Dolutegravir

Generic name
Dolutegravir
Brand name
ATC Code
J05AX12
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Dolutegravir

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

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information available about the pharmacokinetic parameters in children

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

Treatment HIV infection
  • Oral
    • Film-coated tablet
      • ≥ 6 years and 14 up to 20 kg
        [1]
        • 40 mg/day in 1 - 2 doses.
      • ≥ 6 years and ≥ 20 kg
        [1] [2] [3]
        • 50 mg/day in 1 - 2 doses.
      • 6 months up to 6 years and 14 up to 20 kg
        [1]
        • 40 mg/day in 1 - 2 doses.
      • 6 months up to 6 years and ≥ 20 kg
        [1]
        • 50 mg/day in 1 - 2 doses.
    • Orodispersable tablet
      • 4 weeks up to 6 months and 3 up to 6 kg
        [1]
        • 5 mg/day in 1 dose
      • 4 weeks up to 6 months and 6 up to 10 kg
        [1]
        • 10 mg/day in 1 - 2 doses.
      • ≥ 6 months and 6 up to 10 kg
        [1]
        • 15 mg/day in 1 dose

        • Alternatively: 20 mg/day in 2 doses

      • 10 up to 14 kg
        [1]
        • 20 mg/day in 1 - 2 doses.
      • 14 up to 20 kg
        [1]
        • 25 mg/day in 1 dose

        • Alternative: 30 mg/day in 2 doses

      • ≥ 20 kg
        [1]
        • 30 mg/day in 1 - 2 doses.

Renal impaiment in children > 3 months

According to the manufacturer, dose adjustment is not necessary with severely reduced renal function.

Patients on dialysis

There is no data about use in patients undergoing dialysis.

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

The side effect profile in children is similar to the profile in adults. 

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

No information available on specific warnings and precautions in children.

Interactions

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

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

References

  1. ViiV Healthcare UK Limited, SmPC Tivicay (EU/1/13/892/001-002) Rev 34 , 14-08-2023, www.geneesmiddeleninformatiebank.nl
  2. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children., Guidelines for the use of Antiretroviral agents in pediatric HIV infection, https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/dolutegravir?view=full, Geraadpleegd 22 aug 2023
  3. Bamford, A., et al (PENTA Steering Committee) (2015), Paediatric European Network for Treatment of AIDS (PENTA) guidelines for treatment of paediatric HIV-1 infection 2015: optimizing health in preparation for adult life. , HIV Med, doi:10.1111/hiv.12217

Changes

Therapeutic Drug Monitoring


Overdose