Amifampridine (1 brand name, 1 dosage form, 1 route)
Available dosage forms: TABLET.
Routes of administration: ORAL.
Brand Names
- RUZURGI
Indications and Usage
FIRDAPSE ®is 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 [see Warnings and Precautions ( 5.1)] Hypersensitivity to amifampridine phosphate or another aminopyridine [see Warnings and Precautions ( 5.2)]
Adverse Reactions
The following serious adverse reactions are described elsewhere in the labeling: Seizures [see Warnings and Precautions ( 5.1)] Hypersensitivity [see Warnings and Precautions ( 5.2)]
Mechanism of Action
The mechanism by which amifampridine exerts its therapeutic effect in LEMS patients has not been fully elucidated. Amifampridine is a broad-spectrum potassium channel blocker.
Overdosage
Overdose with FIRDAPSE was not reported during clinical studies. In a case report, a 65-year-old patient with LEMS inadvertently received a total daily amifampridine dose of 360 mg/day (approximately 4 times the maximum recommended total daily dose) and was hospitalized for general weakness, paresthesia, nausea, vomiting, and palpitations. The patient developed convulsions and paroxysmal supraventricular tachycardia, and four days after admission, experienced cardiac arrest. The patient was resuscitated and ultimately recovered following withdrawal of amifampridine. Patients with suspected overdose with FIRDAPSE should be monitored for signs or symptoms of exaggerated FIRDAPSE adverse reactions or effects, and appropriate symptomatic treatment instituted immediately.