Modified Release Aqueous Suspension for Intramuscular Injection
Consumer Medicine Information (CMI)
NOTICE: This Consumer Medicine Information (CMI) is intended for persons
living in Australia. This page contains answers to some common
. It does
not contain all the information that is known about
. It does not take the
place of talking to your doctor or pharmacist. All medicines have risks
and benefits. Your doctor has weighed the risk of you using this medicine
against the benefits he/she expects it will have for you. If you have
any concerns about using this medicine, ask your doctor or pharmacist.
Bookmark or print this page, you may need to read it again.
What Invega Sustenna is used for
Invega Sustenna belongs to a group of medicines called antipsychotic agents which improve the symptoms of certain type of
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 include skin rash, itching, shortness of breath, and/or swollen face.
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 do so.
Before you start to use it
Invega Sustenna should be used with caution in some patients.
Tell your doctor if you have or have ever had:
heart or blood vessel diseases, including low or low blood pressure
intraoperative iris syndrome (a complication that may occur during cataract extraction)
disease of the pituitary gland
inflammation of the lungs due to aspiration (the inhalation of food particles or fluids into the lungs).
kidney or liver problems
Dementia or Lewy Bodies dementia
Neuroleptic Malignant Syndrome (a serious reaction to some medicines with a sudden increase in body temperature, extremely
high blood pressure and severe convulsions)
Tardive dyskinesia (a reaction to some medicines with involuntary movements of the tongue, face, mouth, jaws, arms, legs or
disease of the blood vessels of the brain including stroke
priapism (continuous erection) and/or painful erection
Tell your doctor if you or someone else in your family has a history of blood clots. Blood clots in the lungs and legs have
been seen in patients taking Invega Sustenna. Blood clots in the lungs can be fatal
low white blood cell count
As dangerously low numbers of certain types of white blood cells needed to fight infection in your blood has been seen very
rarely with patients taking Invega Sustenna, your doctor may check your white blood cell counts. Tell your doctor if you know
that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines).
Tell your doctor if:
you are pregnant or are planning to become pregnant. Your doctor will advise you whether or not you should use Invega Sustenna.
Shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding may occur
in newborns, if you use Invega Sustenna in your last trimester of pregnancy.
you are breast feeding. 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.
Tell your doctor if you are taking:
sleeping tablets, tranquillisers, pain-killers, antihistamines
medicines to treat depression, panic disorder, anxiety or obsessive-compulsive disorder.
medicines for your heart or blood pressure
other medicines to treat mental illness or psychotic conditions
How is it given
Using it for the first time
Treatment with Invega Sustenna will not be started by your doctor until it is known that you can tolerate oral paliperidone
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 they continue or worry you.
How much of it will be given
Your doctor will decide the dose suitable for you.
How is it given
Invega Sustenna is a modified release medicine that a healthcare professional will give you by injection. This means the medicine
is released gradually into your body and 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. After that you will
only need to get a dose once a month. The usual first 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.
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, 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 elderly patients
In general your doctor would prescribe the same dose as for adult patients, but he/she may adjust the dose if you have impaired
For patients with impaired kidney function
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 function impairment 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 function impairment.
Invega Sustenna cannot be recommended for use in children with schizophrenia under 18 years at the present time as there is
little experience with the product in this group.
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 being given 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 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 pregnant or are planning to become pregnant.
Tell your doctor immediately if you notice any worm-like movements of the tongue, or other uncontrolled movements of the tongue,
mouth, cheeks or jaw which may progress to the arms and legs.
These are symptoms of a condition called tardive dyskinesia, which may develop in people taking antipsychotic medicines, including
Invega Sustenna. This condition is more likely to occur during long term treatment with Invega Sustenna, especially in elderly
women. In very rare cases, this may be permanent. However, if detected early, these symptoms are usually reversible.
Tell any other doctors, dentists, and pharmacists who are treating you that you are taking 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.
These include herbal treatments and those bought in a pharmacy or supermarket.
Be careful driving or operating machinery until you know how Invega Sustenna affects you.
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 or light-headed.
If this occurs do not drive or operate machinery.
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.
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 or working because of:
drowsiness, tiredness, difficulty in concentrating
pain at injection site
behavioural changes such as:
other changes such as:
muscle stiffness or pain, bone or muscle ache
joint stiffness or swelling
blurry vision, eye rolling
inability to or pain when passing urine
lack of emotion
hardening of the skin
weight gain or weight loss
increased or decreased appetite
indigestion, nausea, abdominal pain
unusual secretion of breast milk
missed or irregular menstrual periods
difficulty getting or maintaining an erection; or having continuous and/or painful erection, priapism (prolonged erection)
involuntary movements of the tongue, face, mouth, jaws, arms, legs or trunk. This could occur after taking Invega Sustenna
or other antipsychotic medicines for a long time. Should this happen contact your doctor.
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:
heart or blood pressure problems such as:
fall in blood pressure, particularly on standing. This will be apparent to you as light-headedness or dizziness that passes
after a few seconds or after sitting down again
faster heart rate, slowed heart rate, heart beat irregularities
body temperature changes such as:
abnormally high body temperature
These may be serious side effects of Invega Sustenna. You may need urgent medical attention.
Serious side effects are uncommon.
If any of the following happen, stop taking Invega and tell your doctor immediately or go to Accident and Emergency at your
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
These are 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 consumers.
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 (as palmitate).
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 April 2013.