General Precautions
Avoid alcohol and alcoholic beverages during treatment.
Avoid hepatotoxic drugs or herbal products during treatment.
Patients should inform their physician of all concurrent medications and medical conditions before starting therapy.
Adverse reactions such as dizziness may impair the ability to drive or operate machinery. Advise patients to avoid driving or using machinery if dizziness occurs.
Keep out of reach of children.
Maintain a light diet during medication.
Do not use if the appearance of the product changes.
Drug Interactions
CYP3A4 Inducers and Inhibitors
Coadministration with CYP3A4 inducers may decrease bedaquiline exposure.
Coadministration with CYP3A4 inhibitors may increase bedaquiline exposure.
Other Antibacterial Agents
No dose adjustment of isoniazid or pyrazinamide is required during combination therapy.
In a placebo-controlled clinical study in MDR-TB patients, no significant pharmacokinetic interactions were observed with ethambutol, kanamycin, pyrazinamide, ofloxacin, or cycloserine.
Antiretroviral Agents
Use with caution and only when benefit exceeds risk when coadministered with lopinavir/ritonavir.
No dose adjustment of bedaquiline is needed with nevirapine.
Concomitant use with efavirenz or other moderate CYP3A inducers should be avoided.
QT-Prolonging Drugs
Bedaquiline may have additive or synergistic effects on QT prolongation when combined with other QT-prolonging drugs.
Monitor ECG if used concomitantly; discontinue bedaquiline immediately if severe ventricular arrhythmia occurs or QTcF exceeds 500 ms.
Always consult a physician or pharmacist regarding potential drug interactions.
