Modified Release Aqueous Suspension for Intramuscular Injection
Consumer Medicine Information (CMI)
What is in this leaflet
This leaflet answers some of the common questions about Invega Sustenna. It does
not contain all of the available information. It does not take the place of talking
to your doctor or pharmacist.
If you have any concerns about using Invega Sustenna, ask your doctor or pharmacist.
Your doctor and pharmacist have more information.
Keep this information handy.
You can refer to it later if you have any questions.
What Invega Sustenna is used for
Invega Sustenna belongs to a group of medicines called antipsychotic agents which
improve the symptoms of certain types of mental illness.
It is used to treat symptoms of schizophrenia, a mental illness with disturbances
in thinking, feelings and behaviour. Invega Sustenna helps to correct a chemical imbalance
in the brain associated with this condition. It can also be used to lessen the chance
of your schizophrenia symptoms from coming back.
Some of the most common symptoms of schizophrenia may include:
Seeing, hearing, or sensing things that are not there (hallucinations)
Believing that what other people say is not true (delusions)
Not trusting others and feeling very suspicious (paranoia)
Avoiding family and friends and wanting to be alone
It may take some time before your symptoms of schizophrenia start to improve. Remember
that Invega Sustenna is one part of your overall treatment plan. It is important to
keep all your appointments, so you can get your treatments on time and your doctor
can check your progress.
Your doctor, however, may prescribe this medicine for another use.
Ask your doctor if you have any questions about why it has been prescribed to you.
Before you take it
When you must not use it
Do not use Invega Sustenna if you know you are allergic to any of its ingredients
listed at the end of this leaflet or medicines containing paliperidone (e.g. Invega)
or risperidone (e.g. Risperdal).
Signs of allergy may include skin rash, itching, shortness of breath, and/or swollen
face or tongue.
Do not use it after the expiry date printed on the pack.
If you use it after the expiry date has passed, it may not work as well.
Do not use it if the packaging is torn or shows signs of being tampered with.
Do not use it to treat any other complaints unless your doctor says it is safe to
Before you start to use it
Invega Sustenna should be used with caution in some people, particularly those who
have been diagnosed with more than one medical condition.
1. Before you start using Invega Sustenna, make sure you tell your doctor if you have
or have ever had, the following:
Neuroleptic Malignant Syndrome (a serious reaction to some medicines that causes a
sudden increase in body temperature, very fast heartbeat, extremely high or low blood
pressure and severe muscle stiffness or fits)
Tardive dyskinesia (a reaction to some medicines with involuntary movements of the
tongue, face, mouth, jaws, arms, legs or trunk)
Irregular heart rhythm, high or low blood pressure or you've had a heart attack or
stroke in the past
you are prone to dizziness when standing up from a lying or sitting position
unusual, excessive sweating or diarrhoea, dehydration or problems with your body temperature
epilepsy, fits, seizures, or involuntary movements or unusual restlessness
suicidal thoughts or past suicide attempts
inflammation of the lungs due to aspiration (the inhalation of food particles or fluids
into the lungs)
any problems with swallowing, or stomach or intestinal disorders that reduces your
ability to keep food down and/or pass normal bowel movements
kidney or liver problems
any problems with confusion or unsteadiness
dementia or Lewy Body dementia. Older people suffering dementia may be at increased
risk of stroke or death with Invega Sustenna
Parkinson's disease (a progressive movement and thinking disorder that tends to affect
unusual thirst, tiredness, blurred vision, upset stomach or need to urinate - common
signs of high blood sugars
stroke or other brain blood vessel problem
continuous and/or painful erection (called 'priapism')
Tell your doctor if you or someone else in your family has a history of blood clots.
Blood clots in the lungs and legs can occur when using Invega Sustenna. Blood clots
in the lungs can result in death
low white blood cell count
If you have low numbers of some white blood cells, your risk of contracting an infection
or developing a fever is increased with Invega Sustenna.
you have an eye surgery planned.
Your doctor will need to assess whether you are at an increased risk of a surgical
complication (called 'Intraoperative Floppy Iris Syndrome'. You may be recommended
to stop using Invega Sustenna temporarily leading up to your eye surgery.
you are pregnant or are planning to become pregnant.
Your doctor will advise you whether or not you should use Invega Sustenna.
Newborn babies of mothers taking Invega Sustenna in their last trimester may be at
risk of having dissiculty feeding or breathing, shaking, muscle stiffness and/or weakness,
sleepiness or agitation.
you are breast feeding.
As Invega Sustenna is excreted in breast milk, it is recommended that you do not breast-feed
while you use Invega Sustenna.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy
without a prescription from your pharmacy, supermarket or health food shop.
