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Sirturo
bedaquiline
Black Box Warnings .
QT Prolongation
can occur; use with drugs that also prolong QT interval may cause additive QT prolongation; monitor ECG; D/C if significant ventricular arrhythmia or for QT interval >500 msec
Adult Dosing .
Dosage forms: TAB: 20 mg, 100 mg
tuberculosis, pulmonary
- [multi-drug resistant]
- Dose: 400 mg PO qd x2wk, then 200 mg PO 3x/wk x22wk; Info: administer by directly observed tx; give 3x/wk doses at least 48h apart; part of multi-drug regimen; see pkg insert for missed dose recommendations; give with food
- [multi-drug resistant, tx-intolerant or nonresponsive (off-label)]
- Dose: 400 mg PO qd x2wk, then 200 mg PO 3x/wk x24wk; Alt: 200 mg PO qd x8wk, then 100 mg PO qd x18wk; Info: give with pretomanid and linezolid; administer by directly observed tx; give 3x/wk doses at least 48h apart; see pretomanid pkg insert for missed dose and D/C recommendations; may continue beyond 26wk; give with food
- [extensively drug resistant (off-label)]
- Dose: 400 mg PO qd x2wk, then 200 mg PO 3x/wk x24wk; Alt: 200 mg PO qd x8wk, then 100 mg PO qd x18wk; Info: give with pretomanid and linezolid; administer by directly observed tx; give 3x/wk doses at least 48h apart; see pretomanid pkg insert for missed dose and D/C recommendations; may continue beyond 26wk; give with food
renal dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined, caution advised, consider monitoring bedaquiline levels
- HD/PD: not defined, caution advised, consider monitoring bedaquiline levels
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined, weigh risk/benefit
Peds Dosing .
- Dosage forms: TAB: 20 mg, 100 mg
tuberculosis, multi-drug resistant
- [2 yo and older, 8-9 kg]
- Dose: 80 mg PO qd x2wk, then 40 mg PO 3x/wk x22wk; Info: for patients with pulmonary infection; administer by directly observed tx; give 3x/wk doses at least 48h apart; part of multi-drug regimen; see pkg insert for missed dose recommendations; give with food
- [2 yo and older, 10-14 kg]
- Dose: 120 mg PO qd x2wk, then 60 mg PO 3x/wk x22wk; Info: for patients with pulmonary infection; administer by directly observed tx; give 3x/wk doses at least 48h apart; part of multi-drug regimen; see pkg insert for missed dose recommendations; give with food
- [2 yo and older, 15-29 kg]
- Dose: 200 mg PO qd x2wk, then 100 mg PO 3x/wk x22wk; Info: for patients with pulmonary infection; administer by directly observed tx; give 3x/wk doses at least 48h apart; part of multi-drug regimen; see pkg insert for missed dose recommendations; give with food
- [2 yo and older, >30 kg]
- Dose: 400 mg PO qd x2wk, then 200 mg PO 3x/wk x22wk; Info: for patients with pulmonary infection; administer by directly observed tx; give 3x/wk doses at least 48h apart; part of multi-drug regimen; see pkg insert for missed dose recommendations; give with food
renal dosing
- [see below]
- mild-moderate impairment: no adjustment; severe impairment: not defined, caution advised, consider monitoring bedaquiline levels
- HD/PD: not defined, caution advised, consider monitoring bedaquiline levels
hepatic dosing
- [see below]
- Child-Pugh Class A or B: no adjustment; Child-Pugh Class C: not defined, weigh risk/benefit
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- TB infection, latent
- TB infection, drug-sensitive
- TB infection, extra-pulmonary
- mycobaterial infection, non-tuberculous
- electrolyte abnormalities, uncorrected
- avoid: alcohol use
- QTc >500 msec
- caution: QT prolongation
- caution: long QT syndrome, congenital
- caution: ventricular arrhythmia
- caution: bradycardia
- caution: MI, recent
- caution: CHF
- caution: QT prolongation family history
- caution: torsades de pointes history
- caution: renal impairment, severe
- caution: dialysis
- caution: hepatotoxic agent use, concurrent
- caution: hepatic impairment, severe
Drug Interactions .
