Interactions between Ponesimod and VESIcare

Ponesimod has a moderate potential interaction with Arrhythmia.

The use of ponesimod may result in a transient decrease in heart rate and atrioventricular (AV) conduction delays, especially during treatment initiation. This drug is not recommended in patients with a history of cardiac arrest, cerebrovascular disease (e.g., TIA, stroke occurring more than 6 months prior to treatment initiation), uncontrolled hypertension, or severe untreated sleep apnea, since significant bradycardia may be poorly tolerated in these patients. The use of this drug in patients with a history of recurrent syncope or symptomatic bradycardia should be based on an overall benefit-risk assessment. Obtain an ECG in all patients to determine whether preexisting conduction abnormalities are present and consult a cardiologist if appropriate. Monitor closely patients taking concurrent therapy with drugs that decrease heart rate (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, and other drugs that may decrease heart rate).

Ponesimod has a moderate potential interaction with Central Nervous System Disorders.

Rare cases of posterior reversible encephalopathy syndrome (PRES) have been reported in patients receiving a sphingosine 1-phosphate receptor modulator. It is recommended to promptly schedule a complete physical and neurological examination and should consider an MRI, if a patient develops any unexpected neurological or psychiatric symptoms/signs, any symptom/sign suggestive of an increase of intracranial pressure, or accelerated neurological deterioration. Delay in diagnosis and treatment may lead to permanent neurological sequelae. Exercise care when using this agent in patients with a history of ischemic stroke or cerebral hemorrhage. Treatment should be discontinued if PRES is suspected.

The solifenacin in VESIcare has a moderate potential interaction with Central Nervous System Disorders.

Solifenacin is associated with anticholinergic central nervous system (CNS) effects. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Solifenacin should be used with caution in patients with Parkinson's disease and in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.

The solifenacin in VESIcare has a moderate potential interaction with Dementia.

Solifenacin is associated with anticholinergic central nervous system (CNS) effects. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered. Solifenacin should be used with caution in patients with Parkinson's disease and in patients with preexisting dementia treated with cholinesterase inhibitors due to the risk of aggravation of symptoms.

Ponesimod has a moderate potential interaction with Diabetes Mellitus.

Macular edema has been reported with the use of sphingosine 1-phosphate (S1P) receptor modulators. Care should be exercised when using these drugs in patients with a history of uveitis and patients with diabetes mellitus as these patients are at increased risk for macular edema. Before starting treatment with these agents, an ophthalmic evaluation of the fundus, including the macula, is recommended in all patients and at any time if vision change is reported during treatment. Patients with a history of uveitis and patients with diabetes mellitus should have regular follow-up examinations of the fundus, including the macula during treatment. Continuation of therapy in patients with macular edema has not been evaluated, therefore, a decision on whether or not to discontinue treatment needs to take into account the potential benefits and risks for the individual patients.

The solifenacin in VESIcare has a major potential interaction with Gastrointestinal Obstruction.

The use of solifenacin is contraindicated in patients with gastric retention. Caution is advised even when using this agent in patients with decreased gastrointestinal motility.

The solifenacin in VESIcare has a major potential interaction with Glaucoma, Narrow Angle.

The use of solifenacin is contraindicated in patients with uncontrolled narrow-angle glaucoma. Caution is advised even when using this agent in patients with narrow-angle glaucoma.

Ponesimod has a moderate potential interaction with Heart Disease.

The use of ponesimod may result in a transient decrease in heart rate and atrioventricular (AV) conduction delays, especially during treatment initiation. This drug is not recommended in patients with a history of cardiac arrest, cerebrovascular disease (e.g., TIA, stroke occurring more than 6 months prior to treatment initiation), uncontrolled hypertension, or severe untreated sleep apnea, since significant bradycardia may be poorly tolerated in these patients. The use of this drug in patients with a history of recurrent syncope or symptomatic bradycardia should be based on an overall benefit-risk assessment. Obtain an ECG in all patients to determine whether preexisting conduction abnormalities are present and consult a cardiologist if appropriate. Monitor closely patients taking concurrent therapy with drugs that decrease heart rate (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, and other drugs that may decrease heart rate).