In particular, tell your doctor if you are taking:
sleeping tablets, tranquillisers, pain-killers or come allergy medications called
medicines to treat epilepsy or Parkinson's Disease
medicines to treat depression, panic disorder, anxiety or obsessive-compulsive disorder
any medicines to treat irregular heart rhythms or heart failure
any medicines to treat high blood pressure including water tablets (diuretics)
other medicines to treat mental illnesses or psychotic conditions
medicines that increase the activity of the central nervous system (psychostimulants
such as methylphenidate)
medicines to relieve nausea or vomiting, indigestion, reflux or other stomach problems
some medicines to treat malaria.
You doctor will need to consider whether any of the above medicines will affect your
How is it given
Using it for the first time
Treatment with Invega Sustenna will not be started by your doctor until they know
you have already tolerated oral paliperidone (e.g. Invega) or oral / injectable risperidone
At the start of treatment you may have a fall in blood pressure making you feel dizzy
on standing up, or your heart may beat faster. These should go away after a few days.
Tell your doctor if these symptoms continue or worry you.
How much of it will be given
Your doctor will decide the strength of Invega Sustenna which is suitable for you.
How is it given
Invega Sustenna will be given to you by injection by a healthcare professional. It
is a medicine designed to gradually release into your body so that you do not have
to take this medicine every day.
When you receive your first dose of Invega Sustenna you will need to get a second
dose one week later.
Your doctor may choose to give you this second injection four days before or after
the second scheduled dose is due.
After that you will only need to get a dose once a month. The usual initial dose of
Invega Sustenna is 150 mg and second dose is 100 mg. The usual monthly dose is 75
mg. However, your doctor might decide to give you a lower or higher dose in the range
of 25 mg to 150 mg based on your condition and kidney function.
Your doctor or healthcare provider will give you the injection into the upper arm
or buttocks. You may feel some pain or discomfort, but this may become less over time.
How often it is given
After you have been given the first two doses, it is recommended that Invega Sustenna
is given once every month. However, your doctor may change the dose depending on how
your body responds to the medicine.
How many injections you will need
Invega Sustenna helps control your condition but will not cure it. Therefore, you
will need regular injections. Do not miss any injections, even if you feel better.
What if you miss a dose
It is very important to keep all your appointments and get your medicine on time.
Contact your doctor as soon as you can if you think you are going to miss or have
missed your appointment.
Your doctor will decide what you should do next.
For patients with kidney problems
Invega Sustenna has not been studied in patients whose kidney is not functioning properly.
Your doctor will decide the dose suitable for you.
For patients with mild kidney problems the recommended first dose is 100 mg and second
dose is 75 mg one week later. Thereafter the recommended monthly dose is 50 mg.
Use of Invega Sustenna is not recommended in patients with moderate or severe kidney
Invega Sustenna is not recommended for children under 18 years.
As Invega Sustenna is given to you under the supervision of your doctor, it is very
unlikely that you will receive too much.
However, if you experience any side effects after receiving Invega Sustenna, tell
your doctor immediately or go to Accident and Emergency at your nearest hospital.
You may need urgent medical attention.
While you are using it
Things you must do
Follow your doctor's instructions carefully. Do not miss an injection or stop the
treatment without consulting your doctor first.
Your doctor will be happy to discuss any questions you may have with your treatment.
Tell your doctor if you are pregnant or planning to become pregnant.
Tell your doctor immediately if you notice any involuntary movements of the tongue,
mouth, cheeks or jaw.
These may be symptoms of a condition called tardive dyskinesia, which can develop
in people taking antipsychotic medicines, including Invega Sustenna. This condition
is more likely to occur during longer term treatment and in older women. In very
rare cases, these symptoms may be permanent. However, if detected early, these symptoms
are usually reversible.
Tell any other doctors, dentists, and pharmacists who want to start you on any new
medicines listed under 'Taking other medicines' (above) that you are taking Invega
Your doctor, dentist or pharmacist will need to consider whether any new medicines
will affect your Invega Sustenna.
Things you must not do
Do not miss any injections or any appointments with the doctor.
Do not drink alcohol.
Invega Sustenna can increase the effects of alcohol.
Things to be careful of
Ask your doctor or pharmacist before taking any other medicines.
Invega Sustenna can increase the effects of medicines which slow down your reactions.
Always ask your doctor or pharmacist before taking other medicines including herbal
treatments and medicines that can be bought in a pharmacy or supermarket.
Avoid driving or operating machinery until you are sure that Invega Sustenna does
not affect your alertness.
Invega Sustenna may cause dizziness, drowsiness or light-headedness in some people.
Make sure you know how you react to Invega Sustenna before you drive a car, operate
machinery, or do anything else that could be dangerous if you are dizzy.
If the medicine makes you feel light-headed, dizzy or faint, be careful when getting
up from a sitting or lying position.
