Dosage & Administration
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Adempass Prescribing Information
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
Obtain pregnancy tests prior to start of treatment and monthly during treatment
Adempas is a soluble guanylate cyclase (sGC) stimulator 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. ()1.1 Chronic-Thromboembolic Pulmonary HypertensionAdempas 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 ].• Pulmonary Arterial Hypertension (PAH) (WHO Group 1) to improve exercise capacity, improve WHO functional class and to delay clinical worsening. ()1.2 Pulmonary Arterial HypertensionAdempas 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 ].
• Initiate treatment at 1 mg taken three times a day. ()2.1 Recommended Dosage in Adult PatientsThe recommended starting dosage is 1 mg taken 3 times a day. For patients who may not tolerate the hypotensive effect of Adempas, 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.
Crushed TabletsFor patients who are unable to swallow whole tablets, Adempas may be crushed and mixed with water or soft foods (such as applesauce) immediately before administration
[see Clinical Pharmacology ].• 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 Recommended Dosage in Adult PatientsThe recommended starting dosage is 1 mg taken 3 times a day. For patients who may not tolerate the hypotensive effect of Adempas, 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.
Crushed TabletsFor patients who are unable to swallow whole tablets, Adempas may be crushed and mixed with water or soft foods (such as applesauce) immediately before administration
[see Clinical Pharmacology ].• Increase dosage by 0.5 mg at intervals of no sooner than 2-weeks as tolerated to a maximum of 2.5 mg three times a day. ()2.1 Recommended Dosage in Adult PatientsThe recommended starting dosage is 1 mg taken 3 times a day. For patients who may not tolerate the hypotensive effect of Adempas, 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.
Crushed TabletsFor patients who are unable to swallow whole tablets, Adempas may be crushed and mixed with water or soft foods (such as applesauce) immediately before administration
[see Clinical Pharmacology ].• Tablets may be crushed and mixed with water or soft foods for patients who have difficulty swallowing. ()2.1 Recommended Dosage in Adult PatientsThe recommended starting dosage is 1 mg taken 3 times a day. For patients who may not tolerate the hypotensive effect of Adempas, 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.
Crushed TabletsFor patients who are unable to swallow whole tablets, Adempas may be crushed and mixed with water or soft foods (such as applesauce) immediately before administration
[see Clinical Pharmacology ].
Tablets: film-coated, round, bi-convex:
• 0.5 mg, white, with “BAYER” cross on one side and “0.5” and “R” on the other side• 1 mg, pale-yellow, with “BAYER” cross on one side and “1” and “R” on the other side• 1.5 mg, yellow-orange, with “BAYER” cross on one side and “1.5” and “R” on the other side• 2 mg, pale orange, with “BAYER” cross on one side and “2” and “R” on the other side• 2.5 mg, red-orange, with “BAYER” cross on one side and “2.5” and “R” on the other side
• Lactation: Advise not to breastfeed. ()8.2 LactationRisk SummaryThere are no data on the presence of riociguat in human milk, the effects on the breastfed infant, or the effect on milk production. Riociguat is present in rat milk. Because of the potential for serious adverse reactions from ADEMPAS, such as hypotension, in breastfed infants, advise women not to breastfeed during treatment with ADEMPAS.
• Renal impairment: Not recommended in patients with creatinine clearance <15 mL/min or on dialysis. ()8.6 Renal ImpairmentSafety and efficacy have not been demonstrated in patients with creatinine clearance <15 mL/min or on dialysis
[see Clinical Pharmacology ].• Hepatic impairment: Not recommended in patients with severe (Child Pugh C) hepatic impairment. ()8.7 Hepatic ImpairmentSafety and efficacy have not been demonstrated in patients with severe hepatic impairment (Child Pugh C)
[see Clinical Pharmacology ].• Smoking: May require dosages higher than 2.5 mg three times a day if tolerated. Dose decrease may be required in patients who stop smoking. (,2.4 Use in Patients who SmokeConsider titrating to dosages higher than 2.5 mg three times a day, if tolerated, in patients who smoke. A dose decrease may be required in patients who stop smoking
[see Drug Interactions and Clinical Pharmacology ].)7.2 Pharmacokinetic Interactions with AdempasSmoking:Plasma concentrations in smokers are reduced by 50% to 60% compared to nonsmokers. Based on pharmacokinetic modeling, for patients who are smokers, doses higher than 2.5 mg three times a day may be considered in order to match exposure seen in nonsmoking patients. Safety and effectiveness of Adempas doses higher than 2.5 mg three times a day have not been established. A dose reduction should be considered in patients who stop smoking[see Dosage and Administration and Clinical Pharmacology ].Strong CYP and P-gp/BCRP inhibitors:Concomitant use of riociguat with strong cytochrome CYP inhibitors and P-gp/BCRP inhibitors such as azole antimycotics (for example, ketoconazole, itraconazole) or HIV protease inhibitors (such as ritonavir) increase riociguat exposure and may result in hypotension. Consider a starting dose of 0.5 mg 3 times a day when initiating Adempas in patients receiving strong CYP and P-gp/BCRP inhibitors. Monitor for signs and symptoms of hypotension on initiation and on treatment with strong CYP and P-gp/BCRP inhibitors. A dose reduction should be considered in patients who may not tolerate the hypotensive effect of riociguat[see Dosage and Administration , Warnings and Precautions and Clinical Pharmacology ].Strong CYP3A inducers:Strong inducers of CYP3A (for example, rifampin, phenytoin, carbamazepine, phenobarbital or St. John’s Wort) may significantly reduce riociguat exposure. Data are not available to guide dosing of riociguat when strong CYP3A inducers are co-administered.[see Clinical Pharmacology ].Antacids:Antacids such as aluminum hydroxide/magnesium hydroxide decrease riociguat absorption and should not be taken within 1 hour of taking Adempas[see Clinical Pharmacology ].
