{"id":45,"date":"2025-06-19T19:00:24","date_gmt":"2025-06-19T19:00:24","guid":{"rendered":"https:\/\/firdapsehcp-calems.local\/calems\/?page_id=35"},"modified":"2026-03-20T17:18:03","modified_gmt":"2026-03-20T17:18:03","slug":"safety","status":"publish","type":"page","link":"https:\/\/firdapsehcp.com\/ca-lems\/safety\/","title":{"rendered":"Safety"},"content":{"rendered":"\n

Clinical studies have shown that FIRDAPSE is well tolerated. Most adverse events reported were mild to moderate.1-3<\/sup><\/strong><\/p>\n\n\n\n

Adverse Reactions in \u22655% of Patients With LEMS Newly Treated With FIRDAPSE1<\/sup><\/strong><\/p>\n\n\n\n

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*Includes paresthesia, oral paresthesia, and oral hypoesthesia.1<\/sup><\/p>\n\n\n\n

\u2020<\/sup>Includes elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and gamma-glutamyl transferase (GGT).1<\/sup><\/p>\n<\/div>\n\n\n\n

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During LMS 002 (Study 1), the majority of adult patients (62%) with no prior exposure to amifampridine experienced transient paresthesia while taking FIRDAPSE. Most instances diminished during the course of the study.1,2<\/sup><\/p>\n\n\n\n

Safety of FIRDAPSE was evaluated in pediatric patients in an expanded-access program in which 21 pediatric patients received FIRDAPSE for at least 1 year. Adverse reactions reported in pediatric patients were similar to those seen in adult patients, with the exception of clinically significant weight loss in 2 pediatric patients at doses of 60 mg per day and higher.1<\/sup><\/p>\n\n\n\n

*Includes paresthesia, oral paresthesia, and oral hypoesthesia.1<\/sup><\/p>\n\n\n\n

\u2020<\/sup>Includes elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and gamma-glutamyl transferase (GGT).1<\/sup><\/p>\n\n\n\n

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Do you have a patient taking FIRDAPSE who is pregnant?<\/strong><\/p>\n\n\n\n

The FIRDAPSE Pregnancy Registry1<\/sup>:<\/strong> In conjunction with the FDA, Catalyst Pharmaceuticals has created a registry to collect information about the safety of FIRDAPSE use during pregnancy. Enroll patients with LEMS- even those not taking FIRDAPSE- as soon as you learn of their pregnancy by calling 1-855-212-5856<\/a> or visiting www.firdapsepregnancystudy.com<\/a><\/p>\n\n\n\n

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Request a Rep<\/h3>\n\t\t\t\t

Connect with a FIRDAPSE
\nrepresentative.<\/p>\n\t<\/div>\n\n\t

\n\t\t\n\t\t\tStart Request\t\t<\/a>\n\t<\/div>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\n\n\n
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Dosing FIRDAPSE<\/h3>\n\t\t\t\t

Help patients achieve the optimal
\neffective dose.<\/p>\n\t<\/div>\n\n\t

\n\t\t\n\t\t\tGo to Dosing\t\t<\/a>\n\t<\/div>\n<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n<\/div><\/div>\n","protected":false},"excerpt":{"rendered":"

Clinical studies have shown that FIRDAPSE is well tolerated. Most adverse events reported were mild to moderate.1-3 Adverse Reactions in…<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":true,"em_featured_video_id":0,"footnotes":""},"class_list":["post-45","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/firdapsehcp.com\/ca-lems\/wp-json\/wp\/v2\/pages\/45","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/firdapsehcp.com\/ca-lems\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/firdapsehcp.com\/ca-lems\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/firdapsehcp.com\/ca-lems\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/firdapsehcp.com\/ca-lems\/wp-json\/wp\/v2\/comments?post=45"}],"version-history":[{"count":0,"href":"https:\/\/firdapsehcp.com\/ca-lems\/wp-json\/wp\/v2\/pages\/45\/revisions"}],"wp:attachment":[{"href":"https:\/\/firdapsehcp.com\/ca-lems\/wp-json\/wp\/v2\/media?parent=45"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}