FIRDAPSE is the only formulation that utilizes amifampridine phosphate, a voltage-gated potassium channel blocker, to target the presynaptic nerve terminal of neuromuscular junctions.27-29
Amifampridine phosphate
(3,4-diaminopyridine phosphate)
FIRDAPSE has been tested in more than 70 clinical and nonclinical studies, including two positive Phase 3 studies, over a 9-year period.7
In clinical trials, FIRDAPSE demonstrated a rapid onset of action and clinically meaningful improvements in2,3:
Amifampridine phosphate
(3,4-diaminopyridine phosphate)
In LEMS, autoantibodies block the calcium channels in the nerve cells, reducing ACh release into the neuromuscular junction5,13
FIRDAPSE, a voltage-gated potassium channel blocker, targets the presynaptic nerve terminal of the neuromuscular junction2,27
FIRDAPSE blocks potassium channels in the nerve cells, which allows more ACh to be released into the neuromuscular junction2,27*
The mechanism by which FIRDAPSE exerts its therapeutic effect in LEMS patients has not been fully elucidated. FIRDAPSE is a broad-spectrum potassium channel blocker.
indications and usage:
FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
CONTRAINDICATIONS
FIRDAPSE is contraindicated in patients with:
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.
indications and usage:
FIRDAPSE is a potassium channel blocker indicated for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
CONTRAINDICATIONS
FIRDAPSE is contraindicated in patients with:
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.