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On April 24, 2013, FDA approved revisions to the Prezista (darunavir) tablet and oral suspension label to update labeling with 48 week data from study TMC114-C228 for HIV-1 treatment experienced pediatric patients three to less than 6 years of age. The 48 week data is reflected in the Indications and Usage section and the following sections.
Section 6 Adverse Reactions
Study TMC114-C228
Clinical ADRs to PREZISTA/ritonavir (all grades, greater than or equal to 5%), were diarrhea (24%), vomiting (19%), rash (19%), abdominal pain (5%) and anorexia (5%).
Section 12 Clinical Pharmacology
Table 13 was updated to include the pharmacokinetic results from Study TMC114-C228
Section 14 Clinical Trials
Twenty subjects (95%) completed the 48 week period. One subject prematurely discontinued treatment due to vomiting assessed as related to ritonavir.
The proportion of subjects with HIV-1 RNA less than 50 copies/mL at Week 48 was 71%. The mean change in CD4+ percentage from baseline was 4%. The mean increase in CD4+ cell count from baseline was 187 x 106 cells/L.
The revised label will be made available at Drugs@FDA.
Prezista is a human immunodeficiency virus (HIV-1) protease inhibitor indicated for the treatment of HIV-1 infection in adult patients. PREZISTA is also indicated for the treatment of HIV-1 infection in pediatric patients 3 years of age and older. PREZISTA must be co-administered with ritonavir (PREZISTA/ritonavir) and with other antiretroviral agents.
Prezista is a product of Janssen Pharmaceuticals, Inc.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
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