• Pulmonary tuberculosis due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid (in combination with 3 other drugs).

Contraindicated in:

• Lactation: Lactation.

Use Cautiously in:

• Severe hepatic or renal impairment
• History of torsades de pointes, congenital long QT syndrome, hypothyroidism, bradyarrhythmias, decompensated HF, hypokalemia, hypomagnesemia, or hypocalcemia (↑ risk of QT interval prolongation and serious arrhythmias)
• OB: Safety not established in pregnancy
• Pedi: Children <5 yr (safety and effectiveness not established).

CV: chest pain, QT interval prolongation.

Derm: rash.

GI: nausea, anorexia, HEPATOTOXICITY.

MS: arthralgia.

Neuro: headache.

Resp: hemoptysis.

Drug-Drug:

• Strong CYP3A4 inducers, including rifampin, rifapentine, and rifabutin, and moderate CYP3A4 inducers, including efavirenz, can ↓ levels and effectiveness; avoid concurrent use.
• Strong CYP3A4 inhibitors, including ketoconazole, can ↑ levels and the risk of toxicity; avoid use for >14 consecutive days, if possible.
• Lopinavir/ritonavir may ↑ levels and risk of toxicity.
• Other QT interval prolonging drugs, including fluoroquinolones and macrolides , may ↑ risk of serious arrhythmias.
• Alcohol or hepatotoxic drugs may ↑ risk of adverse hepatic events.

• Tablets: 20 mg; 100 mg;

• PO (Adults and Children 5 yr and 30 kg): 400 mg once daily for 2 wk; then 200 mg 3 times weekly (with 48 hr between doses) for 22 wk.
• PO (Children 5 yr and 15–29 kg): 200 mg once daily for 2 wk; then 100 mg 3 times weekly (with 48 hr between doses) for 22 wk.

Sirturo

• Inhibits bacterial adenosine 5-triphosphate synthase, which is required for mycobacterial energy production.

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

Therapeutic Classification: antituberculars

Pharmacologic Classification: diarylquinolines

Absorption: Absorption following oral administration is doubled by food.

Distribution: Unknown.

Protein Binding: >99.9%.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A4 isoenzyme; eliminated in feces; negligible renal excretion.

Half-life: 5.5 mo.

(plasma concentrations)

• Instruct patient to take bedaquiline as directed 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 wk, skip dose and return to usual schedule. If a dose is missed wk 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. Stopping any medications may decrease effectiveness of therapy and may increase risk of mycobacterium resistance and disease becoming untreatable in future. Advise patient to read Medication Guide before starting therapy.
• Caution patient to avoid alcohol during therapy.
• Advise patient to notify health care professional immediately if signs and symptoms of QT interval prolongation (change in heartbeat, dizziness, fainting) or hepatotoxicity (nausea or vomiting, stomach pain, fever, weakness, itching, unusual tiredness, loss of appetite, light-colored bowel movements, dark-colored urine, yellowing of skin or white of eyes) occur.
• 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.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy.
• Pedi: Advise parents to call the doctor if the child has a fast or abnormal heartbeat, dizziness, or passes out.

bed- AK-wi-leen

NDC Code^*

• 59676- Janssen Products, LP
  • 59676-701- SIRTURO
    • 59676-701-01- 188 TABLET in 1 BOTTLE (59676-701-01)