FDA REMS Update on HIV-1 Pre-exposure Prophylaxis (PrEP)

The FDA has released Risk Evaluation Mitigation Strategy (REMS) Safety Information about an expanded indication for emtricitabine/tenofovir disoproxil fumarate 200 mg/300mg for HIV-1 PrEP to adolescents weighing at least 35 KG in combination with safer sex practices to reduce the risk of sexually acquired HIV-1 infection.  Considerations for prescribing to adolescents:

  • Ability of the individuals to understand the importance of adherence to daily dosing.
  • The need for frequent HIV testing.
  • The need for frequent sexually transmitted infection testing.
  • The continued risk of pregnancy.
  • More frequent visits and counseling.

A new adolescent brochure is available for healthcare providers to provide to patients at the REMS website www.ftc-tdf-preprems.com.