FIRDAPSE WAS WELL TOLERATED IN CLINICAL STUDIES

Clinical studies have shown that FIRDAPSE is well tolerated. Most of the reported adverse events during these studies were mild to moderate3,4

ADVERSE REACTIONS IN ≥5% OF PATIENTS WITH LEMS NEWLY TREATED WITH FIRDAPSE2

Adverse reactions table
*Includes paresthesia, oral paresthesia, and oral hypoesthesia.3 Includes elevated alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), and gamma-glutamyl transferase (GGT).

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.2,28

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 two pediatric patients at doses of 60 mg per day and higher.2

Do you have a patient taking FIRDAPSE who is pregnant?

Pregnant Warning

The FIRDAPSE Pregnancy Registry: 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 or visiting www.firdapsepregnancystudy.com.