Download 95 - Coastal West Sussex Formulary

WORKING IN
PARTNERSHIP
WITH
EFFECTIVE SHARED CARE AGREEMENT (ESCA) – PART B
DRUG NAME: Tolcapone (Tasmar®)
INDICATION/S COVERED: Motor Fluctuations in Idiopathic Parkinson’s Disease
Coastal West Sussex traffic light system classification: Amber
To be read in conjunction with PART A - CWS ESCA Core Documentation V1
Agreement for transfer of prescribing to GENERAL PRACTITIONER
Drug name and dose (standard or expected dose or dose range): Tolcapone 100mg Three times a day
The following tests and investigations have been carried out:
Date treatment initiated:
At the last patient review the drug appeared to be effectively controlling symptoms / providing benefit:
Yes/No
The patient has now demonstrated tolerability and effective clinical response on a dose of:
I will arrange to review this patient regularly. Date of next clinic appointment:
Patient details
Name:
Address:
Date of Birth:
NHS number:
Hospital No:
Consultant details
Name:
Address:
Email:
Contact number:
GP details
Name:
Address:
Email:
Contact number:
Main Carer (if applicable):
Name:
Contact number:
Key worker (if applicable):
Name:
Contact number:
In the absence of written refusal within 14 days of shared care request, it will be assumed that
prescribing responsibility will transfer and shared care arrangements commence.
The responsible Consultant and where differing, the requesting Health Care Professional must be informed in writing within 14 days of the
initial request for shared care should the decline of the transfer of prescribing responsibility to the General Practitioner be necessary.
Effective from: April 2016
Page 1 of 5
Review date: April 2018
Tolcapone Version 2
Information
Additional information to support but not replace the information provided within this document can be
found within the current Summary of Product Characteristics (http://www.medicines.org.uk/emc/) and
also the British National Formulary Online (https://www.medicinescomplete.com/mc/bnf/current/)
1. Link to relevant national or local guidance (e.g NICE, CKS)
Clinical Guideline: Parkinson’s Disease in over 20s: diagnosis and management. 2006.
www.nice.org.uk/CG35
Summary of Product Characteristics. Tasmar® 100mg Tablets. www.medicines.org.uk/emc
2. Background for use
Tolcapone is a licenced Prescription Only Medicine (POM) categorised as a selective and reversible
catechol-O-methyltransferase (COMT) inhibitor. It is indicated for use in patients with levodopa responsive
idiopathic Parkinson’s Disease (PD) and motor fluctuations who have failed to respond to the COMT inhibitor,
entacapone.
Tolcapone is indicated for use in adults over the age of 18 years for age, combination with
levodopa/benserazide or levodopa/carbidopa. Tolcapone is included in the NICE guidelines for PD
(www.nice.org.uk/CG35 ) which state that Tolcapone should only be used after entacapone has failed in
people with later PD
3. Dose (standard or expected dose or dose range), route of administration, frequency and duration
of treatment
100mg Three times daily, always as an adjunct to levodopa/benserazide or levodopa/carbidopa. In
exceptional circumstances when the anticipated incremental clinical benefit justifies the increased risk of
hepatic reactions, the dose may be increased to 200mg three times a day. The first dose of the day should be
taken with the first dose of a levodopa preparation and the subsequent doses taken approximately 6 and 12
hours later regardless of whether or not levodopa is being taken at the time.
4. Contraindications
 Evidence of liver disease or increased liver enzymes.
 Severe dyskinesia
 Previous history of NMS and/or non-traumatic rhabdomyolysis or hyperthermia
 Phaechromocytoma
 Known hypersensitivity to tolcapone or any other ingredient in the tablet.
5. Cautions
Avoid abrupt withdrawal.
Levodopa adjustment during tolcapone treatment: As tolcapone decreases the breakdown of levodopa in
the body, side effects due to increased levodopa concentrations may occur when beginning tolcapone
treatment. In clinical trials, more than 70% of patients required a decrease in their daily levodopa dose if their
daily dose of levodopa was >600mg or if patients had moderate or severe dyskinesia before beginning
treatment.
The average reduction in daily levodopa was about 30% in those patients requiring a levodopa dose
reduction. When beginning treatment all patients should be informed of the symptoms of excessive levodopa
dosage and what to do if it occurs.
Special populations:
Renal Impairment:
Patients with severe renal impairment (creatinine clearance <30ml/min) should be treated with caution.
