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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 Page 2 of 5 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 01903