Interactions between Bedaquiline and Mayzent
1 drug interaction and 22 additional warnings found for the following 2 drugs:
- bedaquiline
- Mayzent (siponimod)
Drug interactions
Major drug interactions
Major:
bedaquiline siponimod
Applies to: bedaquiline and Mayzent (siponimod)
Generally avoid
Due to its significant bradycardic effects, the risk of QT prolongation and torsade de pointes arrhythmia may be increased during initiation of siponimod treatment in patients receiving drugs that prolong the QT interval. Siponimod can cause a decrease in heart rate during initiation of therapy that is apparent within an hour of the first dose, and the day 1 decline is maximal at approximately 3 to 4 hours. The maximal decrease in heart rate from baseline was seen between day 5 and 6. After day 6, heart rate starts increasing and reaches placebo levels within 10 days after treatment initiation. The highest daily postdose-dose decrease in absolute hourly mean heart rate is observed on day 1, with a decrease of 5 to 6 bpm. Following day 1, decreases in heart rate are less pronounced. Heart rates below 40 bpm were rarely observed. In controlled clinical trials, bradycardia (including sinus bradycardia and decreased heart rate) occurred in 6% of siponimod-treated patients compared to 3% of patients receiving placebo. Initiation of siponimod treatment has also resulted in transient AV conduction delays. First-degree AV block (prolonged PR interval on ECG) occurred in 5.1% of siponimod-treated patients and 1.9% of patients receiving placebo. Second-degree AV blocks, usually Mobitz type I (Wenckebach), have been observed at the time of siponimod initiation in less than 1.7% of patients. Bradycardia and conduction abnormalities were usually transient and asymptomatic, and resolved within the first 24 hours, but they occasionally required treatment with atropine. In a study evaluating the effect on QT interval of siponimod 2 or 10 mg at steady-state, siponimod treatment resulted in maximum prolongations of the QTc of 7.8 and 7.2 msec, respectively, with upper bounds of the 90% confidence interval of 9.93 and 9.72 msec, respectively. In general, the risk of an individual agent or a combination of agents causing ventricular arrhythmia in association with QT prolongation is largely unpredictable but may be increased by certain underlying risk factors such as congenital long QT syndrome, cardiac disease, and electrolyte disturbances (e.g., hypokalemia, hypomagnesemia). In addition, the extent of drug-induced QT prolongation is dependent on the particular drug(s) involved and dosage(s) of the drug(s).
Management
Siponimod has not been studied in patients receiving drugs that can prolong the QT interval. Because bradycardia and AV block are recognized risk factors for QT prolongation and torsade de pointes arrhythmia, treatment with siponimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties. Advice from a cardiologist should be sought if treatment with siponimod is considered in patients on concurrent therapy with QT prolonging drugs with a known risk of torsades de pointes or drugs that slow heart rate or AV conduction.
References (2)
- Cerner Multum, Inc. "Australian Product Information."
- (2019) "Product Information. Mayzent (siponimod)." Novartis Pharmaceuticals
Food/lifestyle interactions
Moderate food/lifestyle interactions
Moderate:
bedaquiline Food/Lifestyle
Applies to: bedaquiline
Adjust dosing interval
Food enhances the oral bioavailability of bedaquiline. When administered with a standard meal containing approximately 22 grams of fat (558 total Kcal), the relative bioavailability of bedaquiline increased by approximately 2-fold compared to administration under fasted conditions.
Generally avoid
Coadministration with alcohol may increase the risk of hepatotoxicity associated with the use of bedaquiline. In clinical trials, hepatic adverse drug reactions developed in more bedaquiline-treated patients than in those who received other drugs used to treat tuberculosis. In the controlled Phase IIb study (C208) patients receiving bedaquiline or placebo in combination with other drugs used to treat multidrug-resistant tuberculosis, reversible aminotransferase elevations of at least 3 times the upper limit of normal (ULN) developed more frequently in the bedaquiline treatment group (10.8%) than in the placebo group (5.7%).
Management
To ensure maximal oral absorption, bedaquiline should be taken with food. Patients should avoid alcohol use during treatment.
