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.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. What is APRETUDE and what is it used for?
APRETUDE contains the active ingredient cabotegravir, which belongs to a group of
antiretroviral medicines called integrase inhibitors (INIs). APRETUDE is used to reduce
the risk of getting HIV infection in people weighing 35 kg or more. This is called
pre-exposure prophylaxis (PrEP). For more information, see Section
1. What is APRETUDE and what is it used for? in the full CMI.
2. What should I know before I am given APRETUDE?
Do not use if you have ever had an allergic reaction to cabotegravir or any of the
ingredients listed at the end of the CMI. Do not use unless you have had a recent
HIV test to confirm you are HIV negative.
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 am given APRETUDE? in the full CMI.
3. What if I am taking other medicines?
4. How APRETUDE is given to me?
APRETUDE will be given by a nurse or doctor through an injection in the muscle of
your buttock (intramuscular injection (IM)) as a single injection once every 2 months.
You should be given APRETUDE for as long as your doctor recommends. Do not stop unless
your doctor advises you to.
5. What should I know while being given APRETUDE?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using APRETUDE.
Attend your planned appointments to receive your APRETUDE injection.
Get tested for HIV every 2-3 months
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Things you should not do
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Do not miss your planned appointments to receive your APRETUDE injection. Missing
your dose may increase you risk of getting HIV infection.
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Driving and using machines
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APRETUDE can make you dizzy and have other side effects that make you less alert.
Do not drive or use machines unless you are sure you are not affected.
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Looking after your medicine
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APRETUDE injection will be given to you by a nurse or doctor who will be responsible
for its storage.
APRETUDE injection should be kept in the pack until it is time to use it. It should
be stored below 30°C.
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6. Are there any side effects?
The following very common side effects may occur when using APRETUDE: headache, diarrhoea,
injection site reactions, fever. Contact your doctor promptly if you develop an allergic
reaction or if you have liver problems.
Whilst very rare, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
are serious and life-threatening. Contact your doctor straight away if you develop
painful red or purple skin, blisters on your skin, mouth, nose and genitals and red,
painful, watery eyes.
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.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient:
cabotegravir
Consumer Medicine Information (CMI)
This leaflet provides important information about being given APRETUDE injection.
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 APRETUDE.
Where to find information in this leaflet:
1. What is APRETUDE and what is it used for?
APRETUDE contains the active ingredient cabotegravir, which belongs to a group of antiretroviral medicines called integrase inhibitors (INIs).
APRETUDE is used to reduce the risk of getting HIV infection in people weighing 35
kg or more. This is called pre-exposure prophylaxis (PrEP).
2. What should I know before I am given APRETUDE?
Warnings
You must not be given APRETUDE:
if you are allergic to cabotegravir, or any of the ingredients listed at the end of
this leaflet.
Always check the ingredients to make sure you can be given this medicine.
if you are taking any of these medicines as they may affect the way APRETUDE works:
rifampicin or rifapentine (to treat some bacterial infections such as tuberculosis),
phenytoin, phenobarbital, carbamazepine or oxcarbazepine (also known as anticonvulsants
used to treat epilepsy and prevent seizures).
unless you have had a recent HIV test to confirm you are HIV negative. APRETUDE can
only help reduce your risk of getting HIV before you are infected so, you must get
tested to make sure you don’t already have HIV infection before taking APRETUDE.
Check with your doctor if you:
have any other medical conditions
take any medicines for any other condition
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
If you are pregnant, or think you could be, or if you are planning to have a baby,
don’t receive APRETUDE injections without checking with your doctor. Your doctor will
consider the benefit to you and the risk to your baby of receiving APRETUDE while
you are pregnant.
If you are planning to have a baby, talk to your doctor in advance, as APRETUDE injection
can stay in your system for up to 12 months or longer after the last injection of
APRETUDE.
If you are thinking about breast-feeding, check with your doctor who will consider
the benefit and risk to you and your baby.
It is not known whether the ingredients of APRETUDE can pass into breast milk and
harm your baby. APRETUDE may still pass into breast milk for 12 months after the last
injection of APRETUDE.
