On behalf of the
GREATER MANCHESTER MEDICINES MANAGEMENT GROUP /
SHARED CARE GUIDELINE forRiluzole (Rilutek) / Reference Number
RILU 05 fnl
Scope: Riluzole for the treatment of motor neurone disease / Classification
SHARED CARE GUIDELINE
Issue date:16th March 2006 / Replaces No previous version available
Author(s)/Originator(s) / Greater Manchester Centre For Clinical Neurosciences
To be read in conjunction with the following documents / Pharmaceutical company’s patient information leaflet (PIL)
Summary of product characteristics (SPC)
Authorised by / Salford Royal Hospitals NHS Trust Medicines Management Group / Date:Original issue Dec 2001. Reviewed April 2005.
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.
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 section
c)check LFTs before commencement of treatment
DISEASE MONITORING
Monitoring criteria
Clinical response to therapy.
Responsibility
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 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
Cautions;
- 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 neutropenia
- Safety and effectiveness in children or adolescents has not been studied
Contraindications;
- 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
- 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
RILU 05 fnl