SIRTURO Bedaquiline Application Scope

A diarylquinoline-class antimycobacterial agent specifically indicated for the treatment of multidrug-resistant tuberculosis (MDR-TB) in adult and pediatric patients (≥5 years and ≥15 kg) when an effective treatment regimen cannot otherwise be provided. It must be used in combination with at least 3-4 other active anti-TB drugs to prevent further resistance development.

SIRTURO Bedaquiline Characteristics

Ingredients: Bedaquiline
Properties: 100 mg and 20 mg tablets available
Packaging Specification: Typically supplied as 100 mg tablets (188 tablets per box in China)
Storage: Store at 25 °C (77 °F); excursions 15–30 °C (59–86 °F) permitted
Expiry Date: As labeled by the manufacturer; see bottle
Executive Standard: FDA-approved (2012, full approval 2024)
Approval Number: NDA 204384 (U.S.)
Date of Revision: Last updated in 2024 (FDA full approval)
Manufacturer: Manufactured for Janssen Products, LP, Horsham, PA, USA. (Certain lots manufactured by Janssen-Cilag S.p.A., Italy.)

Guidelines for the Use of SIRTURO

Dosage and Administration:
- Adults & Adolescents (≥12 years & ≥30 kg):
  - Weeks 1–2: 400 mg once daily
  - Weeks 3–24: 200 mg three times per week (≥48 hours between doses)
- Children (5–12 years or 15–30 kg):
  - Weeks 1–2: 200 mg once daily
  - Weeks 3–24: 100 mg three times per week
- Missed Dose: If a dose is missed, administer as soon as possible. Resume monthly dosing from the date of the most recently administered dose.
Adverse Reactions:
- Common Adverse Reactions (≥5% and >3% higher than placebo):
  - Injection site reactions (19%)
  - Decreased platelet count (12%)
  - Arthralgia (9%)
- Serious Adverse Reactions:
  - Hypersensitivity reactions, including bronchospasm, diffuse erythema, facial swelling, urticaria, chills, and myalgias.
Contraindications:Patients with a history of serious hypersensitivity to olezarsen or any of the excipients in TRYNGOLZA.
Precautions:
- Hypersensitivity Reactions: Monitor patients for signs and symptoms. Discontinue use if reactions occur.
- Platelet Count Monitoring: Monitor platelet counts during treatment.
- Pregnancy and Lactation: Advise patients to inform their healthcare provider if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

SIRTURO Interactions

CYP3A4 inducers (↓bedaquiline exposure; reduced efficacy): Avoid—e.g., rifamycins (rifampin, rifapentine, rifabutin), efavirenz, etc.
CYP3A4 inhibitors (↑exposure; ↑risk of AEs): Use with close monitoring—e.g., ketoconazole, lopinavir/ritonavir, etc.
Other QT-prolonging drugs: Use cautiously/avoid additive risk (e.g., certain fluoroquinolones, macrolides, clofazimine).

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.