Riluzole Final Out of Date by Bv1j4K


									                     GREATER MANCHESTER INTERFACE
                          PRESCRIBING GROUP

                                   On behalf of the
SHARED CARE GUIDELINE for Riluzole (Rilutek)               Reference Number
                                                            RILU 05 fnl
Scope: Riluzole for the treatment of motor neurone disease  Classification
                                                            SHARED CARE GUIDELINE
Issue date: 16 March 2006                Replaces No previous version available

Author(s)/Originator(s)                   Greater Manchester Centre For Clinical
To be read in conjunction with the        Pharmaceutical company’s patient information
following documents                       leaflet (PIL)
                                          Summary of product characteristics (SPC)
Authorised by                             Salford Royal Hospitals NHS       Date: Original
                                          Trust Medicines Management        issue Dec 2001.
                                          Group                             Reviewed April
Review Date                               April 2007

           1. Introduction

           Motor Neurone Disease (MND or amyotrophic lateral sclerosis ALS) is a
           progressive and fatal neurodegenerative disorder with a poor prognosis.
           Patients experience a gradual loss of muscle function involved in
           swallowing and breathing. From onset of symptoms 5 year survival is 5 -
           15% and median survival time is about 3 years. Riluzole is indicated to
           extend life or the time to mechanical ventilation in patients with MND. In
           the trials in which Riluzole has shown some benefit, eligible patients were
           up to 75 years of age, were in a reasonable state of general health, had
           suffered from the disease for no greater than 5 years and had a forced
           vital lung capacity of not less than 60% predicted. The National Institute
           for Clinical Excellence has now approved the use of Riluzole for the
           treatment of MND.

           2. Scope

           Riluzole may be considered for shared care arrangements for the
           treatment of motor neurone disease

           3. Clinical condition being treated

           The pathology of MND is poorly understood but it is thought that the
           neurotransmitter glutamate exerts a toxic effect on nerve cells; Riluzole
           inhibits glutamate release and may reduce cell damage.

           Riluzole is licensed to extend life or time to mechanical ventilation for
           patients with ALS.

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    Safety and efficacy of riluzole has only been studied in ALS. Therefore,
    riluzole should not be used in patients with any other form of MND.

    Monitoring criteria

    Serum transaminases: Before starting treatment, monthly for 3 months, 3-
    monthly for 12 months then periodically thereafter.           Frequency of
    monitoring should be increased if patients develop disturbances of liver
    function. Treatment should be stopped if the ALT rises to five times the
    upper limit of normal. Abnormalities are usually transient and tend to occur
    in the first 3 months of treatment.
    Full Blood Count: Monthly during the first 3 months in view of the rare
    reported cases of neutropenia. Patients should be made aware that they
    need to report any febrile illness. Cases to date have occurred during the
    first 2 months of treatment.

    4. Product information and treatment regimen to be used

             Treatment with riluzole should only be initiated by specialist
              physicians with experience in the management of MND.

             The recommended daily dose in adults or elderly is 100mg (50mg
              every 12 hours). No significant increased benefit can be expected
              from higher daily doses.

             Riluzole is available as 50mg, film coated tablets

    5. Regimen Management

    Aspects of care for which the Consultant is responsible

         The Hospital Physician, preferably a Consultant Neurologist with
         expertise in managing MND patients, will:

         a) confirm the diagnosis, if necessary by repeating the EMG
         b) ensure that the patient fulfils the criteria outlined in the Introduction
         c) check LFTs before commencement of treatment


     Monitoring criteria
     Clinical response to therapy.

     The hospital physician will assess response to therapy.

     The Neurologist will review the patient every 3 months, advise the patient,
     carers and GP, monitor LFTs and supervise other treatments that may be
     needed (physiotherapy, occupational therapy, speech therapy, dietary

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     advice, gastrostomy). A telephone helpline will be accessible to patients,
     carers, GPs and any other healthcare workers involved in the case to
     obtain rapid advice on any issues relating to the patient's care.
     Treatment will initially be for 12 months, possibly extended by another 12
     months depending on the patient's condition. Treatment should cease
     when patients enter the terminal phase of the disease.

    Aspects of care for which the GP is responsible

     Upon receipt of written confirmation of the diagnosis and the patient's
     eligibility for treatment, the General Practitioner will:

             prescribe Riluzole 50mg bd after the first 3 months have been
              provided by secondary care
             monitor the LFTs at monthly intervals for the first 3 months and if
              they are normal;
             continue issuing prescriptions at 3-monthly intervals

    6. Summary of cautions, contra indications, side-effects


             Riluzole should be prescribed with care in patients with a history of
              abnormal liver function, or in patients with slightly elevated serum
              transaminases up to 3 times the upper limit of the normal range
             Patients should report any febrile illness – this should prompt a
              check of white blood cell counts and to discontinue in case of
             Safety and effectiveness in children or adolescents has not been


             Severe hypersensitivity to riluzole or any of the excipients
             Hepatic disease or baseline transaminases greater than 3 times the
              upper limit of normal
             Patients who are pregnant or lactating

    Side Effects;

             Asthenia
             Nausea and Vomiting
             Elevations in liver function tests
             Headache
             Abdominal pain
             Pain
             Dizziness
             Tachycardia
             Somnolence

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             Circumoral paraesthesia
             Neutropenia

    7. Special considerations

    No information provided

    8. Back-up care available to GP from Hospital, including emergency
       contact procedures and help line numbers

    For local decision

    9. Statement of agreement

    Shared care is an agreement between the GP and the Consultant. This
    form is a request by the consultant to share the suggested care pathway of
    your patient. If you are unable to agree to the sharing of care and initiating
    the suggested medication, please make this known to the consultant within
    14 days, ideally stating the nature of your concern.

    10. Written information provided to the patient

    See attached information

    11. Supporting References

    BNF 50, September 2005
    Rilutek ® Summary of Product Characteristics, Sanofi-Aventis 16th
    September 2005

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