Updated Information About Prezista (Darunavir): Oral Suspension and Labeling Changes
December 20, 2011
On December 16, 2011, The Food and Drug Administration approved an oral suspension formulation of Prezista (darunavir). Prezista is now available as a 100 mg/mL oral suspension.
Additionally, the product labeling was updated to provide dosing recommendations for pediatric patients ages 3 to less than 6 years of age and for adult and pediatric patients greater than 6 years of age who can not swallow Prezista tablets.
For pediatric patients, dosing with oral suspension or tablets is based on weight. Please refer to full prescribing information for details. Do not use Prezista/ritonavir in pediatric patients below 3 years of age.
Section 6 Adverse Reactions (ADRs) was update to reflect clinical trial experience in pediatric patients from Study TMC1140C228 as follows:
ADRs to PREZISTA/ritonavir (all grades, greater than or equal to 3%), excluding laboratory abnormalities, were diarrhea (19%), vomiting (14%) and rash (10%).
There were no Grade 3 or 4 laboratory abnormalities considered as ADRs in this study.
Section 12.3 Pharmacokinetics was updated to provide population pharmacokinetic estimates of darunavir exposure in pediatric patients.
Section 14: Clinical Studies was updated to reflect the results from the pediatric trial as follows:
The 21 subjects had a median age of 4.4 years (range 3 to less than 6 years), and were 48% male, 57% Black, 29%, Caucasian and 14% other. The mean baseline plasma HIV-1 was 4.34 log10 copies/mL, the median baseline CD4+ cell count was 927 x 106 cells/l (range: 209 to 2,429 x 106 cells/l) and the median baseline CD4+ percentage was 27.7% (range: 15.6% to 51.1%). Overall, 24% of subjects had a baseline plasma HIV-1 RNA greater than or equal to 100,000 copies/mL. All subjects had used greater than or equal to 2 nucleoside reverse transcriptase inhibitors (NRTIs), 62% of subjects had used greater than or equal to 1 non-nucleoside reverse transcriptase inhibitors (NNRTI) and 76% had previously used at least one HIV protease inhibitor (PI).
Twenty subjects (95%) completed the 24 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 and less than 400 copies/mL was -57% and 81%, respectively. The mean change in CD4+ percentage from baseline was 4%. The mean change in CD4+ cell count from baseline was 109 x 106 cells/L.
Dose recommendations from the two studies were based on the following:
Prezista, a protease inhibitor, is a product of Tibotec Therapeutics.
This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.
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