bedaquiline

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).

Adv. Reactions/Side Effects ⬆ ⬇

CV: chest pain,

QT interval prolongation

Derm: rash

GI: nausea, anorexia, HEPATOTOXICITY

MS: arthralgia

Neuro: headache

Resp: hemoptysis

Interactions ⬆ ⬇

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 risk of toxicity; avoid use for >14 consecutive days, if possible.
Lopinavir/ritonavir may ↑ levels and risk of toxicity.
Other
QT interval prolonging drugs may ↑ risk of QT interval prolongation
.
Alcohol or hepatotoxic drugs may ↑ risk of adverse hepatic events.

Availability ⬆ ⬇

Tablets: 20 mg; 100 mg

Route/Dosage ⬆ ⬇

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.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Inhibits bacterial adenosine 5-triphosphate 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.

Classifications ⬆ ⬇

Therapeutic Classification: antituberculars

Pharmacologic Classification: diarylquinolines

Pharmacokinetics ⬆ ⬇

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.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	5 hr	unknown

Patient/Family Teaching ⬆ ⬇

Instruct patient to take bedaquiline as directed for the complete 24-wk course of therapy. Do not stop without discussing with health care provider. If a dose is missed during 1st 2 wk, skip dose and return to usual schedule. If a dose is missed during 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 provider. Stopping any medications may ↓ effectiveness of therapy and may ↑ 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 provider 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 provider of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care provider before taking other medications.
Rep: Advise women of reproductive potential to notify health care provider if pregnancy is planned or suspected and to avoid breastfeeding during therapy.
Pedi: Advise caregivers to call the doctor if the child has a fast or abnormal heartbeat or dizziness or passes out.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code

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

59676- Janssen Products, LP
- 59676-702- SIRTURO
  - 59676-702-60- 60 TABLET in 1 BOTTLE (59676-702-60)

69766- MSN Life Sciences Private Limited
- 69766-058-
  - 69766-058-01- 50 kg in 1 DRUM (69766-058-01)

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Indications ⬇

Contraind./Precautions ⬆ ⬇