Overview
bedaquiline
antimycobacterial
- CYP3A4 substrate
- affected by altered gastrointestinal motility
- alters GI flora
- impairs immunomodulatory bacterial infective agent
- prolongs QT interval (known)
Contraindicated
- cisapride
- domperidone
- dronedarone
- levoketoconazole
- pimozide
- posaconazole
- thioridazine
- ziprasidone
Avoid/Use Alternative
- adagrasib
- albuterol
- albuterol inhaled
- alfuzosin
- amiodarone
- amisulpride
- amitriptyline
- anagrelide
- apalutamide
- apomorphine
- arformoterol inhaled
- arsenic trioxide
- artemether/lumefantrine
- asciminib
- asenapine
- atazanavir
- azithromycin
- BCG live intravesical
- berotralstat
- bosentan
- bremelanotide
- buprenorphine
- butalbital
- cabozantinib
- carbamazepine
- cenobamate
- ceritinib
- chloramphenicol
- chloroquine
- chlorpromazine
- cholera vaccine, live
- ciprofloxacin
- citalopram
- clarithromycin
- clofazimine
- clomipramine
- clozapine
- cobicistat
- crizotinib
- dabrafenib
- dasatinib
- degarelix
- desflurane
- desipramine
- deutetrabenazine
- dexmedetomidine
- dexmedetomidine injection
- disopyramide
- dofetilide
- donepezil
- dordaviprone
- droperidol
- efavirenz
- eliglustat
- encorafenib
- entrectinib
- enzalutamide
- ephedra
- epirubicin
- eribulin
- erythromycin
- escitalopram
- etrasimod
- etravirine
- fexinidazole
- fingolimod
- flecainide
- fluconazole
- fluorouracil
- fluoxetine
- formoterol inhaled
- foscarnet
- fosfomycin injection
- fosphenytoin
- fostemsavir
- gemtuzumab ozogamicin
- gepirone
- gepotidacin
- gilteritinib
- givinostat
- glasdegib
- goserelin
- granisetron
- grapefruit
- haloperidol
- histrelin
- hydrocodone
- hydroxychloroquine
- hydroxyzine
- ibutilide
- idelalisib
- iloperidone
- inotuzumab ozogamicin
- isoflurane
- itraconazole
- ivabradine
- ivosidenib
- ketoconazole
- lapatinib
- lefamulin
- lenvatinib
- leuprolide
- levalbuterol inhaled
- levofloxacin
- lofexidine
- lonafarnib
- loperamide
- lopinavir/ritonavir
- lorlatinib
- lumacaftor/ivacaftor
- lumateperone
- lurasidone
- macimorelin
- mavacamten
- mavorixafor
- mefloquine
- meperidine
- methadone
- metronidazole
- midostaurin
- mifepristone
- milsaperidone
- mirtazapine
- mitapivat
- mitotane
- mobocertinib
- modafinil
- moxifloxacin
- nafcillin
- nefazodone
- nelfinavir
- nilotinib
- ofloxacin
- oliceridine
- olodaterol inhaled
- ondansetron
- osilodrostat
- osimertinib
- oxaliplatin
- ozanimod
- pacritinib
- paliperidone
- palonosetron
- pasireotide
- pazopanib
- pentamidine
- pentobarbital
- pexidartinib
- phenobarbital
- phenytoin
- pimavanserin
- pitolisant
- ponesimod
- pralsetinib
- primaquine
- primidone
- procainamide
- promethazine
- propafenone
- quetiapine
- quinidine (antiarrhythmic)
- quinidine (CYP2D6 inhibitor)
- quinine
- quizartinib
- ranolazine
- relugolix
- repotrectinib
- revumenib
- ribociclib
- rifabutin
- rifampin
- rifapentine
- rilpivirine
- ritonavir
- romidepsin
- rucaparib
- sacituzumab govitecan
- salmeterol inhaled
- sebetralstat
- selpercatinib
- sertraline
- sevoflurane
- siponimod
- solifenacin
- sorafenib
- sotalol
- sotorasib
- St. John's wort
- sunitinib
- tacrolimus
- taletrectinib
- tazemetostat
- telavancin
- terbutaline
- tetrabenazine
- tipranavir
- tolterodine
- toremifene
- tramadol
- trazodone
- triclabendazole
- trifluridine
- triptorelin
- tucatinib
- typhoid vaccine, live
- valbenazine
- vandetanib
- vardenafil
- vemurafenib
- venlafaxine
- vilanterol inhaled
- voclosporin
- voriconazole
- ziftomenib
Monitor/Modify Tx
- exenatide
- lixisenatide
- pramlintide
Caution Advised
- dulaglutide
- fecal microbiota, live
- liraglutide
- tirzepatide
Adverse Reactions .
Serious Reactions
- all-cause mortality including after tx D/C (adult patients)
- QT prolongation
- hepatotoxicity
Common Reactions
- nausea
- arthralgia
- headache
- abdominal pain (peds patients)
- vomiting (peds patients)
- ALT or AST elevated
- rash
- hyperamylasemia
Safety/Monitoring .
Monitoring Parameters
electrolytes including Mg, Ca at baseline, then if QT prolongation risk, continue periodically; ECG at baseline, then in 2wk, 12wk, and 24wk or if QT prolongation risk, qwk; LFTs at baseline, then in 2wk, then qmo or more frequently if pre-existing hepatic disease or concomitant hepatotoxic drug use
Pregnancy/Lactation .
Pregnancy
Clinical Summary
may use during pregnancy; no human data available; no known risk of fetal harm based on animal data at up to 6x systemic exposure
Lactation
Clinical Summary
avoid breastfeeding during tx and for at least 27.5 months after D/C; inadequate human data available, though possible risk of infant harm based on drug excretion into milk; no human data available to assess effects on milk production
Pharmacology .
Metabolism: for bedaquiline: liver; CYP450: 3A4 substrate
Excretion: for bedaquiline: feces primarily, urine (<1%); Half-life: 5.5mo
Subclass: Tuberculosis (TB)
Mechanism of Action
for bedaquiline: inhibits mycobacterial ATP synthesis (diarylquinoline)
Formulary .
No Formulary Selected
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