References (2)
- (2025) "Product Information. Sirturo (bedaquiline)." Janssen Pharmaceuticals
- (2024) "Product Information. Sirturo (bedaquiline)." Janssen-Cilag Ltd
Disease interactions
21 potential interactions Applies to: 18 conditions, including Underactive Thyroid, Multiple Sclerosis, Heart Disease, Diabetes Mellitus, and Liver Disease.
Alcoholism
Moderate:
bedaquiline
Bedaquiline has a moderate potential interaction with Alcoholism.
The use of bedaquiline might increase hepatic-related adverse events and lead to hepatotoxicity. It is recommended to avoid alcohol and other hepatotoxic drugs while on bedaquiline. Close monitoring is recommended in alcoholic patients as they are at a greater risk of hepatic toxicity. Liver function tests should be done at baseline, monthly while on treatment, and as needed thereafter and discontinuance of therapy if evidence of new or worsening liver dysfunction occurs as indicated by the manufacturer.
Cardiovascular Conditions and Disorders
Major:
Mayzent
The siponimod in Mayzent has a major potential interaction with Cardiovascular Conditions and Disorders.
Siponimod is contraindicated in patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III or IV heart failure. It is also contraindicated in presence of Mobitz type II second- degree, third-degree AV block, or sick sinus syndrome, unless the patient has a functioning pacemaker. Siponimod causes a transient decrease in heart rate and atrioventricular conduction delays, and has not been studied in patients with significant QT prolongation (greater than 500 msec) or arrhythmias requiring Class Ia or Class III antiarrhythmic drugs. If treatment with siponimod is considered in these patients or in patients with ischemic heart disease, heart failure, history of myocardial infarction, cerebrovascular disease or uncontrolled hypertension, an advice from a cardiologist should be sought. It is recommended to obtain a baseline EKG, and to monitor patients very closely.
Central Nervous System Disorders
Moderate:
Mayzent
The siponimod in Mayzent 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.
Diabetes Mellitus
Moderate:
Mayzent
The siponimod in Mayzent has a moderate potential interaction with Diabetes Mellitus.
Macular edema was reported in 1.8% of patients receiving siponimod treatment, the majority of cases occurring within the first four months of therapy. Patients with a history of uveitis and patients with diabetes mellitus are at increased risk of macular edema during therapy. An ophthalmic evaluation of the fundus, including the macula, is recommended in all patients before starting treatment and at any time if there is any change in vision while taking siponimod. Patients with diabetes mellitus or a history of uveitis should have regular follow-up examinations 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.
Electrolyte Abnormalities
Major:
bedaquiline
Bedaquiline has a major potential interaction with Electrolyte Abnormalities.
Bedaquiline can cause QT prolongation, which may lead to an increased risk for ventricular arrhythmias, including Torsade de Pointes. Use of bedaquiline should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy, hypothyroidism, and in patients with electrolytes abnormalities. It is recommended to obtain an ECG before initiation of treatment, and at least 2, 12, and 24 weeks after starting treatment and to discontinue treatment if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms develops.
Heart Disease
Major:
bedaquiline
Bedaquiline has a major potential interaction with Heart Disease.
Bedaquiline can cause QT prolongation, which may lead to an increased risk for ventricular arrhythmias, including Torsade de Pointes. Use of bedaquiline should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy, hypothyroidism, and in patients with electrolytes abnormalities. It is recommended to obtain an ECG before initiation of treatment, and at least 2, 12, and 24 weeks after starting treatment and to discontinue treatment if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms develops.
Major:
Mayzent
The siponimod in Mayzent has a major potential interaction with Heart Disease.
Siponimod is contraindicated in patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III or IV heart failure. It is also contraindicated in presence of Mobitz type II second- degree, third-degree AV block, or sick sinus syndrome, unless the patient has a functioning pacemaker. Siponimod causes a transient decrease in heart rate and atrioventricular conduction delays, and has not been studied in patients with significant QT prolongation (greater than 500 msec) or arrhythmias requiring Class Ia or Class III antiarrhythmic drugs. If treatment with siponimod is considered in these patients or in patients with ischemic heart disease, heart failure, history of myocardial infarction, cerebrovascular disease or uncontrolled hypertension, an advice from a cardiologist should be sought. It is recommended to obtain a baseline EKG, and to monitor patients very closely.
