- Product info
Abilify Maintena is a long acting medication that a doctor may prescrible to help relieve the symptoms of schizophrenia. Abilify Maintena helps to correct a chemical imbalance in the brain which may cause schizophrenia. Abilify Maintena belongs to a group of medicines called antipsychotic agents. Abilify Maintena should only be given by a healthcare professional.
Powder and solvent for prolonged release suspension for intramuscular injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions
about Abilify Maintena. It does not contain
all the available information. It does not take
the place of talking to your doctor or
All medicines have risks and benefits. Your
doctor has weighed the potential risks of you
receiving Abilify Maintena against the
If you have any concerns about receiving
this medicine ask your doctor or
Keep this leaflet.
You may need to read it again.
What Abilify Maintena is used for
Abilify Maintena is a long-acting medicine
that is used to treat schizophrenia.
Schizophrenia is characterised by symptoms
• hallucinations; hearing, seeing or
sensing things that are not there,
• suspiciousness, mistaken beliefs and
• incoherent speech and behaviour and
People with this condition may also feel
depressed, guilty, anxious, or tense.
Abilify Maintena belongs to a group of
medicines called antipsychotic agents.
Abilify Maintena helps to correct a chemical
imbalance in the brain which may cause
You and your doctor have decided on Abilify
Maintena to help relieve the symptoms of
your condition. Although Abilify Maintena
cannot cure schizophrenia, it can help to
keep the symptoms under control and reduce
the risk of relapse as you continue treatment.
Ask your doctor if you have any questions
about why this medicine has been
prescribed for you.
Abilify Maintena is available only with a
There is no evidence that Abilify Maintena is
Abilify Maintena should not be given to
children and adolescents under 18 years of
age as safety and efficacy have not been
established in this age group.
Abilify Maintena should not be taken unless
oral Abilify has previously been tolerated.
Before you receive Abilify Maintena
Abilify Maintena should only be given by
a healthcare professional.
When you must not receive it
Do not receive Abilify Maintena if you
have an allergy to:
• aripiprazole; or
• any of the ingredients listed at the end of
Some of the symptoms of an allergic reaction
may include: shortness of breath; wheezing
or difficulty breathing; swelling of the face,
lips, tongue or other parts of the body; and/or
rash, itching or hives on the skin.
Abilify Maintena should not be used after
the expiry date (EXP) printed on the pack.
The expiry date refers to the last day of
It may have no effect at all or, an entirely
unexpected effect if you receive it after the
Abilify Maintena should not be used if the
packaging is torn or shows signs of having
been tampered with.
If you are not sure whether Abilify
Maintena would be beneficial for you, talk
to your doctor or pharmacist.
Before you start to receive it
Tell your doctor if you have allergies to
any other medicines, foods, preservatives
Tell your doctor if you are pregnant, think
you are pregnant or plan to become
Abilify Maintena should not be received
during pregnancy unless the benefit
outweighs the risk. If you need to receive
Abilify Maintena during your pregnancy,
your doctor will discuss with you the risks
and benefits of taking it.
The following symptoms may occur in
newborn babies of mothers that receive
Abilify Maintena in the last three months of
their pregnancy: shaking, muscle stiffness
and/or weakness, sleepiness, agitation,
breathing problems, and difficulty in feeding.
If your baby develops any of these symptoms
you need to contact your doctor immediately.
Tell your doctor if you are breast-feeding
or planning to breast-feed.
If you are receiving Abilify Maintena, your
doctor will discuss with you whether you
should breast-feed considering the benefit to
you of your therapy and the benefit to your
baby of breast-feeding. You should not do
both. Talk to your doctor about the best way
to feed your baby if you are receiving Abilify
Tell your doctor if you have or have had
any medical conditions, especially the
• Dementia (loss of memory or other
mental abilities) and you are elderly.
• Neuroleptic malignant syndrome -
reaction to some medicines with a
sudden increase in body temperature,
sweating, fast heartbeat, muscle stiffness
and fluctuating blood pressure, which
may lead to coma.
