Sirturo

Sirturo

bedaquiline

Manufacturer:

Janssen-Cilag

Distributor:

DKSH
Concise Prescribing Info
Contents
Bedaquiline fumarate
Indications/Uses
As part of combination therapy in adults ≥18 yr w/ pulmonary multi-drug resistant TB.
Dosage/Direction for Use
400 mg once daily for the first 2 wk, followed by 200 mg 3 times wkly (w/ at least 48 hr between doses) for 22 wk. Total duration: 24 wk.
Administration
Should be taken with food.
Special Precautions
Obtain ECG prior to initiation of treatment & at least 2, 12 & 24 wk after starting treatment; serum K, Ca, Mg at baseline, correct if abnormal. Monitor electrolytes if QT prolongation is detected; symptoms (eg, fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness & hepatomegaly) & laboratory tests (ALT, AST, alkaline phosphatase & bilirubin) at baseline, mthly while on treatment & as needed. Patients w/ arrhythmias or recent MI; risk for QT prolongation in patients in concomitant use w/ drugs prolonging QT (eg, fluoroquinolones, macrolides, antimycobacterials & clofazimine); history of Torsades de Pointes, congenital long QT syndrome, ongoing hypothyroidism or bradyarrhythmias, uncompensated heart failure, serum Ca, Mg, or K levels below the lower limits of normal. Discontinue if clinically significant ventricular arrhythmia & a QTcF interval of >500 ms; aminotransferase elevations are accompanied by total bilirubin elevations >2 x ULN, >8 x ULN,  >5 x ULN occur. Avoid concomitant use w/ alcohol & other hepatotoxic drugs especially in patients w/ impaired hepatic function; strong [rifamycins (ie, rifampin, rifapentine, & rifabutin)] & moderate (eg, efavirenz) CYP3A4 inducers; strong CYP3A4 inhibitors for >14 consecutive days. Severe hepatic or renal impairment or end-stage renal disease requiring hemodialysis or peritoneal dialysis. Pregnancy & lactation. Ped patients. Elderly >65 yr.
Adverse Reactions
Nausea, arthralgia, headache, hemoptysis, chest pain, anorexia, increased transaminase, rash, increased blood amylase.
Drug Interactions
Decreased systemic exposure w/ strong CYP3A4 inducers eg, rifamycins (eg, rifampin, rifapentine & rifabutin) or moderate CYP3A4 inducers. Increased systemic exposure w/ strong CYP3A4 inhibitors eg, ketoconazole or itraconazole. Concomitant use w/ lopinavir/ritonavir, efavirenz or other moderate CYP3A inducers. Additive or synergistic QT prolongation may occur w/ drugs that prolong the QT interval.
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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