History - Cerebrovascular Disease
Major:
Mayzent
The siponimod in Mayzent has a major potential interaction with History - Cerebrovascular Disease.
Siponimod is contraindicated in patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III or IV heart failure. It is also contraindicated in presence of Mobitz type II second- degree, third-degree AV block, or sick sinus syndrome, unless the patient has a functioning pacemaker. Siponimod causes a transient decrease in heart rate and atrioventricular conduction delays, and has not been studied in patients with significant QT prolongation (greater than 500 msec) or arrhythmias requiring Class Ia or Class III antiarrhythmic drugs. If treatment with siponimod is considered in these patients or in patients with ischemic heart disease, heart failure, history of myocardial infarction, cerebrovascular disease or uncontrolled hypertension, an advice from a cardiologist should be sought. It is recommended to obtain a baseline EKG, and to monitor patients very closely.
History - Myocardial Infarction
Major:
Mayzent
The siponimod in Mayzent has a major potential interaction with History - Myocardial Infarction.
Siponimod is contraindicated in patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, TIA, decompensated heart failure requiring hospitalization, or Class III or IV heart failure. It is also contraindicated in presence of Mobitz type II second- degree, third-degree AV block, or sick sinus syndrome, unless the patient has a functioning pacemaker. Siponimod causes a transient decrease in heart rate and atrioventricular conduction delays, and has not been studied in patients with significant QT prolongation (greater than 500 msec) or arrhythmias requiring Class Ia or Class III antiarrhythmic drugs. If treatment with siponimod is considered in these patients or in patients with ischemic heart disease, heart failure, history of myocardial infarction, cerebrovascular disease or uncontrolled hypertension, an advice from a cardiologist should be sought. It is recommended to obtain a baseline EKG, and to monitor patients very closely.
Infection
Moderate:
Mayzent
The siponimod in Mayzent has a moderate potential interaction with Infection.
Siponimod causes a dose-dependent reduction in peripheral lymphocyte count to 20%-30% of baseline values because of reversible sequestration of lymphocytes in lymphoid tissues. Initiation of treatment should be delayed in patients with severe active infection until resolution. Before initiating treatment with siponimod, results from a recent complete blood count (i.e., within 6 months or after discontinuation of prior therapy) should be reviewed. Effective diagnostic and therapeutic strategies should be employed in patients with symptoms of infection while on therapy. Suspension of treatment should be considered if a patient develops a serious infection.
Liver Disease
Moderate:
bedaquiline
Bedaquiline has a moderate potential interaction with Liver Disease.
Bedaquiline population pharmacokinetic analysis indicated that mild to moderate hepatic impairment had no significant influence on bedaquiline pharmacokinetics. Close monitoring of liver function is recommended in patients with severe hepatic impairment as the pharmacokinetics of bedaquiline is unknown in these patients.
Moderate:
Mayzent
The siponimod in Mayzent has a moderate potential interaction with Liver Disease.
Elevations of transaminases may occur in siponimod- treated patients, therefore, transaminase and bilirubin levels should be reviewed before initiation of therapy. Patients who develop symptoms suggestive of hepatic dysfunction, such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, rash with eosinophilia, or jaundice and/or dark urine during treatment, should have liver enzymes checked. Siponimod should be discontinued if significant liver injury is confirmed. Although there are no data to establish that patients with preexisting liver disease are at increased risk to develop elevated liver function test values when taking siponimod, caution should be exercised when using the medication in patients with a history of significant liver disease.
Long QT Syndrome
Major:
bedaquiline
Bedaquiline has a major potential interaction with Long QT Syndrome.
Bedaquiline can cause QT prolongation, which may lead to an increased risk for ventricular arrhythmias, including Torsade de Pointes. Use of bedaquiline should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy, hypothyroidism, and in patients with electrolytes abnormalities. It is recommended to obtain an ECG before initiation of treatment, and at least 2, 12, and 24 weeks after starting treatment and to discontinue treatment if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms develops.
Major:
bedaquiline
Bedaquiline has a major potential interaction with Long QT Syndrome.
