Italian Medicines Agency Agenzia Italiana del Farmaco

Direct communication with healthcare professionals on Forxiga (dapagliflozin) - Direct communication with healthcare professionals on Forxiga (dapagliflozin)

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Direct communication with healthcare professionals on Forxiga (dapagliflozin)

Forxiga (dapagliflozin) 5mg should no longer be used for the treatment of Type 1 Diabetes Mellitus.

Summary 

  • Effective 29/10/2021 Forxiga (dapagliflozin) 5mg is no longer authorised for the treatment of patients with type 1 diabetes mellitus (T1DM) and should no longer be used in this population. This is based on Astra Zeneca’s decision to remove the T1DM indication for dapagliflozin 5mg.
  • Diabetic ketoacidosis (DKA) is a known side effect of dapagliflozin. In T1DM studies with dapagliflozin, DKA was reported with common frequency (occurring in at least 1 per 100 patients). 
  • Additional risk minimisation measures for healthcare professionals and patients, implemented to mitigate the risk of DKA with the use of dapagliflozin in T1DM will no longer be available.
  • Discontinuation of dapagliflozin in patients with T1DM must be made by or in consultation with a physician specialised in diabetes care and be conducted as soon as clinically practical. 
  • After stopping dapagliflozin treatment, frequent blood glucose monitoring is recommended, and the insulin dose should be increased carefully to minimise the risk of hypoglycaemia.


Published on: 29 October 2021

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The following has evaluated to null or missing:
==> articleId  [in template "20115#20151#1665546" at line 124, column 44]

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FTL stack trace ("~" means nesting-related):
	- Failed at: ${articleId}  [in template "20115#20151#1665546" at line 124, column 42]
----
1<#attempt> 
2 
3<#assign templateUtilService = serviceLocator.findService('it.gov.aifa.template.util.service.TemplateUtilService') />  
4 
5<#assign splitter = themeDisplay.getURLCurrent()?split("/-/")> 
6<#assign titleJournalDirty = (splitter?last?split("?")?first)> 
7 
8 
9<#assign titleJournal = titleJournalDirty> 
10 
11<#if titleJournal?contains("/-/")> 
12	<#assign titleJournal = titleJournalDirty?substring(0,titleJournalDirty?index_of("/-/"))> 
13</#if> 
14	 
15    <#assign article = templateUtilService.fetchArticleByUrlTitle(groupId,titleJournal)> 
16 
17	<#if article?has_content> 
18		 
19		<#assign docXml = saxReaderUtil.read(article.getContentByLocale(locale)) /> 
20		<#assign rootElement = docXml.document.getRootElement() > 
21	    <#assign listadocumenti = docXml.getRootElement().selectNodes("//dynamic-element[@name='TitoloDocumentoCorrelato']") /> 
22         <#assign articleId = article.getArticleId() >	 
23	 
24		<#assign count = 0 />	 
25        <#list listadocumenti as doc> 
26			<#assign docItem = doc.valueOf("dynamic-content/text()")!""/> 
27			<#assign docItem = docItem?trim/> 
28			 
29			<#if docItem?has_content && docItem?length gt 0> 
30				<#assign count = count + 1 /> 
31			</#if> 
32		</#list> 
33		 
34		<#if count gt 0> 
35			<div class="underline_title istituzionale">  
36				<h2 class="portlet-content portlet-title-text-model portlet-title-text"><@liferay_ui['message'] key='label.templates.documenti.correlati' /></h2> 
37				 
38                        <div class="it-list-wrapper"> 
39		                    <ul class="it-list"> 
40							 
41							    <#list listadocumenti as doc> 
42 
43									<li> 
44										<#assign docTitle = doc.valueOf("dynamic-content/text()") /> 
45										<#assign docItem = doc.valueOf("dynamic-element[@name='DocumentiCorrelati']/dynamic-content/text()") /> 
46 
47										<#assign jsonDocument=jsonFactoryUtil.createJSONObject(docItem)> 
48			 
49												 
50										<#if docItem?has_content && docItem?length gt 0> 
51											<#assign groupId=jsonDocument.getLong("groupId")> 
52											<#assign uuId=jsonDocument.getString("uuid")> 
53											<#assign docName=jsonDocument.getString("title")> 
54											<#assign docItem = "/documents/"+groupId+"/"+0+"/"+docName+"/"+uuId />	 
55											<#assign jsonFile=templateUtilService.buildFileEntryByUrlDocument(themeDisplay.getScopeGroupId(),docItem) /> 
56 
57 
58											<#if ((jsonFile.length())>0)> 
59 
60												<#assign tipoDocumento = jsonFile.extension?upper_case/> 
61											  
62												<#if (tipoDocumento == "PDF")> 
63								 
64													<div class="it-right-zone"> 
65														<a title="${docTitle}" aria-label="<@liferay_ui['message'] key='aria.label.templates.download.file' /> ${docTitle} " href="${jsonFile.url}"> 
66															<span class="text">${docTitle} [${(jsonFile.size?number/(1024*1024))?string["0.##"]} Mb] [${jsonFile.extension}] ></span> 
67														</a> 
68														<span class="it-multiple"> 
69															<a title="<@liferay_ui['message'] key='title.label.preview' />" aria-label="<@liferay_ui['message'] key='aria.label.templates.view.file' /> ${docTitle}" onclick="buildModale('${docItem}');" > 
70																<i class="u-color-blu fas fa-search"></i> 
71															</a> 
72															<a title="<@liferay_ui['message'] key='title.label.download' />" aria-label="<@liferay_ui['message'] key='aria.label.templates.download.file' /> ${docTitle} " href="${jsonFile.url}"> 
73																<i class="fas fa-download"></i> 
74															</a> 
75														</span> 
76													</div> 
77							 
78												<#else> 
79							   
80													<a class="active" title="<@liferay_ui['message'] key='title.label.download' />" aria-label="<@liferay_ui['message'] key='aria.label.templates.download.file' /> ${docTitle} " href="${jsonFile.url}"> 
81														<div class="it-right-zone"> 
82															<span class="text">${docTitle} [${(jsonFile.size?number/(1024*1024))?string["0.##"]} Mb] [${jsonFile.extension}] ></span> 
83															<i class="fas fa-download"></i> 
84														</div> 
85													</a> 
86							   
87												</#if> 
88											</#if> 
89										</#if> 
90									</li>									 
91								</#list> 
92								<div class="yui3-skin-sam" data-toggle="modal"> 
93                                   
94                              <div id="modal-${articleId}" class="container preview-document"> 
95                              </div> 
96                              </div> 
97	                        </ul>		 
98                        </div> 
99            </div> 
100		</#if>	 
101	</#if> 
102				 
103<#recover> 
104</#attempt> 
105 
106<script> 
107 
108function buildModale(urlDocument){ 
109	var modal; 
110	 
111	YUI().use('aui-modal', function(Y) { 
112        var StdMod = Y.WidgetStdMod; 
113 
114		 modal = new Y.Modal({ 
115			bodyContent : '<object style="width:33rem; height:25rem;" data="'+urlDocument+'" type="application/pdf"></object>', 
116			centered : true, 
117            draggable: false, 
118            resizeble: false, 
119			visible : true, 
120			destroyOnHide : true, 
121			headerContent : 'Dettaglio documento', 
122			modal : true, 
123            focused:true, 
124			render : '#modal-${articleId}' 
125		}); 
126	}); 
127    
128    
129
130</script> 

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