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Effective Shared Care Agreement (ESCA) Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA: For the treatment of parkinson’s disease AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE

This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of ropinirole IR/MR for parkinson’s disease can be shared between the specialist and general practitioner (GP). You are invited to participate however, if you do not feel confident to undertake this role, then you are under no obligation to do so. In such an event, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist.

Sharing of care assumes communication between the specialist, GP and patient. The intention to share care will be explained to the patient by the specialist initiating treatment. It is important that patients are consulted about treatment and are in agreement with it. Patients with parkinson’s disease are usually under regular specialist follow-up, which provides an opportunity to discuss drug therapy.

The doctor who prescribes the medication legally assumes clinical responsibility for the drug and the consequences of its use. RESPONSIBILITIES and ROLES Specialist responsibilities 1. Confirm the diagnosis of parkinson’s disease can 2. Discuss the potential benefits, treatment , and possible drug interactions with the patient 3. Ask the GP whether he or she is willing to participate in shared care before initiating therapy so that appropriate follow on prescribing arrangements can be made 4. Do baseline monitoring prior to initiation of ropinirole IR/MR 5. Initiate treatment and stabilise dose of ropinirole IR/MR 6. Review the patient's condition and monitor response to treatment regularly 7. A written summary to be sent promptly to the GP i.e. within 10 working days of a hospital outpatient review or inpatient stay 8. Report serious adverse events to the MHRA 9. Ensure clear backup arrangements exist for GPs, for advice and support (Please complete details below)

General Practitioner responsibilities 1. Reply to the request for shared care as soon as practicable i.e. within 10 working days 2. Prescribe ropinirole IR/MR at the dose recommended 3. In the patient's notes, using the appropriate Read Code listed below, denote that the patient is receiving treatment under a shared care agreement GP Prescribing System Read Code Description GP Prescribing System Read Code Description EMIS and Vision 8BM5.00 Shared care prescribing SystmOne XaB58 Shared care 4. Monitor patient’s response to treatment; make dosage adjustments if agreed with specialist 5. Report to and seek advice from the specialist or clinical nurse specialist on any aspect of patient care that is of concern to the GP, patient or carer and may affect treatment 6. Refer back to specialist if condition deteriorates 7. Report serious adverse events to specialist and MHRA 8. Stop treatment on advice of specialist

Patient's role 1. Report to the specialist, clinical nurse specialist or GP if he or she does not have a clear understanding of the treatment 2. Share any concerns in relation to treatment with ropinirole IR/MR with the specialist, clinical nurse specialist or GP 3. Report any adverse effects to the specialist or GP whilst taking ropinirole IR/MR 4. Attend regular outpatient appointments with the specialist

BACK-UP ADVICE AND SUPPORT Trust Contact details Telephone No. Email address: Consultant:-

Specialist Nurse

Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 1 Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA Interface Lead Pharmacist Birmingham CrossCity CCG Date: July 2015 Review date: July 2018

SUPPORTING INFORMATION Indication Treatment of Parkinson's Disease under the following conditions:  Initial treatment as monotherapy, in order to delay the introduction of levodopa  In combination with levodopa, over the course of the disease, when the effect of levodopa wears off or becomes inconsistent and fluctuations in the therapeutic effect occur (“end of dose” or “on-off” type fluctuations) Dosage and Immediate release tablets Modified release tablets Administration Individual dose titration against efficacy and tolerability is recommended. Individual dose titration against efficacy and tolerability is recommended. Ropinirole should be taken three times a day, preferably with meals to improve Ropinirole prolonged-release tablets should be taken once a day and at a similar gastrointestinal tolerance. time each day. The tablets must be swallowed whole and must not be chewed, crushed or divided. The tablets may be taken with or without food. Treatment initiation: The initial dose should be 0.25 mg three times daily for 1 week. Thereafter, the dose of ropinirole can be increased in 0.25 mg three times Initial titration daily increments, according to the following regimen: The starting dose of ropinirole prolonged-release tablets is 2 mg once daily for the first week; this should be increased to 4 mg once daily from the second week of Week treatment. A therapeutic response may be seen at a dose of 4 mg once daily of ropinirole prolonged-release tablets. 1 2 3 4

