Presentation and Status in Health Basket
56 X 10 mg
The recommended dose is one 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening). Fampyra should not be administered more frequently or at higher doses than recommended. The tablets should be taken without food.
Starting and Evaluating Fampyra Treatment: Initial prescription should be limited to 2 weeks of therapy as clinical benefits should generally be identified within 2-weeks after starting Fampyra. A timed walking test, e.g. the Timed 25 Foot Walk (T25FW), is recommended to evaluate improvement after two weeks. If no improvement is observed, Fampyra should be discontinued. Fampyra should be discontinued if benefit is not reported by patients.
Re-Evaluating Fampyra Treatment: If decline in walking ability is observed physicians should consider an interruption to treatment in order to reassess the benefits of Fampyra. The re-evaluation should include withdrawal of Fampyra and performing the walking test. Fampyra should be discontinued if patients no longer receive walking benefit.
Missed Dose: The usual dosing regimen should always be followed. A double dose should not be taken if a dose is missed.
Older people: Renal function should be checked in older people before starting treatment with Fampyra. Monitoring renal function to detect any renal impairment is recommended in older people.
Patients with renal impairment: Fampyra is contraindicated in patients with mild, moderate and severe renal impairment (creatinine clearances <80 ml/min).
Patients with hepatic impairment: No dose adjustment is required for patients with hepatic impairment.
Paediatric population: The safety and efficacy of Fampyra in children aged 0 to 18 years have not been established. No data are available.
For the improvement of walking in adult patients with multiple sclerosis with walking disability (EDSS 4-7).
Hypersensitivity to fampridine or to any of the excipients listed in section. Concurrent treatment with other medicinal products containing fampridine (4- aminopyridine). Patients with prior history or current presentation of seizure. Patients with mild, moderate or severe renal impairment (creatinine clearances <80 ml/min). Concomitant use of Fampyra with medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2) for example, cimetidine.
Seizure risk: Treatment with fampridine increases seizure risk. Fampyra should be administered with caution in the presence of any factors which may lower seizure threshold. Fampyra should be discontinued in patients who experience a seizure while on treatment.
Renal impairment: Fampyra is primarily excreted unchanged by the kidneys. Patients with renal impairment have higher plasma concentrations which are associated with increased adverse reactions, in particular neurological effects. Determining renal function before treatment and its regular monitoring during treatment is recommended in all patients (particularly in older people in whom renal function might be reduced). Creatinine clearance can be estimated using the Cockroft-Gault formula. Fampyra should not be administered to patients with renal impairment (creatinine clearance <80 ml/min). Caution is required when Fampyra is prescribed concurrently with medicinal products that are substrates of OCT2 for example, carvedilol, propanolol and metformin.
Hypersensitivity Reactions: In post-marketing experience, serious hypersensitivity reactions (including anaphylactic reaction) have been reported, the majority of these cases occurred within the first week of treatment. Particular attention should be given to patients with a previous history of allergic reactions. If an anaphylactic or other serious allergic reaction occurs, Fampyra should be discontinued and not restarted.
Other warnings and precautions: Fampyra should be administered with caution to patients with cardiovascular symptoms of rhythm and sinoatrial or atrioventricular conduction cardiac disorders (these effects are seen in overdose). There is limited safety information in these patients. The increased incidence of dizziness and balance disorder seen with Fampyra in the first 4 to 8 weeks of treatment may result in an increased risk of falls. Patients who are using walking aids should continue to use these aids as needed. In clinical studies low white blood cell counts were seen in 2.1% of Fampyra patients versus 1.9% of patients on placebo. Infections were seen in the clinical studies as stated below. An increased infection rate and impairment of the immune response cannot be excluded.
For full details see prescribing information.
Very common: Urinary tract infection. Common: Insomnia, anxiety, dizziness, headache, balance disorder, paresthesia, tremor, dyspnea, pharyngolaryngeal pain, nausea, vomiting, constipation, dyspepsia, asthenia.
For full details see prescribing information.
Concurrent treatment with with other medicdbinal products containing fampridine (4-aminopyridine). Concomitant use with medicdbinal products that are inhibitors of Organic Cation Transporter 2 (OCT 2), for example cimetidine. See prescribing information for full details.
Pregnancy and Lactation
Pregnancy: There are no data from the use of fampridine in pregnant women. Animal studies have shown reproductive toxicity. As a precautionary measure it is preferable to avoid the use of Fampyra in pregnancy.
Breast-feeding: It is unknown whether fampridine is excreted in human or animal milk. Fampyra is not recommended during breast-feeding.
Fertility: In animal studies no effects on fertility were seen.
Symptoms: Acute symptoms of overdose with Fampyra were consistent with central nervous system excitation and included confusion, tremulousness, diaphoresis, seizure, and amnesia. Central nervous system side effects at high doses of 4-aminopyridine include confusion, seizures, status epilepticus, involuntary and choreoathetoid movements. Other side effects at high doses include cases of cardiac arrhythmias (for example, supraventricular tachycardia and bradycardia) and ventricular tachycardia as a consequence of potential QT prolongation. Reports of hypertension have also been received.
Management: Patients who overdose should be provided supportive care. Repeated seizure activity should be treated with benzodiazepine, phenytoin, or other appropriate acute anti-seizure therapy.