Contraindication with Depression Med Prompts Labeling Update for Several HIV Drugs

The new contraindication is due to the potential for serious and/or life-threatening reactions
The new contraindication is due to the potential for serious and/or life-threatening reactions

The Food and Drug Administration (FDA) announced that the following antiretroviral drug labels have been updated to include Latuda (lurasidone; Sunovion) to the Contraindications section due to the potential for serious and/or life-threatening reactions:

  • Aptivus (tipranavir)
  • Crixivan (indinavir)
  • Genvoya (elvitegravir, cobicistat, emtricitabine, tenofovir alafenamide)
  • Invirase (saquinavir)
  • Kaletra (lopinavir, ritonavir)
  • Lexiva (fosamprenavir) - lurasidone is contraindicated if Lexiva is coadministered with ritonavir
  • Norvir (ritonavir)
  • Prezista (darunavir)
  • Reyataz (atazanavir) - lurasidone is contraindicated if Reyataz is coadministered with ritonavir
  • Stribild (elvitegravir, cobicistat, tenofovir disoproxil fumarate)
  • Viracept (nelfinavir)

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Latuda, an atypical antipsychotic, is indicated to treat adults with major depressive episodes associated with bipolar I disorder as monotherapy and as adjunctive therapy with lithium or valproate; and to treat schizophrenia.

The labels for Evotaz (atazanavir, cobicistat) and Prezcobix (darunavir, cobicistat) already include lurasidone as a contraindicated agent in the Contraindications section. The aforementioned antiretrovirals are indicated to treat HIV-1 infection. 

For more information call (888) 463-6332 or visit FDA.gov.

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