Ponesimod has a moderate potential interaction with High Blood Pressure.

The use of ponesimod may result in a transient decrease in heart rate and atrioventricular (AV) conduction delays, especially during treatment initiation. This drug is not recommended in patients with a history of cardiac arrest, cerebrovascular disease (e.g., TIA, stroke occurring more than 6 months prior to treatment initiation), uncontrolled hypertension, or severe untreated sleep apnea, since significant bradycardia may be poorly tolerated in these patients. The use of this drug in patients with a history of recurrent syncope or symptomatic bradycardia should be based on an overall benefit-risk assessment. Obtain an ECG in all patients to determine whether preexisting conduction abnormalities are present and consult a cardiologist if appropriate. Monitor closely patients taking concurrent therapy with drugs that decrease heart rate (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, and other drugs that may decrease heart rate).

Ponesimod has a moderate potential interaction with High Blood Pressure.

The use of ponesimod may result in increased blood pressure. Care should be exercised when using this drug in hypertensive patients and those at risk for hypertension. It is recommended to monitor blood pressure during treatment and manage it according to clinical practices.

Ponesimod has a moderate potential interaction with Infection.

The use of ponesimod may increase the risk of infections, and some serious infections with opportunistic pathogens including viruses have been reported. Prior to treatment, a recent CBC (i.e., within 6 months or after discontinuation of prior therapy) should be available. It is recommended to delay treatment initiation in patients with an active infection until complete resolution. Consider withholding treatment if a patient develops a serious infection, and reassess the benefits and risks prior to reinitiating therapy.

The solifenacin in VESIcare has a major potential interaction with Liver Disease.

Solifenacin should be used with caution in patients with reduced hepatic function. Increase in half-life and AUC have been demonstrated in patients with reduce hepatic impairment. Caution should be taken when prescribing this agent to patients with moderate hepatic impairment and the use of doses greater than 5 mg in these patients is not recommended by the manufacturer. Solifenacin is not recommended in patients with severe hepatic impairment. .

Ponesimod has a moderate potential interaction with Liver Disease.

The use of this drug may increase liver transaminases. Ponesimod is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh class B and C). No dosage adjustment is necessary for patients with mild hepatic impairment (Child-Pugh class A). Patients should have liver enzymes checked if they develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, a rash with eosinophilia, or jaundice and/or dark urine during treatment. Obtain transaminase and bilirubin levels, if not recently available (i.e., within the last 6 months) before treatment initiation. Treatment should be discontinued if significant liver injury is confirmed.

The solifenacin in VESIcare has a moderate potential interaction with Long QT Syndrome.

Dose dependent prolongation in QT interval has been observed with the use of solifenacin. This drug should be used with caution in patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval.

Ponesimod has a moderate potential interaction with Macular Edema.

Macular edema has been reported with the use of sphingosine 1-phosphate (S1P) receptor modulators. Care should be exercised when using these drugs in patients with a history of uveitis and patients with diabetes mellitus as these patients are at increased risk for macular edema. Before starting treatment with these agents, an ophthalmic evaluation of the fundus, including the macula, is recommended in all patients and at any time if vision change is reported during treatment. Patients with a history of uveitis and patients with diabetes mellitus should have regular follow-up examinations of the fundus, including the macula during treatment. Continuation of therapy in patients with macular edema has not been evaluated, therefore, a decision on whether or not to discontinue treatment needs to take into account the potential benefits and risks for the individual patients.

Ponesimod has a moderate potential interaction with Multiple Sclerosis.

Rare cases of severe exacerbation of multiple sclerosis (MS), including disease rebound, have been reported after discontinuation of sphingosine 1-phosphate receptor modulator in MS treated patients. The possibility of severe exacerbation of disease should be considered after stopping treatment with these agents. Patients should be observed for a severe increase in disability upon discontinuation and appropriate treatment should be instituted, as required.

Ponesimod has a moderate potential interaction with Pulmonary Impairment.

