What is the recommended dose of bedaquiline (Sirturo) for a patient weighing 30 kg?

Bedaquiline Dosing for a 30 kg Patient

For a patient weighing 30 kg, bedaquiline is not recommended as the patient is below the weight threshold of 33 kg for standard bedaquiline dosing. 1

Weight-Based Recommendations

• Bedaquiline is currently only recommended for children >12 years old who weigh >33 kg according to established guidelines 1
• For patients weighing ≥33 kg, the standard adult dosing regimen would be 400 mg daily for 14 days followed by 200 mg three times weekly for an additional 22 weeks 1
• Patients <33 kg do not have established dosing recommendations in current guidelines 1

Clinical Considerations

• Bedaquiline should only be used in multidrug-resistant tuberculosis (MDR-TB) when a four-drug regimen plus pyrazinamide cannot be constructed due to resistance or significant intolerance 1
• The drug should be administered with food to maximize absorption (increases bioavailability 2-fold) 1, 2
• Bedaquiline must always be used in combination therapy with at least three other effective drugs, never as monotherapy 1

Safety Monitoring Requirements

• Baseline ECG to assess QTc interval is mandatory before starting bedaquiline 1
• Contraindications include:
  • Baseline QTc interval greater than 450 ms that does not correct with medical management 1
  • Patient or family history of cardiac arrhythmias 1
  • Severe cardiac disease 1
• Monthly ECG monitoring is required to assess for QTc prolongation 1
• Serum electrolytes (potassium, calcium, and magnesium) should be monitored at baseline and whenever clinically indicated 1

Alternative Approaches

• For patients <33 kg with MDR-TB requiring treatment, consider alternative regimens or consult with pediatric TB specialists 1
• Delamanid may be considered as an alternative for children >6 years old and >20 kg when bedaquiline cannot be used 1
• For children <33 kg who absolutely require bedaquiline, enrollment in clinical trials or compassionate use programs should be considered 1

Emerging Research

• Pediatric pharmacokinetic studies have shown that even at recommended doses, children ≥6 years achieve slightly lower plasma concentrations compared to adults, possibly due to delayed food intake relative to bedaquiline administration 3
• Ongoing clinical trials are evaluating bedaquiline in younger children and those with lower weights 1