Dosing & Uses
Dosage Forms & Strengths
tablet
- 20mg (functionally scored)
- 100mg
Multidrug Resistant Pulmonary Tuberculosis
Diarylquinoline antimycobacterial indicated as part of combination therapy for pulmonary multidrug resistant tuberculosis (MDR-TB); reserve bedaquiline for when an effective treatment TB regimen cannot otherwise be provided
Only use in combination with at least 3 other drugs to which the patient’s MDR-TB isolate has been shown to be susceptible in vitro; if in vitro testing results are unavailable, may be initiated in combination with at least 4 other drugs to which the patient’s MDR-TB isolate is likely to be susceptible
Weeks 1-2: 400 mg PO qDay for 2 weeks, THEN
Weeks 3-24: 200 mg 3 times/week with at least 48 hr between doses
CDC provisional guidelines
- May be used off-label on a case-by-case basis in children, HIV-infected persons, pregnant women, persons with extrapulmonary MDR TB, and patients with comorbid conditions on concomitant medications when an effective treatment regimen cannot otherwise be provided
- May be used on a case-by-case basis for durations longer than 24 weeks when an effective treatment regimen cannot be provided otherwise
- Reference: MMWR Recommendations and Reports. October 25, 2013/62(rr9);1-12
Dosage Modifications
Renal impairment
- Mild-to-moderate: No dosage adjustment required
- Severe or end-stage renal disease requiring hemodialysis or peritoneal dialysis: Use with caution; if used, monitor for adverse reactions of bedaquiline
Hepatic impairment
- Mild or moderate (Child-Pugh A or B): No dosage adjustment required
- Severe (Child-Pugh C): Not studied; use only if benefits outweigh risks
Dosing Considerations
Limitations of use
- Latent infection due to Mycobacterium tuberculosis
- Drug-sensitive tuberculosis
- Extra-pulmonary tuberculosis
- Infections cause by nontuberculous mycobacteria
Nontuberculosis Mycobacteria Infection (Orphan)
Orphan designation for treatment of nontuberculosis mycobacteria infection
Orphan sponsor
- Janssen Research & Development, LLC; 125 Trenton-Harbourton Road; Titusville, New Jersey 08560
Dosage Forms & Strengths
tablet
- 20mg (functionally scored)
- 100mg
Multidrug Resistant Pulmonary Tuberculosis
Diarylquinoline antimycobacterial indicated as part of combination therapy for pulmonary multidrug resistant tuberculosis (MDR-TB); reserve bedaquiline for when an effective treatment TB regimen cannot otherwise be provided
Only use in combination with at least 3 other drugs to which the patient’s MDR-TB isolate has been shown to be susceptible in vitro; if in vitro testing results are unavailable, may be initiated in combination with at least 4 other drugs to which the patient’s MDR-TB isolate is likely to be susceptible
<5 years: Safety and efficacy not established
≥5 years
-
Weight ≥30 kg
- Weeks 1-2: 400 mg PO qDay for 2 weeks, THEN
- Weeks 3-24: 200 mg 3 times/week with at least 48 hr between doses
-
Weight 15 to <30 kg
- Weeks 1-2: 200 mg PO qDay for 2 weeks, THEN
- Weeks 3-24: 100 mg 3 times/week with at least 48 hr between doses
CDC provisional guidelines
- May be used off-label on a case-by-case basis in children, HIV-infected persons, pregnant women, persons with extrapulmonary MDR TB, and patients with comorbid conditions on concomitant medications when an effective treatment regimen cannot otherwise be provided
- May be used on a case-by-case basis for durations longer than 24 weeks when an effective treatment regimen cannot be provided otherwise
- Reference: MMWR Recommendations and Reports. October 25, 2013/62(rr9);1-12
Dosage Modifications
Renal impairment
- Mild-to-moderate: No dosage adjustment required
- Severe or end-stage renal disease requiring hemodialysis or peritoneal dialysis: Use with caution; if used, monitor for adverse reactions of bedaquiline
Dosing Considerations
Limitations of use
- Latent infection due to Mycobacterium tuberculosis
- Drug-sensitive tuberculosis
- Extra-pulmonary tuberculosis
- Infections cause by nontuberculous mycobacteria
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (1)
- lefamulin
lefamulin will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Lefamulin is contraindicated with CYP3A substrates know to prolong the QT interval.
