SUMMARY CMI

MOVAPO^® and MOVAPO^® PFS

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using MOVAPO or MOVAPO PFS?

MOVAPO or MOVAPO PFS contains the active ingredient apomorphine hydrochloride hemihydrate. MOVAPO and MOVAPO PFS are used in the treatment of Parkinson's disease to reduce the number and severity of bouts of freezing and stiffness (or “off” periods).

For more information, see Section 1. Why am I using MOVAPO or MOVAPO PFS? in the full CMI.

2. What should I know before I use MOVAPO or MOVAPO PFS?

Do not use if you have ever had an allergic reaction to apomorphine hydrochloride hemihydrate, sodium metabisulfite or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use MOVAPO or MOVAPO PFS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with MOVAPO or MOVAPO PFS and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use MOVAPO or MOVAPO PFS?

• Your doctor will tell you how much to use.
• MOVAPO and MOVAPO PFS are designed for injection under the skin (subcutaneous).
• You will be trained to recognise when and how to inject. Follow the instructions given by your doctor or pharmacist.

More instructions can be found in Section 4. How do I use MOVAPO and MOVAPO PFS? in the full CMI.

5. What should I know while using MOVAPO or MOVAPO PFS?

For more information, see Section 5. What should I know while using MOVAPO or MOVAPO PFS? in the full CMI.

6. Are there any side effects?

Like all medicines, this medicine can cause side effects, although not everybody gets them. Some side effects can be serious and you need to know what symptoms to look out for. MOVAPO and MOVAPO PFS can cause allergic reactions which may be very serious. If you develop symptoms of allergic reaction, you may need urgent medical attention or hospitalisation.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

MOVAPO^® and MOVAPO^® PFS

Active ingredient(s): apomorphine (a-poe-MOR-feen) hydrochloride hemihydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using MOVAPO and MOVAPO Pre-Filled Syringe (PFS).

You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using MOVAPO and MOVAPO PFS.

Where to find information in this leaflet:

1. Why am I using MOVAPO or MOVAPO PFS?
2. What should I know before I use MOVAPO or MOVAPO PFS?
3. What if I am taking other medicines?
4. How do I use MOVAPO or MOVAPO PFS?
5. What should I know while using MOVAPO or MOVAPO PFS?
6. Are there any side effects?
7. Product details

1. Why am I using MOVAPO or MOVAPO PFS?

MOVAPO and MOVAPO PFS contains the active ingredient apomorphine hydrochloride hemihydrate. Apomorphine belongs to a group of medicines called dopaminergic compounds.

Apomorphine is used in the treatment of Parkinson's disease to reduce the number and severity of bouts of freezing and stiffness (or “off” periods). This medicine works by acting on dopamine receptors. These receptors help control movement by the body.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

This medicine is not addictive.

2. What should I know before I use MOVAPO or MOVAPO PFS?

Warnings

Do not use MOVAPO or MOVAPO PFS if you have an allergy to:

• any medicine containing apomorphine or sodium metabisulfite
• any of the ingredients listed at the end of this leaflet
• certain types of pain killers such as morphine or other opioid analgesics

Some symptoms of allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin.

Always check the ingredients to make sure you can use this medicine.

Do not use MOVAPO or MOVAPO PFS if you have or have had any of the following medical conditions:

• Certain forms of dementia, e.g. Alzheimer's Disease
• Severe kidney or liver disease
• Problems with circulation of blood in the brain (cerebrovascular disease)
• Breathing problems (respiratory depression)

Do not use MOVAPO or MOVAPO PFS if:

• the packaging is torn or shows signs of tampering
• the expiry date printed on the pack has passed
• the solution has turned greed or if the solution is cloudy or you can see particles in it.

Check with your doctor if you:

• have allergies to any other medicines, foods, preservatives or dyes
• you have or have had any of the following medical conditions:
  - a history of nausea and vomiting
  - heart disease
  - kidney disease
  - liver disease
  - lung disease
  - problem gambling
  - any addictive behaviour (e.g. sex, shopping or eating)

Before you use MOVAPO or MOVAPO PFS, your doctor will obtain an ECG (electrocardiogram) and will ask for a list of all medicines you take. This ECG will be repeated in the first days of your treatment and at any point if your doctor thinks this is needed. Your doctor will also ask you about other diseases you have, in particular concerning your heart. Some questions and investigations may be repeated at each medical visit. If you experience symptoms which may come from the heart, e.g. palpitations, fainting or near-fainting, you should report this to your doctor immediately. Also, if you experience diarrhoea or start a new medication, this should be reported to your doctor too.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Children and adolescents

MOVAPO and MOVAPO PFS should not be used in children and adolescents under the age of 18 years.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with MOVAPO or MOVAPO PFS and affect how it works.

