FAMPYRA Prolonged-release tablets Ref.[8707] Active ingredients: Fampridine

Treatment with Fampyra is restricted to prescription and supervision by physicians experienced in the management of MS.

Posology

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 (see section 4.4). The tablets should be taken without food (see section 5.2).

Starting and Evaluating Fampyra Treatment

• Initial prescription should be limited to two to four weeks of therapy as clinical benefits should generally be identified within two to four weeks after starting Fampyra
• An assessment of walking ability, e.g. the Timed 25 Foot Walk (T25FW) or Twelve Item Multiple Sclerosis Walking Scale (MSWS-12), is recommended to evaluate improvement within two to four 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 (see above). The re-evaluation should include withdrawal of Fampyra and performing an assessment of walking ability. 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 (see section 4.4).

Patients with renal impairment

Fampyra is contraindicated in patients with mild, moderate and severe renal impairment (creatinine clearances <80 ml/min) (see section 4.3).

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.

Method of Administration

Fampyra is for oral use.

The tablet must be swallowed whole. It must not be divided, crushed, dissolved, sucked or chewed.

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.

3 years.

After first opening a bottle, use within 7 days.

Store below 25°C. Store the tablets in the original packaging in order to protect from light and moisture.

Fampyra is supplied in either bottles or blister packs.

Bottles:

HDPE (high-density polyethylene) bottle with polypropylene caps, each bottle contains 14 tablets and a silica gel desiccant.

Pack size of 28 (2 bottles of 14) tablets.

Pack size of 56 (4 bottles of 14) tablets.

Blister packs:

Foil blisters (aluminium/aluminium), each blister tray contains 14 tablets.

Pack size of 28 (2 blisters of 14) tablets.

Pack size of 56 (4 blisters of 14) tablets.

Not all pack sizes may be marketed.

No special requirements.