Formulary restrictions:

• Indication: in at-risk adults and adolescents weighing at least 35 kg for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection
• Service Line: All
• Formulary Location: outpatient
• Service Location: ambulatory clinic, outpatient infusion suites
• Patient Population: adult and adolescent 12 years and older weighing at least 35 kg
• Prior Authorization required: yes
• Restriction/Criteria of Use:
  • Patient weight > 35 kg
  • Do not co-administer with UGT1A1 inducers (e.g., rifampin, phenytoin, carbamazepine, oxcarbazepine, or phenobarbital)
  • If initial injection:
    • Documented negative HIV Ag/Ab or RNA test within 1 week before injection AND no sign and symptoms of acute HIV
      • If patient is on cabotegravir oral lead-in and there is a documented HIV RNA test within 1 week, completion of 5 weeks prior to switching to IM cabotegravir is not needed
    • Baseline STD testing completed
    • Female at age of reproduction: negative pregnancy test
  • All subsequent doses:
    • A HIV Ag/Ab test and HIV RNA assay to be drawn AND no sign and symptoms of acute HIV
    • Female at age of reproduction: negative pregnancy test

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