAT (UNII: RU3FE2Y4XI) (RIOCIGUAT - UNII:RU3FE2Y4XI)

Available from:

Bayer HealthCare Pharmaceuticals Inc.

INN (International Name):

RIOCIGUAT

Composition:

RIOCIGUAT .5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. 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)] . 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

Product summary:

Adempas (riociguat) tablets are film-coated, round, and debossed with the “Bayer cross” on one side. Color Debossing Side 2 NDC 50419-xxx-xx Bottle of 9 Bottle of 90 Blister of 42 0.5 mg White 0.5 R 250-91 250-01 250-03 1 mg Pale yellow 1 R 251-91 251-01 251-03 1.5 mg Yellow-orange 1.5 R 252-91 252-01 252-03 2 mg Pale orange 2 R 253-91 253-01 253-03 2.5 mg Red-orange 2.5 R 254-91 254-01 254-03 Store at 25°C (77°F); excursions are permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

ADEMPAS- RIOCIGUAT TABLET, FILM COATED
Bayer HealthCare Pharmaceuticals Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Adempas (a dem pahs)
(riociguat)
tablets
Read this Medication Guide before you start taking Adempas and each
time you get a refill. There may be
new information. This Medication Guide does not take the place of
talking to your doctor about your medical
condition or your treatment.
What is the most important information I should know about Adempas?
•
Serious birth defects.
•
Adempas can cause serious birth defects if taken during pregnancy.
•
Females must not be pregnant when they start taking Adempas or become
pregnant during treatment
with Adempas.
•
Females who are able to get pregnant must have a negative pregnancy
test before beginning treatment
with Adempas, each month during treatment, and 1 month after you stop
treatment with Adempas. Talk
to your doctor about your menstrual cycle. Your doctor will decide
when to do the tests, and order the
tests for you depending on your menstrual cycle.
•
Females who are able to get pregnant are females who:
•
Have entered puberty, even if they have not started their period, and
•
Have a uterus, and
•
Have not gone through menopause (have not had a period for at least 12
months for natural
reasons, or who have had their ovaries removed)
•
Females who are not able to get pregnant are females who:
•
Have not yet entered puberty, or
•
Do not have a uterus, or
•
Have gone through menopause (have not had a period for at least 12
months for natural reasons,
or who have had their ovaries removed)
Females who are able to get pregnant must use 2 acceptable forms of
birth control, during treatment with
Adempas and for 1 month after stopping Adempas because the medicine
may still be in the body.
•
If you have had a tubal sterilization, have a progesterone implant, or
have an IUD (intrauterine device),
these methods can be used alone and no other form of birth control is
needed.
•
Talk with your doctor or gynecologist (a doctor who spe

Summary of Product characteristics

ADEMPAS- RIOCIGUAT TABLET, FILM COATED
BAYER HEALTHCARE PHARMACEUTICALS INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ADEMPAS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ADEMPAS.
ADEMPAS (RIOCIGUAT) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
WARNING: EMBRYO-FETAL TOXICITY
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
•
•
INDICATIONS AND USAGE
Adempas is a soluble guanylate cyclase (sGC) stimulator indicated for
the treatment of adults with:
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
DOSAGE FORMS AND STRENGTHS
Tablets: 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg (3)
CONTRAINDICATIONS
•
•
•
•
••
WARNINGS AND PRECAUTIONS
•
•
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ADVERSE REACTIONS
Adverse reactions occurring more frequently (≥3%) on Adempas
compared to placebo are headache,
dyspepsia/gastritis, dizziness, nausea, diarrhea, hypotension,
vomiting, anemia, gastroesophageal reflux,
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 EFFECTIVE FORMS 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)
Persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension
(CTEPH) (WHO Group 4) after
surgical treatment or inoperable CTEPH to improve exercise capacity
and WHO functional class. (1.1)
Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve
exercise capacity, improve WHO
functional class and to delay clinical worsening. (1.2)
Initiate treatment at 1 mg taken three times a day. (2.1)
For patients who may not tolerate the hypotensive effect of Adempas,
consider a starting dose of 0.5
mg, three times a day. (2.1)
Increase dosa