• Tardive dyskinesia - a reaction to some
medicines with abnormal movements of
the tongue, or other uncontrolled
movements of the mouth, tongue, cheeks
or jaw which may progress to the arms
• low blood pressure.
• high blood pressure or have rapid
heartbeat and a drop in blood pressure
when getting up.
• problems with your heart or blood
vessels, including stroke, "mini" stroke,
or family history of heart or blood vessel
• epilepsy, seizures or fits.
• problems with your oesophagus (food
pipe/gullet) such as difficulty in
• high blood sugar or diabetes mellitus or
a family history of diabetes or high
• blood clots, or you have any of the
following risk factors for developing
blood clots: family history of blood
clots, 65 years of age or older, smoking,
obese, recent major surgery such as hip
or knee replacement, immobility due to
air travel or other reason, or you take
• past experience with excessive gambling
or other compulsive behaviours.
• have or had low white blood cell count.
• other medical conditions including
conditions that may affect you receiving
an injection in your arm or buttocks.
Tell your doctor if you drink alcohol.
You should avoid alcohol as it could magnify
the side effects of this medicine.
If you have not told your doctor about any
of the above, tell them before you receive
Ask your doctor or pharmacist for advice
before taking any medicine.
Taking other medicines
Tell your doctor or pharmacist if you are
taking any other medicines, including any
that you buy without a prescription from a
pharmacy, supermarket or health food
Some medicines and Abilify Maintena may
interfere with each other. These include:
• medicines and herbal remedies used to
treat depression and anxiety.
• certain medicines used to treat nicotine
• anticonvulsants used to treat epilepsy.
• medicines used to treat high blood
• medicines used to treat heart rhythm
• medicines used to treat bacterial, fungal
or viral infections.
These medicines may be affected by
Abilify Maintena, or may affect how well
it works. You may need to use different
amounts of medicines, or take different
Your doctor and pharmacist have more
information on medicines to be careful
with or avoid while receiving this
If you have not told your doctor or
pharmacist about any of these things, tell
them before you receive Abilify Maintena.
How to use Abilify Maintena
Abilify Maintena is a long-acting medicine
that a healthcare professional will give to you
The medicine is slowly released from the
injection site, which means you do not have
to take it every day, but only once a month.
Abilify Maintena can be received regardless
How it is given
Abilify Maintena is a kit that includes a
powder which your healthcare
professional will make into a suspension
that will then be injected into the muscle
in your buttock or shoulder. You may feel
a little pain during the injection, which
may become less over time.
The usual dose is 400 mg every 4 weeks.
Your healthcare professional may
administer a lower dose if required. Your
doctor will decide on the dose of Abilify
Maintena that is right for you.
After your first dose you must take 10 mg
to 20 mg of oral aripiprazole (or
prescribed dose of other oral
antipsychotic) for 14 days in a row.
It is important you take your oral
antipsychotic exactly as directed by your
doctor, because the first injection will not
start to work straight away.
How many injections you will need
Abilify Maintena should be administered
to you once monthly to help reduce your
symptoms and the risk of relapse. Do not
stop your treatment just because you feel
better. It is important that you carry on
receiving Abilify Maintena for as long as
your doctor has told you to.
It may take several days to some weeks,
sometimes longer, before you feel any
Your doctor will check your progress at
What if you miss a dose
If you miss an injection, you should
contact your doctor to arrange your next
injection as soon as you can. You should
be given an injection every 4 weeks. Ask
your doctor if you have any further
questions on the use of this medicine.
If you receive too much (overdose)
This medicine will be given to you under
medical supervision. Therefore, it is
unlikely that you will be given too much. If
you see more than one doctor, be sure to
tell them that you are receiving Abilify
If you have received too much aripiprazole
you may experience:
• rapid beating of the heart,
agitation/aggressiveness, problems with
speech, unusual movements (especially
of the face or tongue) and reduced level
• other symptoms may include: acute
confusion, seizures (epilepsy), coma, a
combination of fever, faster breathing,
sweating, muscle stiffness, and
drowsiness or sleepiness; slower
breathing, choking, high or low blood
pressure, abnormal rhythms of the heart.
