{"id":6967,"date":"2005-12-13T15:30:22","date_gmt":"2005-12-13T14:30:22","guid":{"rendered":"http:\/\/moomango.co.uk\/htb\/?p=6967"},"modified":"2014-05-21T16:31:47","modified_gmt":"2014-05-21T16:31:47","slug":"new-kaletra-tablet-formulation-meltrex-approved-by-fda","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/6967","title":{"rendered":"New Kaletra tablet formulation (meltrex) approved by FDA"},"content":{"rendered":"<p><strong>On 28 October 2005, the Food and Drug Administration (FDA) approved a new formulation of Kaletra. Kaletra (lopinavir\/ritonavir) is now available in the US as a film-coated tablet (200mg\/50mg) that provides advantages over the currently marketed capsule formulation for HIV-1 infected patients. Specifically, the tablet formulation:<\/strong><\/p>\n<ul>\n<li>does not require refrigeration<\/li>\n<li>can be administered without regard to meals<\/li>\n<li>does not require dose adjustments for concomitant use with certain NNRTIs and PIs in treatment-naive patients<\/li>\n<li>has a decreased pill burden compared to the capsule formulation (2 tablets twice daily or 4 tablets once daily in treatment-naive patients only vs 3 capsules twice daily or 6 capsules once daily in treatment-naive patients only)<\/li>\n<\/ul>\n<p>Selected changes to the SPC for the tablet formulation are included below. Please refer to the full SPC for full details of the changes.<\/p>\n<ul>\n<li>Two 200\/50 mg lopinavir\/r tablets are similar to three 133.3\/33.3 mg KALETRA capsules under fed conditions with less pharmacokinetic variability.<\/li>\n<\/ul>\n<p>No clinically significant changes in Cmax and AUC were observed following administration of lopinavir\/r tablets under fed conditions compared to fasted conditions. Relative to fasting, administration of lopinavir\/r tablets with a moderate fat meal (500 &#8211; 682 Kcal, 23 to 25% calories from fat) increased lopinavir AUC and Cmax by 26.9% and 17.6%, respectively. Relative to fasting, administration of lopinavir\/r tablets with a high fat meal (872 Kcal, 56% from fat) increased lopinavir AUC by 18.9%, but not Cmax. Therefore, lopinavir\/r tablets may be taken with or without food.<\/p>\n<ul>\n<li>Lopinavir\/r oral solution must be taken with food.<\/li>\n<li>Lopinavir\/r tablets should be swallowed whole and not chewed, broken, or crushed.<\/li>\n<\/ul>\n<p>The \u0091dosage and administration\u0092 section was revised to include the following information:<\/p>\n<ul>\n<li>Although the label includes an option to dose lopinavir\/r once-daily for treatment naive patients, once-daily administration of lopinavir\/r is not recommended in therapy-experienced patients.<\/li>\n<\/ul>\n<p>Drug interactions with the tablet and capsule formulation are similar and require similar dose adjustments.<\/p>\n<p>The \u0091how supplied\u0092 section was revised to include storage information for the Kaletra tablets as follows:<\/p>\n<ul>\n<li>Recommended storage for the film-coated tablets is at 20\u00b0- 25\u00b0C (68\u00b0-77\u00b0F); excursions permitted to 15\u00b0-30\u00b0C (59\u00b0 to 86\u00b0F) [see USP controlled room temperature]. Exposure of this product to high humidity outside the original container for longer than 2 weeks is not recommended.<\/li>\n<\/ul>\n<p>Abbott plan to phase out the capsule formulation of lopinavir\/r<\/p>\n<h3>Comment<\/h3>\n<p><strong>European approval is not expected until early Summer 2006. However a named patient programme is being planned within the next month, that will enable earlier access for patients who currently have adherence or storage problems associated with the current formulation.<\/strong><\/p>\n<p><strong>The cost premium in the US for the new formulation was an 8% increase, although this is not expected in Europe. Once the meltrex formulation is available, Abbott will discontinue production of the current formulation.<\/strong><\/p>\n<p>Source: FDA list serve<\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 28 October 2005, the Food and Drug Administration (FDA) approved a new formulation of Kaletra. Kaletra (lopinavir\/ritonavir) is now available in the US as a film-coated tablet (200mg\/50mg) that provides advantages over the currently marketed capsule formulation for HIV-1 &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-6967","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/6967","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=6967"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/6967\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=6967"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=6967"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=6967"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}