{"id":34341,"date":"2018-06-29T08:45:43","date_gmt":"2018-06-29T08:45:43","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=34341"},"modified":"2018-06-29T09:34:49","modified_gmt":"2018-06-29T09:34:49","slug":"janssen-dear-doctor-letter-prezista-darunavir-rezolsta-%e2%96%bcdarunavircobicistatand-symtuza-%e2%96%bcdarunavircobicistatemtricitabinetenofovir-alafenamide","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/34341","title":{"rendered":"Janssen Dear Doctor letter: Prezista (darunavir), Rezolsta \u25bc(darunavir\/cobicistat)and Symtuza \u25bc(darunavir\/cobicistat\/emtricitabine\/tenofovir alafenamide)"},"content":{"rendered":"<h2 class=\"HTBBODYtext\"><span lang=\"EN-US\">Direct Healthcare Professional Communication:\u00a0<\/span><\/h2>\n<p><strong><span lang=\"EN-US\">Darunavir\/cobicistat: Increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection when darunavir and cobicistat co-administered, due to low exposure values during the second and third trimesters of pregnancy.<\/span><\/strong><\/p>\n<p class=\"HTBBODYtext\"><em><span lang=\"EN-US\">Dear Healthcare Professional<\/span><\/em><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Janssen in agreement with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) would like to inform you of the following: <\/span><\/p>\n<h2 class=\"HTBsubhead3authorcredit\"><span lang=\"EN-US\">Summary<\/span><\/h2>\n<ul>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">Therapy with darunavir\/cobicistat should not be initiated during pregnancy. \u2028<\/span><\/li>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">Women who become pregnant during therapy with darunavir\/cobicistat should be switched to an alternative regimen: darunavir\/ritonavir may be \u2028considered as an alternative. \u2028<\/span><\/li>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">This is because pharmacokinetic data showed low exposure values of \u2028darunavir and cobicistat during the second and third trimesters of \u2028pregnancy. \u2028<\/span><\/li>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">Low darunavir exposure may be associated with an increased risk of \u2028treatment failure and an increased risk of mother-to-child transmission of HIV infection. \u2028<\/span><\/li>\n<\/ul>\n<h2><span lang=\"EN-US\">Background \u2028<\/span><\/h2>\n<p><span lang=\"EN-US\">The pharmacokinetic data from the Phase 3b study TMC114HIV3015 in 6 pregnant women demonstrated that the mean exposure (AUC) of darunavir boosted with cobicistat was 56% and 50% lower during the second and third trimesters of pregnancy, respectively, compared with 6 to 12 weeks postpartum. <\/span><span lang=\"EN-US\">Mean darunavir Cmin concentrations were around 90% lower during the second and third trimesters of pregnancy as compared to postpartum. <\/span><\/p>\n<p><span lang=\"EN-US\">Exposure of cobicistat was 63% and 49% lower during the second and third trimesters of pregnancy, respectively, as compared to postpartum. \u2028<\/span><\/p>\n<ul>\n<li class=\"HTBBODYindent\"><span lang=\"EN-US\">Low darunavir exposure may be associated with an increased risk of treatment failure and an increased risk of HIV-1 transmission to the child. Therefore, therapy with darunavir\/cobicistat should not be initiated during pregnancy and women who become pregnant during therapy with darunavir\/cobicistat should be switched to an alternative regimen. <\/span><\/li>\n<\/ul>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Based upon this information, the product information for PREZISTA (darunavir), REZOLSTA (darunavir and cobicistat) and SYMTUZA (darunavir, cobicistat, emtricitabine, tenofovir alafenamide), will be updated, as recommended by the European Medicines Agency (EMA). <\/span><\/p>\n<h2 class=\"HTBBODYtext\"><span lang=\"EN-US\">Call for reporting <\/span><\/h2>\n<p class=\"HTBBODYtext\"><b><span lang=\"EN-US\">\u25bc<\/span><span lang=\"EN-US\">This medicinal product is subject to additional monitoring to support risk management and it is therefore important to report any suspected adverse events. <\/span><\/b><b><\/b><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Please continue to report suspected adverse reactions with any medicine or vaccine to the MHRA through the Yellow Card Scheme. <\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">It is easiest and quickest to report adverse drug reactions online via the Yellow Card website: <a href=\"http:\/\/www.mhra.gov.uk\/yellowcard\">www.mhra.gov.uk\/yellowcard<\/a> or search for MHRA Yellow Card in the Google Play or Apple App Store. <\/span><\/p>\n<p>Alternatively, prepaid Yellow Cards for reporting are available by:<\/p>\n<ul>\n<li>Write to: FREEPOST YELLOW CARD (no other address details necessary)<\/li>\n<li>Emai: yellowcard@mhra.gov.uk<\/li>\n<li>See the form at the back of the British National Formulary (BNF).<\/li>\n<li>Telephone the Commission on Human Medicines (CHM) free phone line: 0800 731 6789,<span class=\"Apple-converted-space\">\u00a0<\/span><\/li>\n<li>Download and print a form from the Yellow Card section of the MHRA website.<\/li>\n<\/ul>\n<p><span lang=\"EN-US\">When reporting please provide as much information as possible, including information about medical history, any concomitant medication, onset, treatment dates, product brand name and batch numbers. <\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Suspected adverse reactions should also be reported to Janssen-Cilag Limited on telephone: 01494 567447, fax: 01494 567799 or by email at dsafety@its.jnj.com. <\/span><\/p>\n<h2 class=\"HTBBODYtext\"><span lang=\"EN-US\">Company contact points <\/span><\/h2>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">If you have further questions or require additional information, please contact: Janssen- Cilag Ltd. Medical Information Department: email: medinfo@its.jnj.com, telephone: 0800 731 8450 or 01494 567 444. <\/span><\/p>\n<p class=\"HTBBODYtext\"><span lang=\"EN-US\">Janssen, UK &amp; Ireland,\u00a0<\/span><span lang=\"EN-US\">50\u2013100 Holmers Farm Way, \u2028High Wycombe, Buckinghamshire, HP12 4EG.\u00a0<\/span><span lang=\"EN-US\">Telephone: (01494) 567567.<\/span><span lang=\"EN-US\"><br \/>\n<\/span><a href=\"http:\/\/www.janssen-cilag.co.uk\" rel=\"noopener\"><span lang=\"EN-US\">www.janssen-cilag.co.uk<\/span><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Direct Healthcare Professional Communication:\u00a0 Darunavir\/cobicistat: Increased risk of treatment failure and increased risk of mother-to-child transmission of HIV infection when darunavir and cobicistat co-administered, due to low exposure values during the second and third trimesters of pregnancy. Dear Healthcare Professional &hellip;<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[40,35],"tags":[],"class_list":["post-34341","post","type-post","status-publish","format-standard","hentry","category-treatment-alerts","category-pmtct-and-maternal-health"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/34341","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=34341"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/34341\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=34341"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=34341"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=34341"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}