APO-go®
Apomorphine hydrochloride
PRESCRIBING INFORMATION
Consult Summary of Product Characteristics before prescribing.
Uses Treatment of motor fluctuations (“on-off” phenomena) in patients with Parkinson’s disease which are not sufficiently controlled by oral anti-Parkinson medication Dosage and Administration Apomorphine hydrochloride is administered subcutaneously either as an intermittent bolus injection or by continuous subcutaneous infusion. Its rapid onset (5-10 mins) and duration of action (about 1 hour) may prevent an “off” episode which is refractory to other treatments. Apomorphine should be initiated in the controlled environment of a specialist clinic. The patient should be supervised by a physician experienced in the treatment of Parkinson’s disease (e.g. neurologist). Please refer to the Summary of Product Characteristics for full details before initiating therapy. Treatment with domperidone (typical dosage 20mg three times a day) before and during apomorphine HCl therapy is essential. The optimal dosage of apomorphine HCl has to be determined on an individual patient basis; individual bolus injections should not exceed 10mg and the total daily dose should not exceed 100mg. Do not use if the solution has turned green. The solution should be inspected visually prior to use. Only clear, colourless and particle free solution should be used. Contraindications Children and adolescents (up to 18 years of age). Known sensitivity to apomorphine or any other ingredients of the product. Respiratory depression, dementia, psychotic disease or hepatic insufficiency. Intermittent apomorphine HCl treatment is not suitable for patients who have an “on” response to levodopa which is marred by severe dyskinesia or dystonia.
Pregnancy and lactation Apomorphine should not be used in pregnancy unless clearly necessary. Breast-feeding should be avoided during apomorphine HCl therapy.
Interactions Patients should be monitored for potential interactions during initial stages of apomorphine therapy. Particular caution should be given when apomorphine is used with other medications that have a narrow therapeutic window. It should be noted that there is potential for interaction with neuroleptic and antihypertensive agents. It is recommended to avoid the administration of apomorphine with other drugs known to prolong the QT interval. Apomorphine can increase the antihypertensive effects of domperidone.
Precautions Use with caution in patients with renal, pulmonary or cardiovascular disease, or who are prone to nausea or vomiting. Extra caution is recommended during initiation of therapy in elderly. and/or debilitated patients. Since apomorphine may produce hypotension, care should be exercised in patients with cardiac disease or who are taking vasoactive drugs, particularly when pre-existing postural hypotension is present. Neuropsychiatric disturbances are common in Parkinsonian patients. APO-go should be used with special caution in these patients. Apomorphine has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson’s disease. Patients must be informed of this and advised to exercise caution whilst driving or operating machines during treatment with apomorphine. Haematology tests should be undertaken at regular intervals as with levodopa with given concomitantly with apomorphine. Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including apomorphine. Dose reduction/tapered discontinuation should be considered if such symptoms develop. Since apomorphine, especially at high dose, may have the potential for QT prolongation, caution should be exercised when treating patients at risk for torsades de pointes arrhythmia. Apomorphine has been associated with local subcutaneous effects that can be reduced by rotation of injection sites or use of ultrasound on areas of nodularity and induration. Contains sodium metabisulphite which rarely causes severe allergic reactions and broncospasm.
Side Effects Local induration and nodules (usually asymptomatic) often develop at subcutaneous site of injection leading to areas of erythema, tenderness, induration and panniculitus. Irritation, itching, bruising and pain may also occur. Rarely injection site necrosis and ulceration have been reported. Pruritus may occur at the site of injection. Drug-induced dyskinesias during “on” periods can be severe, and in a few patients may result in cessation of therapy. Postural hypotension is seen infrequently and is usually intransient. Transient sedation following each dose of apomorphine may occur at the start of therapy, but this usually resolves after a few weeks of treatment. Dizziness and light-headedness have also been reported. Nausea and vomiting may occur, particularly when APO-go treatment is initiated, usually as a result of the omission of domperidone. Neuropyschiatric disturbances (including transient mild confusion and visual hallucinations) have occurred during apomorphine therapy and neuropsychiatric disturbances may be exacerbated by apomorphine. Positive Coombs’ tests and haemolytic anaemia and thrombocytopenia have been reported in patients receiving apomorphine and levodopa. Local and generalised rashes have been reported. Eosinophilia has occurred in only a few patients during treatment with apomorphine HCl. Patients treated with dopamine agonists, including apomorphine, have been reported as exhibiting signs of pathological gambling, increased libido and hypersexuality (especially at high doses). Apomorphine is associated with somnolence. Yawning and breathing difficulties have been reported as has peripheral oedema.
Prescribers should consult the Summary of Product Characteristics in relation to other side effects
Presentation and Basic NHS Cost APO-go ampoules contain apomorphine hydrochloride 10mg/ml, as follows: 20mg in 2ml – basic NHS cost £37.96 per carton of 5 ampoules. 50mg in 5ml – basic NHS cost £73.11 per carton of 5 ampoules. APO-go pens (disposable multiple dosage injector system) contain apomorphine hydrochloride 10mg/ml, as follows: 30mg in 3ml – basic NHS cost £123.91 per carton of 5 pens. APO-go Pre-filled syringes contain apomorphine hydrochloride 5mg/ml, as follows: 50mg in 10ml – basic NHS cost £73.11 per carton of 5 syringes.
Marketing Authorisation Numbers:
APO-go Ampoules: PL 06831/0245
APO-go Pens: PL 06831/0246
APO-go Pre filled syringes: PL 06831/0247
Legal Category POM
Date of last revision: September 2014
For further information please contact: Genus Pharmaceuticals, Park View House, 65 London Road, Newbury, Berkshire, RG14 1JN, UK
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Medical Information on 0870 851 0207 or dso@genuspharma.com
Version Number: APG.PI.V21