Darunavir

Generic name
Darunavir
Brand name
ATC Code
J05AE10
Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

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

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

HIV (ART-naive and pre-treated patients)
  • Oral
    • Suspension for oral 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.

    • Tablet
      • 3 years up to 12 years and 30 up to 40 kg
        • 900 mg/day in 2 doses. combined with ritonavir 200 mg/day in 2 doses.
      • 3 years up to 12 years and ≥ 40 kg
        • 1.200 mg/day in 2 doses. combined with ritonavir 200 mg/day in 2 doses.
      • 3 years up to 12 years and 20 up to 30 kg
        • 750 mg/day in 2 doses. combined with ritonavir 200 mg/day in 2 doses.
      • 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
        • 900 mg/day in 2 doses. combined with ritonavir 200 mg/day in 2 doses.
      • 12 years up to 18 years and ≥ 40 kg
        • 800 mg/day in 1 dose combined with ritonavir: 100 mg/day in a single dose or cobicistat 150 mg/day in a single dose.

        • Increase the dosage of darunavir in children who have been previously treated and who have at least one mutation associated with resistance to darunavir to 1200 mg/day in 2 doses in combination with ritonavir 200 mg/day in 2 doses.

      • 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.

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

The side effect profile in children is comparable to that of adults.

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

Interactions

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

DIRECT ACTING ANTIVIRALS

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

Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05AB01
J05AB12
J05AB06
J05AB16
J05AB04
J05AB11
J05AB14
Phosphonic acid derivatives
J05AD01
Protease inhibitors
J05AE08
J05AE07
J05AE02
J05AE04
J05AE03
J05AE01
Nucleoside and nucleotide reverse transcriptase inhibitors
J05AF06
J05AF02
J05AF09
J05AF10
J05AF05
J05AF04
J05AF07
J05AF13
J05AF13
J05AF01
Non-nucleoside reverse transcriptase inhibitors
J05AG06
J05AG03
J05AG04
J05AG01
J05AG05
Neuraminidase inhibitors
J05AH02
J05AH01
Antivirals for treatment of HIV infections, combinations
J05AR02
J05AR20
J05AR13
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Other antivirals
J05AX28
J05AX12
J05AX07
J05AX09
J05AX08
J05AX24
ANTIVIRALS FOR TREATMENT OF HIV INFECTIONS, COMBINATIONS
J05AR02
J05AR20
J05AR13
J05AR25
J05AR18
J05AR19
J05AR03
J05AR09
J05AR10
Integrase inhibitors
J05AJ04
Antivirals for treatment of HCV infections
J05AP54
J05AP57
J05AP51
J05AP08
J05AP55

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
  4. 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