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.

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Protease Inhibitors (PIs)

Saquinavir

Last Updated: May 22, 2018; Last Reviewed: May 22, 2018

Saquinavir (SQV, Invirase)
Saquinavir (SQV, Invirase)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Capsules: 200 mg
Tablets: 500 mg
Dosing Recommendations Selected Adverse Events
Pediatric Dose:
  • Not approved for use in infants, children, and adolescents aged <16 years.
Adolescent and Adult Dose:
  • Saquinavir should only be used in combination with ritonavir.
  • Saquinavir 1000 mg plus ritonavir 100 mg twice daily
  • Gastrointestinal intolerance, nausea, and diarrhea
  • Elevated transaminases
  • Hyperlipidemia
  • Hyperglycemia
  • Fat maldistribution
  • PR interval prolongation, QT interval prolongation, and ventricular tachycardia (Torsades de Pointes)
Special Instructions
  • Administer within 2 hours after a full meal.
  • Sun exposure can cause photosensitivity reactions; advise patients to use sunscreen or protective clothing.
  • Pre-therapy electrocardiogram is recommended; saquinavir is contraindicated in patients with a prolonged QT interval.
Metabolism/Elimination
  • Cytochrome P450 3A4 (CYP3A4) substrate and inhibitor
  • 90% metabolized in the liver
  • Use saquinavir with caution in patients who have hepatic impairment; no dose adjustment recommended.

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