Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: SERB S.A., Avenue Louise 480, 1050 Bruxelles, Belgium
Symptomatic treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults.
Treatment should be initiated under supervision of a physician experienced in the treatment of the disease.
FIRDAPSE should be given in divided doses, three or four times a day. The recommended starting dose is 15 mg amifampridine a day, which can be increased in 5 mg increments every 4 to 5 days, to a maximum of 60 mg per day. No single dose should exceed 20 mg.
Tablets are to be taken with food. Please see section 5.2 for further information about bioavailability of amifampridine in the fed and fasted state.
If treatment is discontinued, patients may experience some of the symptoms of LEMS.
FIRDAPSE should be used with caution in patients with renal or hepatic impairment. A starting dose of 5 mg amifampridine (half tablet) once per day is recommended in patients with moderate or severe impairment of renal or hepatic function. For patients with mild impairment of renal or hepatic function, a starting dose of 10 mg amifampridine (5 mg twice a day) per day is recommended. Patients should be titrated more slowly than those without renal or hepatic impairment with doses increased in 5 mg increments every 7 days. If any adverse reaction occurs, upward dose titration should be discontinued (see sections 4.4 and 5.2).
The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established. No data are available.
For oral use only.
There is little experience with overdose. The manifestations of acute overdose include vomiting and abdominal pain. Patient should discontinue the treatment in the event of overdose. No specific antidote is known. Supportive care should be given as clinically indicated, including close monitoring of vital signs.
3 years.
Do not store above 30°C. Store in the original package in order to protect from light and moisture.
Perforated unit dose thermoformed blisters (Thermoformed aluminium-PVC/PVDC laminate sheets) containing 10 tablets.
One box contains 100 tablets comprising 10 strips with 10 tablets each.
Any unused product or waste material should be disposed of in accordance with local requirements.
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