Serious - Use Alternative (107)
- abametapir
abametapir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.
- adagrasib
adagrasib, bedaquiline. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Each drug prolongs the QTc interval, which may increased the risk of Torsade de pointes, other serious arryhthmias, and sudden death. If coadministration unavoidable, more frequent monitoring is recommended for such patients.
- amisulpride
amisulpride and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.
- amobarbital
amobarbital will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- anagrelide
bedaquiline and anagrelide both increase QTc interval. Avoid or Use Alternate Drug.
- apalutamide
apalutamide will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.
- aripiprazole
aripiprazole and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- artemether
artemether and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- atazanavir
atazanavir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- atomoxetine
atomoxetine and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- BCG intravesical live
BCG intravesical live decreases effects of bedaquiline by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid concomitant use of intravesical BCG and antibiotics, particulary those given via IV or oral routes and those with activity against mycobacteria.
- BCG vaccine live
BCG vaccine live decreases effects of bedaquiline by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Avoid concomitant use of intravesical BCG and antibiotics, particulary those given via IV or oral routes and those with activity against mycobacteria.
- bosentan
bosentan will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- buprenorphine
bedaquiline and buprenorphine both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine buccal
buprenorphine buccal and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine subdermal implant
buprenorphine subdermal implant and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine transdermal
buprenorphine transdermal and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine, long-acting injection
buprenorphine, long-acting injection and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- carbamazepine
carbamazepine will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- ceritinib
ceritinib and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
ceritinib will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. - chloramphenicol
chloramphenicol will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- chloroquine
chloroquine increases toxicity of bedaquiline by QTc interval. Avoid or Use Alternate Drug.
- clarithromycin
clarithromycin will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- cobicistat
cobicistat will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- conivaptan
conivaptan will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- darunavir
darunavir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- desflurane
desflurane and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- dexamethasone
dexamethasone will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- donepezil
donepezil and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- efavirenz
efavirenz will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
efavirenz and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug. - eliglustat
bedaquiline and eliglustat both increase QTc interval. Avoid or Use Alternate Drug.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
elvitegravir/cobicistat/emtricitabine/tenofovir DF will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- encorafenib
bedaquiline and encorafenib both increase QTc interval. Avoid or Use Alternate Drug.
- entrectinib
entrectinib and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- enzalutamide
enzalutamide will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- eribulin
bedaquiline and eribulin both increase QTc interval. Avoid or Use Alternate Drug.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- etravirine
etravirine will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- fexinidazole
fexinidazole and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.
fexinidazole will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates. - fingolimod
fingolimod and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- fosamprenavir
fosamprenavir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- fosphenytoin
fosphenytoin will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- gadobenate
gadobenate and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- gemtuzumab
bedaquiline and gemtuzumab both increase QTc interval. Avoid or Use Alternate Drug.
- gilteritinib
bedaquiline and gilteritinib both increase QTc interval. Avoid or Use Alternate Drug.
- glasdegib
bedaquiline and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.
- granisetron
bedaquiline and granisetron both increase QTc interval. Avoid or Use Alternate Drug.
- hydroxychloroquine sulfate
hydroxychloroquine sulfate and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- hydroxyzine
bedaquiline and hydroxyzine both increase QTc interval. Avoid or Use Alternate Drug.
- idelalisib
idelalisib will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates
- imatinib
imatinib will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- indinavir
indinavir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- inotuzumab
inotuzumab and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.
- isoflurane
bedaquiline and isoflurane both increase QTc interval. Avoid or Use Alternate Drug.
- isoniazid
isoniazid will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- itraconazole
itraconazole will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
bedaquiline and itraconazole both increase QTc interval. Avoid or Use Alternate Drug. - ivosidenib
ivosidenib and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.
ivosidenib will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs. - ketoconazole
ketoconazole will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- lefamulin
bedaquiline and lefamulin both increase QTc interval. Avoid or Use Alternate Drug.
- levoketoconazole
levoketoconazole will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- lithium
bedaquiline and lithium both increase QTc interval. Avoid or Use Alternate Drug.
- lofexidine
bedaquiline and lofexidine both increase QTc interval. Avoid or Use Alternate Drug.
- lonafarnib
lonafarnib will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.
- loperamide
bedaquiline and loperamide both increase QTc interval. Avoid or Use Alternate Drug.
