Apomorphine Hydrochloride

PRODUCT: APO-go Ampoules 10 mg/mL solution for injection or infusion (UK SPC). THRESHOLD DOSE DETERMINATION: 1 mg apomorphine HCl (0.1 mL) injected subcutaneously during a hypokinetic or 'off' period, with the patient observed over 30 minutes for a motor response; if no or inadequate response, a second dose of 2 mg (0.2 mL) subcutaneously with a further 30 minutes' observation; the dose may then be increased by incremental injections with at least a forty minute interval between succeeding injections until a satisfactory motor response is obtained. Once the appropriate dose is determined, the patient should be observed for the next hour to assess the quality of response; absorption may differ with different injection sites within an individual. CONTINUOUS SUBCUTANEOUS INFUSION (for patients with a good 'on' response during initiation but unsatisfactory overall control on intermittent injections, or requiring more than 10 injections per day): start at a rate of 1 mg apomorphine HCl (0.1 mL) per hour, then increase according to 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 has severe night-time problems, 24 hour infusions are not advised, and an overnight period without treatment of at least 4 hours appears to prevent tolerance. The infusion site should be changed every 12 hours. Patients may supplement continuous infusion with intermittent bolus boosts as directed by their physician, and a reduction in the dosage of other dopamine agonists may be considered. INITIATION: apomorphine should be initiated in the controlled environment of a specialist clinic, with the patient supervised by a physician experienced in the treatment of Parkinson's disease (e.g. a neurologist); levodopa treatment, with or without dopamine agonists, should be optimised first. Patients must be able to recognise the onset of their 'off' symptoms and be capable of injecting themselves, or have a responsible carer able to inject for them. DOMPERIDONE: patients treated with apomorphine will usually need to start domperidone at least two days prior to initiation, titrated to the lowest effective dose and discontinued as soon as possible; QT-prolongation risk factors must be assessed before initiating domperidone and apomorphine. Once treatment is established, domperidone may be gradually reduced in some patients but is successfully eliminated only in a few. It has usually been possible to make some reduction in the dose of levodopa. ELDERLY: management has not differed from that of younger patients, but extra caution is recommended during initiation because of the risk of postural hypotension. PAEDIATRIC: this product is contraindicated for children and adolescents under 18 years of age. INTERACTIONS CAVEAT: SPC section 4.5 was not included in this source bundle - the interaction entries below are taken from the statements made in sections 4.3 and 4.4 only, and section 4.5 should be reviewed in full.