Download RILUZOLE for Amylotrophic Lateral Sclerosis

Gwent Shared Care Protocol
RILUZOLE (e.g. Rilutek®)
to extend life or the time to mechanical ventilation for patients with
amyotrophic lateral sclerosis (ALS)
Protocol No. 14
General guidance
PLEASE CHECK http://www.wales.nhs.uk/sites3/page.cfm?orgid=814&pid=38180
FOR THE LATEST VERSION OF THIS PROTOCOL
ABUHB’s Medicines and Therapeutics Committee has agreed this protocol. It outlines the
shared care arrangements for patients initiated on riluzole for the extension of life or the time
to mechanical ventilation for patients with ALS and should be read in conjunction with the:
1. Shared Care Agreement Form (see Page 4).
2. Summary of Product Characteristics for riluzole – available at:
https://www.medicines.org.uk/emc/medicine/1672
Although this Shared Care Protocol does NOT specifically cover use of riluzole in other ‘off
label’ uses (e.g. progressive muscular atrophy [PMA]) specialist prescribers may consider using
it as the basis of a shared care arrangement with a non specialist. Informed consent for any
‘off-label’ uses should be obtained from the patient/carer and documented. See the GMC's
Good practice in prescribing and managing medicines and devices1 for further information. This
consent should be communicated to the GP.
1. Therapeutic use &
Background
information
ALS is the most common variant of MND accounting for 65% to 85% of all cases. It is a
progressive, fatal neurodegenerative disorder and is characterised by both upper and lower
motor neurone signs. Death usually results from ventilatory failure, resulting from progressive
weakness and wasting of respiratory and bulbar muscles within approximately 3 years of the
onset of symptoms.
Riluzole is the only drug currently licensed for the treatment of ALS however symptomatic
management, supportive, and palliative care are also available for patients with ALS.
In 2001 NICE (TA20) recommended that riluzole should be available for the treatment of
individuals with MND in accordance with its licensed indications. See:
http://www.nice.org.uk/guidance/ta20
2. Contra-indications
/ Cautions
Contraindications:
1. Hepatic disease or in patients with baseline transaminases greater than 3 times the
upper limit of normal.
2. Hypersensitivity to riluzole or any excipients,
3. Pregnancy and lactating women.
Cautions:
1. Concomitant use with digoxin or other agents that reduce heart rate
2. Use in the frail elderly.
3. Cases of interstitial lung disease have been reported in patients treated with riluzole.
3. Typical dosage
regimen (adults)
Adults or elderly:
50mg every 12 hours.
No significant increased benefit can be expected from higher daily doses.
4. Drug interactions
There have been no clinical studies to evaluate the interactions of riluzole with other medicinal
products.
Enzyme inhibitors (caffeine, diclofenac, diazepam, nicergoline, clomipramine, imipramine,
fluvoxamine, phenacetin, theophylline, amitriptyline & quinolones) could potentially decrease
the rate of riluzole elimination.
1
http://www.gmc-uk.org/guidance/ethical_guidance/14316.asp
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: March 2007 (updated April 2016)
Approved by: ABUHB MTC
Page 1 of 4
Review Date: April 2019
Enzyme inducers (rifampicin and omeprazole) could increase the rate of riluzole elimination.
5. Adverse drug
reactions
Clinical condition
(reported frequency)
Nausea
Asthenia
(Very Common >10%)
Raised LFTs
(Very Common >10%)
Headache, dizziness, oral paraesthesia, somnolence
Diarrhoea, vomiting, abdominal pain
Tachycardia
(Common ≥1/100 to <1/10)
Neutropenia
(3 cases have been recorded in 5000 patients who
have received riluzole)
All healthcare
professionals have a
responsibility to
patients in
advising/acting on
suspected adverse drug
reactions
Action
Discuss with specialist if severe or persistent
See Section 7
Discuss with specialist if severe or persistent
Check patient’s white cell count if any febrile
illness reported.
Patients should be particularly warned to report any febrile illness or unexplained respiratory
symptoms develop such as dry cough and/or dyspnoea.
All serious adverse events should be reported to MHRA.
6. Baseline
investigations
To be undertaken by Neurology Dept:
7. Monitoring
Monitoring: (by Neurology Dept)
Initial: LFTs (inc. ALT) every month for first 3 months
FBC, LFTs (inc. ALT)
Ongoing Monitoring: (by GP)
Test and frequency
LFTs
1. At six, nine and twelve
months after initiation
2. then annually thereafter
ALT > 5 times the
upper limit of the
normal range (≥ 225
IU/l)
Action
Stop drug and discuss
There is no experience with dose reduction or
rechallenge in such patients –
readministration of riluzole cannot be
recommended.
ALT levels should be measured more frequently in patients with a history of elevated ALT
levels. Normal range (ABUHB) of ALT is 0 to 45 IU/l
White blood cell counts should be checked in patients with febrile illness. In the case of
neutropenia riluzole should be discontinued.
8. Specialist centre
contact
information
9. Criteria for shared
care
If stopping the medication or needing advice please contact:
Dr Ken Dawson 01873 732739 (Clinical Lead for MND services) or the prescribing neurologist.
