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FDA HIV Update – Important Labeling Update

FDA HIV Update – Important Labeling Update
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Information about 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.
  • Stribild (elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil fumarate)
  • Viracept (nelfinavir)

Of note, Evotaz (atazanavir/cobicistat) and Prezcobix (darunavir/cobicistat) labels already include lurasidone as a contraindicated medication in section 4.

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