{"id":34976,"date":"2018-09-19T09:16:38","date_gmt":"2018-09-19T09:16:38","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=34976"},"modified":"2018-09-19T12:02:44","modified_gmt":"2018-09-19T12:02:44","slug":"fda-update-labels-for-dolutegravir-and-dolutegravir-based-fdcs-to-reflect-potential-risk-of-neural-tube-defects","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/34976","title":{"rendered":"FDA update labels for dolutegravir and dolutegravir-based FDCs to reflect potential risk of neural tube defects"},"content":{"rendered":"<p class=\"HTBsubhead3authorcredit\"><strong><span lang=\"EN-US\">Polly Clayden, HIV i-Base<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><b><span lang=\"EN-US\">On 6 September 2018, the US FDA approved revisions to the dolutegravir (Tivicay), abacavir\/dolutegravir\/lamivudine (Triumeq) and dolutegravir\/rilpivirine (Juluca) labels to include information on the risk of neural tube defects.<\/span><\/b><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">These changes include:<\/span><\/p>\n<ul>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">Pregnancy testing before starting dolutegravir in adolescent and adult women of childbearing potential.<\/span><\/li>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">Advise pregnant adolescents and adults of the potential risk to the embryo exposed to dolutegravir from the time of conception through the first trimester of pregnancy.<\/span><\/li>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">If there are plans to become pregnant or if pregnancy is confirmed within the first trimester while on dolutegravir, if possible, switch to an alternative regimen.<\/span><\/li>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">Advise adolescents and adults of childbearing potential to consistently use effective contraception.<\/span><\/li>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">Register patients who become pregnant to the Antiretroviral Pregnancy Registry (APR).<\/span><\/li>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">Weight gain was also added to the postmarketing experience subsection for each label.<\/span><\/li>\n<\/ul>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">The updated labels are available at\u00a0<\/span>drugs@fda,\u00a0(listed by trade name)<span lang=\"EN-US\">. <\/span><\/p>\n<p class=\"HTBBODYtext\"><strong><span lang=\"EN-US\">Link<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Updated dolutegravir label (Tivicay).<br \/>\n<\/span><span lang=\"EN-US\"><a href=\"(listed%20by trade name). https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/204790s016s018lbl.pdf (PDF)\" rel=\"noopener\">https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/204790s016s018lbl.pdf<\/a> (PDF)<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Polly Clayden, HIV i-Base On 6 September 2018, the US FDA approved revisions to the dolutegravir (Tivicay), abacavir\/dolutegravir\/lamivudine (Triumeq) and dolutegravir\/rilpivirine (Juluca) labels to include information on the risk of neural tube defects. These changes include: Pregnancy testing before starting &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-34976","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/34976","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\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=34976"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/34976\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=34976"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=34976"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=34976"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}