{"id":16645,"date":"2012-06-01T12:00:42","date_gmt":"2012-06-01T12:00:42","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=16645"},"modified":"2012-07-21T05:41:53","modified_gmt":"2012-07-21T05:41:53","slug":"fosamprenavir-paediatric-dosing-approved-in-us-for-ages-4-weeks-to-6-years","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/16645","title":{"rendered":"Fosamprenavir paediatric dosing approved in US for ages 4 weeks to &lt;6 years"},"content":{"rendered":"<p><strong>On 27 April 2012, the Food and Drug Administration approved dosing recommendations for use of fosamprenavir (Lexiva) oral suspension in pediatric patients.<\/strong><\/p>\n<p>Data submitted to FDA included three studies to support a new dosing regimen for fosamprenavir (FOS), with ritonavir (RTV), in combination with other antiretroviral drugs, for the treatment of HIV-1 infection in pediatric patients from at least 4 weeks to less than 6 years of age.<\/p>\n<p>The fosamprenavir label now includes dosing for pediatric patients aged at least 4 weeks to 18 years. The dosage of fosamprenavir should be calculated based on body weight (kg) and not exceed the recommended adult dose.<\/p>\n<p>Twice daily dosage regimens by weight with ritonavir are as follows:<\/p>\n<ul>\n<li>For protease inhibitor-na\u00efve pediatric patients (greater than or equal to 4 weeks of age) and<\/li>\n<li>For protease inhibitor-experienced pediatric patients greater than or equal to 6 months of age. (fosamprenavir plus ritonavir is not recommended for protease inhibitor experienced pediatric patients less than 6 month of age.)<\/li>\n<\/ul>\n<table border=\"0\">\n<tbody>\n<tr>\n<th scope=\"row\">Less than 11 kg<\/th>\n<td>FOS 45 mg\/kg plus RTV 7 mg\/kg<\/td>\n<\/tr>\n<tr>\n<th scope=\"row\">11 kg to less than 15 kg<\/th>\n<td>FOS 30 mg\/kg plus RTV 3 mg\/kg<\/td>\n<\/tr>\n<tr>\n<th scope=\"row\">15 kg to less than 20 kg<\/th>\n<td>FOS 23 mg\/kg plus RTV 3 mg\/kg<\/td>\n<\/tr>\n<tr>\n<th scope=\"row\">Greater than and equal to 20 kg<\/th>\n<td>FOS 18 mg\/kg plus RTV 3 mg\/kg<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>Alternatively, protease inhibitor na\u00efve children 2 years of age and older can be administered fosamprenavir (without ritonavir) 30 mg\/kg twice daily. Fosamprenavir should only be administered to infants born at 38 weeks gestation or greater and who have attained a post-natal age of 28 days. For pediatric patients, pharmacokinetic and clinical data:<\/p>\n<ul>\n<li>Do not support once-daily dosing of fosamprenavir alone or in combination with ritonavir.<\/li>\n<li>Do not support administration of fosamprenavir alone or in combination with ritonavir for protease inhibitor-experienced children younger than 6 months of age.<\/li>\n<li>Do not support twice-daily dosing of fosamprenavir without ritonavir in pediatric patients younger than 2 years of age.<\/li>\n<\/ul>\n<p>Other sections were updated to include safety and activity data from the three open label trials in pediatric subjects aged at least 4 weeks to 18 years.<\/p>\n<p>The complete updated labeling will be posted soon to on the FDA web site. Fosamprenavir is an HIV protease inhibitor manufactured by GlaxoSmithKline.<\/p>\n<p><a href=\"http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda\/index.cfm\">http:\/\/www.accessdata.fda.gov\/scripts\/cder\/drugsatfda\/index.cfm<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 27 April 2012, the Food and Drug Administration approved dosing recommendations for use of fosamprenavir (Lexiva) oral suspension in pediatric patients. Data submitted to FDA included three studies to support a new dosing regimen for fosamprenavir (FOS), with ritonavir &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-16645","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/16645","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=16645"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/16645\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=16645"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=16645"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=16645"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}