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

Interactions
PK
Renal impairment
References

Darunavir

Generic name
Darunavir
Brand name
ATC Code
J05AE10

Pharmacokinetics in children

The exposure to darunavir in children is similar to that in adults

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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

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Dosages

HIV (ART-naive and pre-treated patients)
  • Oral
    • Suspension for oral use
      • 3 years up to 12 years and 10 up to 15 kg
        [2] [3]
        • 40 mg/kg/day in 2 doses. combined with ritonavir: 6 mg/kg/day in 2 doses.
        • Directions for administration:

          Take with food. Shake the suspension thoroughly before use.

      • 3 years up to 12 years and 15 up to 30 kg
        [2] [3]
        • 750 mg/day in 2 doses. combined with ritonavir, 96 mg/day in 2 doses.
        • Directions for administration:

          Take with food. Shake the suspension thoroughly before use.

      • 3 years up to 12 years and 30 up to 40 kg
        [2] [3]
        • 900 mg/day in 2 doses. combined with ritonavir 200 mg/day in 2 doses.
        • Directions for administration:

          Take with food. Shake the suspension thoroughly before use.

      • 3 years up to 12 years and ≥ 40 kg
        [2] [3]
        • 1.200 mg/day in 2 doses. combined with ritonavir 200 mg/day in 2 doses.
        • Directions for administration:

          Take with food. Shake the suspension thoroughly before use.

    • Tablet
      • 3 years up to 12 years and 15 up to 30 kg
        [2] [3]
        • 750 mg/day in 2 doses. combined with ritonavir 96 mg/day in 2 doses.
        • Directions for administration:

          Take with food.

      • 3 years up to 12 years and 30 up to 40 kg
        [2] [3]
        • 900 mg/day in 2 doses. combined with ritonavir 200 mg/day in 2 doses.
        • Directions for administration:

          Take with food.

      • 12 years up to 18 years and 30 up to 40 kg
        [2] [3]
        • 675 mg/day in 1 dose combined with ritonavir 100 mg/day in a single dose.
        • Directions for administration:

          Take with food.

      • 12 years up to 18 years and ≥ 40 kg
        [2] [3]
        • 800 mg/day in 1 dose combined with ritonavir: 100 mg/day in a single dose.
        • Directions for administration:

          Take with food

      • 3 years up to 12 years and ≥ 40 kg
        [2] [3]
        • 1.200 mg/day in 2 doses. combined with ritonavir 200 mg/day in 2 doses.
        • Directions for administration:

          Take with food.

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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.

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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 comparable to that of 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 in children

Do not use in children younger than 3 years.

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

Patients who have previously been exposed to antiretroviral medication but who do not have any
darunavir resistance-associated mutations (DRV-RAMs)* and who have
< 100,000 copies of HIV-1 RNA per ml in the plasma and ≥100 x 10E6 CD4+ cells per litre can use a dosing regimen
with once-daily intake of darunavir, taken together with ritonavir and food,

* DRV-RAMs: V11I, V32I, L33F, I47V, I50V, I54M, I54L, T74P, L76V, I84V and L89V

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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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Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB04
J05AB11
J05AB14
Protease inhibitors
J05AE03
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF10
J05AF05
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG01
Neuraminidase inhibitors
J05AH02
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR10
Other antivirals
J05AX12
J05AX08
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR10
Antivirals for treatment of HCV infections
J05AP57
J05AP08
J05AP55

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References

  1. Janssen-Cilag International NV, SmPC Prezista (EU/1/06/380/004) 28-11-14, Geraadpleegd 16 jan 2015
  2. Panel on Antiretroviral Therapy and Medical Management of HIV-Infected Children. , Guideline for the use of Antiretroviral agents in pediatric HIV infection, https://aidsinfo.nih.gov/guidelines/html/2/pediatric-arv-guidelines/129/darunavir, Geraadpleegd 15 feb 2017
  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