Allergic reaction
APRETUDE contains cabotegravir, which is an integrase inhibitor. Other integrase inhibitors
can cause a serious allergic reaction known as a hypersensitivity reaction. You need
to know about important signs and symptoms to look out for while you’re receiving
APRETUDE. See additional information under Section
6. Are there any side effects ?
You must not be given APRETUDE injection after the expiry date shown on the pack.
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 APRETUDE and affect how it works or make it more
likely that you will have side effects. APRETUDE can also affect how some other medicines work.
You must not be given APRETUDE with these medicines:
carbamazepine, oxcarbazepine, phenobarbital, or phenytoin (also known as anticonvulsants
used to treat epilepsy and prevent seizures).
rifampicin or rifapentine (to treat some bacterial infections such as tuberculosis).
Tell your doctor if you are taking any of the medicines in the following list:
rifabutin (to treat some bacterial infections such as tuberculosis). You may need
to receive APRETUDE injections more often.
Tell your doctor or pharmacist if you are taking any of these. Your doctor may decide
you need extra check-ups.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect APRETUDE.
4. How APRETUDE is given to me?
How much is given
When you first start PrEP with APRETUDE, you and your doctor may decide to either:
start PrEP directly with APRETUDE injection.
Or
start PrEP with APRETUDE tablets. If you start with APRETUDE tablets, the doctor
will advise you to:
take one 30 mg APRETUDE tablet once a day, for approximately one month, then receive
injections every 2 months.
Your first injection should preferably be on the same day as your last tablet or no
later than 3 days after.
This first month of tablets is called the oral lead-in period. It allows your doctor
to assess whether it’s appropriate to proceed with injections.
When APRETUDE is given
You will be given APRETUDE as a single injection once every 2 months.
Injection Schedule for every 2 month dosing
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Which medicine
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When
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First and second injections one month apart
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Third injection onwards, every two months.
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APRETUDE
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3 mL (600 mg)
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3 mL (600 mg)
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How APRETUDE is given
A nurse or doctor will give you APRETUDE through an injection in the muscle of your
buttock (intramuscular injection [IM]).
If you miss an APRETUDE injection
Contact your doctor immediately to make a new appointment
It is important that you keep your regular planned appointments to receive your APRETUDE
injection to reduce the risk of getting HIV. Talk to your doctor if you are thinking
about stopping APRETUDE.
Talk to your doctor if you think you will not be able to receive your APRETUDE injection
at the usual time. Your doctor may recommend you take APRETUDE tablets instead, until
you are able to receive an APRETUDE injection again.
If you are given too much APRETUDE
A doctor or nurse will give this medicine to you, so it is unlikely that you will
be given too much. If you are worried, tell the doctor or nurse.
Do not stop receiving APRETUDE injections without advice from your doctor.
You should be given APRETUDE for as long as your doctor recommends. Don’t stop unless
your doctor advises you to. If you miss an appointment to receive your injection,
contact your doctor right away to make a new appointment.
5. What should I know while being given APRETUDE?
Things you should do
It is important that you attend your planned appointments to receive your APRETUDE
injections. Talk to your doctor if you are thinking about stopping injections as this
may increase your risk of getting HIV infection. If you do stop or are late receiving
your APRETUDE injections, you will need to take other medicines or precautions to
reduce your risk of getting HIV and possibly developing viral resistance.
Get tested for HIV every 2-3 months.
Call your doctor straight away if you:
think you were infected with HIV (you may get a flu-like illness). They may want to
do more tests to make sure you are still HIV negative.
Remind any doctor, dentist or pharmacist you visit that you are using APRETUDE.
Things you should not do
Do not stop or be late receiving your APRETUDE injection. APRETUDE injection is a
long-acting medication, so if you stop, cabotegravir will remain in your system for
up to a year or more after your last injection. It is important that you attend your
planned appointments to receive APRETUDE injection and talk to your doctor if you
are thinking about stopping PrEP. You may need to take other medicines to reduce the
risk of getting HIV infection or use other safe sex precautions if you stop APRETUDE
injections.
Just receiving APRETUDE may not stop you getting HIV
You can still get HIV when taking this medicine, although APRETUDE lowers the risk.