- lopinavir
lopinavir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- lorlatinib
lorlatinib will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- macimorelin
macimorelin and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.
- midostaurin
bedaquiline and midostaurin both increase QTc interval. Avoid or Use Alternate Drug.
- mirtazapine
bedaquiline and mirtazapine both increase QTc interval. Avoid or Use Alternate Drug.
- mobocertinib
mobocertinib and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.
- nafcillin
nafcillin will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- nefazodone
nefazodone will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- nelfinavir
nelfinavir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- nevirapine
nevirapine will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- nicardipine
nicardipine will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- oxaliplatin
bedaquiline and oxaliplatin both increase QTc interval. Avoid or Use Alternate Drug.
- oxcarbazepine
oxcarbazepine will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- panobinostat
bedaquiline and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.
- pentobarbital
pentobarbital will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- phenobarbital
phenobarbital will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- phenytoin
phenytoin will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- pimavanserin
bedaquiline and pimavanserin both increase QTc interval. Avoid or Use Alternate Drug.
- pitolisant
bedaquiline and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.
- ponesimod
ponesimod, bedaquiline. Either increases effects of the other by QTc interval. Avoid or Use Alternate Drug. Consult cardiologist if considering treatment. Generally, should not be initiated in patients who are concurrently taking QT prolonging drugs with known arrhythmogenic properties, such as HR-lowering calcium channel blockers (eg, verapamil, diltiazem).
bedaquiline and ponesimod both increase QTc interval. Avoid or Use Alternate Drug. - posaconazole
posaconazole will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- primaquine
primaquine and bedaquiline both increase QTc interval. Avoid or Use Alternate Drug.
- primidone
primidone will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- quinidine
quinidine will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- ribociclib
ribociclib will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
ribociclib increases toxicity of bedaquiline by QTc interval. Avoid or Use Alternate Drug. - rifabutin
rifabutin will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- rifampin
rifampin will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- rifapentine
rifapentine will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inducers due to potential for decreased therapeutic effect
- rilpivirine
bedaquiline and rilpivirine both increase QTc interval. Avoid or Use Alternate Drug.
- ritonavir
ritonavir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- saquinavir
saquinavir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- secobarbital
secobarbital will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.
- sevoflurane
bedaquiline and sevoflurane both increase QTc interval. Avoid or Use Alternate Drug.
- siponimod
bedaquiline and siponimod both increase QTc interval. Avoid or Use Alternate Drug.
- tetrabenazine
bedaquiline and tetrabenazine both increase QTc interval. Avoid or Use Alternate Drug.
- tipranavir
tipranavir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- trazodone
bedaquiline and trazodone both increase QTc interval. Avoid or Use Alternate Drug.
- triclabendazole
bedaquiline and triclabendazole both increase QTc interval. Avoid or Use Alternate Drug.
- tucatinib
tucatinib will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
- umeclidinium bromide/vilanterol inhaled
bedaquiline increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- vilanterol/fluticasone furoate inhaled
bedaquiline increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.
- voriconazole
voriconazole will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of bedaquiline with strong CYP3A4 inhibitors for >14 consecutive days, unless the benefit of treatment outweighs the risk
- voxelotor
voxelotor will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.
Monitor Closely (129)
- albuterol
albuterol and bedaquiline both increase QTc interval. Use Caution/Monitor.
- alfuzosin
alfuzosin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- amiodarone
amiodarone and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- amitriptyline
amitriptyline and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- amoxapine
amoxapine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- apomorphine
apomorphine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- arformoterol
arformoterol and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- arsenic trioxide
arsenic trioxide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- artemether/lumefantrine
artemether/lumefantrine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- asenapine
asenapine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- asenapine transdermal
asenapine transdermal and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- azithromycin
azithromycin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- belzutifan
belzutifan will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.
- bosutinib
bosutinib and bedaquiline both increase QTc interval. Use Caution/Monitor.
- capecitabine
capecitabine and bedaquiline both increase QTc interval. Use Caution/Monitor.
- cenobamate
cenobamate will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
- chlorpromazine
chlorpromazine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- ciprofloxacin
ciprofloxacin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- citalopram
citalopram and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- clarithromycin
clarithromycin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- clomipramine
clomipramine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- clozapine
clozapine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- crizotinib
crizotinib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- crofelemer
crofelemer increases levels of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Crofelemer has the potential to inhibit CYP3A4 at concentrations expected in the gut; unlikely to inhibit systemically because minimally absorbed.