• Pregnancy ()4.1 PregnancyBased 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
[see Use in Specific Populations ].• Use with nitrates or nitric oxide donors in any form (,4.2 Nitrates and Nitric Oxide DonorsCo-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated
[see Drug Interactions (7.1) and Clinical Pharmacology ].)7.1 Pharmacodynamic Interactions with AdempasOther Soluble Guanylate Cyclase Stimulators: Co-administration of Adempas is contraindicated in patients with use of other soluble guanylate cyclase (sGC) stimulators
[see Contraindications ].Nitrates:Co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated because of hypotension[see Contraindications and Clinical Pharmacology ].PDE Inhibitors:Co-administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) and nonspecific PDE inhibitors (such as dipyridamole or theophylline), is contraindicated because of hypotension.Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil[see Dosage and Administration (2.6)].Clinical experience with co-administration of Adempas and other phosphodiesterase inhibitors (for example, milrinone, cilostazole, roflumilast) is limited.• Use with PDE inhibitors (,2.6 Transitioning to and from Adempas• Discontinue sildenafil at least 24 hours prior to administering Adempas[see Contraindications and Drug Interactions ].• Discontinue tadalafil at least 48 hours prior to administering Adempas[see Contraindications and Drug Interactions ]. Consider initiating Adempas at a starting dose of 0.5 mg in patients at risk of hypotension[see Dosage and Administration ]. Monitor for signs and symptoms of hypotension on initiation.• Discontinue Adempas at least 24 hours prior to administering a PDE5-inhibitor[see Dosage and Administration , Contraindications , and Drug Interactions ].Monitor for signs and symptoms of hypotension on initiation.
,4.3 Phosphodiesterase InhibitorsConcomitant administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or nonspecific PDE 5 inhibitors (such as dipyridamole or theophylline) is contraindicated
[see Dosage and Administration (2.6), Drug Interactions and Clinical Pharmacology ].Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil.)7.1 Pharmacodynamic Interactions with AdempasOther Soluble Guanylate Cyclase Stimulators: Co-administration of Adempas is contraindicated in patients with use of other soluble guanylate cyclase (sGC) stimulators
[see Contraindications ].Nitrates:Co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated because of hypotension[see Contraindications and Clinical Pharmacology ].PDE Inhibitors:Co-administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) and nonspecific PDE inhibitors (such as dipyridamole or theophylline), is contraindicated because of hypotension.Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil[see Dosage and Administration (2.6)].Clinical experience with co-administration of Adempas and other phosphodiesterase inhibitors (for example, milrinone, cilostazole, roflumilast) is limited.• Patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators. (,4.4 Soluble Guanylate StimulatorsAdempas is contraindicated in patients with concomitant use of other soluble guanylate cyclase (sGC) stimulators
[see Drug Interactions ].)7.1 Pharmacodynamic Interactions with AdempasOther Soluble Guanylate Cyclase Stimulators: Co-administration of Adempas is contraindicated in patients with use of other soluble guanylate cyclase (sGC) stimulators
[see Contraindications ].Nitrates:Co-administration of Adempas with nitrates or nitric oxide donors (such as amyl nitrite) in any form is contraindicated because of hypotension[see Contraindications and Clinical Pharmacology ].PDE Inhibitors:Co-administration of Adempas with specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) and nonspecific PDE inhibitors (such as dipyridamole or theophylline), is contraindicated because of hypotension.Do not administer within 24 hours of sildenafil. Do not administer 24 hours before or within 48 hours after tadalafil[see Dosage and Administration (2.6)].Clinical experience with co-administration of Adempas and other phosphodiesterase inhibitors (for example, milrinone, cilostazole, roflumilast) is limited.• • Pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP) ()4.5 Pulmonary Hypertension Associated with Idiopathic Interstitial Pneumonias (PH-IIP)Adempas is contraindicated in patients with pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP).