Sandbox Riociguat: Difference between revisions
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|blackBoxWarningBody=*Do not administer Adempas to a pregnant female because it may cause fetal harm. | |blackBoxWarningBody=*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. | *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. | *For females, Adempas is available only through a restricted program called the Adempas REMS Program. | ||
|fdaLIADAdult=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. | |fdaLIADAdult=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. | ||
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Sandbox Riociguat in adult patients. | |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Sandbox Riociguat in adult patients. | ||
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*Co-administration of Adempas with nitrates or nitric oxide donors (such as [[amyl nitrite]]) in any form is contraindicated. | *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 | *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=*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. | |||
*Adempas reduces blood pressure. Consider the potential for symptomatic [[hypotension]] or [[ischemia]] in patients with [[hypovolemia]], [[left ventricular outflow tract obstruction]], resting [[hypotension]], [[autonomic dysfunction]], or concomitant treatment with [[antihypertensives]] or strong [[CYP]] and P-gp/BCRP inhibitors | |||
|alcohol=Alcohol-Sandbox Riociguat interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=Alcohol-Sandbox Riociguat interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
}} | }} | ||
Revision as of 21:14, 25 July 2014
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.
|
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.
|
- 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.
- Adempas reduces blood pressure. Consider the potential for symptomatic hypotension or ischemia in patients with hypovolemia, left ventricular outflow tract obstruction, resting hypotension, autonomic dysfunction, or concomitant treatment with antihypertensives or strong CYP and P-gp/BCRP inhibitors
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
{{#ask: Page Name::Sandbox Riociguat |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Sandbox Riociguat |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
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.