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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 and pediatric patients 6 years of age and older.
CONTRAINDICATIONS
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.
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.
Please see full Prescribing Information for additional Important Safety Information.
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.
References:
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- Full Prescribing Information for FIRDAPSE (amifampridine). Catalyst Pharma; 2023.
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- Shieh P, Sharma K, Kohrman B, Oh SJ. Amifampridine phosphate (FIRDAPSE) is effective in a confirmatory phase 3 clinical trial in LEMS. J Clin Neuromuscul Dis. 2019;20(3):111-119.
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- Data on file, Catalyst Pharmaceuticals.
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