No dose adjustment for patients with mild or moderate renal impairment (CrCl ≥ 30ml/min).
Hepatotoxicity:
Potentially life threatening hepatotoxicity including fulminant hepatitis twice as likely in females and during
first 6 months. Later onset liver injury reported.
Neuroleptic malignant syndrome (NMS):
Isolated cases of NMS have been associated with tolcapone treatment, usually during treatment or shortly
after discontinuation. NMS is characterised by motor symptoms (rigidity, myoclonus and tremor), mental state
changes (agitation, confusion, stupor and coma), elevated temperature, autonomic dysfunction and elevated
serum phosphokinase. To reduce the risk of NMS, tolcapone should not be prescribed to people with severe
dyskinesia or previous history of NMS. Patients receiving multiple medications with effects on different CNS
pathways e.g. antidepressants, neuroleptics, anticholinergics may be at greater risk of developing NMS.
Effective from: April 2016
Review date: April 2018
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Tolcapone Version 2
Urine discolouration: Tolcapone and its metabolites are yellow and can cause a harmless intensification in
the colour of the patient’s urine.
Impulse control disorders: Pathological gambling, increased libido, hypersexuality, compulsive spending or
buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other
dopaminergic treatments such as tolcapone in association with levodopa.
Lactose intolerance - Tasmar® contains lactose. Patients with hereditary probalmes of galactose
intolerance, lactose deficiency or glucose-galactose malabsorption should not take this medicine
6. Side effects / adverse effects (including incidence, identification, importance and management)
 Diarrhoea
 Dopaminergic side effects resulting from an increase in bioavailability of levodopa e.g. dyskinesia,
nausea, vomiting, abdominal pain, syncope, orthostatic complaints, constipation, sleep disorders,
somnolence, and hallucinations.
7. Interactions
 MAO inhibitors – Tolcapone should not be given with non-selective monoamine oxidase inhibitors
e.g. phenelzine and tranylcypromine.
 Warfarin- since clinical information is limited regarding the combination of warfarin and tolcapone,
coagulation parameters should be monitored when these drugs are co-administered.
 Catechols and other drugs metabolised by COMT – benserazide levels may increase. The effects
of tolcapone on other drugs metabolised by COMT, such as methyldopa, dobutamine, apomorphine,
adrenaline, and isoprenaline, have not been evaluated but prescribers should be observant of
adverse effects caused by increased plasma levels.
8. Monitoring requirements
Monitoring
Baseline liver enzymes (ALT and/or AST) with follow up monitoring every two weeks for the first year,
every 4 weeks for the following 6 months and then every 8 weeks thereafter.
In exceptional cases in which the tolcapone dose is increased to 200mg three times a day, liver enzyme
levels should be rechecked before increasing the dose and the follow-up monitoring should be reinitiated,
commencing as at week one. Treatment should be immediately stopped if ALT and/or AST exceed
the upper limit of normal.
9. Training requirements (patient and clinical) specific to the proposed treatment
Ensure that patient and/or carer has understanding of how this medicine is taken.
10. Criteria for use
In combination with levodopa/benserazide or levodopa/carbidopa for use in adult patients with levodopa –
responsive idiopathic Parkinson’s disease and motor fluctuations, who failed to respond to or are intolerant of
other COMT inhibitors.
11. Any further information (e.g. supporting therapies)
If substantial clinical benefits are not seen within 3 weeks of initiation of treatment, tolcapone should be
discontinued.
Because of the risk of potentially fatal acute lever injury tolcapone should not be considered as a first-line
adjunct therapy to levodopa/benserazide or levodopa/carbidopa.
12. References
 Meda Pharmaceuticals, Tasmar® 100mg Tablets – Summary of Product Characteristics
http://www.medicines.org.uk/emc/medicine/15900 Accessed 11 November 2015)
 British National Formulary (BNF) Tolcapone,
https://www.medicinescomplete.com/mc/bnf/current/PHP3124-tolcapone.htm Accessed 11
November 2015)
 NICE CG35. Parkinson's disease in over 20s: diagnosis and management. June 2006.
https://www.nice.org.uk/guidance/cg35 Accessed 11 November 2015)
Effective from: April 2016
Review date: April 2018
Page 3 of 5
Tolcapone Version 2
RESPONSIBILITIES and ROLES
Consultants responsibilities
Responsibilities in addition to those detailed within the core document.