- dabrafenib
dabrafenib will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.
- dasatinib
dasatinib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- degarelix
degarelix and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- desipramine
desipramine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- deutetrabenazine
bedaquiline and deutetrabenazine both increase QTc interval. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
- disopyramide
disopyramide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- dofetilide
dofetilide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- dolasetron
dolasetron and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- doxepin
doxepin and bedaquiline both increase QTc interval. Use Caution/Monitor.
- dronedarone
dronedarone and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- droperidol
droperidol and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- elagolix
elagolix will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.
- encorafenib
encorafenib, bedaquiline. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.
- erythromycin base
erythromycin base and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- erythromycin ethylsuccinate
erythromycin ethylsuccinate and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- erythromycin lactobionate
erythromycin lactobionate and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- erythromycin stearate
erythromycin stearate and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- escitalopram
escitalopram and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- ezogabine
ezogabine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- fedratinib
fedratinib will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- flecainide
flecainide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- floxuridine
floxuridine and bedaquiline both increase QTc interval. Use Caution/Monitor.
- fluconazole
fluconazole and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- fluoxetine
fluoxetine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- fluphenazine
fluphenazine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- formoterol
formoterol and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- foscarnet
foscarnet and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- fostemsavir
bedaquiline and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.
- gemifloxacin
gemifloxacin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- goserelin
goserelin increases toxicity of bedaquiline by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- haloperidol
haloperidol and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- histrelin
histrelin increases toxicity of bedaquiline by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- ibutilide
ibutilide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- iloperidone
iloperidone and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
iloperidone increases levels of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Iloperidone is a time-dependent CYP3A inhibitor and may lead to increased plasma levels of drugs predominantly eliminated by CYP3A4. - indapamide
indapamide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- isradipine
isradipine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- istradefylline
istradefylline will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.
- lapatinib
lapatinib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- lenvatinib
bedaquiline and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- leuprolide
leuprolide increases toxicity of bedaquiline by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- levalbuterol
bedaquiline and levalbuterol both increase QTc interval. Use Caution/Monitor.
- levofloxacin
levofloxacin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- lopinavir
lopinavir and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- lumefantrine
lumefantrine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- maprotiline
maprotiline and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- mefloquine
mefloquine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- methadone
methadone and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- mifepristone
mifepristone and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
mifepristone will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Avoid concurrent use of bedaquiline for more than 14 days unless benefits justify risks - mitotane
mitotane decreases levels of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.
- moxifloxacin
moxifloxacin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- nilotinib
nilotinib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- nirmatrelvir
nirmatrelvir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor for bedaquiline adverse effects (eg, QT prolongation).
- nirmatrelvir/ritonavir
nirmatrelvir/ritonavir will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor for bedaquiline adverse effects (eg, QT prolongation).
- nortriptyline
nortriptyline and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- octreotide
octreotide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- octreotide (Antidote)
octreotide (Antidote) and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- ofloxacin
ofloxacin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- olanzapine
olanzapine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- ondansetron
ondansetron and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- osilodrostat
osilodrostat and bedaquiline both increase QTc interval. Use Caution/Monitor.
- osimertinib
osimertinib and bedaquiline both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.
- oxaliplatin
oxaliplatin will increase the level or effect of bedaquiline by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.
- ozanimod
ozanimod and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.
- paliperidone
paliperidone and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- pasireotide
pasireotide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- pazopanib
pazopanib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- pentamidine
pentamidine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- perphenazine
perphenazine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- pimozide
pimozide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- posaconazole
posaconazole and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- procainamide
procainamide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- propafenone
propafenone and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- protriptyline
protriptyline and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- quetiapine
quetiapine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- quinidine
quinidine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- quinine
quinine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- ranolazine
ranolazine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- risperidone
risperidone and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- romidepsin
romidepsin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- rucaparib
rucaparib will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- saquinavir
saquinavir and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- selpercatinib
selpercatinib increases toxicity of bedaquiline by QTc interval. Use Caution/Monitor.
- sertraline
sertraline and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- solifenacin
solifenacin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- sorafenib
sorafenib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- sotalol
sotalol and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- stiripentol
stiripentol, bedaquiline. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.
- sunitinib
sunitinib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- tacrolimus
tacrolimus and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- tazemetostat
tazemetostat will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- tecovirimat
tecovirimat will decrease the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.
