Download PRAMIPEXOLE for Parkinson`s Disease

Shared Care Protocol
PRAMIPEXOLE for treatment of idiopathic Parkinson’s disease
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FOR THE LATEST VERSION OF THIS PROTOCOL
Protocol No. 13
General
guidance
Licensed
indication
Background
information
The Gwent Partnership Medicines and Therapeutics Committee has agreed this protocol.
It outlines shared care arrangements for patients taking pramipexole for the treatment of
Parkinson’s Disease.
This document should be read in conjunction with:
1. The Shared Care Agreement Form
2. The Summary of Product Characteristics (Data Sheet) for Mirapexin® see:
http://www.medicines.org.uk/
The treatment of the signs and symptoms of idiopathic Parkinson's disease, alone (without
levodopa) or in combination with levodopa, i.e. over the course of the disease, through to
late stages when the effect of levodopa wears off or becomes inconsistent and
fluctuations of the therapeutic effect occur (end of dose or “on off” fluctuations).
Pramipexole is a non-ergot derived dopamine (D3) receptor agonist. Dopamine agonists
are used to minimise the end-of-dose or wearing-off effects encountered with levodopa
therapy. Dopamine agonists, compared with levodopa, have lower symptomatic efficacy
and more adverse effects, particularly in the elderly and those with poor cognitive function.
Patient selection criteria for treatment with pramipexole are:
 patients already on levodopa who are experiencing on/off fluctuations
 patients with Parkinson’s disease who are not on levodopa & have a life-expectancy
greater than 5 years.
Contraindications
 Hypersensitivity to pramipexole or to any of the excipients.
Dosage regimen
Special Warnings/Precautions
 Avoid in patients with renal impairment; pregnancy or breast feeding; psychotic
disorders; severe cardiovascular disease; avoid abrupt withdrawal (risk of neuroleptic
malignant syndrome).
 OPHTHALMIC COMPLICATIONS: there is a theoretical risk of degeneration of outer
retina (seen in albino rats given high doses, but not reported in humans). If patients
have visual problems or history of retinal disease baseline testing is recommended by
an ophthalmologist. At review by consultant patients will be asked about any night
vision problems and checked for visual field loss.
 DRIVING: Drowsiness (including sudden onset of sleep) may affect performance of
skilled tasks; patients should not drive or undertake potentially dangerous activities
until stabilised on treatment & not experiencing problems. Patients should be
warned about the possible additive effects of other sedating drugs and/or
alcohol.

Pre-treat with domperidone 20mg three times daily (to prevent nausea & postural
hypotension) and continue until on stable dose of pramipexole.
Pramipexole is prescribed as pramipexole (base).
Initially, 88micrograms three times daily, after one week increase dose to 180micrograms
three times daily, after a further week increase dose to 350micrograms three times daily
and then a week later increase, if necessary, to 700micrograms three times daily.
Concurrent levodopa dose may need to be reduced during dose titration and
maintenance.
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Approved by: GPMTC
Issue Date
Review Date
Page 1 of 3
8th March 2007
March 2009
ASCENDING Dose Schedule (provided patients do not experience intolerable sideeffects)
Dosage (base)
Week 1
Week 2
Week 3
Week 4
onwards
Total daily Dose (base)
264micrograms
3 x 88micrograms
540micrograms
3 x 180micrograms
1.05mg
3 x 350micrograms
IF NECESSARY further increases, at weekly intervals, of 3 x
180micrograms daily to a max of 3.3mg daily in 3 divided doses.
TAPERING OFF Schedule
If total daily dose MORE THAN 540micrograms (3 x 180 micrograms)
Each day
Reduce by 3 x 180micrograms (540micrograms)
If total daily dose is 540micrograms OR BELOW (3 x 180 micrograms)
Each day
Reduce by 3 x 88micrograms (264micrograms)
Adverse effects
Very common (>10%): Nausea, dyskinesia.
