Bedaquiline Brand Name– SIRTURO
What is Bedaquiline
Bedaquiline is a diarylquinoline antimycobacterial approved for the treatment of adults and pediatric patients 12 years and older weighing at least 30 kg with pulmonary multi-drug resistant tuberculosis (MDR-TB) for which no other effective treatment regimens are available.
It is not indicated for monotherapy and should only be used in combination with at least 3 other drugs proven to be or at least 4 other drugs suspected of being active against the patient’s Mycobacterium tuberculosis isolate.
Approval was based on the results of clinical trials comparing bedaquiline plus other MDR-TB active drugs with placebo plus MDR-TB active drugs.
In clinical trials, the bedaquiline treatment groups experienced decreased time to culture conversion and improved culture conversion rates when compared to the placebo treatment groups.
However, despite its efficacy, it should only be used when other treatment options are unavailable because, in 1 trial in adult patients, more deaths occurred in the bedaquiline treatment group (9/79, 11.4%) than in the placebo treatment group (2/81, 2.5%).
According to the FDA-approved labeling, data could not explain the increased risk of death.
A Black Box Warning has been issued to alert health care providers of these data and of the potential for QT prolongation.
Indications
- Mycobacterium abscessus
- Mycobacterium avium
- Mycobacterium fortuitum
- Mycobacterium kansasii
- Mycobacterium sp.
- Mycobacterium tuberculosis
- tuberculosis infection
Side Effects
- abdominal pain
- anorexia
- arthralgia
- chest pain (unspecified)
- elevated hepatic enzymes
- headache
- hemoptysis
- nausea
- QT prolongation
- rash
Monitoring Parameters
- ECG
- LFTs
- serum bilirubin
- serum calcium
- serum magnesium
- serum potassium
Contraindications
- alcoholism
- bradycardia
- breast-feeding
- cardiac arrhythmias
- cardiac disease
- coronary artery disease
- diabetes mellitus
- females
- geriatric
- heart failure
- hepatic disease
- hypertension
- hypocalcemia
- hypokalemia
- hypomagnesemia
- long QT syndrome
- malnutrition
- mortality
- myocardial infarction
- pregnancy
- QT prolongation
- thyroid disease
Interactions
- Acetaminophen; Butalbital
- Acetaminophen; Butalbital; Caffeine
- Acetaminophen; Butalbital; Caffeine; Codeine
- Aclidinium; Formoterol
- Albuterol
- Albuterol; Ipratropium
- Alfuzosin
- Amiodarone
- Amitriptyline
- Amitriptyline; Chlordiazepoxide
- Amobarbital
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Anagrelide
- Apalutamide
- Apomorphine
- Aprepitant, Fosaprepitant
- Arformoterol
- Aripiprazole
- Armodafinil
- Arsenic Trioxide
- Artemether; Lumefantrine
- Asenapine
- Aspirin, ASA; Butalbital; Caffeine
- Aspirin, ASA; Butalbital; Caffeine; Codeine
- Atazanavir
- Atazanavir; Cobicistat
- Atomoxetine
- Atropine; Hyoscyamine; Phenobarbital; Scopolamine
- Azithromycin
- Barbiturates
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Bexarotene
- Bismuth Subcitrate Potassium; Metronidazole; Tetracycline
- Bismuth Subsalicylate; Metronidazole; Tetracycline
- Boceprevir
- Bosentan
- Budesonide; Formoterol
- Buprenorphine
- Buprenorphine; Naloxone
- Butabarbital
- Carbamazepine
- Cenobamate
- Ceritinib
- Chloramphenicol
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Cisapride
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Cobicistat
- Codeine; Phenylephrine; Promethazine
- Codeine; Promethazine
- Conivaptan
- Crizotinib
- Dabrafenib
- Darunavir
- Darunavir; Cobicistat
- Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Dasatinib
- Deferasirox
- Degarelix
- Delavirdine
- Desflurane
