Subject: FDA HIV Update - Important Labeling Update
From: "U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>
Date: Mon, 19 Sep 2016 14:49:40 -0500
Title: FDA HIV Update - Important Labeling Update
Informationabout FDA HIV product approvals, safety warnings, medical product labeling changes, notices of upcoming public meetings, and notices about proposed regulatory guidances.
The Food and Drug Administration is announcing that the following HIV drug labels have been updated to include Latuda
(lurasidone), an antipsychotic used to treat adult patients with depressive episodes in bipolar I disorder (bipolar depression), and schizophrenia, in adults. Lurasidone was added to Section 4 of the label, Contraindications, due to the
potential for serious and/or life-threatening reactions to the following product labels:
Aptivus (tipranavir)
Crixivan (indinavir)
Genvoya (elvitegravir, cobicistat, emtricitabine, and
tenofovir alafenamide)
Invirase (saquinavir)
Kaletra (lopinavir/ritonavir)
Lexiva (fosamprenavir) note: lurasidone is contraindicated
due to the potential for serious and/or life-threatening reactions if Lexiva is
coadministered with ritonavir.
Norvir (ritonavir)
Prezista (darunavir)
Reyataz (atazanavir) – note: lurasidone is
contraindicated due to the potential for serious and/or life-threatening
reactions if Reyataz is coadministered with ritonavir.
Of note, Evotaz
(atazanavir/cobicistat) and Prezcobix (darunavir/cobicistat) labels already
include lurasidone as a contraindicated medication in section 4.
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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