Common (1-10%): Constipation, peripheral oedema, headache, fatigue, confusional
state, hallucinations (mostly visual), insomnia and
Somnolence (8.6%) – including excessive daytime somnolence and sudden sleep
onset (see Background information above and: Current Problems in
Pharmacovigilance: Volume 25, (Pages 13-20) November 1999).
Hypotensive reactions may be disturbing in some patients during the first few days of
treatment.
Monitoring
(by Secondary
Care)
Baseline monitoring (by Hospital Dept.)
BP, U&Es, baseline ophthalmic examination is recommended by an ophthalmologist for
patients with visual problems or history of retinal disease
Ongoing monitoring (by Hospital Dept.)
Patients should be asked about night vision problems and checked for visual field loss at
regular intervals. A referral for an ophthalmic examination should be made if patient
reports visual abnormalities.
BP.
Responsibilities
of Secondary
Care
 Confirm the diagnosis of Parkinson’s disease or the deterioration of Parkinson’s
disease e.g. increasing mobility problems.
 To confirm patient/carer understanding and consent to treatment.
 To advise the patient/carer on potential side effects and the action to be taken should
they occur particularly the possibility of hallucinations and somnolence and/or an
episode of sudden sleep onset and the implication for driving or operating machines.
 Provide a minimum of one month’s supply of pramipexole together with a dose titration
schedule.
 Assess side-effects and response (Consultant or Parkinson’s Disease Specialist
Nurse).
 To send the GP a Shared Care Agreement Form and invite them to participate in the
shared care management of the patient.
 Review the patient’s response and the continued appropriateness of pramipexole
throughout the course of treatment (Consultant or Parkinson’s Disease Specialist
Nurse), normally reviews should be every 3 months over the first year.
 Stop the treatment when considered to be no longer appropriate (Consultant or
Parkinson’s Disease Specialist Nurse).
 To provide the GP with an outline clinical management plan including a dosage
schedule for pramipexole.
 To make any subsequent changes to the dose, as required.
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Approved by: GPMTC
Issue Date
Review Date
Page 2 of 3
8th March 2007
March 2009
 To perform baseline and on-going monitoring (as above).
 To inform the GP of dosage schedule, monitoring measurements and progress of
treatment after each appointment.
 To inform the GP if the patient fails to attend an appointment and clearly indicate that
the patient is taking pramipexole.
Responsibilities
of
patients/carers
 To attend hospital and GP appointments Failure to attend will result in the
medication being stopped.
 To report any worsening of control of symptoms and/or adverse events immediately to
their specialist or GP.
Responsibilities
of Primary Care
 To issue ongoing prescriptions for pramipexole as per dosage schedule recommended
by the specialist.
 To check for drug interactions in BNF Appendix 1 before co-prescribing any other drug
 To inform the specialist services if the patient shows significant worsening of control of
symptoms or deterioration of Parkinson’s disease.
 To inform the specialist services of severe untoward events or side effects and to
report these to the MHRA (using the Yellow Card scheme) as appropriate. In cases of
significant adverse effects, pramipexole may be tapered off at a rate of
540micrograms of base per day, daily doses at or below 540micrograms should be
reduced by 264micrograms of base per day. (see tapering schedule in ‘Dosage
Regime’)
Contact details
Dr. Huw Morris
Dr. Gareth Llewelyn
Debbie Davies
Dr. Ken Dawson
Dr. David Sykes
Dr. Michael Edwards
Dr. Mukund Joglekar
Neurology, RGH
Neurology, RGH
Neurology, RGH
Neurology, NHH
Medicine, RGH
Medicine, NHH
Medicine, CDMH
01633 234829
01633 234453
01633 234151
01873 732739
01633 238322
01873 732517
02920 807351 or 807183
MHRA links:
Sudden onset of sleep Current Problems in Pharmacovigilance: Volume 25, (Pages 13-20) November 1999
(at:http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON0
07463&ssTargetNodeId=368)
This Shared Care Protocol should be read in conjunction with the Summary of Product Characteristics
Status: APPROVED
Approved by: GPMTC
Issue Date
Review Date
Page 3 of 3
8th March 2007
March 2009