Sirturo

Sirturo

bedaquiline

Manufacturer:

Janssen

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Bedaquiline fumarate
Indications/Uses
Part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
Dosage/Direction for Use
4 tab once daily for wk 1-2 then 2 tab 3 times wkly w/ at least 48 hr between doses for wk 3-24.
Administration
Should be taken with food: Swallow whole w/ water.
Contraindications
Special Precautions
No clinical data on the use to treat extrapulmonary 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. Discontinue use if clinically significant ventricular arrhythmia & QTcF interval >500 ms confirmed by repeated ECG develops. Not recommended in patients w/ heart failure; QT interval as corrected by Fridericia method; history of congenital QT prolongation, Torsade de pointes; history of or ongoing hypothyroidism, bradyarrhythmia; hypokalemia; syncope; HIV-infected patients. Obtain ECG prior to & at least mthly after initiation; serum K, Ca & Mg at baseline. Follow-up monitoring of electrolytes if QT prolongation is detected. Monitor symptoms & laboratory tests (ALT, AST, alkaline phosphatase, bilirubin) at baseline. Not to be taken in patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Avoid use w/ other hepatotoxic medicinal products & alcohol especially in patients w/ diminished hepatic reserve; moderate or strong CYP3A4 inducers & inhibitors. Concomitant use of medicinal products w/ known risk of QT prolongation; fluoroquinolones eg, gatifloxacin, moxifloxacin, sparfloxacin. Co-administration w/ clofazimine recommends clinical monitoring (frequent ECG assessment). May affect ability to drive & use machines. Not recommended in severe hepatic impairment. Moderate hepatic & severe renal impairment (CrCl <30 mL/min), end-stage renal disease requiring haemodialysis or peritoneal dialysis. Avoid use during pregnancy, lactation, in childn <18 yr & elderly ≥65 yr.
Adverse Reactions
Headache, dizziness; nausea, vomiting; arthralgia. ECG QT prolonged; diarrhoea; increased AST, ALT, hepatic enzyme & transaminases, abnormal hepatic function; myalgia.
Drug Interactions
Reduced exposure w/ moderate or strong CYP3A4 inducers eg, efavirenz, etravirine, rifamycins (rifampicin, rifapentine, rifabutin), carbamazepine, phenytoin, St. John's wort (Hypericum perforatum). Increased exposure w/ moderate or strong CYP3A4 inhibitors eg, ciprofloxacin, erythromycin, fluconazole, clarithromycin, ketoconazole, ritonavir; antiretrovirals. Additive or synergistic effect w/ medicinal products prolonging QT interval. Mean increases in QTcF w/ clofazimine.
MIMS Class
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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