bedaquiline (Rx)

Brand and Other Names:Sirturo
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Dosing & Uses

AdultPediatric

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
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Interactions

Interaction Checker

and bedaquiline

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      Serious - Use Alternative

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            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 (98)

            • 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.

            • 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.

            • 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.

            • 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.

            • deutetrabenazine

              bedaquiline and deutetrabenazine 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.

            • 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

            • 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.

            • 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

            • 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 (123)

            • 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

            • 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

            • 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

            • 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

            • 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.

            • 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 (0)

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              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

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              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
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              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.

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              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

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              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

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              Images

              No images available for this drug.
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              Patient Handout

              Patient Education
              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 tube from the nose to the stomach. 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 persist or worsen, 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 dark urine, persistent nausea/vomiting/loss of appetite, 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.Laboratory and/or medical tests (such as liver function, EKG, potassium/calcium/magnesium levels) should be performed before you start treatment and periodically to monitor your progress or check for side effects. 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 October 2021. Copyright(c) 2021 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.

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              Formulary

              FormularyPatient Discounts

              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.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              Tier Description
              1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
              2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
              3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
              4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
              NC NOT COVERED – Drugs that are not covered by the plan.
              Code Definition
              PA Prior Authorization
              Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
              QL Quantity Limits
              Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
              ST Step Therapy
              Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
              OR Other Restrictions
              Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.