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

Interactions
PK
Renal impairment
References

Dolutegravir

Generic name
Dolutegravir
Brand name
ATC Code
J05AX12

Pharmacokinetics in children

No information available about the pharmacokinetic parameters in children

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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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.

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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.

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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. 

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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.

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Interactions

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

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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

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Changes

Changes