Bedaquiline causes QT prolongation. Use with drugs that prolong the QT interval may cause additive QT prolongation. Monitor ECG before initiation of treatment, and at least 2, 12, and 24 weeks after starting treatment and obtain serum potassium, calcium, and magnesium at baseline and correct if abnormal. Discontinue bedaquiline if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms. develops. If syncope occurs, obtain an ECG to detect QT prolongation.
Multiple Sclerosis
Moderate:
Mayzent
The siponimod in Mayzent 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.
Renal Dysfunction
Moderate:
bedaquiline
Bedaquiline has a moderate potential interaction with Renal Dysfunction.
No dose adjustment is required for patients with mild or moderate renal impairment. Care should be exercised when using bedaquiline in patients with severe renal impairment or end-stage renal disease requiring hemodialysis or peritoneal dialysis. It is recommended to monitor patients closely for adverse events.
Skin Cancer
Moderate:
Mayzent
The siponimod in Mayzent has a moderate potential interaction with Skin Cancer.
Cases of malignancies, including skin malignancies have been reported in patients treated with some sphingosine -1-receptor (S1P) receptor modulators. Skin examinations are recommended prior and during treatment in all patients, particularly in those with risk factors for skin cancer. Suspicious skin lesions should be promptly evaluated, and patients at increased risk should wear protective clothing and use sunscreen with high protection factor.
Underactive Thyroid
Major:
bedaquiline
Bedaquiline has a major potential interaction with Underactive Thyroid.
Bedaquiline can cause QT prolongation, which may lead to an increased risk for ventricular arrhythmias, including Torsade de Pointes. Use of bedaquiline should be avoided in patients with congenital long QT syndrome, known prolongation of the QTc interval, uncompensated heart failure, or severe left ventricular hypertrophy, hypothyroidism, and in patients with electrolytes abnormalities. It is recommended to obtain an ECG before initiation of treatment, and at least 2, 12, and 24 weeks after starting treatment and to discontinue treatment if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms develops.
Uveitis
Moderate:
Mayzent
The siponimod in Mayzent has a moderate potential interaction with Uveitis.
Macular edema was reported in 1.8% of patients receiving siponimod treatment, the majority of cases occurring within the first four months of therapy. Patients with a history of uveitis and patients with diabetes mellitus are at increased risk of macular edema during therapy. An ophthalmic evaluation of the fundus, including the macula, is recommended in all patients before starting treatment and at any time if there is any change in vision while taking siponimod. Patients with diabetes mellitus or a history of uveitis should have regular follow-up examinations 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.
Vaccination
Moderate:
Mayzent
The siponimod in Mayzent has a moderate potential interaction with Vaccination.
The use of live attenuated vaccines should be avoided while patients are taking siponimod and for 4 weeks after stopping treatment. Vaccinations may be less effective if administered during treatment. Siponimod treatment discontinuation 1 week prior to and until 4 weeks after a planned vaccination is recommended. Additionally, patients without a healthcare professional confirmed history of chickenpox or without documentation of a full course of vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV before initiating siponimod treatment. A full course of vaccination for antibody- negative patients with varicella vaccine is recommended prior to commencing treatment, following which initiation of treatment with siponimod should be postponed for 4 weeks to allow the full effect of vaccination to occur.
Ventricular Arrhythmia
Major:
bedaquiline
Bedaquiline has a major potential interaction with Ventricular Arrhythmia.
Bedaquiline causes QT prolongation. Use with drugs that prolong the QT interval may cause additive QT prolongation. Monitor ECG before initiation of treatment, and at least 2, 12, and 24 weeks after starting treatment and obtain serum potassium, calcium, and magnesium at baseline and correct if abnormal. Discontinue bedaquiline if significant ventricular arrhythmia or if QTcF interval prolongation of greater than 500 ms. develops. If syncope occurs, obtain an ECG to detect QT prolongation.
More resources
bedaquiline
A total of 595 drugs are known to interact with bedaquiline.
- Bedaquiline is in the drug class diarylquinolines.
- Bedaquiline is used to treat Tuberculosis, Resistant.
Mayzent
A total of 779 drugs are known to interact with Mayzent.
- Mayzent is in the drug class selective immunosuppressants.
- Mayzent is used to treat Multiple Sclerosis.
Drug Interaction Classification
| Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. | |
| Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. | |
| Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. | |
| No interaction information available. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.