These include:

• tetrabenazine, a medicine used to treat movement disorders
• metoclopramide, a medicine used to treat nausea
• medicines used to treat some psychiatric (mental) conditions (e.g. phenothiazines, haloperidol, flupenthixol)
• papaverine, a medicine which expands blood vessels
• amphetamines
• ondansetron, a medicine used to treat nausea and vomiting. This may result in a severe drop in blood pressure or loss of consciousness.

MOVAPO and MOVAPO PFS may affect these medicines and how well they work. You may need different amounts of your medicines, or different medicines.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect MOVAPO or MOVAPO PFS.

4. How do I use MOVAPO and MOVAPO PFS?

How much to use

• Your doctor will tell you what dose to use. This depends on your initial response to MOVAPO or MOVAPO PFS.
• Follow the instructions provided and use MOVAPO or MOVAPO PFS until your doctor tells you to stop.

When to use MOVAPO or MOVAPO PFS

• You and/or your carer will be trained by hospital staff to recognise when to use MOVAPO or MOVAPO PFS.

How to use MOVAPO or MOVAPO PFS

You will usually be in hospital when you start using this medicine. It is recommended you are given an anti-nausea drug (domperidone) for a few days, and that you will temporarily stop all other anti-Parkinsonian medication so that the correct dose of MOVAPO or MOVAPO PFS can be determined.

• MOVAPO and MOVAPO PFS is to be given as an injection under the skin (subcutaneously), usually in your lower abdomen or outer thigh. MOVAPO is either injected several times a day (intermittent injection) or continuously as an infusion (i.e. slow injection via a pump). MOVAPO PFS is injected continuously as an infusion.
• You and/or your carer will be trained by hospital staff on how to give the injections. If you do not understand the instructions, ask your doctor, nurse or pharmacist to help.
• It is advisable to change the site of injection every time you insert the needle to avoid getting lumps under the skin.
• When using MOVAPO ampoules for continuous infusion, it is recommended that MOVAPO is first diluted with an equal volume of sodium chloride 0.9% (normal saline).
• When using MOVAPO ampoules for intermittent injections, there is no need to dilute prior to use.
• When using MOVAPO PFS for continuous infusion, there is no need to dilute prior to use.
• This medicine is for individual patient use only.

If you use too much MOVAPO or MOVAPO PFS

If you think that you have used too much MOVAPO or MOVAPO PFS, you may need urgent medical attention. Symptoms of overdose may include severe nausea and vomiting, slow or troubled breathing, restlessness, hallucinations or unconsciousness.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using MOVAPO or MOVAPO PFS?

Things you should do

• If you plan to have surgery, tell the surgeon or anaesthetist you are taking this medicine. It may affect any medicines used during surgery.
• Keep all your doctor's appointments so that your progress can be checked.

Call your doctor straight away if you:

• are about to start on any new medication
• become pregnant
• have any symptoms which may come from your heart, e.g. palpitations, fainting, or near-fainting
• experience diarrhoea

Remind any doctor, dentist or pharmacist you visit that you are using MOVAPO or MOVAPO PFS.

Things you should not do

• Do not use MOVAPO or MOVAPO PFS to treat any other complaints unless your doctor tells you to.
• Do not give this medicine to anyone else, even if they have the same condition as you.
• Do not stop MOVAPO or MOVAPO PFS abruptly or change the dose, without speaking to your doctor to discuss a taper treatment plan.
• It is important not to suddenly stop taking your MOVAPO or MOVAPO PFS, unless advised to do so by your doctor. If you stop taking it suddenly, your condition may worsen, or you may have unwanted side effects. The dose will normally be reduced gradually over several days.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how MOVAPO or MOVAPO PFS affects you.

MOVAPO or MOVAPO PFS may cause drowsiness, sudden onset of sleepiness, dizziness or light-headedness in some people. If you have any of these symptoms do not drive, operate machinery or do anything else that could be dangerous.

Looking after your medicine

Store MOVAPO and MOVAPO PFS below 25°C.

