Bedaquiline

Sharing is caring!

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

  1. Mycobacterium abscessus
  2. Mycobacterium avium
  3. Mycobacterium fortuitum
  4. Mycobacterium kansasii
  5. Mycobacterium sp.
  6. Mycobacterium tuberculosis
  7. tuberculosis infection

Side Effects

  1. abdominal pain
  2. anorexia
  3. arthralgia
  4. chest pain (unspecified)
  5. elevated hepatic enzymes
  6. headache
  7. hemoptysis
  8. nausea
  9. QT prolongation
  10. 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

Sharing is caring!

15585

Sign up to receive the trending updates and tons of Health Tips

Join SeekhealthZ and never miss the latest health information

15856
Scroll to Top