HIV infection is spread by sexual contact with someone who has the infection or by
transfer of infected blood. To reduce your risk of getting HIV:
use a condom when you have oral or penetrative sex
Do no risk blood transfer, do not share needles.
Discuss with your doctor the additional precautions needed to further decrease the
risk of getting HIV.
Liver problems
Let your doctor know if you have liver problems. Signs of liver problems include yellowing
of the skin and the whites of eyes, loss of appetite, itching, tenderness of the stomach,
light coloured stools or unusually dark urine.
Your liver function may need to be closely monitored.
You may need regular blood tests
While you are using APRETUDE, your doctor may arrange regular blood tests to check
for side effects. See additional information under Section
6. Are there any side effects?
Driving or using machines
Be careful before you drive or use any machines or tools until you know how APRETUDE
affects you.
APRETUDE may cause dizziness in some people and have other side effects that make
you less alert. Do not drive or use machines unless you are sure you are not affected.
Looking after your medicine
APRETUDE injection will be given to you by a doctor or a nurse who will be responsible
for its storage.
APRETUDE injections should be kept in the pack until it is time to use it. It should
be stored below 30°C.
Getting rid of any unwanted medicine
Your healthcare professional will be responsible for discarding APRETUDE injections..
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.
Some side effects may only be seen in your blood tests and may not appear immediately
after you start taking APRETUDE. If you get any of these effects, and if they are
severe, your doctor may advise you to stop taking APRETUDE.
Less serious side effects
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Less serious side effects
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What to do
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Stomach or bowel problems:
Very common
Diarrhoea
Common
Feeling sick (nausea)
Vomiting
Stomach pain (abdominal pain)
Wind (flatulence)
General disorders:
Very common
Headache
Common
Depression
Abnormal dreams
Difficulty in sleeping (insomnia)
Dizziness
Lack of energy (fatigue)
Generally feeling unwell (malaise)
Skin problem:
Common
Rash
Injection site reactions:
Very common
Pain & tenderness, a hardened mass or lump
Common
Redness, itching, swelling, warmth, numbness or bruising (which may include discolouration
or a collection of blood under the skin)
Uncommon
An abscess (collection of pus)
Other:
Very common
Feeling hot (fever)
Common
Muscle pain (myalgia)
Uncommon
Weight gain
Feeling lightheaded, during or following an injection. This may lead to fainting
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
Tell your doctor or pharmacist if you experience severe or troublesome reactions at
the site where you are given your injection
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Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Serious side effects
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Serious side effects
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What to do
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Conditions you need to look out for
Some other conditions may develop while you are taking APRETUDE:
Allergic Reaction
Skin rash
A high temperature (fever)
Lack of energy (fatigue)
Swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
Muscle or joint aches
Liver problems
Very common
changes in liver blood tests (increase in transaminases)
Uncommon
liver damage (signs may include yellowing of the skin and the whites of the eyes,
loss of appetite, itching, tenderness of the stomach, light-coloured stools or unusually
dark urine). (hepatotoxicity)
Psychological
Uncommon
suicidal thoughts*
Suicidal attempt*
* mainly in patients who have had depression or mental health problems before.
Skin and subcutaneous tissue disorders:
Very rare
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are serious life-threatening
conditions which usually start with flu-like symptoms. A few days later other symptoms
appear including:
painful red or purple skin that looks burned and peels off
blisters on your skin, mouth, nose and genitals
red, painful, watery eyes
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Very rare: may affect up to 1 in 10,000 people
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 APRETUDE contains
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Active ingredient
(main ingredient)
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Cabotegravir
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Other ingredients
(inactive ingredients)
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mannitol
polysorbate 20
macrogol 3350
water for injections
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You must not be given this medicine if you are allergic to any of these ingredients.
What APRETUDE looks like
APRETUDE prolonged-release suspension for injection is a white to light pink suspension.
Each 3 mL vial contains 600 mg cabotegravir.
AUST R 377474
Who distributes APRETUDE
ViiV Healthcare Pty Ltd
Level 4, 436 Johnston Street
Abbotsford, VIC 3067
Australia
Trademarks are owned by or licensed to the ViiV Healthcare group of companies.
© 2024 ViiV Healthcare group of companies or its licensor.
This leaflet was prepared in December 2024.
Version 3.0