Dyspnea has been reported with the use of ponesimod. Dose-dependent reductions in forced expiratory volume over 1 second (FEV1) and reductions in diffusion lung capacity for carbon monoxide have been observed in patients mostly occurring in the first month after treatment initiation. Use with caution in patients with severe respiratory disease such as pulmonary fibrosis, asthma, and chronic obstructive pulmonary disease. Spirometric evaluation of respiratory function should be performed during therapy if clinically indicated.

The solifenacin in VESIcare has a major potential interaction with Renal Dysfunction.

Solifenacin should be used with caution in patients with renal impairment. Increase in half-life and AUC have been demonstrated in patients with severe renal impairment. Caution should be taken when prescribing this agent to patients with renal impairment. Doses greater than 5 mg in patients with severe renal impairment is not recommended by the manufacturer.

Ponesimod has a moderate potential interaction with Sleep Apnea.

The use of ponesimod may result in a transient decrease in heart rate and atrioventricular (AV) conduction delays, especially during treatment initiation. This drug is not recommended in patients with a history of cardiac arrest, cerebrovascular disease (e.g., TIA, stroke occurring more than 6 months prior to treatment initiation), uncontrolled hypertension, or severe untreated sleep apnea, since significant bradycardia may be poorly tolerated in these patients. The use of this drug in patients with a history of recurrent syncope or symptomatic bradycardia should be based on an overall benefit-risk assessment. Obtain an ECG in all patients to determine whether preexisting conduction abnormalities are present and consult a cardiologist if appropriate. Monitor closely patients taking concurrent therapy with drugs that decrease heart rate (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, and other drugs that may decrease heart rate).

Ponesimod has a moderate potential interaction with Syncope.

The use of ponesimod may result in a transient decrease in heart rate and atrioventricular (AV) conduction delays, especially during treatment initiation. This drug is not recommended in patients with a history of cardiac arrest, cerebrovascular disease (e.g., TIA, stroke occurring more than 6 months prior to treatment initiation), uncontrolled hypertension, or severe untreated sleep apnea, since significant bradycardia may be poorly tolerated in these patients. The use of this drug in patients with a history of recurrent syncope or symptomatic bradycardia should be based on an overall benefit-risk assessment. Obtain an ECG in all patients to determine whether preexisting conduction abnormalities are present and consult a cardiologist if appropriate. Monitor closely patients taking concurrent therapy with drugs that decrease heart rate (e.g., beta-blockers, non-dihydropyridine calcium channel blockers, and other drugs that may decrease heart rate).

The solifenacin in VESIcare has a major potential interaction with Urinary Retention.

The use of solifenacin is contraindicated in patients with urinary retention. Caution is advised even when using this agent in patients with clinically significant bladder outflow obstruction.

Ponesimod has a moderate potential interaction with Uveitis.

Macular edema has been reported with the use of sphingosine 1-phosphate (S1P) receptor modulators. Care should be exercised when using these drugs in patients with a history of uveitis and patients with diabetes mellitus as these patients are at increased risk for macular edema. Before starting treatment with these agents, an ophthalmic evaluation of the fundus, including the macula, is recommended in all patients and at any time if vision change is reported during treatment. Patients with a history of uveitis and patients with diabetes mellitus should have regular follow-up examinations of the fundus, including the macula during treatment. Continuation of therapy in patients with macular edema has not been evaluated, therefore, a decision on whether or not to discontinue treatment needs to take into account the potential benefits and risks for the individual patients.

Ponesimod has a moderate potential interaction with Vaccination.

The use of live attenuated vaccines should be avoided while patients are taking ponesimod and for 1 to 2 weeks after stopping treatment. Patients without a healthcare professional documented history of chickenpox or documentation of a full course of vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV before the start of treatment. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to treatment initiation. Vaccinations may be less effective if administered during treatment and for up to 1 to 2 weeks after treatment discontinuation. It is recommended to postpone treatment with ponesimod for 4 weeks to allow the full effect of vaccination to occur. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of treatment.