- telavancin
telavancin and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- thioridazine
thioridazine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- thiothixene
thiothixene and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- toremifene
toremifene and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- trimipramine
trimipramine and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- triptorelin
triptorelin increases toxicity of bedaquiline by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- valbenazine
valbenazine and bedaquiline both increase QTc interval. Use Caution/Monitor.
- vandetanib
vandetanib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- vardenafil
vardenafil and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- vemurafenib
vemurafenib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- voclosporin
voclosporin, bedaquiline. Either increases effects of the other by QTc interval. Use Caution/Monitor.
- voriconazole
voriconazole and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- vorinostat
vorinostat and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
- ziprasidone
ziprasidone and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely
Minor (4)
- acetazolamide
acetazolamide will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- cyclophosphamide
cyclophosphamide will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- larotrectinib
larotrectinib will increase the level or effect of bedaquiline by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
Adverse Effects
>10%
Adults
- Nausea (38%)
- Arthralgia (33%)
- Headache (28%)
- Chest pain (11%)
Pediatrics
- Arthralgia (40%)
- Nausea (13%)
- Abdominal pain (13%)
1-10%
Adults
- Anorexia (9%)
- Rash (8%)
Adults or children
- Transaminases increased (9%)
- Blood amylase increased (3%)
Frequency Not Defined
QT prolongation
Warnings
Black Box Warnings
An increased risk of death was seen in the bedaquiline treatment group (9/79, 11.4%) compared to the placebo treatment group (2/81, 2.5%) in 1 clinical trial
Only use when an effective treatment regimen cannot otherwise be provided
QT prolongation can occur; coadministration with drugs that prolong the QT interval may cause additive QT prolongation
Contraindications
None
Cautions
Increased risk of death in bedaquiline treatment group
Administered by directly observed therapy (DOT)
Potential for development of resistance to bedaquiline in M tuberculosis exists; must only be used in an appropriate combination regimen fo treatment of pulmonary MDR-TB to reduce risk of developing resistance
Hepatotoxicity
- Hepatic-related adverse effects increased when bedaquiline added to multidrug regimen; avoid alcohol and other hepatotoxic drugs, especially in patients with hepatic impairment
- Monitor symptoms (eg, fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) and laboratory tests (ALT, AST, alkaline phosphatase, and bilirubin) at baseline, monthly while on treatment, and as needed; test for viral hepatitis and discontinue other hepatotoxic medications if evidence of new or worsening liver dysfunction occurs
- Monitor ALT, AST, Alkaline phosphatase, and bilirubin at baseline, and monthly while on treatment
-
Discontinue if
- Aminotransferase increases are accompanied by total bilirubin elevation >2x ULN
- Aminotransferase elevations >8x ULN
- Aminotransferase elevations persist beyond 2 weeks
QT prolongation
- Prolongs QT interval; obtain ECG before initiating treatment and at least 2, 12, and 24 weeks after starting treatment
- Obtain baseline serum levels for potassium, calcium, and magnesium and correct if abnormal; follow-up electrolyte monitoring if QT prolongation detected
-
Increased risk for QT prolongation with
- Coadministration with QT prolonging drugs (eg, fluoroquinolones, macrolides, clofazimine)
- History of Torsade de Pointes, congenital long-QT syndrome, uncompensated heart failure, or hypothyroidism with bradyarrhythmias
-
Discontinue bedaquiline and other QT prolonging drugs if the following develops
- Clinically significant ventricular arrhythmia
- QTcF interval >500 ms
- Monitor ECG to confirm QT interval returned to baseline
- If syncope occurs, obtain ECG
Drug interaction overview
- May prolong QT interval; assess thoroughly and if possible, avoid coadministration with other drugs that prolong QT interval
- Metabolized by CYP3A4; avoid strong CYP3A4 inducers (eg, rifampin, rifapentine, rifabutin) and antiretroviral drugs that are moderate inducers (eg, efavirenz) that may reduce bedaquiline’s effect
- Coadministration with CYP3A4 inhibitors may increase systemic exposure and result in adverse effects; avoid coadministration with strong CYP3A4 inhibitors >14 consecutive days, unless the benefit of treatment outweighs the risk
- Use bedaquiline with caution when coadministered with lopinavir/ritonavir and only if the benefit outweighs the risk
- There are no clinical data on the combined use of antiretroviral agents and bedaquiline in HIV/MDR-TB coinfected patients and only limited clinical data on use in HIV/MDR-TB coinfected patients not receiving antiretroviral therapy
