FIRDAPSE is the first and only FDA-approved, evidence-based therapy indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
INDICATION AND IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE: FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
CONTRAINDICATION FIRDAPSE is contraindicated in patients with: • A history of seizures • Hypersensitivity to amifampridine phosphate or another aminopyridine
WARNINGS AND PRECAUTIONS Seizures: FIRDAPSE can cause seizures. Consider discontinuation or dose-reduction of FIRDAPSE in patients who have a seizure while on treatment. FIRDAPSE is contraindicated in patients with a history of seizures.
Hypersensitivity: If a hypersensitivity reaction such as anaphylaxis occurs, FIRDAPSE should be discontinued and appropriate therapy initiated.
ADVERSE REACTIONS The most common (> 10%) adverse reactions are: paresthesia, upper respiratory tract infection, abdominal pain, nausea, diarrhea, headache, elevated liver enzymes, back pain, hypertension, and muscle spasms.
To report SUSPECTED ADVERSE REACTIONS, contact Catalyst Pharmaceuticals at 1-844-347-3277 (1-844-FIRDAPSE) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.