FAMPYRA

What it is

FAMPYRA is a potassium channel blocker, available in a 10 mg tablet strength. Each tablet contains 10 mg fampridine, formulated as a modified release tablet for twice-daily oral administration. Fampridine is a non-selective potassium channel blocker and is a lipid-soluble drug which readily crosses the blood-brain barrier.

Approved indications

— Symptomatic improvement of walking ability in adult patients with Multiple Sclerosis (MS) who have shown improvement after 8 weeks of treatment.

Dosing overview

The recommended dosage of FAMPYRA for adults is one 10 mg tablet, twice daily, taken approximately 12 hours apart. Tablets must be swallowed whole, and as the tablets are modified release tablets, doses cannot be divided, crushed, dissolved, sucked, or chewed. Prescribers should re-evaluate the patient 8 weeks after the first treatment, and continued therapy should not be considered unless a walk test demonstrates response.

Key safety warnings

A dose-dependent increase in risk of seizures has been observed in clinical studies with FAMPYRA at doses above the recommended 10 mg taken twice daily. The recommended daily dose of FAMPYRA, 10 mg, twice daily, taken 12 hours apart should not be exceeded. 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. Fampridine is primarily excreted unchanged through the kidneys, and patients with renal impairment may have higher plasma concentrations, which are associated with increased adverse drug reactions, in particular, neurological effects. FAMPYRA should be used with caution, and monitoring of renal function considered in patients with mild renal impairment (creatinine clearance 50 to 80 mL/min or eGFR 60–89 mL/min/1.73 m²). The highest incidence of adverse reactions identified from placebo-controlled trials in MS patients with FAMPYRA given at the recommended dose relate to nervous system excitation, including insomnia, balance disorder, dizziness, headache and asthenia.

Contraindications

FAMPYRA is contraindicated in patients with known hypersensitivity to fampridine or any excipients in this product. FAMPYRA should not be administered to patients with moderate or severe renal impairment (Creatinine clearance <50 mL/min or eGFR less than 59 mL/min/1.73 m²). FAMPYRA should not be administered to patients with prior history of seizure. FAMPYRA should not be administered to patients currently on treatment with other forms of fampridine / 4-aminopyridine.

Regulatory history

FAMPYRA was first listed on the Australian Register of Therapeutic Goods on 24 May 2011. The TGA approved the registration of FAMPYRA for the symptomatic improvement of walking ability in adult patients with Multiple Sclerosis following satisfactory resolution of quality issues. The quality evaluation found all issues satisfactorily resolved with no objections to registration.