Download Apomorphine - Wolverhampton Formulary

Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Apomorphine (APO-go®)
ESCA: For the treatment of disabling motor fluctuations (“on-off” phenomena) in patients with
Parkinson's disease which persist despite individually titrated treatment with levodopa (with a
peripheral decarboxylase inhibitor) and/or other dopamine agonists.
SECONDARY CARE SECTION TO BE COMPLETED BY INITIATING DOCTOR
Patient’s Name:
NHS Number:
Date of Birth:
Date Treatment Started:
(Add Date)
One copy of information leaflet given to patient
One copy of agreement sent to general practitioner
One copy filed in patients notes
Name of Initiating Doctor:
Consultant:
Speciality:
Fax Number:
PRIMARY CARE SECTION TO BE COMPLETED BY GENERAL PRACTITIONER
I agree*/don’t agree* to enter into a shared care arrangement for the treatment of the above patient with
this medicine (*delete as appropriate)
GP Name:
Signature:
Date:
Once signed please detach this sheet and fax to the number shown above.
File copy in patient’s record and add read code 66S2 or XaK6z depending on GP clinical system.
BACK-UP ADVICE AND SUPPORT
Contact details
Telephone No.
Bleep:
Fax:
Email address:
Specialist: Dr D. D’Costa
01902 695262
3522
5613
[email protected]
Hospital Pharmacy
Department – Mrs J Morey
01902 695136
7846
[email protected]
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Apomorphine (APO-go)
Date approved: December 2012
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Apomorphine (APO-go®)
ESCA: For the treatment of disabling motor fluctuations (“on-off” phenomena) in patients with
Parkinson's disease which persist despite individually titrated treatment with levodopa (with a
peripheral decarboxylase inhibitor) and/or other dopamine agonists.
Patient’s Name:
Date treatment commenced:
AREAS OF RESPONSIBILITY FOR THE SHARING OF CARE
This shared care agreement outlines suggested ways in which the responsibilities for managing the prescribing of
apomorphine for adults can be shared between the specialist and general practitioner (GP). GPs are invited to
participate. If the GP is not confident to undertake these roles, then he or she is under no obligation to do so. In that
case, the total clinical responsibility for the patient for the diagnosed condition remains with the specialist. If a
specialist asks the GP to prescribe this drug, the GP should reply to this request as soon as practicable.
Sharing of care assumes communication between the specialist, GP and patient. The intention to share care should
be explained to the patient by the doctor initiating treatment. It is important that patients are consulted about
treatment and are in agreement with it. Patients are under regular follow-up, which provides opportunities 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
Diagnosis of Parkinson’s disease and initiation of apomorphine treatment. This would include developing a
treatment strategy via pen or by subcutaneous infusion.
2. Discuss the benefits and side effects of treatment with the patient carers and community team.
3. Dose stabilisation: initial dosage adjustment until stable. Thereafter, during maintenance treatment, advice to
the GP on any further dose adjustments required.
4. Ask the GP whether he or she is willing to participate in shared care, and agree with the GP as to who will
discuss the shared care arrangement with the patient.
5. Monitor regular blood count. These will be checked regularly at outpatient visits.
6. Communicate promptly with the GP when treatment is changed.
7. Have a mechanism in place to receive rapid referral of a patient from the GP in the event of deteriorating
clinical condition.
8. Advise the GP on stopping treatment (if appropriate).
9. Report serious adverse events to the MHRA.
10. Ensure that clear backup arrangements exist for GPs to obtain advice and support.
General Practitioner responsibilities
1. Reply to the request for shared care as soon as practicable.
2. Prescribe apomorphine at the dose recommended after stabilisation of treatment.
3. Adjust the dose as advised by the specialist.
4. Report to and seek advice from the specialist on any aspect of patient care that is of concern and may affect
treatment e.g. occurrence of side-effects or inability to administer apomorphine.
5. Refer patient to the specialist if his or her condition deteriorates.
6. Stop treatment on the advice of the specialist or immediately if an urgent need to stop treatment arises.
7. Report adverse events to the specialist and MHRA.
Patient's role
1. Report to the 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 apomorphine.
3. Ensure regular attendance for review and blood monitoring tests.
4. Report any adverse effects to the specialist or GP whilst taking apomorphine.
1.
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Apomorphine (APO-go)
Date approved: December 2012
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Apomorphine (APO-go®)
ESCA: For the treatment of disabling motor fluctuations (“on-off” phenomena) in patients with
Parkinson's disease which persist despite individually titrated treatment with levodopa (with a
peripheral decarboxylase inhibitor) and/or other dopamine agonists.
SUPPORTING CLINICAL INFORMATION
Parkinson’s disease is a chronic, progressive, neurological disorder that affects 1.8/1000 people in the UK. It is a
relatively common disease of the elderly, with approximately 1 in 200 patients over the age of 65 years affected. The
disease is characterised by resting tremors, muscular rigidity and bradykinesia (slowness of initiating and carrying
out voluntary movements). The patient has a mask-like face, monotonous voice and walks with a stoop and slow
shuffling gait.
Current Treatment Options
Levodopa (in combination with a peripheral dopa-decarboxylase inhibitor) is the corner stone of symptomatic therapy
