Formulary
Bedaquiline: Indications, Dosing, Side Effects and Interactions
Bedaquiline clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Bedaquiline: Indications, Dosing, Side Effects and Interactions
Bedaquiline clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Multiple-drug resistant pulmonary tuberculosis, in combination with other drugs (under expert supervision)**
- **Adult** (By Mouth): Initially 400 mg once daily for 2 weeks, then 200 mg 3 times a week for 22 weeks, intervals of at least 48 hours between each dose, continue appropriate combination therapy after bedaquiline.
**Multiple-drug resistant pulmonary tuberculosis, in combination with other drugs (under expert supervision) for bedaquiline**
- **Child 5-17 years (body-weight 15-19 kg)** (By mouth): Initially 160 mg once daily for 2 weeks, then 80 mg 3 times a week for 22 weeks, intervals of at least 48 hours between each dose, continue appropriate combination therapy after bedaquiline.
- **Child 5-17 years (body-weight 20-29 kg)** (By mouth): Initially 200 mg once daily for 2 weeks, then 100 mg 3 times a week for 22 weeks, intervals of at least 48 hours between each dose, continue appropriate combination therapy after bedaquiline.
- **Child 5-17 years (body-weight 30 kg and above)** (By mouth): Initially 400 mg once daily for 2 weeks, then 200 mg 3 times a week for 22 weeks, intervals of at least 48 hours between each dose, continue appropriate combination therapy after bedaquiline.
Cautions
Hypothyroidism; QTc interval (derived using Fridericia's formula) 450-500 milliseconds; risk factors for QT interval prolongation (e.g. electrolyte disturbances, heart failure, history of symptomatic arrhythmias, bradycardia, congenital long QT syndrome)
Contraindications
QTc interval more than 500 milliseconds (derived using Fridericia's formula); ventricular arrhythmia
Side effects
Common or very common Arthralgia; diarrhoea; dizziness; headache; hepatic function abnormal; myalgia; nausea; QT interval prolongation; vomiting Side-effects, further information If syncope occurs, obtain ECG to identify if QT interval prolongation present.
Interactions
**Other interactions (7):**
- Antimycobacterials Bedaquiline (single dose) (Lopinavir/ritonavir 400/100 mg BID, multiple dose) Bedaquiline: AUC: 22% C max : A more pronounced effect on bedaquiline plasma exposures may be...
- Due to the risk of bedaquiline related adverse events, the combination of bedaquiline and Kaletra should be avoided.
- If the benefit outweighs the risk, co-administration of bedaquiline with Kaletra must be done with caution.
- More frequent electrocardiogram monitoring and monitoring of transaminases is recommended (see section 4.4 and refer to the bedaquiline SmPC).
- Concomitant use not recommended Risk of decreased plasma concentrations due to increased metabolism induced by primidone for: - Drugs affecting nervous system* (except anti-epileptics): mianserin,...
- ANTI-TB (Tuberculosis) Bedaquiline ND No change in bedaquiline kinetics.
Pregnancy
Manufacturer advises avoid unless potential benefit outweighs risk.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution in moderate impairment; avoid in severe impairment-no information available.
Renal impairment
Caution if creatinine clearance less than 30 mL/minute, M see Prescribing in renal impairment .
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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