Labeling for Prezista Expanded
July 18, 2016 – The U.S. FDA has expanded the use of Prezista® (darunavir), manufactured by Janssen, to include pregnant women with human immunodeficiency virus (HIV). The expanded indication recommends that pregnant women receive 600mg of Prezista with ritonavir 100mg twice daily. The updated label is based on an analysis of women treated with Prezista during pregnancy and postpartum, and on results from prospective reports from the Antiretroviral Pregnancy Registry. Prezista was originally approved in 2006 to be used in combination with other antiretroviral drugs to treat HIV.
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 regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular 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 a 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.