Update: January 2023
Forms and strengths
- 100 mg tablet
- 20 mg dispersible tablet
Dosage
- Child up to 15 kg: according to weight and age
- Child 16 to 29 kg: 200 mg once daily for 2 weeks, then 100 mg 3 times a week
- Child 30 kg and over and adult: 400 mg once daily for 2 weeks, then 200 mg 3 times a week
When administered 3 times a week, keep an interval of 48 hours between doses (Monday, Wednesday, Friday = M/W/F).
|
Weight (kg) |
Weeks 1 and 2 Once daily |
Subsequent weeks 3 times a week (M/W/F) |
||||
|---|---|---|---|---|---|---|
|
Dose (mg) |
100 mg tablet |
20 mg dispersible tablet |
Dose (mg) |
100 mg tablet |
20 mg dispersible tablet |
|
| 5-6 | 30-60 | – |
< 3 months: 1½ tab ≥ 3 months: 3 tab |
10-20 | – |
< 3 months: ½ tab ≥ 3 months: 1 tab |
| 7-9 | 30-80 | – |
< 3 months: 1½ tab ≥ 3 months: 3 tab ≥ 6 months: 4 tab |
10-40 | – |
< 3 months: ½ tab ≥ 3 months: 1 tab ≥ 6 months: 2 tab |
| 10-15 | 60-120 | – |
< 6 months: 3 tab ≥ 6 months: 6 tab |
20-60 | – |
< 6 months: 1 tab ≥ 6 months: 3 tab |
| 16-29 | 200 | 2 tab | – | 100 | 1 tab | – |
| ≥ 30 | 400 | 4 tab | – | 200 | 2 tab | – |
- Alternatively, for children 16 to 29 kg: 10 dispersible tablets of 20 mg (200 mg) once daily on Weeks 1 and 2, then 5 dispersible tablets of 20 mg (100 mg) 3 times a week.
- If 20 mg dispersible tablets are not available, 100 mg tablets can be crushed and suspended in 10 ml of water or fruit juice to obtain a solution containing 10 mg of bedaquiline per ml, then administered as follows:
|
Weight (kg) |
Weeks 1 and 2 Once daily |
Subsequent weeks 3 times a week (M/W/F) |
||
|---|---|---|---|---|
| Dose (mg) |
100 mg tablet in 10 ml (10 mg/ml) |
Dose (mg) |
100 mg tablet in 10 ml (10 mg/ml) |
|
|
5-6 |
30-60 |
< 3 months: 3 ml ≥ 3 months: 6 ml |
10-20 |
< 3 months: 1 ml ≥ 3 months: 2 ml |
|
7-9 |
30-80 |
< 3 months: 3 ml ≥ 3 months: 6 ml ≥ 6 months: 8 ml |
10-40 |
< 3 months: 1 ml ≥ 3 months: 2 ml ≥ 6 months: 4 ml |
|
10-15 |
60-120 |
< 6 months: 6 ml ≥ 6 months: 12 ml |
20-60 |
< 6 months: 2 ml ≥ 6 months: 6 ml |
Contra-indications, adverse effects, precautions
- Do not administer (or discontinue) to patients with severe hepatic impairment, QTcF > 500 ms or clinically significant ventricular arrhythmia.
- Avoid or use with caution and under close monitoring in patients with:
- history of syncopal episodes, torsades de pointes, congenital QT prolongation;
- uncompensated heart failure, severe coronary artery disease, bradycardia;
- electrolyte disturbances (correct first K, Ca, Mg), hypothyroidism (provide thyroxine);
- severe renal impairment, end-stage renal disease (optimal dosing not established).
- May cause:
- hepatotoxicity, moderate QT prolongation;
- nausea, vomiting, arthralgia, headache, increased amylase level;
- hypersensitivity reactions.
- For the management of adverse effects, see Appendix 17.
- Avoid or use with caution and under close monitoring in patients taking CYP450 inducers/inhibitors, some ARVs, or other QT prolonging drugs (Appendix 19).
Pregnancy: use if the benefits outweigh the risks (safety not established).
Breastfeeding: avoid breastfeeding during treatment (safety not established).
Monitoring
- Symptomatic monitoring.
- Liver function, ECG, electrolytes (K, Ca, Mg).
Patient instructions
- Take with food.
- 100 mg tablets can be crushed and mixed with water or fruit juice.
- 20 mg tablets should be dispersed in water, juice, milk, yogurt, porridge, etc.
- Avoid alcohol during treatment.
Remarks
-
For patients over 14 years who receive the regimen BPaLM or BPaL, bedaquiline can be given daily instead of 3 times a week: 200 mg once daily for the first 8 weeks then, 100 mg once daily.