for Parkinson’s disease. Unfortunately, within 3-5 years of initiating treatment at least 50% of patients develop
fluctuations with dyskinesia and end-of-dose akinesia or ‘wearing-off’. Current management strategies for fluctuating
patients involve the use of controlled release formulations, and adjunct therapies such as dopamine agonists and
selegiline, to provide additional symptom control. In very difficult cases subcutaneous administration of apomorphine
may be required.
Pharmacology
Apomorphine is a dopamine D2-receptor agonist used in the management of parkinsonism, especially the control of
the “on-off” effect. Although apomorphine is a morphine derivative, it has no opiate or addictive properties.
Apomorphine is used in patients who suffer from disabling “off” periods, or painful dystonias, depressions, bladder
dysfunction and swallowing difficulties.
Many patients experience peak dose, or biphasic dyskinesias which can be as, or even more, disabling than an “off”
period. In some cases, a reduction in oral medication is possible, gaining better symptomatic control of a patient’s
fluctuations.
Indications
The treatment of disabling motor fluctuations (“on-off” phenomena) in patients with Parkinson's disease which persist
despite individually titrated treatment with levodopa (with a peripheral decarboxylase inhibitor) and/or other dopamine
agonists.
Patient Selection
Apomorphine injections are only considered suitable for Parkinson’s disease patients capable of recognising and
anticipating “off” episodes in motor performance. An apomorphine challenge is necessary to determine whether a
patient has a positive response, the individual dose and observe patient for side-effects e.g. postural hypotension
and hallucinations.
Dosage and Administration
The optimal dose of apomorphine has to be determined on an individual patient basis, under specialist supervision.
The dosage will vary depending on the formulation chosen. Apomorphine ampoules 10 mg/ml solution for injection
or infusion is for subcutaneous use by intermittent bolus injection. Apomorphine ampoules 10 mg/ml solution for
injection or infusion may also be administered as a continuous subcutaneous infusion by minipump and/or syringedriver
Apomorphine is usually highly emetogenic, so all patients are treated with DOMPERIDONE 20-30 mg three
times a day, starting at least 3 days prior to initiation of therapy. It is sometimes possible to withdraw this
after a couple of months. The domperidone may also prevent/reduce postural hypotension.
Determination of the threshold dose
The appropriate dose for each patient is established by incremental dosing schedules. The following schedule is
suggested:- 1mg of apomorphine HCl (0.1ml), that is approximately 15-20 micrograms/kg, may be injected
subcutaneously during a hypokinetic or 'off' period and the patient is observed over 30 minutes for a motor response.
If no response, or an inadequate response, is obtained a second dose of 2 mg of apomorphine HCl (0.2ml) is
injected subcutaneously and the patient observed for an adequate response for a further 30 minutes. The dosage
may be increased by incremental injections with at least a forty minute interval between succeeding injections, until a
satisfactory motor response is obtained.
The optimal dosage of apomorphine hydrochloride varies between
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Apomorphine (APO-go)
Date approved: December 2012
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Apomorphine (APO-go®)
ESCA: For the treatment of disabling motor fluctuations (“on-off” phenomena) in patients with
Parkinson's disease which persist despite individually titrated treatment with levodopa (with a
peripheral decarboxylase inhibitor) and/or other dopamine agonists.
individuals but, once established, remains relatively constant for each patient.
Precautions on continuing treatment
The daily dose of APO-go varies widely between patients, typically within the range of 3-30 mg, given as 1-10
injections and sometimes as many as 12 separate injections per day.
It is recommended that the total daily dose of apomorphine HCl should not exceed 100 mg and that individual bolus
injections should not exceed 10 mg.
In clinical studies it has usually been possible to make some reduction in the dose of levodopa; this effect varies
considerably between patients and needs to be carefully managed by an experienced physician.
Once treatment has been established, domperidone therapy may be gradually reduced in some patients but
successfully eliminated only in a few, without any vomiting or hypotension.
Continuous Infusion
Patients who have shown a good 'on' period response during the initiation stage, but whose overall control remains
unsatisfactory using intermittent injections, or who require many and frequent injections (more than 10 per day), may
be commenced on or transferred to continuous subcutaneous infusion by minipump and/or syringe-driver (see
section 6.6) as follows:Continuous infusion is started at a rate of 1 mg apomorphine HCl (0.1 ml) per hour then increased according to the
individual response. Increases in the infusion rate should not exceed 0.5 mg per hour at intervals of not less than 4
hours. Hourly infusion rates may range between 1 mg and 4 mg (0.1 ml and 0.4 ml), equivalent to 0.015 - 0.06
mg/kg/hour. Infusions should run for waking hours only. Unless the patient is experiencing severe night-time
problems, 24 hour infusions are not advised. Tolerance to the therapy does not seem to occur as long as there is an
overnight period without treatment of at least 4 hours. In any event, the infusion site should be changed every 12
hours.
Patients may need to supplement their continuous infusion with intermittent bolus boosts via the pump system as
necessary.
A reduction in dosage of other dopamine agonists may be considered during continuous infusion.
Contraindications