Unit dose (mg) of ropinirole 0.25 0.5 0.75 1.0 Patients who initiate treatment with a dose of 2 mg/day of ropinirole prolonged- Total daily dose (mg) of ropinirole 0.75 1.5 2.25 3.0 release tablets and who experience side effects that they cannot tolerate, may benefit from switching to treatment with ropinirole film-coated (immediate Therapeutic regimen: After the initial titration, weekly increments of 0.5 to 1 mg release) tablets at a lower daily dose, divided into three equal doses. three times daily (1.5 to 3 mg/day) of ropinirole may be given. Therapeutic regimen A therapeutic response may be seen between 3 and 9 mg/day of ropinirole. If Patients should be maintained on the lowest dose of ropinirole prolonged-release sufficient symptomatic control is not achieved, or maintained after the initial tablets that achieves symptomatic control. titration as described above, the dose of ropinirole may be increased up to 24 mg/day. If sufficient symptomatic control is not achieved or maintained at a dose of 4 mg once daily of ropinirole prolonged-release tablets, the daily dose may be increased Doses of ropinirole above 24 mg/day have not been studied. by 2 mg at weekly or longer intervals up to a dose of 8 mg once daily of prolonged- release tablets. If treatment is interrupted for one day or more re-initiation by dose titration should be considered (see above). If sufficient symptomatic control is still not achieved or maintained at a dose of 8 mg once daily of ropinirole prolonged-release tablets, the daily dose may be When ropinirole is administered as adjunct therapy to L-dopa, the concurrent increased by 2 mg to 4 mg at two weekly or longer intervals. The maximum daily dose of L-dopa may be reduced gradually according to the symptomatic response. dose of ropinirole prolonged-release tablets is 24 mg. In clinical trials, the levodopa dose was reduced gradually by around 20% in patients treated with ropinirole as adjunct therapy.. In patients with advanced It is recommended that patients are prescribed the minimum number of ropinirole Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 2 Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA Interface Lead Pharmacist Birmingham CrossCity CCG Date: July 2015 Review date: July 2018

Parkinson's disease receiving ropinirole in combination with L-dopa, dyskinesias prolonged-release tablets that are necessary to achieve the required dose by can occur during the initial titration of ropinirole. In clinical trials it was shown that utilising the highest available strengths of ropinirole prolonged-release tablets. a reduction of the L-dopa dose may ameliorate dyskinesia When ropinirole prolonged-release tablets are administered as adjunct therapy to When switching treatment from another to ropinirole, the levodopa, it may be possible to gradually reduce the levodopa dose, depending on manufacturer's guidance on discontinuation should be followed before initiating the clinical response. In clinical trials, the levodopa dose was reduced gradually by ropinirole. approximately 30% in patients receiving ropinirole prolonged-release tablets concurrently. In patients with advanced Parkinson's disease receiving ropinirole As with other dopamine , it is necessary to discontinue ropinirole prolonged-release tablets in combination with L-dopa, dyskinesias can occur treatment gradually by reducing the number of daily doses over the period of one during the initial titration of ropinirole prolonged-release tablets. In clinical trials it week. was shown that a reduction of the L-dopa dose may ameliorate dyskinesia

When switching treatment from another to ropinirole, the marketing authorisation holder's guidance on discontinuation should be followed before initiating ropinirole.

As with other dopamine agonists, it is necessary to discontinue ropinirole treatment gradually by reducing the daily dose over the period of one week.

Switching from ropinirole immediate release tablets to ropinirole prolonged- release tablets Patients may be switched overnight from ropinirole immediate release tablets to ropinirole prolonged-release tablets.

The dose of ropinirole prolonged-release tablets should be based on the total daily dose of immediate release formulation that the patient was receiving. The recommended dose for switching from ropinirole immediate release tablets to ropinirole prolonged-release tablets are provided in the following table. If patients are taking a different total daily dose of ropinirole immediate release tablets to those typically prescribed doses as shown in the table, they should be switched to the nearest available dose of ropinirole prolonged-release tablets as stated in the table:

Ropinirole immediate release tablets Ropinirole prolonged-release tablets Total daily dose (mg) Total daily dose (mg) 0.75 – 2.25 2 3 - 4.5 4 6 6 7.5 - 9 8 Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 3 Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA Interface Lead Pharmacist Birmingham CrossCity CCG Date: July 2015 Review date: July 2018

12 12 15 - 18 16 21 20 24 24 After switching to ropinirole prolonged-release tablets, the dose may be adjusted depending on the therapeutic response

Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 4 Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA Interface Lead Pharmacist Birmingham CrossCity CCG Date: July 2015 Review date: July 2018

