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. 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.

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 FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch

1.     Orange Book: Approved drug products with therapeutic equivalence evaluations. US Food and Drug Administration website.
        https://www.accessdata.fda.gov/Scripts/cder/ob/search_product.cfm. Accessed April 24, 2019.

2.      Full Prescribing Information for FIRDAPSE (amifampridine). Catalyst Pharma.; 2018