Interactions between Bedaquiline and Pasireotide
1 drug interaction and 19 additional warnings found for the following 2 drugs:
- bedaquiline
- pasireotide
Drug interactions
Major drug interactions
Major:
pasireotide bedaquiline
Applies to: pasireotide and bedaquiline
Monitor closely
Pasireotide can cause bradycardia and QT prolongation. Theoretically, coadministration with other agents that can prolong the QT interval may result in additive effects and increased risk of ventricular arrhythmias including torsade de pointes and sudden death. In healthy study subjects given therapeutic (0.6 mg twice daily) and supratherapeutic (1.95 mg twice daily) dosages of pasireotide, the maximum mean placebo-subtracted QTcI change from baseline was 12.7 msec and 16.6 msec, respectively. Both dosages decreased heart rate, with a maximum mean placebo-subtracted change from baseline of -10.9 beats per minute (bpm) observed at 1.5 hours for the therapeutic dosage and -15.2 bpm at 0.5 hours for the supratherapeutic dosage. The mean steady-state peak plasma concentration (Cmax) produced by the supratherapeutic dosage was 3.3-fold that observed with the therapeutic dosage. In clinical studies of patients with Cushing's disease, two of 201 patients experienced single occurrences of QTcF exceeding 500 msec. Torsade des pointes arrhythmias were not observed in these or other studies. 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
Caution is recommended if pasireotide is used in combination with other drugs that can prolong the QT interval. ECG and serum electrolytes, including potassium, magnesium and calcium, should be monitored before starting pasireotide therapy and periodically during treatment in accordance with the product labeling. Hypokalemia and hypomagnesemia must be corrected prior to pasireotide administration. Patients should be advised to seek prompt medical attention if they experience symptoms that could indicate the occurrence of torsade de pointes such as dizziness, lightheadedness, fainting, palpitation, irregular heart rhythm, shortness of breath, or syncope.
References (4)
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Canadian Pharmacists Association (2006) e-CPS. http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink
- Cerner Multum, Inc. "Australian Product Information."
- (2013) "Product Information. Signifor (pasireotide)." 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
18 potential interactions Applies to: 13 conditions, including Underactive Thyroid, Arrhythmia, Hypokalemia, Heart Disease, and Diabetes Mellitus.
Adrenal Insufficiency
Moderate:
pasireotide
Pasireotide has a moderate potential interaction with Adrenal Insufficiency.
Treatment with somatostatin analogs may suppress the pituitary hormones other than GH/IGF-1. It is recommended to monitor pituitary function prior to initiation of therapy and periodically during treatment, as clinically appropriate. Patients should be monitored for and instructed on the signs and symptoms of adrenal insufficiency during therapy. If adrenal insufficiency is suspected it should be confirmed and treated per standard of care with exogenous glucocorticoids at replacement doses.
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.
Arrhythmia
Moderate:
pasireotide
Pasireotide has a moderate potential interaction with Arrhythmia.
The use of pasireotide is associated with QT prolongation. Pasireotide should be used with caution in patients who are at significant risk of developing QT prolongation. It is recommended to correct levels of hypokalemia and hypomagnesemia prior to starting therapy with this agent. Assess ECG at the beginning of therapy and monitor during therapy. Care should be taken in predisposed patients.
Diabetes Mellitus
Moderate:
pasireotide
Pasireotide has a moderate potential interaction with Diabetes Mellitus.
Elevations in blood glucose levels have been reported with the use of somatostatin analogs. Cushing's disease patients with poor glycemic control may be at a higher risk of developing severe hyperglycemia and associated complications, e.g., ketoacidosis. It is recommended to assess the glycemic status of hemoglobin A1C prior to starting treatment with these agents. Self-monitoring of blood glucose and/or FPG assessments should be done every week for the first two to three months and periodically thereafter, as clinically appropriate, as well as over the first two to four weeks after any dose increase. If uncontrolled hyperglycemia persists, despite appropriate medical management, the dose of these agents should be reduced or discontinued.
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.
Moderate:
pasireotide
Pasireotide has a moderate potential interaction with Electrolyte Abnormalities.
The use of pasireotide is associated with QT prolongation. Pasireotide should be used with caution in patients who are at significant risk of developing QT prolongation. It is recommended to correct levels of hypokalemia and hypomagnesemia prior to starting therapy with this agent. Assess ECG at the beginning of therapy and monitor during therapy. Care should be taken in predisposed patients.
Gallbladder Disease
Moderate:
pasireotide
Pasireotide has a moderate potential interaction with Gallbladder Disease.
Somatostatin analogs may reduce gallbladder motility and lead to gallstones formation. It is recommended to assess the gallbladder prior to starting therapy and periodically thereafter.
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.
Moderate:
pasireotide
Pasireotide has a moderate potential interaction with Heart Disease.
Bradycardia has been reported with the use of somatostatin analogs. It is recommended to carefully monitor patients with cardiac disorders for the development of bradycardia. Dose adjustments of beta-blockers, calcium channel blockers, or correction of electrolyte disturbances may be necessary. Care should be taken when initiating treatment with these agents in patients with bradycardia.
Hypokalemia
Moderate:
pasireotide
Pasireotide has a moderate potential interaction with Hypokalemia.
The use of pasireotide is associated with QT prolongation. Pasireotide should be used with caution in patients who are at significant risk of developing QT prolongation. It is recommended to correct levels of hypokalemia and hypomagnesemia prior to starting therapy with this agent. Assess ECG at the beginning of therapy and monitor during therapy. Care should be taken in predisposed patients.
Liver Disease
Major:
pasireotide
Pasireotide has a major potential interaction with Liver Disease.
The use of pasireotide causes elevations in ALT or AST. No dose adjustment is required in patients with mild hepatic impairment, but is required for patients with moderate hepatic impairment. The use of pasireotide should be avoided in patients with severe hepatic impairment. Regular monitoring of liver function test is recommended and interruption of treatment should be considered if abnormal values exceeding 5 times ULN or rising values are obtained during the course of therapy.
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.
Long QT Syndrome
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.
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.
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.
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.
Moderate:
pasireotide
Pasireotide has a moderate potential interaction with Underactive Thyroid.
Bradycardia has been reported with the use of somatostatin analogs. It is recommended to carefully monitor patients with cardiac disorders for the development of bradycardia. Dose adjustments of beta-blockers, calcium channel blockers, or correction of electrolyte disturbances may be necessary. Care should be taken when initiating treatment with these agents in patients with bradycardia.
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.
pasireotide
A total of 426 drugs are known to interact with pasireotide.
- Pasireotide is in the drug class somatostatin and somatostatin analogs.
- Pasireotide is used to treat the following conditions:
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
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