Lucius LuciBeda Bedaquiline 100mg

Product Information

• Product name: LuciBeda Bedaquiline 100mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Bedaquiline
• Current strength: 100mg
• SKU: LU-ITEM-140
• Site category: tuberculosis, other cancer

Product Summary

LuciBeda Bedaquiline 100mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Bedaquiline is the active ingredient used for this product page. Public prescribing information for Bedaquiline was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Bedaquiline is a diarylquinoline antimycobacterial drug .

Reference Indications

Bedaquiline is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in the treatment of adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. Bedaquiline is a diarylquinoline antimycobacterial drug indicated as part of combination therapy in adult and pediatric patients (2 years and older and weighing at least 8 kg) with pulmonary tuberculosis (TB) due to Mycobacterium tuberculosis resistant to at least rifampin and isoniazid. Limitations of Use : Do not use Bedaquiline for the treatment of latent, extra-pulmonary or drug-sensitive TB or for the treatment of infections caused by non-tuberculous mycobacteria.

Reference Dosage and Administration

Recommended dosage in adult patients: 400 mg (4 of the 100 mg tablets OR 20 of the 20 mg tablets) once daily for 2 weeks followed by 200 mg (2 of the 100 mg tablets OR 10 of the 20 mg tablets) 3 times per week (with at least 48 hours between doses) for 22 weeks. Administer Bedaquiline by directly observed therapy (DOT).

With this 100mg product, that corresponds to 4 x 100mg tablets when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: QTc PROLONGATION QTc prolongation can occur with Bedaquiline. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Discontinue Bedaquiline if significant ventricular arrhythmia or QTc interval greater than 500 ms develops . WARNING: QTc PROLONGATION See for complete boxed warning. QTc Prolongation QTc prolongation can occur with Bedaquiline. Use with drugs that prolong the QTc interval may cause additive QTc prolongation. Discontinue Bedaquiline if significant ventricular arrhythmia or QTc interval greater than 500 ms develops. A mortality imbalance was seen in clinical trials in Bedaquiline-treated patients with pulmonary TB due to Mycobacterium tuberculosis resistant to at least rifampin. Hepatotoxicity may occur with use of Bedaquiline. Monitor liver-related laboratory tests.

Common Adverse Reactions and Monitoring

The most common adverse reaction reported in 10% or more of pediatric patients (5 years to less than 12 years of age) treated with Bedaquiline was elevation in liver enzymes. The most common adverse reaction reported in 10% or more of pediatric patients (2 years to less than 5 years of age) treated with Bedaquiline was vomiting. Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

Drug Interactions and Special Populations

Avoid use of strong and moderate CYP3A4 inducers with Bedaquiline. Closely monitor patient safety (e.g., liver function) when Bedaquiline is coadministered with CYP3A4 inhibitors. ( 5.4 , 7.1 ) 7.1 Effect of Other Drugs on Bedaquiline Strong and Moderate CYP3A4 Inducers Coadministration of Bedaquiline with moderate or strong CYP3A4 inducers may decrease systemic exposure of bedaquiline. Avoid coadministration of Bedaquiline with strong or moderate CYP3A4 inducers . Closely monitor patient safety (e.g., liver function) when Bedaquiline is coadministered with CYP3A4 inhibitors. No dose adjustment of Bedaquiline is needed when coadministered with CYP3A4 inhibitors .

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: SIRTURO public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.