Guidelines for the Use of Antiretroviral Agents in Pediatric HIV Infection
The information in the brief version is excerpted directly from the full-text guidelines. The brief version is a compilation of the tables and boxed recommendations.
Protease Inhibitors (PIs)
Last Updated: May 22, 2018; Last Reviewed: May 22, 2018
|Darunavir (DRV, Prezista)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
|Oral Suspension: 100 mg/mL
Tablets: 75 mg, 150 mg, 600 mg, and 800 mg
Fixed-Dose Combination Tablets:
|Dosing Recommendations||Selected Adverse Events|
|Note: Darunavir should not be used without a pharmacokinetic (PK) enhancer (i.e., boosting agent): ritonavir (for children and adults) or cobicistat (for adults only).
Boosting darunavir with cobicistat is currently not recommended in children aged <18 years; PK, efficacy, and safety of darunavir/cobicistat is currently under investigation in children aged 12 to 18 years.
Adolescent (Weighing ≥40 kg)e and Adult Dose (Treatment-Naive or Treatment-Experienced with No Darunavir Resistance-Associated Mutations)
|a Once-daily dosing is Food and Drug Administration (FDA)-approved, but the Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV (the Panel) does not recommend it for children (see Frequency of Administration section below).
b Note that the dose in children weighing 10 kg to 15 kg is 20 mg/kg darunavir and 3 mg/kg ritonavir per kg body weight per dose, which is higher than the weight-adjusted dose in children with higher weight.
c Ritonavir 80 g/mL oral solution.
d The volumes for the 375-mg and 450-mg darunavir doses are rounded for suspension-dose convenience.
e Some Panel members recommend the FDA-approved dose of once-daily darunavir 675 mg (combination of tablets) plus ritonavir 100 mg once daily for adolescents weighing ≥30 kg to <40 kg (see Table B below).
f See cobicistat section for important information about toxicity, drug interactions, and monitoring patients who receive cobicistat.