APOMORPHINE (Adults) Shared Care Guidelines DRUG:

Transcription

1 Shared Care Guidelines DRUG: APOMORPHINE (Adults) Indication: Treatment of motor fluctuations in patients with Parkinson's disease which is not sufficiently controlled by oral anti-parkinson medication. Licensing Information: Treatment of motor fluctuations ( on-off phenomena) in patients with Parkinson's disease which are not sufficiently controlled by oral anti-parkinson medication. Formulations: APO-go pen 10mg/mL solution for injection 3mL = 30mg APO-go prefilled syringe 5mg/mL solution for infusion 10mL=50mg The preferred infusion sets (Nov 2012) used to administer the continuous infusion are Neria. These are easier to use than a conventional butterfly line and generally mean patients/carers can manage with district nurse input and consequently tend to be associated with fewer injection site reactions. Dosage & administration: Administration subcutaneously by bolus or continuous infusion. The appropriate dose for each patient is established by incremental dosing schedules. Typical bolus dose - The daily dose is typically within the range of 3-30mg, given as 1-10 injections. The manufacturer recommends that individual bolus injections should not exceed 10mg. Patients on a subcutaneous infusion may also need intermittent bolus doses to supplement their continuous infusion. Typical infusion dose - Hourly infusion rates may range between 1mg and 4mg. Infusions should run for waking hours only, unless the patient is experiencing severe night-time problems. The manufacturer recommends that patients should have at least a 4 hour break from treatment in 24 hours to avoid the development of tolerance. The manufacturer recommends that the total daily dose of apomorphine should not exceed 100mg As apomorphine is usually emetogenic and patients should be established on domperidone (usually 20mg three times daily), three days prior to initiation of therapy. The dose of domperidone may be able to be reduced in time, but in many cases cannot be discontinued completely. The domperidone may also prevent/reduce postural hypotension. Contraindications & Warnings: Contra-indications: Hypersensitivity to the active substance or to any of the excipients. Patients with respiratory depression, dementia, psychotic diseases or hepatic insufficiency. Name: Apomorphine Shared Care Guideline Page 1 of 6

2 Interactions: Patients who have an 'on' response to levodopa which is marred by severe dyskinesia or dystonia. Cautions: Patients with renal, pulmonary or cardiovascular disease (especially those on antihypertensives or risk factors for QT prolongation). Patients prone to nausea and vomiting and/or pre-existing postural hypotension. Neuroleptics - may negate the benefits of apomorphine. There is a potential interaction between clozapine and apomorphine, (Note however clozapine may also be used to reduce the symptoms of neuropsychiatric complications). If neuroleptic medicinal products have to be used a gradual reduction in apomorphine dose may be considered (symptoms suggestive of neuroleptic malignant syndrome have been reported rarely with abrupt withdrawal of dopaminergic therapy). Antihypertensive and other vasoactive drugs - apomorphine may potentiate the hypotensive effects of these medicinal products Drugs known to prolong the QT interval avoid co-administration with apomorphine (see Ondansetron BNF advises to avoid as increased risk of hypotension (ondansetron can also prolong the QT interval) For full list see BNF or SPC at Adverse Effects: The most commonly reported adverse reactions are Neuropsychiatric disturbances (including transient mild confusion and visual hallucinations) - these are common in parkinsonian patients and may also occur with apomorphine therapy. Nausea and vomiting - particularly when apomorphine treatment is first initiated domperidone can be used to help control this Injection site reactions - these can sometimes be reduced by the rotation of injection sites. Nodule formation cannot usually be avoided completely, but sites are checked at each clinic appointment. Other side effects include Postural hypotension usually transient. QT prolongation apomorphine has the potential to prolong the QT interval, especially at high doses (care with drug interactionsn and patient with risk factors). Somnolence and sudden sleep onset episodes - patients must be advised to exercise caution while driving or operating machines and refrain if they experience this side effect. A reduction of dosage or termination of therapy may be considered. Transient sedation may also occur which resolves over the first few weeks of treatment. Pathological gambling, increased libido and hypersexuality has been Name: Apomorphine Shared Care Guideline Page 2 of 6

3 reported in patients treated with dopamine agonists for Parkinson's disease, including apomorphine. Haemolytic anaemia and thrombocytopenia uncommon. For full list see BNF or SPC at Responsibilities of the specialist initiating treatment: General: To assess the suitability of the patient for treatment. To ensure that the patient/carer has received counselling and understands the therapy, its benefits, limitations, continued monitoring (where applicable), adverse effects, and is aware of actions to take if adverse effects are suspected. If the patient or carer is going to (self) administer the infusions and or bolus injections, ensure they are trained prior to hand over to the GP and supply a sharps bin. Make patient aware they need to report any unexplained bruising /bleeding Inform the GP of the information provided to the patient. To review the patient as agreed intervals and copy any relevant results to the GP Carry out disease and drug monitoring as listed below Formally hand over to GP by letter and patient informed - send a copy (either electronically or paper copy) of the shared care guideline to the GP and ask whether they are willing to participate in shared care. Prescribing: Prescribe apomorphine until GP agrees to shared care. Routinely patients should be issued with 28 days supply medication, lines and needles on discharge from hospital, The GPs will be typically asked to take up the ongoing prescribing of apomorphine and consumables thereafter. Ensure that the patient and/or carer receives the right device and the education in using and storing the medication by an appropriate medical professional Disease & drug monitoring: Monitor according to schedule: Baseline At each clinic visit ECG (consultant will review) Check for injection site reactions Check for general side effects/tolerability Check how patient is managing practically with treatment. (If the patient is having severe and frequent hypotensive episodes refer to practice nurse for random BP monitoring) Discuss shared care arrangement with patient. Support and advise GPs as required. Assess response to treatment and initiate any dose changes as clinically appropriate including discontinuation of treatment. Name: Apomorphine Shared Care Guideline Page 3 of 6