Patients with respiratory depression, dementia, psychotic diseases or hepatic insufficiency

Patients who have “on” response to levodopa which is marred by severe dyskinesia, hypotonia or
psychotoxicity

Patients who have a known hypersensitivity to apomorphine or any excipients of the medicinal product.

Children and adolescents under 18 years of age.
Side Effects
Side-effects are rarely a problem as those who have found to have adverse effects at the challenge state are
deemed unsuitable for continued treatment. The most common adverse effects are neuropsychiatric disorders,
including transient hallucinations and confusion. Transient sedation may occur at the beginning of treatment which
usually resolves over the first few weeks. Somnolence, dizziness and lightheadedness have also been reported.
Haemolytic anaemia and thrombocytopenia have been reported; hence the need for regular blood counts.
Nausea and vomiting have been reported but this is only usually due to the domperidone not being administered.
Most patients experience injection site reactions, including subcutaneous nodules, induration, erythema, tenderness
and panniculitis. Various other local reactions (such as irritation, itching, bruising and pain) may also occur.
Monitoring
Regular full blood count as haemolytic anaemia and thrombocytopenia have been reported in patients treated with
apomorphine.
Drug Interactions
Patients selected for treatment with apomorphine are almost certain to be taking concomitant medicines for their
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Apomorphine (APO-go)
Date approved: December 2012
Expiry date: 31/12/2017
Royal Wolverhampton
NHS Trust
Wolverhampton City
Clinical Commissioning Group
Wolverhampton Shared
Care Agreement
Black Country Cluster
Apomorphine (APO-go®)
ESCA: For the treatment of disabling motor fluctuations (“on-off” phenomena) in patients with
Parkinson's disease which persist despite individually titrated treatment with levodopa (with a
peripheral decarboxylase inhibitor) and/or other dopamine agonists.
Parkinson’s disease. In the initial stages of treatment with apomorphine, patients should be monitored for unusual
side-effects or signs of potentiation of effect.
Drugs that interfere with central amine mechanisms should be avoided if possible, however if their administration is
considered essential extreme care should be taken and the patient monitored for signs of potentiation, antagonism or
other unusual side effects. Drugs include:

tetrabenazine, metoclopramide

phenothiazines (e.g. chlorpromazine), thioxanthenes (e.g. flupenthixol) and butyrophenones (e.g.
haloperidol)

amphetamines
 papaverine
It is recommended that administration of apomorphine should be avoided with other drugs known to prolong the QT
interval.
Vaccination
The use of LIVE vaccine is not recommended during drug treatment with immunosuppressant drugs. This section
may be excluded if the shared care agreement related to a drug which is not an immunosuppressant.
Version Control
Version
Date of Issue
Author/s
Brief Description of Changes
25/06/2013
R Eardley
Removal of pharmacy fax numbers
1.0
1.1
This Shared Care Agreement should be read in conjunction with the Summary of Product Characteristics (SPC) for Apomorphine (APO-go)
Date approved: December 2012
Expiry date: 31/12/2017