Sirturo

Sirturo

bedaquiline

Manufacturer:

Kemwell Biopharma

Distributor:

DCH Auriga - Healthcare
/
Four Star

Marketer:

Janssen
Concise Prescribing Info
Contents
Bedaquiline fumarate
Indications/Uses
As part of an appropriate combination regimen for pulmonary multi-drug resistant TB (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Dosage/Direction for Use
Wk 1-2: 400 mg once daily; wk 3-24: 200 mg 3 times per wk (w/ at least 48 hr between doses).
Administration
Should be taken with food.
Contraindications
Special Precautions
No data on treatment >24 wk w/in the clinical studies. No clinical data on the use to treat: extra-pulmonary TB, infections due to mycobacterial species other than Mycobacterium tuberculosis, latent infections w/ Mycobacterium tuberculosis, as part of combination regimens used to treat drug-susceptible Mycobacterium tuberculosis. QT prolongation. ECG should be obtained before initiation or at least mthly after starting treatment. Use w/ caution when concomitantly used w/ medicinal products w/ known risk of QT prolongation. Increases in transaminases or aminotransferase elevations accompanied by total bilirubin ≥2x ULN. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Minor influence on the ability to drive & use machines. Pregnancy & lactation.
Adverse Reactions
Headache, dizziness; nausea, vomiting; arthralgia.
Drug Interactions
Reduced exposure w/ CYP3A4 inducers. Increased exposure w/ CYP3A4 inhibitors or antiretrovirals. Additive or synergistic effect on QT prolongation w/ QT interval prolonging medicinal products. Mean increases in QTcF w/ clofazimine.
MIMS Class
Anti-TB Agents
ATC Classification
J04AK05 - bedaquiline ; Belongs to the class of other drugs used in the systemic treatment of tuberculosis.
Presentation/Packing
Form
Sirturo tab 100 mg
Packing/Price
188's
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