Can you take Ponesimod with Sodium phenylbutyrate / taurursodiol?

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).

The taurursodiol in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Biliary Obstruction.

Sodium phenylbutyrate-taurursodiol contains taurursodiol, a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for diarrhea and patients should be monitored appropriately. Other conditions such as pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids, may also lead to decreased absorption of this drug and its components. Consider consulting with a GI specialists with experience managing these GI disorders. Patients with disorders of enterohepatic circulation (e.g., biliary infection, active cholecystitis, etc.), severe pancreatic disorders (e.g., pancreatitis), and intestinal disorders that may alter concentrations of bile acids (e.g., ileal resection, regional ileitis, etc.) were excluded from clinical studies and there is no experience in patients with these conditions. Caution is advised.

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 sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Central Nervous System Disorders.

Sodium phenylbutyrate is a pro-drug and is rapidly metabolized to the active, phenylacetate. Neurotoxicity, including exacerbation of a preexisting neuropathy, has been reported with the use of intravenous phenylacetate. The acute onset and reversibility when the phenylacetate infusion was discontinued suggested a drug effect. Care should be exercised when prescribing sodium phenylbutyrate to patients at risk for neurotoxicity.

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 sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a major potential interaction with Fluid Retention.

The use of sodium phenylbutyrate may cause fluid retention in patients with congestive heart failure, renal dysfunction, or sodium retention with edema. Sodium phenylbutyrate is primarily excreted by the kidney and these patients may exhibit reduced excretion. Therapy with sodium phenylbutyrate should be administered cautiously in these patients. Monitoring plasma levels of ammonia, arginine, branched-chain amino acids and serum proteins to maintain within normal limits and glutamine to less than 1000 mcmol/L is recommended.

The taurursodiol in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Gallbladder Disease.

Sodium phenylbutyrate-taurursodiol contains taurursodiol, a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for diarrhea and patients should be monitored appropriately. Other conditions such as pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids, may also lead to decreased absorption of this drug and its components. Consider consulting with a GI specialists with experience managing these GI disorders. Patients with disorders of enterohepatic circulation (e.g., biliary infection, active cholecystitis, etc.), severe pancreatic disorders (e.g., pancreatitis), and intestinal disorders that may alter concentrations of bile acids (e.g., ileal resection, regional ileitis, etc.) were excluded from clinical studies and there is no experience in patients with these conditions. Caution is advised.

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).

The sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a major potential interaction with Heart Failure.

The use of sodium phenylbutyrate may cause fluid retention in patients with congestive heart failure, renal dysfunction, or sodium retention with edema. Sodium phenylbutyrate is primarily excreted by the kidney and these patients may exhibit reduced excretion. Therapy with sodium phenylbutyrate should be administered cautiously in these patients. Monitoring plasma levels of ammonia, arginine, branched-chain amino acids and serum proteins to maintain within normal limits and glutamine to less than 1000 mcmol/L is recommended.

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 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 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.

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 sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Liver Disease.

Sodium phenylbutyrate is primarily metabolized in the liver and kidney. Therapy with sodium phenylbutyrate should be administered cautiously in patients with liver disease. Monitoring plasma levels of ammonia, arginine, branched-chain amino acids and serum proteins to maintain within normal limits and glutamine to less than 1000 mcmol/L is recommended.

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.

The taurursodiol in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Malabsorption Syndrome.

Sodium phenylbutyrate-taurursodiol contains taurursodiol, a bile acid. In patients with disorders that interfere with bile acid circulation, there may be an increased risk for diarrhea and patients should be monitored appropriately. Other conditions such as pancreatic insufficiency, intestinal malabsorption, or intestinal diseases that may alter the concentration of bile acids, may also lead to decreased absorption of this drug and its components. Consider consulting with a GI specialists with experience managing these GI disorders. Patients with disorders of enterohepatic circulation (e.g., biliary infection, active cholecystitis, etc.), severe pancreatic disorders (e.g., pancreatitis), and intestinal disorders that may alter concentrations of bile acids (e.g., ileal resection, regional ileitis, etc.) were excluded from clinical studies and there is no experience in patients with these conditions. Caution is advised.

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.

The sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Myoneural Disorder.

Sodium phenylbutyrate is a pro-drug and is rapidly metabolized to the active, phenylacetate. Neurotoxicity, including exacerbation of a preexisting neuropathy, has been reported with the use of intravenous phenylacetate. The acute onset and reversibility when the phenylacetate infusion was discontinued suggested a drug effect. Care should be exercised when prescribing sodium phenylbutyrate to patients at risk for neurotoxicity.

The sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Peripheral Neuropathy.

Sodium phenylbutyrate is a pro-drug and is rapidly metabolized to the active, phenylacetate. Neurotoxicity, including exacerbation of a preexisting neuropathy, has been reported with the use of intravenous phenylacetate. The acute onset and reversibility when the phenylacetate infusion was discontinued suggested a drug effect. Care should be exercised when prescribing sodium phenylbutyrate to patients at risk for neurotoxicity.

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 sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a major potential interaction with Renal Dysfunction.

The use of sodium phenylbutyrate may cause fluid retention in patients with congestive heart failure, renal dysfunction, or sodium retention with edema. Sodium phenylbutyrate is primarily excreted by the kidney and these patients may exhibit reduced excretion. Therapy with sodium phenylbutyrate should be administered cautiously in these patients. Monitoring plasma levels of ammonia, arginine, branched-chain amino acids and serum proteins to maintain within normal limits and glutamine to less than 1000 mcmol/L is recommended.

The sodium phenylbutyrate in sodium phenylbutyrate / taurursodiol has a moderate potential interaction with Renal Dysfunction.

Sodium phenylbutyrate is primarily metabolized in the liver and kidney. Therapy with sodium phenylbutyrate should be administered cautiously in patients with liver disease. Monitoring plasma levels of ammonia, arginine, branched-chain amino acids and serum proteins to maintain within normal limits and glutamine to less than 1000 mcmol/L is recommended.

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).

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.