- Desipramine
- Deutetrabenazine
- Dexamethasone
- Dextromethorphan; Promethazine
- Dextromethorphan; Quinidine
- Disopyramide
- Dofetilide
- Dolasetron
- Dolutegravir; Rilpivirine
- Donepezil
- Donepezil; Memantine
- Doxepin
- Dronedarone
- Droperidol
- Efavirenz
- Efavirenz; Emtricitabine; Tenofovir
- Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
- Elagolix
- Elbasvir; Grazoprevir
- Eliglustat
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Alafenamide
- Elvitegravir; Cobicistat; Emtricitabine; Tenofovir Disoproxil Fumarate
- Emtricitabine; Rilpivirine; Tenofovir alafenamide
- Emtricitabine; Rilpivirine; Tenofovir disoproxil fumarate
- Encorafenib
- Enflurane
- Entrectinib
- Enzalutamide
- Eribulin
- Erythromycin
- Erythromycin; Sulfisoxazole
- Escitalopram
- Eslicarbazepine
- Ethanol
- Etravirine
- Ezogabine
- Felbamate
- Fingolimod
- Flecainide
- Fluconazole
- Fluoxetine
- Fluoxetine; Olanzapine
- Fluphenazine
- Fluticasone; Salmeterol
- Fluticasone; Umeclidinium; Vilanterol
- Fluticasone; Vilanterol
- Fluvoxamine
- Formoterol
- Formoterol; Mometasone
- Fosamprenavir
- Foscarnet
- Fosphenytoin
- Gemifloxacin
- Gemtuzumab Ozogamicin
- Gilteritinib
- Glasdegib
- Glycopyrrolate; Formoterol
- Goserelin
- Granisetron
- grapefruit juice
- Halogenated Anesthetics
- Haloperidol
- Halothane
- Histrelin
- Hydroxychloroquine
- Hydroxyzine
- Ibutilide
- Idelalisib
- Iloperidone
- Imatinib
- Imipramine
- Indacaterol
- Indacaterol; Glycopyrrolate
- Indinavir
- Inotuzumab Ozogamicin
- Isavuconazonium
- Isoflurane
- Isoniazid, INH; Pyrazinamide, PZA; Rifampin
- Isoniazid, INH; Rifampin
- Itraconazole
- Ivosidenib
- Ketoconazole
- Lapatinib
- Lefamulin
- Lenvatinib
- Lesinurad
- Lesinurad; Allopurinol
- Letermovir
- Leuprolide
- Leuprolide; Norethindrone
- Levalbuterol
- Levofloxacin
- Lithium
- Lofexidine
- Long-acting beta-agonists
- Loperamide
- Loperamide; Simethicone
- Lopinavir; Ritonavir
- Lorlatinib
- Lumacaftor; Ivacaftor
- Macimorelin
- Maprotiline
- Mefloquine
- Meperidine; Promethazine
- Mephobarbital
- Metaproterenol
- Methadone
- Methohexital
- Metronidazole
- Midostaurin
- Mifepristone
- Mirtazapine
- Mitotane
- Modafinil
- Moxifloxacin
- Nafcillin
- Nefazodone
- Nelfinavir
- Nevirapine
- Nilotinib
- Norfloxacin
- Nortriptyline
- Octreotide
- Ofloxacin
- Olanzapine
- Olodaterol
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole; Amoxicillin; Rifabutin
- Ondansetron
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Paliperidone
- Panobinostat
- Pasireotide
- Pazopanib
- Pentamidine
- Pentobarbital
- Perphenazine
- Perphenazine; Amitriptyline
- Phenobarbital
- Phenylephrine; Promethazine
- Phenytoin
- Pimavanserin
- Pimozide
- Pirbuterol
- Pitolisant
- Posaconazole
- Primaquine
- Primidone
- Procainamide
- Prochlorperazine
- Promethazine
- Propafenone
- Protriptyline
- Quetiapine
- Quinidine
- Quinine
- Ranolazine
- Ribociclib
- Ribociclib; Letrozole
- Rifabutin
- Rifampin
- Rifamycins
- Rifapentine
- Rilpivirine
- Risperidone
- Ritonavir
- Romidepsin
- Salmeterol
- Saquinavir
- Secobarbital
- Sertraline
- Sevoflurane
- Short-acting beta-agonists
- Siponimod
- Solifenacin
- Sorafenib
- Sotalol
- St. John’s Wort, Hypericum perforatum
- Sunitinib
- Tacrolimus
- Tamoxifen
- Telaprevir
- Telavancin
- Telithromycin
- Telotristat Ethyl
- Terbutaline
- Tetrabenazine
- Thiopental
- Thioridazine
- Tiotropium; Olodaterol
- Tipranavir
- Tolterodine
- Toremifene
- Trazodone
- Tricyclic antidepressants
- Trifluoperazine
- Trimipramine
- Triptorelin
- Umeclidinium; Vilanterol
- Vandetanib
- Vardenafil
- Vemurafenib
- Venlafaxine
- Voriconazole
- Vorinostat
- Ziprasidone
