Also found in: Wikipedia.


(bed- ak-wi-leen) ,


(trade name)


Therapeutic: antituberculars
Pharmacologic: diarylquinolines
Pregnancy Category: B


Part of treatment (with at least three other drugs) of multi-drug resistant pulmonary tuberculosis in adults, when other treatment regimens cannot be provided. Not to be used for latent, extra-pulmonary or other-drug sensitive tuberculosis.


Inhibits bacterial adenosine 5'triphosphate (ATP) synthase which is required for mycobacterial energy production.

Therapeutic effects

Shortened time to sputum conversion to negativity and resultant decrease in infectiousness and sequelae of tuberculosis.


Absorption: Absorption following oral administration is doubled by food.
Distribution: Unk
Protein Binding: >99.9%
Metabolism and Excretion: Mostly metabolized (CYP3A4 enzyme system) and eliminated in feces, negligable renal excretion
Half-life: 5.5 months (terminal elimination half-life)

Time/action profile (blood levels)

POunk5 hrunk


Contraindicated in: Systemic potent CYP3A4 inducers should be avoided. Use of potent CYP3A4 inhibitors for more than 14 consecutive days should be avoided[ Lactation: Avoid use during lactation.
Use Cautiously in: Concurrent use of lopinavir/ritonavir; Electrolyte abnormalities (correct prior to use); Severe hepatic or renal impairment; Concurrent use of other drugs that prolong the QT interval, history of Torsades de Pointes, prolonged QT interval, hypothyroidism and bradyarrhythmias, uncompensated CHF (↑ risk of QT prolongation and serious arrhythmias). Obstetric: Use during pregnancy only if clearly needed. Pediatric: Safe and effective use in children <18 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • headache (most frequent)


  • hemoptysis


  • QT prolongation (life-threatening)
  • chest pain


  • nausea (most frequent)
  • anorexia
  • hepatitis


  • rash


  • arthralgia (most frequent)


Drug-Drug interaction

Systemic potent CYP3A4 inducers including rifampin, rifapentine and rifabution can ↓ levels and effectiveness and should be avoided. Potent CYP3A4 inhibitors including ketoconazole can ↑ levels and the risk of toxicity; avoid use for more than 14 consecutive days if possible.Concurrent use of lopinavir/ritonavir may ↑ blood levels and risk of adverse reactions. Concurrent use of other drugs that prolong the QT interval including fluoroquinolones, macrolides and clofazamine ) may ↑ risk of serious arrhythmias. Concurrent use of alcohol or hepatotoxic drugs may ↑ risk of adverse hepatic events.


Oral (Adults) 400 mg once daily for 2 wk, then 200 mg three times weekly (at least 48 hr between doses) for 22 wk.


Tablets: 100 mg

Nursing implications

Nursing assessment

  • Obtain ECG prior to starting therapy and at least 2, 12 and 24 wks after starting therapy to monitor for QT prolongation of >500 ms, clinically significant ventricular arrythmias, or if syncope occurs.
  • Lab Test Considerations: Monitor serum potassium, calcium, and magnesium at baseline and if Q-T prolongation is detected. Correct abnormalities.
    • Monitor liver function tests (ALT, AST, alkaline phosphatase, and bilirubin at baseline, monthly during therapy, and as needed. If serum AST and ALT ↑ to 3 times the upper limit of normal, repeat test within 48 hr and test for viral hepatitis and other hepatotoxic medications. If symptoms of liver dysfunction (clinically significant ↑ serum ALT, AST or bilirubin and/or symptoms of fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, and hepatomegaly) occur re-evaluate. If AST and ALT ↑ accompanied by total bilirubin ↑ >2 times upper limit of normal, or if AST and ALT ↑ 8 time upper limits of normal, or if AST and ALT ↑ persist beyond 2 wks, discontinue bedaquiline.

Potential Nursing Diagnoses

Risk for infection (Indications)
Noncompliance (Patient/Family Teaching)


  • Only administer by direct observation therapy (DOT).
  • Must be taken in combination with 3–4 other antitubercular drugs.
  • Oral: Administer with food. Swallow tablet whole; do not crush, break, or chew.
    • Weeks 1–2: administer 400 mg once daily.
    • Weeks 3–24: administer two 100 mg tablets 3 times/wk with at least 48 hrs between doses for a total of 600 mg/wk.

Patient/Family Teaching

  • Instruct patient to take bedaquiline as direct for the complete 24 wk course of therapy. Do not stop without discussing with health care professional. If a dose is missed during first 2 wks, skip dose and return to usual schedule. If a dose is missed wks 3–24, take missed dose as soon as remembered, then resume 3 times/wk regimen. Emphasize that bedaquiline is always taken with 3–4 other antitubercular medications and these medications should be continued unless discussed with health care professional. If any medications are stopped may decrease effectiveness of therapy and may increase risk of mycobacterium resistance and disease becoming untreatable in future.
  • Caution patient to avoid alcohol during therapy.
  • Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications or alcohol.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Shortened time to sputum conversion to negativity and resultant decrease in infectiousness of patient and sequelae of tuberculosis.
References in periodicals archive ?
Extensively drug-resistant cases will now be treated with individual treatment regimens using new drugs, Bedaquiline and Delamanid.
In 2013, following US Food and Drug Administration approval of bedaquiline (in 2012), the WHO released interim guidance on the use of this drug (6).
A number of new drugs are being looked at as add-on therapy to the current drug-resistant combination treatment, including Bedaquiline, Linezolid etc.
After five decades, two new anti-TB drugs, bedaquiline and delamanid, were developed, with an accelerated approval of bedaquiline.
Certain products for diseases of poverty that have been launched over recent years by the pharmaceutical industry are already included on some country lists but have yet to be submitted for evaluation by the SUS, such as miltefosine for leishmaniasis, bedaquiline for tuberculosis, arterolane + piperaquine for malaria, and even new soluble formulations of benznidazole for Chagas disease, all of which are not registered in Brazil.
In line with further work from the TB Alliance who have Phase I, II, III & IV trials ongoing using a mix of pharmaceutical agents including Ethambutol, Pyrazinamide, Isoniazid, Pretomanid, Moxifoxacin, Linezolid and Bedaquiline, the outlook for identifying new treatments looks very positive, regardless of identification of new drug entities.
The compound SQ109, which was developed by US-based Sequella, works by boosting existing drugs such as isoniaside, rifampicine and bedaquiline.
GDF will continue to play a key role in increasing access to and scaling up the use of new anti-TB medicines, including bedaquiline and delamanid, new pediatric formulations and the rapid introduction of shorter drug-resistant TB treatment regimens," she added.
Baliga measured the microbe's transcriptome in the presence of different doses of bedaquiline and at different times after introducing the drug.
As there is limited data on the safety of delamanid and bedaquiline in pregnancy for the treatment of M/XDR-TB, these drugs should be avoided.
Here, there is some promising news: Bedaquiline recently became the first new TB drug to be approved by the US Food and Drug Administration in 40 years.