{"id":15934,"date":"2011-12-01T12:28:15","date_gmt":"2011-12-01T12:28:15","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=15934"},"modified":"2011-12-01T12:28:15","modified_gmt":"2011-12-01T12:28:15","slug":"fda-updates-us-label-for-darunavir-for-serious-rash","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/15934","title":{"rendered":"FDA updates US label for darunavir for serious rash"},"content":{"rendered":"<p>On 19 October 2011 the FDA approved updates to the darunavir (Prezista) package insert to include 192-week results from the Phase 3 registrational studies.<\/p>\n<p>  In addition, section 5.3 Severe Skin Reactions now includes the following text about combinations that include darunavir\/ritonavir plus raltegravir:<\/p>\n<p>  Rash occurred more commonly in treatment-experienced subjects receiving regimens containing darunavir\/ritonavir + raltegravir compared to subjects receiving darunavir \/ritonavir without raltegravir or raltegravir without darunavir \/ritonavir. However, rash that was considered drug related occurred at similar rates for all three groups. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash.<\/p>\n<p>  Source:<\/p>\n<p>  FDA HIV\/AIDS Update &#8211; Prezista label update includes 192-week safety, resistance and efficacy data (21 October 2011).<\/p>\n<p>  <a href=\"http:\/\/dailymed.nlm.nih.gov\/dailymed\/drugInfo.cfm?id=59314\">New label and supporting information<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 19 October 2011 the FDA approved updates to the darunavir (Prezista) package insert to include 192-week results from the Phase 3 registrational studies. In addition, section 5.3 Severe Skin Reactions now includes the following text about combinations that include &hellip;<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-15934","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15934","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=15934"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/15934\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=15934"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=15934"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=15934"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}