[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-283958-105":53,"doc-detail-283958-en":130},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":123,"head_meta":125,"extra_data":127,"updated_unix":129},105,"en","hereditary-angioedema-agents-clinical-criteria-cc-0034","Hereditary Angioedema Agents - Clinical Criteria - CC-0034","","Clinical criteria for drugs used to treat or prevent hereditary angioedema (HAE) attacks, including prophylaxis and acute treatment options. The document lists specific agents and summarizes each agent’s role, indications, routes of administration, and key safety considerations such as risks of serious anaphylactic reactions and thromboembolic events. Background clinical context covers HAE types, C1-INH deficiency and screening using C4, characteristic attack presentations, triggers, and selected treatment considerations for different patient groups.",{"@graph":63,"@context":122},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":46,"@type":70,"position":76},"https://docshare.wps.com/template/paper-templates/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/hereditary-angioedema-agents-clinical-criteria-cc-0034/283958/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/hereditary-angioedema-agents-clinical-criteria-cc-0034/283958.png","ImageObject",442,249,{"name":88,"@type":89},"Đào","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-09-29","2026-09-17",true,{"@type":98,"interactionType":99,"userInteractionCount":79},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114,118],{"name":105,"@type":106,"acceptedAnswer":107},"What is the purpose of the Hereditary Angioedema Agents clinical criteria document?","Question",{"text":108,"@type":109},"It defines clinical criteria for using specific drugs to treat or prevent hereditary angioedema (HAE) attacks, covering both prophylaxis and acute treatment approaches.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"How are HAE types and C1-INH deficiency related to diagnosis and screening?",{"text":113,"@type":109},"HAE is an autosomal dominant disorder with types I and II most common, both associated with C1-INH mutations. C4 testing is a useful screening tool, and a normal C4 during an angioedema episode excludes HAE-C1INH.",{"name":115,"@type":106,"acceptedAnswer":116},"Which agents are listed for prophylaxis versus acute treatment?",{"text":117,"@type":109},"The document lists multiple prophylactic agents (e.g., Cinryze, Haegarda, Takhzyro, Orladeyo, Andembry, Dawnzera) and acute treatment agents (e.g., Berinert, Firazyr, Kalbitor, Ruconest, Ekterly).",{"name":119,"@type":106,"acceptedAnswer":120},"What safety concerns are highlighted for acute and prophylactic agents?",{"text":121,"@type":109},"Key safety considerations include risk of serious anaphylactic reactions for certain agents, and risk of serious arterial and venous thromboembolic events for some C1-INH products. Additional precautions include warnings such as QT prolongation and contraindication-related guidance for specific drugs.","https://schema.org",{"og:url":78,"og:type":124,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":126,"canonical":78},"index,follow",{"doc_id":128,"site_id":56},283958,1790048055,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":88,"user_avatar":133,"doc_module":9,"category_id":45,"category_name":46,"doc_title":59,"doc_description":61,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":79,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":139,"language":140,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":61,"update_tm":144,"read_time":76},1374402968488,"https://ap-avatar.wpscdn.com/davatar_29158cc5080c5b710cf443261637dec0","Medical Drug Clinical Criteria  \nSubject:  \nDocument \\#: Status:  \nHereditary Angioedema Agents CC-0034  \nRevised  \nPublish Date:  \nLast Review Date:  \n03/01/2026  \n09/08/2025  \nTable of Contents  \nOverview  Coding  References  \nClinical criteria  Document history  \nOverview  \nThis document addresses the use of drugs for the treatment or prevention of hereditary angioedema (HAE) attacks. The agents are listed in the following table.  \nFor the clinical criteria for these drugs please refer to their respective Clinical Criteria documents:  \n• Hereditary Angioedema Agents Step Therapy Clinical Criteria  \n• Hereditary Angioedema Prophylactic Oral Agent Orladeyo (berotralstat)  \n• Hereditary Angioedema Acute Oral Agent Ekterly (sebetralstat)  \n\n| Agent | Prophylaxis or Treatment | Indication | Route of\u003Cbr>Administration | Safety |  |\n| --- | --- | --- | --- | --- | --- |\n| Cinryze\u003Cbr>(C1 Esterase Inhibitor, Human) | Prophylaxis | Routine prophylaxis against HAE attacks in adolescent (≥ 6 years) and adult patients | Intravenous infusion | ✓\u003Cbr>✓\u003Cbr>✓ | Risk of serious anaphylactic reactions\u003Cbr>Serious arterial and venous thromboembolic events\u003Cbr>Made from human plasma and may contain infectious agents |\n| Haegarda\u003Cbr>(C1 Esterase Inhibitor, Human) | Prophylaxis | Routine prophylaxis against HAE attacks (≥ 6 years) | Subcutaneous |  |  |\n| Berinert\u003Cbr>(C1 Esterase Inhibitor, Human) | Treatment | Treatment of acute abdominal, facial, or laryngeal attacks of HAE in adult and pediatric patients (≥5 years) | Intravenous infusion |  |  |\n| Firazyr (icatibant) | Treatment | Treatment of acute attacks of HAE in adult patients (≥ 18 years) | Subcutaneous | ✓ | Laryngeal attacks |\n| Kalbitor\u003Cbr>(ecallantide) | Treatment | Treatment of acute attacks of HAE in adult and pediatric patients (≥12 years) | Subcutaneous | ✓ | Black box warning: Risk of serious anaphylactic reactions |\n| Ruconest\u003Cbr>(C1 Esterase Inhibitor, Recombinant) | Treatment | Treatment of acute attacks of HAE in adult and adolescent patients (≥13 years)\u003Cbr>Note: Effectiveness not established inpatients with laryngeal attacks | Intravenous infusion | ✓\u003Cbr>✓ | Risk of serious anaphylactic reactions\u003Cbr>Serious arterial and venous |\n\n\n|  |  |  |  | thromboembolic events |\n| --- | --- | --- | --- | --- |\n| Takhzyro\u003Cbr>(lanadelumab-flyo) | Prophylaxis | Routine prophylaxis against HAE attacks in adult and pediatric patients (≥2 years) | Subcutaneous | ✓ Adverse events were mild to moderate, mainly injectionsite reactions |\n| Orladeyo (berotralstat) | Prophylaxis | Routine prophylaxis against HAE attacks in adult and pediatric patients (≥12 years) | Oral | ✓ QT prolongation can occur in those taking more than one capsule per day |\n| Andembry\u003Cbr>(garadacimab-gxii) | Prophylaxis | Routine prophylaxis against HAE attacks in adult and pediatric patients (≥12 years) | Subcutaneous | ✓ Adverse events were injectionsite reactions, nasopharyngitis, abdominal pain |\n| Ekterly\u003Cbr>(sebetralstat) | Acute Treatment | Treatment of acute attacks of HAE in adult and pediatric patients (≥12 years) | Oral | ✓ Avoid use in: Strong CYP3A4 inhibitors; moderate to strong CYP3A4 inducers; severe hepatic impairment. |\n| Dawnzera\u003Cbr>(donidalorsen) | Prophylaxis | Routine prophylaxis against HAE attacks in adult and pediatric patients (≥12 years) | Subcutaneous | ✓ Avoid use in those with moderate or severe hepatic impairment. |\n\nHereditary Angioedema (HAE) is a chronic autosomal dominant disorder associated with recurrent, unpredictable, and potentially lifethreatening acute attacks. There are three known types of HAE with types I and II being most common. Types I and II are associated with mutations to C1-INH. C1-INH deficiency results in an overproduction of bradykinin which is a vasodilator thought to be responsible for the characteristic HAE symptoms of localized swelling, inflammation, and pain. Mutations that cause type I HAE lead to reduced levels of C1-INH. A serum C4 level is a useful screening test","cbCaijGtxPgGGOo1","https://ap.wps.com/l/cbCaijGtxPgGGOo1","pdf",255497,8,"English","# Overview\n## Clinical criteria\n# Coding\n## References\n# Document history","[{\"question\":\"What is the purpose of the Hereditary Angioedema Agents clinical criteria document?\",\"answer\":\"It defines clinical criteria for using specific drugs to treat or prevent hereditary angioedema (HAE) attacks, covering both prophylaxis and acute treatment approaches.\"},{\"question\":\"How are HAE types and C1-INH deficiency related to diagnosis and screening?\",\"answer\":\"HAE is an autosomal dominant disorder with types I and II most common, both associated with C1-INH mutations. C4 testing is a useful screening tool, and a normal C4 during an angioedema episode excludes HAE-C1INH.\"},{\"question\":\"Which agents are listed for prophylaxis versus acute treatment?\",\"answer\":\"The document lists multiple prophylactic agents (e.g., Cinryze, Haegarda, Takhzyro, Orladeyo, Andembry, Dawnzera) and acute treatment agents (e.g., Berinert, Firazyr, Kalbitor, Ruconest, Ekterly).\"},{\"question\":\"What safety concerns are highlighted for acute and prophylactic agents?\",\"answer\":\"Key safety considerations include risk of serious anaphylactic reactions for certain agents, and risk of serious arterial and venous thromboembolic events for some C1-INH products. Additional precautions include warnings such as QT prolongation and contraindication-related guidance for specific drugs.\"}]","Hereditary Angioedema Agents - Clinical Criteria - CC-0034 | PDF",1789623479]