If you think that you or anyone else may
have received too much Abilify Maintena,
immediately telephone your doctor or
Poisons Information Centre (Telephone 13
11 26) for advice, or go to the Accident
and Emergency department at your
nearest hospital. Do this even if there are
no signs of discomfort or poisoning. Keep
the telephone number handy.
You may need urgent medical attention.
While you are receiving Abilify
Things you must do
Tell your doctor immediately if you
become pregnant while taking Abilify
If you are about to be started on any new
medicine, remind your doctor and
pharmacist that you are receiving Abilify
Tell all doctors, dentists and pharmacists
who are treating you that you are
receiving Abilify Maintena.
If you are going to have surgery that
requires a general anaesthetic, tell your
doctor or dentist that you are receiving
It may affect other medicines used during
Keep all of your doctor's appointments so
that your progress can be checked.
Your doctor will check your progress and
may want to take some blood tests from
time-to-time. This helps reduce unwanted
effects. Abilify Maintena may be associated
with changes in:
• liver blood values,
• muscle enzyme blood levels,
• sodium blood levels,
• blood sugar levels,
• lipid blood levels, or
• white blood cell levels.
Your doctor may check your body weight
before starting Abilify Maintena and
continue to monitor it for as long as you are
Patients and care givers should pay
attention to any of the warning signs of
suicide-related behaviour such as thoughts
or talk about death or suicide; or thoughts
or talk about self-harm or doing harm to
others. Tell your doctor immediately if
you have any of these signs.
Things to be careful of
Driving or operating machinery should be
avoided until you know how Abilify
Maintena affects you. If Abilify Maintena
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 alcohol while you are taking Abilify
Abilify Maintena can increase the effects of
Abilify Maintena may affect the way your
body reacts to temperature changes. It
may prevent sweating, even during
heatwaves. You may feel dizzy or faint if
you are too hot. To stay cool in hot
weather, try to do the following:
• wear light clothing.
• spend time in air-conditioned
environments (or keep windows open
and use electric fans).
• drink plenty of water.
• take cool baths or showers and avoid hot
baths and saunas.
• try to restrict exercise or heavy work to
cool parts of the day.
Tell your doctor or pharmacist as soon as
possible if you do not feel well while you
are receiving Abilify Maintena.
All medicines can have side effects.
Sometimes they are serious, most of the time
they are not. You may need medical
treatment if you get some of the side effects.
Do not be alarmed by the following lists of
side effects. You may not experience any
Ask your doctor or pharmacist to answer
any questions you may have.
Tell your doctor if you notice any of the
following side effects and they worry you:
• fatigue, drowsiness or sleepiness
• speech disorder
• agitation or restlessness
• inability to sit or stand still; restless
movement of the arms and legs such as
tapping, marching in places, rocking,
crossing and uncrossing legs
• pain or swelling at the site of injection
• weight loss or gain
• decreased appetite
• muscle ache or stiffness
• dry mouth
• difficulty in passing urine or
• inability for a man to have an erection or
a persistent and painful erection
• blurred or double vision
• abnormal hair loss
• constipation or diarrhoea
• high blood pressure
• abnormal liver blood values
• low sodium levels in the blood
• abnormally low or high body
temperature or excessive sweating
• excessive compulsive urges such as
gambling, sexual urges, spending, binge
or compulsive eating
Tell your doctor as soon as possible if you
notice any of the side effects listed below.
• feeling dizzy or fainting, especially
when getting up from a lying or sitting
• frequent infections such as fever, severe
chills, sore throat or mouth ulcers.
• difficulty swallowing or accidental
inhalation of food or liquids with risk of
• bruise easily.
Tell your doctor immediately, or go to
Accident and Emergency at your nearest
hospital, if you notice any of the side
effects listed below.
• serious allergic reaction (symptoms of
an allergic reaction may include swelling
of the face, lips, mouth or throat which
may cause difficulty in swallowing or
breathing, or rash, itching or hives).