4 Responsibilities of other prescribers (GP): General and Prescribing: To reply to the request for shared care within 2 weeks of receipt of the consultant letter. Prescribe as recommended by the specialist. Routinely patients should be issued with 28 days supply medication, lines and needles on discharge from hospital, The GPs will be typically asked to take up the ongoing prescribing of apomorphine and consumables thereafter. The preferred lines used to administer the continuous infusion are Neria 10mm (or 8mm in slender patients). Both sizes are available in 60cm or 110cm length. If the patient or carer is administering the infusion and/or bolus doses prescribe a sharps bin upon request by patient. These should be prescribed on an FP10 as 'Sharpsguard 1 Litre' and include the instructions 'yellow lid'.' Notify consultant if treatment with apomorphine is discontinued. Ensure there are no drug interactions with any other medications initiated in primary care. Disease & drug monitoring: Carry out the following drug monitoring and communicate abnormal results to the specialist. Urgent drug discontinuation/ referral to specialist as clinically appropriate To stop treatment on the advice of the specialist. To refer back to the specialist if the patient s condition deteriorates. To identify adverse effects if the patient presents with any signs and liaise with the hospital specialist where necessary. To report adverse effects to the specialist and where appropriate to the Commission on Human Medicines/MHRA (Yellow Card scheme). Unless otherwise stated by the secondary care specialist, apply the following monitoring frequencies following handover from secondary care: FBC Random BP monitoring Only if the patient reports any unexplained bruising /bleeding to check for thrombocytopenia. At regular intervals (eg every 6 months in patients co-administered levodopa) Only if requested by secondary care - if the patient is having severe and frequent hypotensive episodes the patient will be referred to the practice nurse for random BP monitoring) Responsibilities of the Patient / Carer: General : Report any possible side effects to their GP. In particular, they should report any unexplained bruising or bleeding that may be indicative of thrombocytopenia Ensure they have adequate supply of medication. Attend appointments. Disease & drug monitoring: As above contact GP or initiating team if side effects develop (see adverse effects) and attend appointments including those for routine blood Name: Apomorphine Shared Care Guideline Page 4 of 6

5 tests/investigations Communication: Specialist to GP: The specialist will inform the GP when they have initiated apomorphine and when there are any subsequent changes in treatment standard clinic letter. Send a copy (either electronically or paper copy) of the shared care guideline to the GP and ask whether they are willing to participate in shared care. Inform the GP of the information provided to the patient GP to Specialist: To reply to the request for shared care within 2 weeks of receipt of the consultant letter. Irrespective of whether you accept prescribing responsibility or not, you should inform the consultant of relevant medical information regarding the patient and changes to the patient s medication regime irrespective of indication. Notify consultant if treatment with apomorphine is discontinued. Contact names & details: If you have any concerns regarding individual patients, see consultant letter for medical contact details or contact one of the following: Name Title/Location Telephone / Bleep Dr P Duffey Consultant Neurologist (Secretary) Dr A Heald Consultant Neurologist (Secretary) Dr P Crawford Consultant Neurologist (Secretary) Dr R Mir Consultant Neurologist (Secretary) Dr G Tzimas Consultant Neurologist (Secretary) Fiona Ronan Parkinson s Disease specialist nurse York Lynnette Bayes Parkinson s Disease specialist nurse Scarborough Costs: BNF (March 2013) APO-go pen 10mg/mL 3mL = APO-go prefilled syringe 5mg/mL 10mL= Drug Tariff (July 2013) Neria Lines (Unomedical) Product code Cost for 10 60cm tubing 8mm/29 gauge cm tubing 10mm/29 gauge cm tubing 8mm/27 gauge cm tubing 10mm/29 gauge References: 1. Summary of Product Characteristics APO- go. Date of last update BNF March 2013 Document Control: This information is not inclusive of all prescribing information and potential adverse effects. Please refer to the SPC (data sheet) or BNF for further prescribing information. The original Microsoft Word file of this document is located on: York Teaching Hospital NHS Foundation Trust Pharmacy Department X:\MEDICINES INFORMATION\Shared Care Name: Apomorphine Shared Care Guideline Page 5 of 6

6 Guidelines\Approved Shared Care Guidelines\APOMORPHINE (Adults) Shared Care Guideline V1.0 Shared Care Guidelines also available electronically via Prepared by: Checked by: Version: 1.0 Jane Crewe Date of Issue / Review: December 2013 Date for next Review: December 2015 Approved by: Kirsten Evans (Pharmacist YH) Layla Al-Ani (Former Parkinson s Disease specialist nurse) Diane Tomlinson (Pharmacist NY & Humber Commissioning Support Unit) Drug & Therapeutics Committee Name: Apomorphine Shared Care Guideline Page 6 of 6