February 21, 2020
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.