Riociguat

Riociguat
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Black Box Warning

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. 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.

Overview

Riociguat is a {{{drugClass}}} that is FDA approved for the treatment of persistent,recurrent chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include headache, dyspepsia,gastritis, dizziness, nausea, diarrhea, hypotension, vomiting, anemia, gastroesophageal reflux, and constipation..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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.

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%).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Riociguat in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Riociguat in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Riociguat in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Riociguat in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Riociguat in pediatric patients.

Contraindications

• Condition1

Warnings

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. 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.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Riociguat in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Riociguat in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Riociguat in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Riociguat during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Riociguat with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Riociguat with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Riociguat with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Riociguat with respect to specific gender populations.

Race

There is no FDA guidance on the use of Riociguat with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Riociguat in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Riociguat in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Riociguat in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Riociguat in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Riociguat in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Riociguat in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Riociguat in the drug label.

Pharmacology

There is limited information regarding Riociguat Pharmacology in the drug label.

Mechanism of Action

Structure

File:Riociguat01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Riociguat in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Riociguat in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Riociguat in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Riociguat in the drug label.

How Supplied

Storage

There is limited information regarding Riociguat Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Riociguat in the drug label.

Precautions with Alcohol

• Alcohol-Riociguat interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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