{"id":10218,"date":"2010-04-02T12:02:40","date_gmt":"2010-04-02T12:02:40","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=10218"},"modified":"2013-08-08T12:21:17","modified_gmt":"2013-08-08T12:21:17","slug":"fda-updates-us-label-for-darunavir-prezista","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/10218","title":{"rendered":"FDA updates US label for darunavir (Prezista)"},"content":{"rendered":"<p><strong>On 27 January 2010, the FDA\u00a0approved revisions to the darunavir (Prezista) product labeling to include the 96 week data from two trials; one trial in treatment-experienced patients\u00a0(TMC114-C214) and one trial in treatment-naive patients (TMC114-C211).<\/strong><\/p>\n<p>Additional revisions included:<\/p>\n<ul>\n<li>Updating the contraindications to include for alfuzosin<\/li>\n<li>Adding drug hypersensitivity, angioedema and\u00a0urticaria as less common adverse reactions<\/li>\n<li>Adding a new section to identify osteonecrosis as an Adverse Drug Reaction (ADR).<\/li>\n<li>Including\u00a0redistribution of body fat and toxic epidermal necrolysis as potential side effects (from post-marketing reports).<\/li>\n<li>Updating maraviroc drug\u00a0interaction data. In summary maraviroc concentrations are increased when co-administered with darunavir\/ritonavir, requiring a dose reduction of maraviroc\u00a0to 150 mg twice daily.<\/li>\n<li>Additional resistance data and baseline genotype and phenotype virologic analyses and cross-resistance data were also\u00a0included.<\/li>\n<\/ul>\n<p>The updated labeling will be posted to the FDA website (Prezista):<\/p>\n<p><a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda\">http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda<\/a><\/p>\n<p>Source: FDA list serve (27 January 2010)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 27 January 2010, the FDA\u00a0approved revisions to the darunavir (Prezista) product labeling to include the 96 week data from two trials; one trial in treatment-experienced patients\u00a0(TMC114-C214) and one trial in treatment-naive patients (TMC114-C211). Additional revisions included: Updating the contraindications &hellip;<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-10218","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/10218","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\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=10218"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/10218\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=10218"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=10218"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=10218"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}