• Do not freeze.
• Keep in the original carton to protect from light.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

This medicine is for single use only. Once opened, the contents of the ampoule or pre-filled syringe should be used immediately. Discard any unused solution.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Very serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What MOVAPO and MOVAPO PFS contains

Do not take this medicine if you are allergic to any of these ingredients.

What MOVAPO and MOVAPO PFS look like

MOVAPO 50 mg/5 mL is a clear, colourless, sterile solution, supplied in a box of 5 ampoules (AUST R 142093).

MOVAPO PFS 50 mg/10 mL is a clear, colourless, sterile solution, is supplied in a box of 5 pre-filled syringes (AUST R 129948).

Who distributes MOVAPO and MOVAPO PFS

In Australia:

STADA Pharmaceuticals Australia Pty Ltd
Suite 2.04, 26 Rodborough Road
Frenchs Forest NSW 2086
Australia
www.stada.com.au

In New Zealand:

CARSL Consulting
Clinical and Regulatory Services
24 Side Road, Parkhill Farm, RD10, Hastings
PO Box 766 Hastings
New Zealand

MOVAPO^® is a registered trademark of Britannia Pharmaceuticals Limited.

This leaflet was prepared in January 2024.

Published by MIMS March 2024

1 Name of Medicine

Apomorphine hydrochloride hemihydrate.

2 Qualitative and Quantitative Composition

Each 10 mL prefilled syringe contains 50 mg apomorphine hydrochloride hemihydrate.
Sodium metabisulfite is included in the formulation as an antioxidant.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection in prefilled syringe.
Movapo Pre-Filled Syringe (PFS) is a clear solution, practically colourless, odourless and practically free from visible particles.

4 Clinical Particulars

4.1 Therapeutic Indications

Movapo PFS is indicated to reduce the number and severity of 'off' phases in patients with Parkinson's disease severely disabled by motor fluctuations refractory to conventional therapy. Initiation of therapy with apomorphine should be undertaken in a specialist unit in a hospital setting. Conventional therapy should be continued during 'on' phases.

4.2 Dose and Method of Administration

The optimal dosage of Movapo PFS has to be determined on an individual patient basis. Hospital admission under appropriate specialist supervision is advised when establishing a patient's therapeutic regime.
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 is a pre-diluted prefilled syringe intended for use as a continuous subcutaneous infusion with suitable pumps/syringe drivers.
There is no need to dilute Movapo PFS prior to use.
Movapo PFS is for single use in one patient only. Contains no antimicrobial agent. For microbial reasons, once opened the contents of the prefilled syringe should be used for infusion immediately. The infusion site should be changed every 12 hours. Any unused solution should be discarded.
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.
Movapo PFS must not be used via the intravenous route.

Patient selection.

Pre-treatment.

After provoking an 'off' phase in motor performance.

Determination of the threshold dose.

Initiation of treatment.

Monitoring treatment.

4.3 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, e.g. Alzheimer's disease, or to patients whose 'on' response to L-dopa is marred by severe dyskinesia, hypotonia 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 (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

