Generic Name and Formulations:
Bedaquiline 100mg; tabs.
Indications for SIRTURO:
As part of combination therapy in pulmonary multi-drug resistant tuberculosis (MDR-TB) only when an effective treatment regimen cannot otherwise be provided.
Limitations Of use:
Safety and efficacy for treatment of latent infection, drug-sensitive or extra-pulmonary tuberculosis (eg, CNS), non-tuberculous mycobacterial infections, or use in HIV-infected patients have not been established.
Administer by directly observed therapy and in combination with ≥3 other drugs to which the isolate is susceptible. Swallow whole with water. Take with food. ≥18yrs: 400mg once daily for 2 weeks followed by 200mg three times weekly (≥48hrs between doses) for 22 weeks.
<18yrs: not established.
Increased risk of mortality. Increased risk of QT prolongation in patients with history of Torsade de Pointes, congenital long QT syndrome, hypothyroidism, bradyarrhythmias, uncompensated heart failure, electrolyte abnormalities; monitor closely. Obtain ECG prior to therapy, and at least 2, 12, and 24 weeks after starting. Correct any electrolyte abnormalities at baseline and monitor if QT prolongation is detected. Discontinue Sirturo and all other QT prolonging drugs if ventricular arrhythmia or QTcF interval >500ms develops. Monitor ALT/AST, phosphatase, bilirubin at baseline, monthly during treatment, and as needed. Test for viral hepatitis and discontinue other hepatotoxic drugs if serum aminotransferases >3XULN (repeat testing within 48hrs). Discontinue if aminotransferase elevation with total bilirubin >2XULN, aminotransferase elevation >8XULN, or >5XULN that persists >2 weeks. Severe hepatic or severe renal impairment/ESRD. Pregnancy (Cat.B). Nursing mothers: not recommended.
Avoid concomitant use with strong CYP3A4 inducers (eg, rifampin, rifapentine, rifabutin). Avoid concomitant use with strong CYP3A4 inhibitors (eg, ketoconazole) for >14 days; monitor. Avoid concomitant moderate CYP3A inducers (eg, efavirenz). Additive QT prolongation with other drugs that prolong the QT interval (eg, fluoroquinolones, macrolides, clofazimine). Avoid alcohol and other hepatotoxic drugs. Sirturo exposure increased with Kaletra (caution).
Nausea, arthralgia, headache, hemoptysis, chest pain; arrhythmias, syncope (obtain ECG), hepatic dysfunction, QT prolongation.
Psychiatry Advisor Articles
- ACOG Update: Marijuana Use Discouraged During Pregnancy, Breastfeeding
- Asenapine Prevents Recurrence of Mood Events in Bipolar Disorder
- Continuing Research, Emerging Treatments Hold Promise for Treating Anorexia Nervosa
- Depression Profiles in Patients With Type 1 Diabetes vs Type 2 Diabetes
- Purpose, Questions of Social Interaction Lead Physicians to Delay Retirement
- CBT, Acceptance Commitment Therapy Helpful for Those With Chronic Pain
- Suicidal Behavior, Thoughts Associated With Perfectionist Tendencies
- Depression Reduced by Social Belonging, Feelings of Inclusion
- Sleep Disturbance May Be Causal Factor in Psychotic Experiences
- Is Antidepressant Use in Pregnancy Tied to Psychiatric Disorders in Offspring?
- Cardiovascular Risk Management May Slow Neurocognitive Decline in HIV
- Maintenance rTMS for Treatment-Resistant Depression
- New Study Compares Opioid Dependence Relapse Treatments
- Increase Use of Nursing Home for Patients With Cognitive Impairment Category
- Venlafaxine XR Safe, Effective in Treating Generalized Anxiety Disorder