|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
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
Prezista is a product of Janssen Pharmaceuticals, Inc.