Pregnancy & Lactation
Pregnancy
Available data from published literature of use in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Clinical considerations
- Active tuberculosis in pregnancy is associated with adverse maternal and neonatal outcomes including, maternal anemia, caesarean delivery, preterm birth, low birth weight, birth asphyxia, and perinatal infant death
Animal studies
- Reproduction studies in rats and rabbits revealed no evidence of harm to fetuses of pregnant rats and rabbits during organogenesis at exposures up to 6x the clinical dose based on AUC comparisons
Lactation
No data are available regarding presence in human milk
Monitor infants exposed for signs of bedaquiline-related adverse reactions (eg, hepatotoxicity)
Animal studies
- Bedaquiline concentrations in rat milk were 6-fold to 12-fold higher than the maximum concentration observed in maternal plasma at exposures 1-2x the clinical exposure (based on AUC comparisons)
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Diarylquinoline; inhibits mycobacterial adenosine 5'-triphosphate (ATP) synthase, an enzyme essential for the generation of energy in Mycobacterium tuberculosis
Absorption
Bioavailability: Increased 2-fold when taken with standard meal compared with fasted conditions
Peak plasma time
- Adults: 5 hr
- Age 14-18 years: 4 hr
Plasma concentrations
-
Peak
- Adults: 1659 ng/mL
- Age 14-18 years: 1800 ng/mL
-
Minimum
- Adults: 654 ng/mL
- Age 14-18 years: 544 ng/mL
AUC
Adults: 25,863 ng⋅hr/mL
Age 14-18 years: 26,300 ng⋅hr/mL
Distribution
Protein Bound: >99.9%
Vd: 164 L
Metabolism
Metabolized primarily by CYP3A4 to form N-monodesmethyl metabolite (M2) which is 4- to 6-times less active
Elimination
Half-life: 5.5 months (mean terminal half-life of bedaquiline and the M2 metabolite from peripheral tissues)
Renal clearance: <0.001%
Excretion: Mainly in feces
Administration
Oral Administration
Administer by directly observed therapy (DOT)
Only use in combination with at least 3 other drugs to which the patient’s MDR-TB isolate has been shown to be susceptible in vitro
Must take with food
Swallow 100-mg tablets whole with water
20-mg tablets: Functionally scored tablets that can be split into 2 equal halves of 10 mg each
Missed dose
- During first 2 weeks of treatment: Do not make up the missed dose but continue the usual dosing schedule
- From week 3 onwards: If dose is missed, patients should take the missed dose as soon as possible, and then resume the 3 times/week regimen
- Total dose during a 7-day period should not exceed the recommended weekly dose (with at least 24 hr between each dose)
Patients unable to swallow 20-mg tablet(s)
-
Disperse in water and administer with beverage or soft food
- Disperse tablets in water (maximum of 5 tablets in 5 mL of water) in a drinking cup
- Mix contents well until tablets are completely dispersed and then orally administer immediately with food To aid with administration, dispersed mixture can be further mixed with at least 5 mL of beverage (eg, water, milk products, apple juice, orange juice, cranberry juice, carbonated beverage) or 1 teaspoonful of soft food (eg, yogurt, apple sauce, mashed banana, porridge) and then orally administer the contents of the cup immediately
- If total dose requires >5 tablets, repeat above preparation steps with appropriate number of additional tablets until the desired dose is reached
- Ensure no tablet residue is left in cup, rinse with beverage or add more soft food and orally administer contents immediately
-
Crush and mix with soft food
- 20-mg tablet can be crushed and mixed with soft food (eg, yogurt, apple sauce, mashed banana, porridge) immediately before administration
- Ensure no tablet residue is left in container, add more soft food and administer the contents immediately
-
Administration via NG tube (8 French or greater)
- Disperse <5 tablets in 50-mL of noncarbonated water and mix well
- Mixture should be white to almost white with visible particles expected
- Administer through the nasogastric tube immediately
- Repeat with additional tablets until desired dose is reached
- Rinse and flush with 25 mL of additional water to ensure no tablet residue is left in materials used for preparation or the nasogastric tube
Storage
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
Protect from light and moisture
Keep container tightly closed
20-mg tablets: Store in original container; bottle contains desiccant (do not discard)
100-mg tablets: Dispense in original container; store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months
Images
Patient Handout
bedaquiline oral
BEDAQUILINE - ORAL
(bed-AK-wi-leen)
COMMON BRAND NAME(S): Sirturo
WARNING: This medication may increase the risk of death. It should only be used when other treatments have not worked.Bedaquiline may cause a condition that affects the heart rhythm (QT prolongation). The risk of QT prolongation may be increased if you are taking other drugs that may cause QT prolongation. (See also Precautions section).