Getting up slowly may help.
Avoid excessive eating.
There is a possibility of weight gain when taking Invega Sustenna. Your doctor may
monitor your body weight or recommend strategies to assist with weight management.
All medicines may have some unwanted side effects. Sometimes they are serious, but
most of the time they are not. Your doctor has weighed the risks of using this medicine
against the benefits they expect it will have for you.
All medicines can have side effects. You may need medical treatment if you get some
of the side effects.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor or pharmacist as soon as possible if you do not feel well while you
are taking Invega Sustenna.
It helps most people with symptoms of schizophrenia, but it may have unwanted side
effects in a few people.
Tell your doctor if you notice any of the following and they worry you:
difficulty thinking, working or carrying out your usual daily activities because of:
trembling, muscle weakness, unsteadiness on your feet, lack of coordination or slow,
sleeplessness, drowsiness, tiredness or difficulty in concentrating
pain at injection site
behavioural changes such as:
irritability or agitation
unusual anxiety or depression
unusually elated mood
lack of emotion
joint or movement changes such as:
muscle stiffness or pain, bone or muscle ache
unusual restlessness, repetitive or involuntary movements
unusual facial movements or a sustained upwards stare
other changes such as:
unexplained increased in appetite
"flu-like" symptoms, cough, stuffy nose
urinary tract infection
inability to or pain when passing urine
dry mouth, distorted taste sensation, drooling
hardening of the skin
vomiting, indigestion, heartburn, abdominal pain
breast swelling and/or unusual secretion of breast milk
missed or irregular menstrual periods
difficulty getting or maintaining an erection; or having continuous and/or painful
These are mild side effects of Invega Sustenna but may require medical attention.
Tell your doctor immediately, or go to Accident and Emergency at your nearest hospital
if you notice any of the following:
signs of heart or blood pressure problems including:
fall in blood pressure, blurry vision, light-headedness or dizziness particularly
on standing that persists despite sitting or lying down
very fast heart rate, slowed heart rate, heart rhythm irregularities
body temperature changes such as:
unexplained high body temperature, excessive sweating or rapid breathing
involuntary movements of the tongue, mouth, cheeks or jaw
signs of high blood sugar or diabetes such as unusual thirst, tiredness, upset stomach
or need to urinate more often than usual
These may be serious side effects of Invega Sustenna. You may need urgent medical
Serious side effects are uncommon.
If any of the following happen, stop taking Invega Sustenna and tell your doctor immediately
or go to Accident and Emergency at your nearest hospital:
rash, itching or hives on the skin; shortness of breath, wheezing or difficulty breathing;
swelling of the face, lips, tongue or other parts of the body. If you have them, you
may have had a serious allergic reaction to Invega Sustenna
sudden weakness or numbness of the face, arms, or legs, especially on one side, or
instances of slurred speech (these are called mini-strokes)
involuntary movements of the tongue, face, mouth, jaws, arms, legs or trunk (symptoms
of tardive dyskinesia).
These may be very serious side effects. You may need urgent medical attention or hospitalisation.
Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may occur in some people.
Do not hesitate to report any other side effects to your doctor or pharmacist.
Do not be alarmed by this list of possible side effects.
You may not experience any of them.
After using it
Invega Sustenna will be stored by your doctor or pharmacist. The injection is kept
in a cool dry place, protected from light, where the temperature stays below 25°C.
Your doctor or pharmacist will not use it beyond the expiry date (month and year)
printed on the pack.
Medicines cannot be stored indefinitely, even if stored properly.
What it looks like
Invega Sustenna is available in prefilled syringes which contain different amounts
of paliperidone (as palmitate). The pack also contains safety needles.
The active ingredient in Invega Sustenna is paliperidone (as palmitate).
The prefilled syringes contain either 25 mg, 50 mg, 75 mg, 100 mg or 150 mg of paliperidone
Inactive ingredients are polysorbate 20, polyethylene glycol 4000, citric acid monohydrate,
disodium hydrogen phosphate anhydrous, sodium dihydrogen phosphate monohydrate, sodium
hydroxide, and water for injection.
Janssen-Cilag Pty Ltd
1-5 Khartoum Road Macquarie Park NSW 2113
Telephone: 1800 226 334
NZ Office: Auckland, New Zealand
Telephone: 0800 800 806
25 mg modified release aqueous suspension for intramuscular injection - AUST R 160858
50 mg modified release aqueous suspension for intramuscular injection - AUST R 160856
75 mg modified release aqueous suspension for intramuscular injection - AUST R 160859
100 mg modified release aqueous suspension for intramuscular injection - AUST R 160860
150 mg modified release aqueous suspension for intramuscular injection - AUST R 160857
This leaflet was prepared in August 2018.