Truvada Receives Expanded Indication
May 15, 2018 – The U.S. FDA has approved an expanded indication for Truvada® (emtricitabine/tenofovir disoproxil fumarate), manufactured by Gilead Pharmaceuticals. The product is now indicated to provide pre-exposure prophylaxis (PrEP) for teenagers who may be at risk of acquiring HIV-1 and who weigh at least 35kg (77lbs).
According to a study from the U.S. Centers for Disease Control and Prevention (CDC), in which 21% of new cases of HIV identified in 2016 occurred in adolescents and young adults ranging from 13 to 24 years of age. A clinical trial demonstrated that Truvada, when used in combination with safe sex practices, had a similar safety profile in adolescents as in adults.
Truvada carries a black box warning that patients using the medication for a PrEP indication must test negative for HIV-1. Testing for the virus should be conducted once every three months during therapy. An additional black box warning states that discontinuing Truvada in patients co-infected with both HIV-1 and hepatitis B virus (HBV) could lead to severe, acute exacerbations of hepatitis B.
Treatment with Truvada is not intended to replace safe-sex practices, such as responsible use of condoms.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.