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  • Apo-Go
    / Salomon, Levin & Elstein Ltd


    Active Ingredient
    Apomorphine HCl 10 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Ampoule

    5 x 20 mg / 2 ml

    partial basket chart 63825

    Ampoule

    5 X 50 mg / 5 ml

    partial basket chart 63826 1961

    Pre-filled Pen

    5 x 3 ml

    partial basket chart 65941 9800

    Related information


    Dosage

    Selection of Patients Suitable for APO-go injections: Patients selected for treatment with APO-go should be able to recognise the onset of their ‘off’ symptoms and be capable of injecting themselves or else have a responsible carer able to inject for them when required. It is essential that the patient is established on domperidone, usually 20 mg three times daily for at least two days prior to initiation of therapy. 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). The patient’s treatment with levodopa, with or without dopamine agonists, should be optimised before starting APO-go treatment.
    Adults:
    Administration:
    APO-go Ampoules 10 mg/ml Solution for Injection or infusion is for subcutaneous use by intermittent bolus injection. APO-go ampoules 10 mg/ml Solution for Injection or infusion may also be administered as a continuous subcutaneous infusion by minipump and/or syringe-driver. Apomorphine must not be used via the intravenous route. 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.
    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.
    Establishment of treatment:
    Once the appropriate dose is determined a single subcutaneous injection may be given into the lower abdomen or outer thigh at the first signs of an ‘off’ episode. It cannot be excluded that absorption may differ with different injection sites within a single individual. Accordingly, the patients should then be observed for the next hour to assess the quality of their response to treatment. Alterations in dosage may be made according to the patient’s response. The optimal dosage of apomorphine hydrochloride varies between 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 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, and as directed by their physician. A reduction in dosage of other dopamine agonists may be considered during continuous infusion.
    Children and adolescents: APO-go Ampoules 10 mg/ml Solution for Injection or infusion is contraindicated for children and adolescents under 18 years of age.
    Elderly: The elderly are well represented in the population of patients with Parkinson’s disease and constitute a high proportion of those studied in clinical trials of APO-go. The management of elderly patients treated with APO-go has not differed from that of younger patients. However, extra caution is recommended during initiation of therapy in elderly patients because of the risk of postural hypotension.
    Renal impairment: A dose schedule similar to that recommended for adults, and the elderly, can be followed for patients with renal impairment.


    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.


    Contra-Indications

    In patients with respiratory depression, dementia, psychotic diseases 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. APO-go should not be administered to patients who have a known hypersensitivity to apomorphine or any excipients of the medicinal product. APO-go is contraindicated for children and adolescents under 18 years of age.


    Special Precautions

    Apomorphine HCl should be given with caution to patients with renal, pulmonary or cardiovascular disease and persons prone to nausea and vomiting. Extra caution is recommended during initiation of therapy in elderly and/or debilitated patients. Since apomorphine may produce hypotension, even when given with domperidone pretreatment, care should be exercised in patients with preexisting cardiac disease or in patients taking vasoactive medicinal products such as antihypertensives, and especially in patients with pre-existing postural hypotension. 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 is associated with local subcutaneous effects. These can sometimes be reduced by the rotation of injection sites or possibly by the use of ultrasound (if available) to areas of nodularity and induration. Haemolytic anaemia has been reported in patients treated with levodopa and apomorphine. Haematology tests should be undertaken at regular intervals as with levodopa when given concomitantly with apomorphine. Caution is advised when combining apomorphine with other medicinal products, especially those with a narrow therapeutic range. Neuropsychiatric problems co-exist in many patients with advanced Parkinson’s disease. There is evidence that for some patients neuropsychiatric disturbances may be exacerbated by apomorphine. Special care should be exercised when apomorphine is used in these patients.Apomorphine has been associated with somnolence, and other dopamine agonists can be associated with sudden sleep onset episodes, particularly in patients with Parkinson’s disease. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with apomorphine. Patients who have experienced somnolence must refrain from driving or operating machines. Furthermore a reduction of dosage or termination of therapy may be considered. Impulse control disorders 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. APO-go Ampoules 10mg/ml Solution for Injection or infusion contains sodium metabisulphite which may rarely cause severe allergic reactions and bronchospasm. This medicinal product contains less than 1 mmol sodium (23mg) per 10ml, i.e. essentially “sodium-free”.


    Side Effects

    Psychiatric disorders: Common: Neuropsychiatric disturbances are common in parkinsonian patients. APO-go should be used with special caution in these patients. Neuropsychiatric disturbances (including transient mild confusion and visual hallucinations) have occurred during apomorphine HCl therapy.
    Nervous system disorders: Common: Transient sedation with each dose of apomorphine HCl at the start of therapy may occur; this usually resolves over the first few weeks. Apomorphine is associated with somnolence. Dizziness / light-headedness have also been reported.
    Respiratory, thoracic and mediastinal disorders: Common: Yawning has been reported during apomorphine therapy.
    Gastrointestinal disorders: Common: Nausea and vomiting, particularly when apomorphine treatment is first initiated, usually as a result of the omission of domperidone.
    General disorders and administration site conditions: Very common: Most patients experience injection site reactions, particularly with continuous use. These may include subcutaneous nodules, induration, erythema, tenderness and panniculitis. Various other local reactions (such as irritation, itching, bruising and pain) may also occur.
    For full details see prescribing information.


    Drug interactions

    Patients selected for treatment with apomorphine HCl are almost certain to be taking concomitant medications for their Parkinson’s disease. In the initial stages of apomorphine HCl therapy the patient should be monitored for unusual side-effects or signs of potentiation of effect. Neuroleptic medicinal products may have an antagonistic effect if used with apomorphine. There is a potential interaction between clozapine and apomorphine, however clozapine may also be used to reduce the symptoms of neuropsychiatric complications. If neuroleptic medicinal products have to be used in patients with Parkinson’s disease treated by dopamine agonists, a gradual reduction in apomorphine dose may be considered when administration is by minipump and/or syringedriver (symptoms suggestive of neuroleptic malignant syndrome have been reported rarely with abrupt withdrawal of dopaminergic therapy). The possible effects of apomorphine on the plasma concentrations of other drugs have not been studied. Therefore caution is advised when combining apomorphine with other medicinal products, especially those with a narrow therapeutic range. Antihypertensive and Cardiac Active Medicinal Drugs Even when co-administered with domperidone, apomorphine may potentiate the antihypertensive effects of these drugs. It is recommended to avoid the administration of apomorphine with other drugs known to prolong the QT interval.


    Pregnancy and Lactation

    There is no experience of apomorphine usage in pregnant women. Animal reproduction studies do not indicate any teratogenic effects, but doses given to rats which are toxic to the mother can lead to failure to breathe in the newborn. The potential risk for humans is unknown. APO-go should not be used in pregnancy unless clearly necessary. It is not known whether apomorphine is excreted in breast milk. A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with APO-go should be made taking into account the benefit of breastfeeding to the child and the benefit to APO-go to the woman.


    Overdose

    There is little clinical experience of overdose with apomorphine by this route of administration. Symptoms of overdose may be treated empirically as suggested below: Excessive emesis may be treated with domperidone. Respiratory depression may be treated with naloxone. Hypotension: appropriate measures should be taken, e.g. raising the foot of the bed. Bradycardia may be treated with atropine.


    Manufacturer
    Britannia Pharmaceuticals Limited. UK
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