Company: Biogen Idec (Ireland) Ltd.
Legal category: Prescription. GMS reimbursable. Sport permitted.
Active ingredient: Fampridine 10mg.
Description: Off-white, oval biconvex, film coated prolonged-release tablet marked A10.
Presentation: 56, €146.16.
Indications: For walking improvement in multiple sclerosis patients with walking disability (EDSS 4-7).
Pharmacology: Fampridine is a potassium channel blocker. Blocking potassium channels reduces the leakage of ionic current through these channels, thereby prolonging repolarization and thus enhancing action potential formation in demyelinated axons and neurological function. Presumably, by enhancing action potential formation, more impulses might be conducted in the central nervous system.
Dosage: Adult: Swallow whole. One tablet twice daily, taken 12 hours apart without food. After two weeks, evaluate using a timed walking test, e.g. the Timed 25 Foot Walk; discontinue if no improvement. Consider suspending treatment if decline observed. Elderly: As per adults. Children: 18 years and under, not recommended.
Contraindications: Hypersensitivity to fampridine or to any of the excipients. Seizure (or history). Mild, moderate or severe renal impairment. Pregnancy, lactation.
Special precautions: Monitor renal function before and during treatment (especially in elderly). Caution: Factors lowering seizure threshold (discontinue if seizure occurs), cardiovascular symptoms of rhythm and sinoatrial or atrioventricular conduction cardiac disorders. Permanently discontinue if anaphylactic or other serious allergic reaction occurs. May increase risk of falls, infection rate or impair immune response. Driving/using machines.
Drug interactions: Contraindicated: Other drugs containing fampridine (4-aminopyridine), Organic Cation Transporter 2 (OCT2) inhibitors. Caution: OCT2 substrates.
Adverse drug reactions: Urinary tract infection, insomnia, anxiety, dizziness, headache, balance disorder, paraesthesia, tremor, dyspnoea, pharyngolaryngeal pain, gastrointestinal disorders, back pain, asthenia.
Full prescribing information and references available from Biogen Idec (Ireland) Ltd. Telephone: 1800 812 719.
Fax: +44 1748 828 801. E-mail: biogenidec@professionalinformation.co.uk