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APO-GO PEN

Information leaflet

                                                   Irish Medicines Board




                                 Summary of Product Characteristics
 1 NAME OF THE MEDICINAL PRODUCT

 APO-go PEN 10 mg/ml Solution for Injection

 2 QUALITATIVE AND QUANTITATIVE COMPOSITION

 1ml contains 10mg apomorphine hydrochloride

 Excipients: Also contains sodium bisulphite 0.93 mg per ml.

 For a full list of excipients see section 6.1

 3 PHARMACEUTICAL FORM

 Solution for injection.

 Solution is clear and colourless.

 4 CLINICAL PARTICULARS

 4.1 Therapeutic 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.

 4.2 Posology and method of administration

 APO-go Pen 10 mg/ml Solution for Injection is for subcutaneous use by intermittent bolus injection. See section 4.4

 Dosage

 Adults

 Administration

 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 treatment 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.




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Date Printed 13/03/2012                               CRN 2105137                                         page number: 1
                                                     Irish Medicines Board




 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 (0.1 ml), 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 (0.2 ml) 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 patient 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 3-30mg, 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.

 Children and adolescents:
 APO-go Pen 10mg/ml Solution for Injection is contra-indicated for children and adolescents under 18 years of age (see
 section 4.3 Contraindications).

 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.

 Renal impairment:
 A dose schedule similar to that recommended for adults, and the elderly, can be followed for patients with renal
 impairment (see section 4.4 Special warnings and precautions for use).

 4.3 Contraindications

 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.




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Date Printed 13/03/2012                               CRN 2105137                                         page number: 2
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