All Wales criteria for Shared Care can be found at:
http://www.awmsg.org/docs/awmsg/medman/Criteria%20for%20Shared%20Care.pdf
GMC guidance on Shared Care (2013) states:
Decisions about who should take responsibility for continuing care or treatment after initial
diagnosis or assessment should be based on the patient’s best interests, rather than on
convenience or the cost of the medicine and associated monitoring or follow-up.
Shared care requires the agreement of all parties, including the patient. Effective communication
and continuing liaison between all parties to a shared care agreement are essential .
10. Responsibilities of
initiating
consultant
i.
Having decided to offer riluzole as an option, to undertake the baseline clinical
investigations (see Section 6).
ii. To discuss the risks and benefits treatment with the patient/carer as well as the parameters
for continuation and cessation of riluzole.
iii. The advice to the patient/carer should include:
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: March 2007 (updated April 2016)
Approved by: ABUHB MTC
Page 2 of 4
Review Date: April 2019
a. The provision of a patient information leaflet.
b. An explanation of the shared care arrangement with the patient’s GP practice
and importance of regular LFT monitoring.
c. The potential side effects and the action to be taken should they occur
(particularly in relation to reporting any febrile illness or unexplained
respiratory symptoms [such as dry cough and/or dyspnoea], or liver toxicity
[e.g. nausea, vomiting, abdominal discomfort and dark urine]).
iv. To confirm patient/carer understanding and consent to treatment.
v. To initiate and prescribe/monitor riluzole for the first 3 months (see Section 7).
vi. Following three satisfactory LFT results at months 1 to 3, to send/fax/email the Shared
Care Agreement Form (see Page 4) to the GP practice.
vii. To keep GP practice fully informed of any treatment changes and non attendance following
subsequent specialist appointments.
viii. Stop treatment when indicated, or advise the GP on when and how to stop treatment.
11. Responsibilities of
Primary Care
i.
ii.
iii.
iv.
v.
From month 3, to prescribe riluzole and monitor the patient in accordance with the
schedule above (see Section 7).
To inform specialist of any non attendance for ongoing monitoring. Patients should be
informed of the consequences to their safety if they fail to attend for LFT monitoring.
Whenever practicable, to reaffirm with the patient the importance of reporting any febrile
illness or unexplained respiratory symptoms [such as dry cough and/or dyspnoea], or liver
toxicity [e.g. nausea, vomiting, abdominal discomfort and dark urine]).
Prompt referral to the specialist if there is clinically important deterioration in the patient’s
condition.
Stop treatment on advice of specialist, or immediately in the case of neutropenia.
12. Responsibilities of
patients/carer
 To attend hospital and GP practice blood test/monitoring appointments.
 Significant failure to attend (which affects patient safety) may result in riluzole being
stopped.
 To report adverse effects to their specialist or GP (particularly any febrile illness or
unexplained respiratory symptoms [such as dry cough and/or dyspnoea], or liver toxicity
[e.g. nausea, vomiting, abdominal discomfort and dark urine]).
13. Responsibilities of
all prescribers
Any suspected serious adverse reaction to an established drug should be reported to MHRA
via the “yellow card scheme.” http://yellowcard.mhra.gov.uk/
14. Supporting
documentation /
information
Patient information leaflet at: https://www.medicines.org.uk/emc/PIL.3133.latest.pdf
October 2015 NICE advice (TA20)
Orthostatic hypotension due to autonomic dysfunction: midodrine
https://www.nice.org.uk/advice/esnm61
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: March 2007 (updated April 2016)
Approved by: ABUHB MTC
Page 3 of 4
Review Date: April 2019
Shared Care Agreement Form
CONSULTANT REQUEST
To: Dr.
Your patient:
NHS No. (10digit):
was seen on:
with a diagnosis of:
I recommend that the following drug is continued:
This drug has been accepted as suitable for shared care by the ABUHB’s MTC.
I agree to the responsibilities set out in the protocol SCP No. 14 (copy attached and also at:
http://www.wales.nhs.uk/sites3/page.cfm?orgid=814&pid=38180)
I am requesting your agreement to sharing the care of this patient. The preliminary tests set out in the protocol have
been carried out. I am currently prescribing the stabilising treatment.
I would like you to undertake treatment from:
The initial dose regime will be:
The baseline tests are:
If you undertake treatment I will reassess the patient in ____ weeks. You will be sent a written summary within 14
days. I will accept referral for reassessment at your request.
The medical staff of the department are available at all times to give you advice.
Consultant Name:
Signature:
Department:
Hospital:
Date:
Contact Telephone Nos:
GP RESPONSE (Please circle the appropriate number below detailing your response)
1. I am willing to undertake shared care as set out in SCP No. 14 for this patient.
2. I would like further information. Please contact me on: _______________________
3. I am unable to undertake shared care for this patient because: (Please state)
_________________________________________________________________________________
G.P. Signature _________________________________________ Date _________
Practice Address/Stamp ________________________________________________
PLEASE RETURN WHOLE COMPLETED FORM OR A COPY TO THE REQUESTING CONSULTANT WITHIN 1 WEEK
BY FAXING TO
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Issue Date: March 2007 (updated April 2016)
Approved by: ABUHB MTC
Page 4 of 4
Review Date: April 2019