Fampridine to Improve Walking in Multiple Sclerosis (922)

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A guideline is intended to assist healthcare professionals in the choice of disease-specific treatments.

Clinical judgement should be exercised on the applicability of any guideline, influenced by individual patient characteristics. Clinicians should be mindful of the potential for harmful polypharmacy and increased susceptibility to adverse drug reactions in patients with multiple morbidities or frailty.

If, after discussion with the patient or carer, there are good reasons for not following a guideline, it is good practice to record these and communicate them to others involved in the care of the patient.

Background

Fampridine (Fampyra®) is accepted for use within NHS Scotland for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability, defined as EDSS [expanded disability status scale] 4-7.

Clinical trials show that between 35 – 43% of patients taking fampridine responded to treatment compared to patients in placebo group. For those responding to fampridine an average increase walking speed of 25% can be expected.

Agent and route

Oral tablet.

Patient eligibility

Adult patients with multiple sclerosis with walking disability, defined as EDSS [expanded disability status scale] 4-7.

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 2-4 weeks.

Authorised and Designated Areas applicable to

The decision to initiate prescribing of fampridine should be made by a clinician experienced in the management of MS, with the MS Team providing ongoing prescription, monitoring and review under the supervision of the clinician.

Indication and place in therapy

• Adult patients with multiple sclerosis with walking disability, defined as EDSS [expanded disability status scale] 4-7.

• Restricted to walking <500m (approx. 10 mins unaided).

• Patient can walk at least 5m with walking aids

• Urea & Electrolytes checked within past 3 months.

Dose, duration and administration

Dose is 10mg twice daily (12 hours apart, one tablet in the morning and one tablet in the evening).

Fampridine should not be administered more frequently or at higher doses than recommended. The tablets should be swallowed whole and taken without food.

Monitoring

Starting and evaluating fampridine treatment

• Patients will receive a prescription for a 4-week trial of fampridine, as clinical benefits should generally be identified within two to four weeks after starting treatment.

• An assessment of walking ability, e.g. the timed 25 foot walk (T25FW) or Twelve Item Multiple Sclerosis Walking Scale (MSWS-12), will be performed to evaluate improvement within two to four weeks. If no improvement is observed, fampridine will be discontinued.

• A positive response is defined as a ≥20% improvement in T25FW or ≥8-point improvement in MSWS-12.

• Fampridine should be discontinued if benefit is not reported by patients.

 

Re-evaluating fampridine treatment

• Patients will be reassessed after 6-12 months on fampridine to ensure they continue to benefit from treatment.

• If decline in walking ability is observed, physicians should consider an interruption to treatment in order to reassess the benefits of fampridine. The re-evaluation should include withdrawal of fampridine and performing an assessment of walking ability. Fampridine should be discontinued if patients no longer receive walking benefit.

• Fampridine should be discontinued if benefit is not reported by patients.

Contraindications

• Hypersensitivity to fampridine or to any of the excipients.

• Patients with prior history or current presentation of seizure.

• Patients with moderate or severe renal impairment.

• Pregnant or breastfeeding.

• Concomitant use of Fampyra with medicinal products that are inhibitors of Organic Cation Transporter 2 (OCT2).

Please note this list is not exhaustive. Refer to Summary of Product Characteristics (SPC) for full information or Stockley’s Drug Interactions at https://www.medicinescomplete.com/#/interactions/stockley

Cautions

• Fampridine should be administered with caution in the presence of any factors which may lower seizure threshold.

• Mild renal impairment.

• Patients using medicinal products that are substrates of OCT2.

• Patients with a previous history of allergic reactions.

• Cardiovascular symptoms of rhythm and sinoatrial or atrioventricular conduction cardiac disorders (these effects are seen in overdose).

Please note this list is not exhaustive. Refer to Summary of Product Characteristics (SPC) for full information.

Adverse effects

Adverse reactions identified are mostly neurological and include:

• Seizure, insomnia, anxiety, balance disorder, dizziness, paraesthesia, tremor, headache and asthenia.

• The highest incidence of adverse reactions identified from placebo-controlled trials in multiple sclerosis patients with fampridine given at the recommended dose, are reported as urinary tract infection (in approximately 12% of patients).

 

For full list of adverse effects, see Summary of Product Characteristics (SPC).

Strength of preparation used

10mg oral tablets.

Licensed status

Licensed medicine.

Authorised prescribers

Consultant Neurologists with specialist interest in Multiple Sclerosis Designated non-medical prescribers (e.g. clinical nurse specialist, pharmacist, physiotherapist)

Last reviewed: 28 April 2021

Next review: 28 April 2024

Author(s): Paul Gallagher

Version: 1

Author Email(s): [email protected]

Approved By: Medicines Utilisation Subcommittee of ADTC

Document Id: 922