On November 20, 2009, the Food and Drug Administration approved a supplemental NDA to expand the indication for Selzenttry (maraviroc) to include combination antiretroviral treatment of therapy naïve adults infected with CCR5-tropic HIV-1 virus. Maraviroc was previously approved (8/6/2007) for treatment of therapy experienced adult patients infected with CCR5-tropic HIV-1 virus. The expanded indication is based upon data collected through 96 weeks from Study A4001026, demonstrating safety and efficacy.
The new label can be found on the FDA website at Drugs@FDA.
The following changes were made to the labeling:
Under HIGHLIGHTS OF PRESCRIBING INFORMATION:
RECENT MAJOR CHANGES
Indication and Usage (1)
Warnings and Precautions (5.1), (5.2), (5.4), (5.5)
--------INDICATIONS AND USAGE---------
SELZENTRY is a CCR5 co-receptor antagonist indicated for combination antiretroviral
treatment of adults infected with only CCR5-tropic HIV-1.
• In treatment-naïve subjects, more subjects treated with SELZENTRY experienced virologic
failure and developed lamivudine resistance compared to efavirenz [see Microbiology
(12.4) Clinical Studies (14.3].
• Tropism testing with a highly sensitive assay is required for the appropriate use of
SELZENTRY (1).
-------DOSAGE AND ADMINISTRATION-------- (see the full-text, below)
abrir aquí: (pdf, 30 páginas, prospecto rectificado)
http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022128s002lbl.pdf
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