Renal Impairment Mild - Moderate No dosage adjustment is necessary (creatinine clearance between 30 and 50 ml/min) Severe ( The use of ropinirole IR and MR in patients with severe renal impairment without regular haemodialysis has not creatinine clearance less than 30 ml/min) been studied End stage renal disease (patients on Immediate release tablets Modified release tablets haemodialysis) The initial dose of ropinirole should be 0.25 mg three The recommended initial dose of ropinirole XL is 2 mg times a day. Further dose escalations should be based on once daily. Further dose escalations should be based on tolerability and efficacy. The recommended maximum tolerability and efficacy. The recommended maximum dose is 18 mg/day in patients receiving regular dose is 18 mg/day in patients receiving regular dialysis. haemodialysis. Supplemental doses after haemodialysis Supplemental doses after dialysis are not required are not required Hepatic Ropinirole IR and MR should not be administered in patients with hepatic impairment impairment Contra-indications Contraindication:- / Special Hypersensitivity to the active substance or to any of the excipients. precautions Severe renal impairment (creatinine clearance < 30ml/min). Severe hepatic impairment. Ropinirole should not be used to treat neuroleptic akathisia, tasikinesia (neuroleptic-induced compulsive tendency to walk), or secondary (e.g. caused by renal failure, iron deficiency anaemia or ). It is recommended that ropinirole is not used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the foetus. Ropinirole should not be used in nursing mothers as it may inhibit lactation

Cautions: Immediate release tablets Modified release tablets Patients with major psychiatric or psychotic disorders, or a history of these Due to the risk of hypotension, blood pressure monitoring is recommended, disorders, should only be treated with dopamine agonists if the potential benefits particularly at the start of treatment, in patients with severe cardiovascular outweigh the risks. disease (in particular coronary insufficiency). Patients with a history or presence of major psychotic disorders should only be Ropinirole has been associated with somnolence and episodes of sudden sleep treated with dopamine agonists if the potential benefits outweigh the risks onset, particularly in patients with Parkinson's Disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been Impulse control disorders reported uncommonly. Patients must be informed of this and advised to exercise Patients should be regularly monitored for the development of impulse control caution while driving or operating machines during treatment with ropinirole. disorders. Patients and carers should be made aware that behavioural symptoms Patients who have experienced somnolence and/or an episode of sudden sleep of impulse control disorders including pathological gambling, increased libido, onset must refrain from driving or operating machines. Furthermore, a reduction , compulsive spending or buying, binge eating and compulsive of dosage or termination of therapy may be considered. eating can occur in patients treated with dopamine agonists including Ropinirole MR.

Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 5 Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA Interface Lead Pharmacist Birmingham CrossCity CCG Date: July 2015 Review date: July 2018

Dose reduction/tapered discontinuation should be considered if such symptoms develop. Impulse control disorders were reported especially at high doses and were generally reversible upon reduction of the dose or treatment discontinuation. Risk factors such as a history of compulsive behaviours were present in some cases.

Ropinirole has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported uncommonly. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with ropinirole. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore, a reduction of dosage or termination of therapy may be considered.

Ropinirole MR. tablets are designed to release medication over a 24hr period. If rapid gastrointestinal transit occurs, there may be risk of incomplete release of medication, and of medication residue being passed in the stool.

This medicinal product also contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine. The 4 mg tablets contain the azo colouring agent sunset yellow (E110), which may cause allergic reactions.

Side Effects Very common Somnolence, syncope, dyskinesia, nausea Common , confusion dizziness (including vertigo), heartburn, vomiting, abdominal pain, leg oedema Monitoring Renal function function Sudden onset of sleep and somnolence Blood pressure INR monitoring

Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 6 Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA Interface Lead Pharmacist Birmingham CrossCity CCG Date: July 2015 Review date: July 2018

Drug Interactions Ropinirole has the following interaction information:

Antipsychotics manufacturer of ropinirole advises avoid concomitant use of (antagonism of effect) Note: Increased risk of toxicity with myelosuppressive drugs

Ciprofloxacin metabolism of ropinirole inhibited by (increased plasma concentration)

Metoclopramide manufacturer of ropinirole advises avoid concomitant use of (antagonism of effect)

Oestrogens plasma concentration of ropinirole increased by oestrogens Ropinirole belongs to and will have the following interactions:

Memantine effects of dopaminergics possibly enhanced by

Methyldopa antiparkinsonian effect of dopaminergics antagonised by

References Ropinirole IR and MR SmPC RopiniroleIR and MR BNF NICE CG 35 - Parkinson's disease: Diagnosis and management in primary and secondary care

Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 7 Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA Interface Lead Pharmacist Birmingham CrossCity CCG Date: July 2015 Review date: July 2018

______

I agree to participate in this shared care agreement for the treatment of the below named patient with ropinirole IR/MR for parkinson’s disease

General Practitioner Name (please print)______Signature ______Date______

Hospital Specialist/Consultant Name (please print)______Signature______Date______

Patient’s name Date of birth Sex Home Address Hospital Number

NHS Number

Please keep a copy of this agreement for your own records and forward the original to the above named Consultant at:

Birmingham, Sandwell, Solihull and environs Area Prescribing Committee (BSSE APC) Based on MTRAC template Prepared by Satnaam Singh Nandra 8 Ropinirole Immediate Release (IR) and Modified Release (MR) ESCA Interface Lead Pharmacist Birmingham CrossCity CCG Date: July 2015 Review date: July 2018