FDA Approves Once-Daily Prezista Dosing for Treatment-Experienced Adults
December 13, 2010
On December 13, 2010, FDA approved new labeling for Prezista (darunavir) to include a once daily dosing for treatment-experienced adult patients with no darunavir resistance associated substitutions. The major revisions to the package insert are summarized below. Other minor changes to the package insert and patient package insert were made for consistency.
A DOSAGE AND ADMINISTRATION Section 2.1 Treatment-Experienced Adult patient was revised as follows:
The recommended oral dose for treatment-experienced adult patients with no darunavir resistance associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V and L89V) is 800 mg Prezista once daily withView Full Article
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