• abnormal movements of the tongue, or
other uncontrolled movements of the
tongue, mouth, cheeks, or jaw which
may progress to the arms and legs.
• high fever, stiff muscles, confusion,
sweating, and changes in pulse, heart
rate, and blood pressure, which may lead
to coma. This reaction is called
neuroleptic malignant syndrome.
• convulsions or seizures.
• chest pain.
• rapid pulse
• swelling, pain or redness in the leg, chest
pain or difficulty in breathing.
• a combination of any of the following:
excessive sleepiness, dizziness,
confusion, disorientation, difficulty
talking, difficulty walking, muscle
stiffness or shaking, fever, weakness,
irritability, aggression, anxiety, increase
in blood pressure, or seizures that lead to
loss of consciousness.
• high or unstable blood sugar levels
(feeling very thirsty and/or hungry,
needing to urinate more often than usual,
feeling weak or tired, feeling sick to
your stomach, feeling confused, have
fruity smelling breath) ), or the onset or
worsening of diabetes.
• thoughts of suicide, attempts at suicide
or suicide. See also section "Things you
• yellowing of the skin and/or eyes, also
called jaundice with or without nausea,
vomiting, loss of appetite, feeling
generally unwell, fever, itching and dark
• inflammation of the pancreas or liver,
severe upper stomach pain often with
nausea and vomiting.
• muscle pain, muscle weakness or muscle
cramps, high blood levels of the enzyme
• spasm of the muscles around the voice
Elderly patients with dementia may suffer
serious side effects such as "mini" stroke,
stroke, pneumonia, or heart problems. These
serious side effects can be life threatening.
Other side effects not listed above may
also occur in some people. Tell your
doctor or pharmacist if you notice
anything else that is making you unwell.
Storage of Abilify Maintena
Abilify Maintena will be stored by your
healthcare professional until it is time for
them to administer the injection to you.
Abilify Maintena should be stored in its
package in a dry place where the
temperature stays below 30°C. Do not
freeze. Your healthcare professional will
not use Abilify Maintena beyond the
expiry date printed on the carton.
Abilify Maintena description
What Abilify Maintena looks like
Abilify Maintena is available in one-month
therapeutic kits. A single kit contains either
400 mg or 300 mg of aripiprazole (as
monohydrate). The therapeutic kit contains
all that is required for your healthcare
professional to reconstitute and administer
the required dose of medicine to you. After
reconstitution, each mL of suspension
contains 200 mg of aripiprazole.
The therapeutic kit contains the following
• one vial containing a white to off-white
powder containing aripiprazole (as
• one vial containing water for injections
for mixing with the powder;
• one sterile syringe with a needle;
• one sterile syringe without a needle;
• three safety needles; and
• one vial adapter.
• Abilify Maintena 400 mg therapeutic kit
contains 400 mg aripiprazole (as
monohydrate) per vial.
• Abilify Maintena 300 mg therapeutic kit
contains 300 mg aripiprazole (as
monohydrate) per vial.
Abilify Maintena also contains:
• carmellose sodium
• sodium hydroxide
• monobasic monohydrate sodium
Abilify Maintena does not contain lactose,
gluten, sucrose, tartrazine or any other azo
Lundbeck Australia Pty Limited
Ground Floor, 1 Innovation Road
North Ryde NSW 2113
Ph: 02 8669 1000
Abilify Maintena is co-marketed by
Lundbeck Australia and Otsuka Australia
Otsuka Australia Pharmaceutical Pty.
'Tower A The Zenith'
Level 20, 821 Pacific Highway
Chatswood NSW 2067
This leaflet was prepared in October 2016.
Australian Registration Numbers:
Abilify Maintena 400 mg: AUST R 211150
Abilify Maintena 300 mg: AUST R 211122
Abilify Maintena is a registered trade
mark of Otsuka Pharmaceutical Co., Ltd.
Copyright© 2016 Otsuka Pharmaceutical
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