1 Diagnosis of PD and assessment of suitability of patient for tolcapone treatment including a check for previous use of an
alternative COMT inhibitor, i.e. entacapone.
2 Discuss the aims, benefits and side effects of treatment, particularly liver toxicity, with the patient, as well as their role as
outlined under patient/carer’s role.
3 Explain to the patient their treatment plan including dosing schedule.
4 To initiate therapy and prescribe until treatment has been demonstrated to be tolerated and clinically effective patient is stable
on therapy (not before 3 months), including levodopa dose reductions where appropriate.
5 Baseline of Liver Function Tests (LFTs) must be normal. Only possible exception is raised bilirubin in patients with Gilbert’s
syndrome. LFTs fortnightly for 12 months, 4 weekly for next six months, then 8 weekly for duration of treatment. Act on the
results appropriately and communicate these results to the primary care prescriber.
6 Check that response is seen in the first 2 or 3 weeks, and stop treatment if there is no response.
7 Monitor and evaluate response to tolcapone therapy, including adverse drug reactions with the patient and continue/discontinue
treatment in line with agreed treatment plan.
8 Discontinue tolcapone therapy if patient’s ALT and/or AST exceed upper limit of normal or if signs suggesting onset of liver
failure develop.
9 If the dose is increased to 200mg three times a day, undertake liver enzyme monitoring before increasing the dose, and then be
reinitiated following the subsequent of frequencies as above (see section 8).
GP’s responsibilities
Responsibilities in addition to those detailed within the core document.
1 Inform in writing the responsible Consultant and where differing, the requesting Health Care Professional within 14 days of the
initial request for shared care should the decline of the transfer of prescribing responsibility be necessary.
2 Provide repeat prescriptions once the ESCA is agreed and in place and the treatment has been demonstrated to be tolerated
and clinically effective (not before initial 3 month period).
3 Ensure patient/carer is fully informed of treatment and potential side effects.
4 To monitor the patient’s overall health and well-being and to report any adverse drug reactions or interactions to secondary care.
5 Liaise with the Neurology department if any cause for concern, signs/symptoms change/appear if drug is discontinued (abrupt
discontinuation should be avoided.
6 Inform secondary care if patient is not requesting repeat prescriptions.
Patient's / Carer’s role
Responsibilities in addition to those detailed within the core document.
1 Report to their neurologist or nurse specialist any symptoms such as described in sections 5 & 6 of the drug information.
Effective from: April 2016
Review date: April 2018
Page 4 of 5
Tolcapone Version 2
BACK-UP ADVICE AND SUPPORT
Specialist /
Consultant:
Alternative
specialist (e.g.
departmental
contact):
Hospital Pharmacy:
Out of hours (e.g.
medical team on
call):
Name / position
Dr Richard Chalmers
Telephone
Ext 85401 RC Secretary
Email
N/A
Dr Mirdhu Wickremaratchi
Ext 85419 MW Secretary
Departmental
285152
Neurology Nurse
Specialists:
Helen Moore (Worthing)
Rosie Bradley (Worthing)
Julie Webb (SRH)
01903 205111 ext 85534
As above
01243 788122 ext 2208
or bleep 118
01903 205111 ext 85471
[email protected]
Worthing Hospital
St Richards Hospital
Fax:
01243 788122, ext 3343
Via Switchboard:
Worthing: 01903 205111
SRH: 01243 788122
On call physicians
On call
Version History
Document Name:
Effective Shared Care Agreement (ESCA) PART B – Tolcapone for motor fluctuations in idiopathic
Parkinson’s Disease
Document Type:
Effective Shared Care Agreement
Relevant to:
All GPs working within CWS and all relevant clinicians at WSfHT. SPfT / SCfT
Version
Date
Author of original development or review
1
May 2015
2
March
2016
Catherine Cornford
Senior Pharmacist
Helen Moore (and Chris Kershaw)
Neurology Nurse Specialist
Dr Richard Chalmers
Consultant Neurologist
Dr Mirdhu Wickremaratchi
Consultant Neurologist
Details of document development
Original development
Full review and re-draft
Approval for organisational use
ESCA authorised
for use in Coastal
West Sussex by
Coastal West Sussex Area Prescribing Committee (APC): April 2016
Effective from: April 2016
Review date: April 2018
Page 5 of 5
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