Bedaquiline

Generic name
Bedaquiline
Brand name
ATC Code
J04AK05
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Bedaquiline

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

In adolescents weighing between 30 and 40 kg, average exposure is predicted to be higher compared to adult patients. [SmPC]

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Multi-drug resistant tuberculosis
  • Oral
    • 5 years up to 18 years and 15 up to 20 kg
      [1]
      • Initial dose: Week 1 and 2: 160 mg/day in 1 dose
      • Maintenance dose: Week 3-24 80 mg/dose 3 times a week. Minimal dosing interval between 2 doses: 48 hours.
      • Directions for administration:

        Administer with food.

      • In combination with at least three drugs for which in vitro sensitivity of the patient's isolate has been demonstrated.

    • 5 years up to 18 years and 20 up to 30 kg
      [1]
      • Initial dose: Week 1 and 2: 200 mg/day in 1 dose
      • Maintenance dose: Week 3-24 100 mg/dose 3 times a week. Minimal dosing interval between 2 doses: 48 hours.
      • Directions for administration:

        Administer with food.

      • In combination with at least three drugs for which in vitro sensitivity of the patient's isolate has been demonstrated.

    • 5 years up to 18 years and ≥ 30 kg
      [1]
      • Initial dose: Week 1 and 2: 400 mg/day in 1 dose
      • Maintenance dose: Week 3-24 200 mg/dose 3 times a week. Minimal dosing interval between 2 doses: 48 hours.
      • Directions for administration:

        Administer with food.

      • In combination with at least three drugs for which in vitro sensitivity of the patient's isolate has been demonstrated.

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Based on limited study data (n=15), there is no evidence of any difference in the safety profile in adolescents compared to adults.(SmPC)

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In adolescents weighing between 30 and 40 kg, the average exposure is expected to be higher than in adult patients. This may be associated with an increased risk of QT prolongation or hepatotoxicity.

Administration together with food increases the bioavailability by a factor 2.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

DRUGS FOR TREATMENT OF TUBERCULOSIS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Antibiotics
J04AB02
Hydrazides
J04AC01
Other drugs for treatment of tuberculosis
J04AK06
J04AK02
J04AK01

Reference

  1. Janssen-Cilag International NV, SmPC Sirturo (EU/1/13/901/001-002) Rev 20. 13-07-2021, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose