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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Entry and Fusion Inhibitors

Ibalizumab

Last Updated: April 16, 2019; Last Reviewed: April 16, 2019

Ibalizumab (IBA, Trogarzo)
Ibalizumab (IBA, Trogarzo)
For additional information see Drugs@FDA: https://www.accessdata.fda.gov/scripts/cder/daf/
Formulations
Single-Dose Vial for Intravenous Administration: 200 mg/1.33 mL (150 mg/mL) in a single-dose vial
Dosing Recommendations Selected Adverse Events
Child and Adolescent Dose:
  • The safety and efficacy of using ibalizumab in children and adolescents has not been established.
Adult Dose:
  • A single loading dose infusion of 2,000 mg administered intravenously (IV) over 30 minutes is followed by a maintenance dose of 800 mg administered IV over 15 minutes every 2 weeks.
  • Food and Drug Administration approval is limited to heavily treatment-experienced adults with multidrug-resistant HIV infection who are experiencing treatment failure on their current regimen.
  • Ibalizumab is used in combination with other antiretroviral drugs.
  • Diarrhea, dizziness, nausea, rash
  • Immune reconstitution inflammatory syndrome
  • Potential for immunogenicity in the form of anti-ibalizumab antibodies
Special Instructions
  • Using aseptic technique, withdraw 1.33 mL from each vial and transfer into a 250 mL bag of 0.9% sodium chloride for IV injection. Other IV diluents must not be used.
  • Once diluted, the solution should be administered immediately. If not used immediately, the solution can be stored at room temperature for up to 4 hours or refrigerated for up to 24 hours. Refrigerated solution should be allowed to stand at room temperature for at least 30 minutes but no more than 4 hours prior to administration.
  • Diluted solution is administered as an IV infusion, not as a bolus or IV push.
Metabolism/Elimination
  • Monoclonal antibodies are metabolized to peptides and amino acids.

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