- 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.
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.
Protein Binding: >99.9%.
Metabolism and Excretion: Mostly metabolized (CYP3A4 enzyme system) and eliminated in feces, negligible renal excretion.
Half-life: 5.5 mo (terminal elimination half-life).
TIME/ACTION PROFILE (blood levels)
- 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 HF (↑ risk of QT prolongation and serious arrhythmias).
- OB: Use during pregnancy only if clearly needed.
- Pedi: Safety and effectiveness not established.
Adverse Reactions/Side Effects
CV: QT PROLONGATION, chest pain
GI: nausea, anorexia, hepatitis
* CAPITALS indicate life-threatening.
Underline indicate most frequent.
- Strong CYP3A4 inducers, including rifampin, rifapentine and rifabutin and moderate CYP3A4 inducers, including efavirenz 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.
PO (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
- 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 ↑ >5 times upper limit of normal and persist beyond 2 wks, discontinue bedaquiline.
- Test patient for viral hepatitis prior to starting therapy.
- Only administer by direct observation therapy (DOT).
- Must be taken in combination with 3–4 other antitubercular drugs.
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.
- 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.
Shortened time to sputum conversion to negativity and resultant decrease in infectiousness of patient and sequelae of tuberculosis.
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