4.4 Special Warnings and Precautions for Use

For subcutaneous use only (see Section 4.8 Adverse Effects (Undesirable Effects)).
Patients sensitive to morphine or its derivatives may be sensitive to Movapo PFS. Movapo PFS should therefore not be administered to patients with a known hypersensitivity or allergy to apomorphine, morphine or chemically related compounds (see Section 4.3 Contraindications).
Movapo PFS contains sodium metabisulfite which may cause allergic type reactions, including anaphylactic symptoms and life threatening or less severe asthmatic episodes in susceptible people (see Section 4.3 Contraindications).
In patients with cardiac decompensation or cerebrovascular disease, vomiting may cause an increase in blood pressure that may lead to haemorrhage and vascular accidents. Apomorphine is therefore contraindicated in these patients (see Section 4.3 Contraindications).
Caution should be used in administering Movapo PFS to patients with a predisposition to nausea and vomiting. Apomorphine may cause an increased risk of persistent vomiting. A risk-benefit assessment should be considered in these patients.
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.
When used in combination with domperidone, risk factors in the individual patient should be carefully assessed. This should be done before treatment initiation, and during treatment. Important risk factors include serious underlying heart conditions such as congestive cardiac failure, severe hepatic impairment or significant electrolyte disturbance. Also medication possibly affecting electrolyte balance, CYP3A4 metabolism or QT interval should be assessed.
Monitoring for an effect on the QTc interval is advisable. An ECG should be performed:
prior to treatment with domperidone;
during the treatment initiation phase;
as clinically indicated thereafter.
The patient should be instructed to report possible cardiac symptoms including palpitations, syncope, or near-syncope. They should also report clinical changes that could lead to hypokalaemia, such as gastroenteritis or the initiation of diuretic therapy. At each medical visit, risk factors should be revisited.
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) in order to avoid areas of nodularity and induration (see Section 4.8 Adverse Effects (Undesirable Effects)).
Haemolytic anaemia and thrombocytopenia have been reported in patients treated with 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 (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
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 episodes of sudden sleep onset, 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 and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore a reduction of dosage or termination of therapy may be considered.
The use of apomorphine in conjunction with levodopa treatment may cause Coombs' positive haemolytic anaemia. An initial screen prior to commencement of treatment and at 6 monthly intervals is recommended. In the event of the development of a haemolytic anaemia, a haematological specialist should be consulted. The dose of apomorphine and/or levodopa should be reduced, with careful monitoring of the patient's motor state. It may be necessary to discontinue treatment with levodopa and/or apomorphine in the event that it is not possible to control the anaemia satisfactorily.
Apomorphine should be used with caution in patients with endocrine, renal, pulmonary or cardiovascular disease.
Periodic evaluation of hepatic, haemopoietic, renal and cardiovascular function is advised.
Patients with severe renal insufficiency may require the dosing interval for domperidone to be less frequent (see Section 4.2 Dose and Method of Administration, Pre-treatment).

Neuroleptic malignant syndrome.

Dopamine agonist withdrawal syndrome.

Impulse control disorders.

Use in debilitated patients.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Patients selected for treatment with apomorphine are almost certain to be taking concomitant medications for their Parkinson's disease. In the initial stages of apomorphine therapy the patient should be monitored for unusual side-effects or signs of potentiation of effect.
Drugs which interfere with central amine mechanisms such as tetrabenazine, metoclopramide, antipsychotic dopamine blocking agents (such as phenothiazines, thioxanthenes and butyrophenones), amphetamines and papaverine should be avoided. If their administration is considered essential, extreme care should be taken and the patient monitored for signs of potentiation, antagonism or other interactions and for any unusual adverse effects.
Neuroleptic medicinal products may have an antagonistic effect if used with apomorphine. There is a potential interaction between clozapine and apomorphine.
The possible side effects of apomorphine on the plasma concentrations of other medicinal products have not yet been studied. Therefore caution is advised when combining apomorphine with other medicinal products, especially those with a narrow therapeutic range.
Based on reports of profound hypotension and loss of consciousness when apomorphine was administered with ondansetron, the concomitant use of apomorphine with 5HT₃ antagonists including antiemetics (for example ondansetron, granisetron, palonosetron) is contraindicated (see Section 4.3 Contraindications).

Antihypertensive and cardiac active medicinal drugs.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Apomorphine has varying degrees of impairment which influences the ability to drive and use machines.
Patients being treated with apomorphine and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities (e.g. operating machines) where impaired alertness may put themselves or others at risk of serious injury or death until such recurrent episodes and somnolence have resolved (also see Section 4.4 Special Warnings and Precautions for Use).

4.8 Adverse Effects (Undesirable Effects)

Very common (> 10%).

Common (1-10%).

Uncommon (0.1-1%).

Rare (0.01-0.1%).

Not known (can not be estimated from available data).

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

The peripheral pharmacokinetics of apomorphine have been studied following subcutaneous injection, subcutaneous infusion and intravenous infusion.

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium metabisulfite.
Water for injections.
Hydrochloric acid may also be included in the formulation to adjust the pH. The pH of the injection is 3.0 to 4.0.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
For microbial reasons, once opened the contents of the pre-filled syringe should be used for infusion immediately. Any unused solution should be discarded.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light. (Keep the container in the outer carton).

6.5 Nature and Contents of Container

Clear glass (Type 1) pre-filled syringe with a chlorobutyl rubber stopper and tip.
Packs contain 5 x 10 mL (5 mg/ mL) pre-filled syringes.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements. After single use, adaptors and plastic syringes should also be discarded and disposed of in a "Sharps" bin.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes