MOVAPO

What it is

MOVAPO PFS is a solution for injection in pre-filled syringe containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL. It is a clear solution, practically colourless, odourless and practically free from visible particles. Apomorphine is a directly acting dopamine receptor agonist, structurally related to dopamine. MOVAPO PFS is a pre-diluted pre-filled syringe intended for use as a continuous subcutaneous infusion with suitable pumps or syringe drivers.

Approved indications

— Reduce the number and severity of 'off' phases in patients with Parkinson's disease severely disabled by motor fluctuations refractory to conventional therapy.

Dosing overview

The optimal dosage of MOVAPO PFS has to be determined on an individual patient basis. Infusion rates can be commenced at 1 mg per hour, and then increased as necessary, with the maximum daily dose in general not exceeding 200 mg per day. In clinical studies the required infusion rate varies between 1.25 and 5.5 mg per hour, with most patients requiring between 2 and 4 mg per hour. Infusions should be run for waking hours only, and unless the patient is experiencing night time problems, 24 hour infusions are not advised.

Key safety warnings

It is essential that the patient is established on the antiemetic domperidone for at least 48–72 hours prior to initiation of therapy. MOVAPO PFS must not be used via the intravenous route. Since apomorphine may produce hypotension, even when given with domperidone pre-treatment, care should be exercised in patients with pre-existing cardiac disease or in patients taking vasoactive medicinal products such as anti-hypertensives, and especially in patients with pre-existing postural hypotension. Since apomorphine, especially at high doses, may have the potential for QT prolongation, caution should be exercised when treating patients at risk for Torsades de pointes arrhythmia, and when used in combination with domperidone, risk factors in the individual patient should be carefully assessed before treatment initiation and during treatment. Apomorphine has been associated with somnolence and episodes of sudden sleep onset, particularly in patients with Parkinson's disease, and patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with apomorphine. The use of apomorphine in conjunction with levodopa treatment may cause Coombs' positive haemolytic anaemia, and an initial screen prior to commencement of treatment and at 6 monthly intervals is recommended. Patients should be regularly monitored for the development of impulse control disorders, and patients and carers should be made aware that behavioural symptoms 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.

Contraindications

MOVAPO PFS is contraindicated in patients with a known hypersensitivity or allergy to apomorphine, morphine or chemically related products. MOVAPO PFS should not be administered to patients with pre-existing neuropsychiatric problems or dementias due to either pathological processes such as Alzheimer's disease, or to patients whose 'on' response to L-dopa is marred by severe dyskinesia, hypotonía or psychotoxicity. MOVAPO PFS is also contraindicated in patients with inadequate renal or liver function, unstable coronary vascular disease, cerebrovascular disease, respiratory depression or CNS depression. MOVAPO PFS is contraindicated for children and adolescents under 18 years of age. MOVAPO PFS is contraindicated in patients with a known hypersensitivity to sodium metabisulfite. Concomitant use with 5HT3 antagonists including antiemetics (for example ondansetron, granisetron, palonosetron) is contraindicated.

PBS listing

The solution for subcutaneous infusion containing apomorphine hydrochloride hemihydrate 50 mg in 10 mL pre-filled syringe is listed on the PBS with 4 items under streamlined authority required restriction, with an ex-manufacturer price of A$222.70 as of the latest schedule on 2026-05-01.

Regulatory history

MOVAPO PFS (apomorphine hydrochloride hemihydrate 50 mg per 10 mL solution for subcutaneous infusion pre-filled syringe) was first registered on the ARTG on 2008-08-08. The PBAC recommended PBS listing in July 2016 under authority required streamlined restriction as part of the Highly Specialised Drugs Program for treatment of motor fluctuations associated with Parkinson disease. In March 2020, the PBAC recommended expanding the listing to include a general schedule for patients requiring maintenance treatment of Parkinson disease.