USES: This medication must be used with other medications to treat active multi-drug-resistant tuberculosis (TB) of the lungs in people with limited treatment options. Bedaquiline belongs to a class of drugs known as antibiotics. It works by stopping the growth of the bacteria that causes TB.This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking bedaquiline and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with food as directed by your doctor, usually once daily for the first 2 weeks, followed by 3 times a week for the next 22 weeks. The dosage is based on your medical condition, age, and response to treatment. Children's dosage is also based on weight.The manufacturer directs to swallow the 100-milligram tablets whole. However, many similar drugs (immediate-release tablets) can be split/crushed. Follow your doctor's direction on how to take this medication.If you are using the 20-milligram tablets and do not have trouble swallowing tablets, swallow the tablets (whole or split) with water.If you are using the 20-milligram tablets and have trouble swallowing tablets, you may take your dose 2 different ways: (1) Add your dose (up to 5 tablets) to 1 teaspoonful (5 milliliters) of water in a cup and mix well. You can then either swallow the mixture right away, or you can add the mixture to at least 1 teaspoonful (5 milliliters) of beverage or soft food and take right away. Examples of beverages you can take this with include water, milk products, apple juice, orange juice, cranberry juice, or carbonated beverages. Soft foods such as yogurt, apple sauce, mashed banana, or porridge may also be used. Make sure to take all of your dose by rinsing the cup with beverage or soft food and swallowing right away. (2) Crush tablets and mix with soft food. Soft foods such as yogurt, apple sauce, mashed banana, or porridge may be used. Mix well and take all of the mixture right away. Make sure to take all of your dose by adding more soft food and swallowing right away. Do not prepare a mixed dose ahead of time.The 20-milligram tablets may also be given through a feeding tube. For specific directions, ask your health care professional.For the best effect, take this antibiotic at evenly spaced times. If you are taking this medication daily, take it at the same time each day. If you are taking this medication 3 times a week, take it at least 48 hours apart on the same days of the week (for example, Mondays, Wednesdays, and Fridays) at the same time of day. Mark the days on the calendar when you need to take the medication.Continue to take this medication (and other TB medications) until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early or skipping doses may allow bacteria to continue to grow, which may result in a return of the infection.Tell your doctor if your condition lasts or gets worse.
SIDE EFFECTS: See also Warning section.Nausea, joint pain, and headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: symptoms of liver damage (such as nausea/vomiting that doesn't stop, loss of appetite, dark urine, stomach/abdominal pain, yellowing eyes/skin).Get medical help right away if you have any very serious side effects, including: coughing up blood, chest pain, fast/irregular heartbeat, severe dizziness, fainting.Bedaquiline can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Tell your doctor right away if you develop any rash.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking bedaquiline, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease.Bedaquiline may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using bedaquiline, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using bedaquiline safely.Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.Bedaquiline may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using bedaquiline before having any immunizations/vaccinations.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Other medications can affect the removal of bedaquiline from your body, which may affect how bedaquiline works. Examples include efavirenz, rifamycins (such as rifampin, rifapentine), among others.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.Lab and/or medical tests (such as liver function, EKG, potassium/calcium/magnesium levels) should be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a daily dose during the first 2 weeks of treatment, skip the missed dose. Take your next dose at the regular time.If you miss a dose from week 3 onward, take it as soon as you remember, then go back to your usual 3-times-a-week dosing schedule. Make sure that there is at least 24 hours between your doses and that you do not take more than the weekly dose in a 7-day period. If you are unsure of what to do after a missed dose, talk to your doctor or pharmacist.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Store the 20-milligram tablets in the original container. Keep the desiccant (drying agent) in the bottle and close the bottle tightly after each use to protect from moisture.Store the 100-milligram tablets in the original container. If necessary, the 100-milligram tablets may be stored in another container for up to 3 months. Close the bottle tightly after each use to protect from light.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
