Sandbox Riociguat

Sandbox 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];

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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 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 acceptable methods of contraception. For females, Adempas is available only through a restricted program called the Adempas REMS Program.

Overview

Sandbox Riociguat is a Soluble Guanylate Cyclase Stimulator that is FDA approved for the treatment of Chronic Thromboembolic Pulmonary Hypertension (CTEPH) and Pulmonary Arterial Hypertension. There is a Black Box Warning for this drug as shown here. Common adverse reactions include fetal harm (teratogenic effects).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

The recommended starting dosage is 1 mg taken 3 times a day. For patients who may not tolerate the hypotensive effect of Riociguat, consider a starting dose of 0.5 mg taken three times a day. If systolic blood pressure remains greater than 95 mmHg and the patient has no signs or symptoms of hypotension, up-titrate the dose by 0.5 mg taken three times a day. Dose increases should be no sooner than 2 weeks apart. The dose can be increased to the highest tolerated dosage, up to a maximum of 2.5 mg taken three times a day. If at any time, the patient has symptoms of hypotension, decrease the dosage by 0.5 mg taken three times a day.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

The safety and effectiveness of Adempas in pediatric patients have not been established

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

• Adempas may cause fetal harm when administered to a pregnant woman. Adempas 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.
• Co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated.
• Concomitant administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE inhibitors (such as dipyridamole or theophylline) is contraindicated

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 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 acceptable methods of contraception. For females, Adempas is available only through a restricted program called the Adempas REMS Program.

There is limited information regarding Sandbox Riociguat Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Sandbox Riociguat Clinical Trials Experience in the drug label.

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Sandbox Riociguat Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Sandbox Riociguat in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sandbox Riociguat in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Sandbox Riociguat in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Sandbox Riociguat in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Sandbox Riociguat in geriatric settings.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

There is limited information regarding Sandbox Riociguat Administration in the drug label.

Monitoring

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

IV Compatibility

There is limited information regarding the compatibility of Sandbox Riociguat and IV administrations.

Overdosage

There is limited information regarding Sandbox Riociguat overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

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

Mechanism of Action

There is limited information regarding Sandbox Riociguat Mechanism of Action in the drug label.

Structure

There is limited information regarding Sandbox Riociguat Structure in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Sandbox Riociguat How Supplied in the drug label.

Storage

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

Precautions with Alcohol

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

Brand Names

There is limited information regarding Sandbox Riociguat Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Sandbox Riociguat Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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