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. Why am I taking VOCABRIA TABLETS?
VOCABRIA TABLETS contain the active ingredient cabotegravir. VOCABRIA TABLETS are
used to treat Human Immunodeficiency Virus (HIV) infection in adults.
2. What should I know before I take VOCABRIA TABLETS?
Do not use VOCABRIA TABLETS if you have ever had an allergic reaction to cabotegravir
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.
3. What if I am taking other medicines?
Some medicines may interfere with VOCABRIA TABLETS and affect how they work.
4. How do I take VOCABRIA TABLETS?
VOCABRIA TABLETS should be taken once a day and must always be taken with another
HIV medicine (rilpivirine). You should also follow the instructions for rilpivirine
carefully.
Take VOCABRIA TABLETS for as long as your doctor tells you. Don't stop unless your
doctor advises you to.
5. What should I know while using VOCABRIA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using VOCABRIA TABLETS.
Have regular blood tests and stay in regular contact with your doctor.
Continue to protect people as VOCABRIA TABLETS may not stop you passing HIV infection
on to others.
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Things you should not do
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Do not miss any doses of VOCABRIA TABLETS or stop taking them without talking to your
doctor.
Do not take VOCABRIA TABLETS with certain medicines that treat bacterial infections
or anticonvulsants.
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Driving or using machines
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VOCABRIA TABLETS 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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Keep your tablets in a cool, dry place where the temperature stays below 30°C.
Keep your tablets in the bottle until it is time to take them.
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6. Are there any side effects?
The following common side effects may occur when taking VOCABRIA TABLETS: headache,
feeling hot, diarrhoea, nausea, vomiting, stomach pain, wind, dizziness, depression,
anxiety, abnormal dreams, insomnia, muscle pain, rash and fatigue.
Contact your doctor promptly if you develop an allergic reaction or if you have liver
problems.
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 (as cabotegravir sodium)
Consumer Medicine Information (CMI)
This leaflet provides important information about using VOCABRIA TABLETS. 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 VOCABRIA TABLETS.
Where to find information in this leaflet:
1. Why am I taking VOCABRIA TABLETS?
VOCABRIA TABLETS contain the active ingredient cabotegravir, which belongs to a group of antiretroviral medicines called integrase inhibitors (INIs).
VOCABRIA TABLETS are used to treat Human Immunodeficiency Virus (HIV) infection in
adults.
VOCABRIA TABLETS do not cure HIV infection; they keep the amount of virus in your
body at a low level. This helps maintain the number of CD4+ cells in your blood. CD4+
cells are a type of white blood cell that are important in helping your body to fight
infection.
VOCABRIA TABLETS are always given in combination with another antiretroviral medicine
called rilpivirine to treat HIV infection. To control your HIV infection, and to stop
your illness from getting worse, you must keep taking all your medicines, unless your
doctor tells you to stop taking them.
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.
There is not enough information to recommend the use of this medicine for children
and adolescents under the age of 18 years.
VOCABRIA TABLETS are not addictive.
2. What should I know before I take VOCABRIA TABLETS?
Warnings
Do not use VOCABRIA TABLETS if:
you are allergic to cabotegravir or any of the ingredients listed at the end of this
leaflet.
if you are taking rifampicin or rifapentine (to treat some bacterial infections such
as tuberculosis) or phenytoin, phenobarbital, carbamazepine or oxcarbazepine (anticonvulsants
used to treat epilepsy and prevent seizures)
always check the ingredients to make sure you can use this medicine.
the expiry date printed on the pack has passed or if the packaging is torn or shows
signs of tampering.
Check with your doctor if you:
have any other medical conditions, such as liver problems. Your liver function will be monitored by your doctor during treatment with VOCABRIA
TABLETS.
take any medicines for any other condition
Symptoms of infection and inflammation:
People with advanced HIV infection (AIDS) have weak immune systems and are more likely
to develop serious infections (opportunistic infections). When they start treatment,
the immune system becomes stronger, so the body starts to fight infections.
Symptoms of infection and inflammation may develop, caused by either:
old, hidden infections flaring up again as the body fights them
the immune system attacking healthy body tissue (autoimmune disorders).
The symptoms of autoimmune disorders may develop many months after you start taking
medicine to treat your HIV infection.
Symptoms may include:
muscle weakness and/or muscle pain
joint pain or swelling
weakness beginning in the hands feet and moving towards the trunk of the body
palpitations or tremor
hyperactivity (excessive restlessness and movement).
If you get any symptoms of infection or if you notice any of the symptoms above tell
your doctor immediately. Don’t take other medicines for the infection without your
doctors' advice.
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.
Your doctor can discuss with you the risks and benefits, to you and your baby, of
receiving VOCABRIA TABLETS while pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Where possible, women who are HIV-positive should not breastfeed, because HIV infection
can be passed on to the baby in breast milk.
It is not known whether the ingredients of VOCABRIA TABLETS can pass into breast milk
and harm your baby.
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 and VOCABRIA TABLETS may interfere with each other. These include:
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)
rifabutin (to treat some bacterial infections such as tuberculosis)
medicines call antacids to treat indigestion and heartburn.
medicines for the treatment of hepatitis C.
These medicines may be affected by VOCABRIA TABLETS or may affect how well it works.
You may need different amounts of your medicines, or you may need to take 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
VOCABRIA TABLETS.
4. How do I take VOCABRIA TABLETS?
When you first start treatment with cabotegravir, you and your doctor may decide to
start directly with the cabotegravir injection and rilpivirine injection, CABENUVA.
Alternatively, your doctor may advise you to take one VOCABRIA TABLET and one rilpivirine
tablet once a day for one month (lead-in period) before you receive your cabotegravir
injection and rilpivirine injection. Taking VOCABRIA and rilpivirine tablets will
allow your doctor to test how well you tolerate these medicines.
How much to take
The usual dose of VOCABRIA TABLETS is one tablet (30 mg cabotegravir) taken once a
day for one month (or at least 28 days).
VOCABRIA TABLETS are always given with another HIV medicine called rilpivirine 25
mg tablets.
Follow the instructions provided and use VOCABRIA TABLETS until your doctor tells
you to stop.
When to take VOCABRIA TABLETS
Take VOCABRIA TABLETS once a day at the same time each day. Taking your tablet at
the same time each day will have the best effect. It will also help you remember when
to take it.
If you need to take an antacid, take it at least 2 hours before or 4 hours after you
take your VOCABRIA TABLET.
How to take VOCABRIA TABLETS
VOCABRIA TABLETS should be swallowed whole with some liquid.
VOCABRIA TABLETS can be taken with or without food, however, if you take VOCABRIA
TABLETS at the same time as rilpivirine tablets, you must take them with a meal.
If you will miss your cabotegravir injection
If you are not able to receive your cabotegravir injection, your doctor may recommend
instead you take one VOCABRIA TABLET with one rilpivirine tablet, until you can receive
the injection again.
If you forget to take VOCABRIA TABLETS
VOCABRIA TABLETS should be used regularly at the same time each day. If you miss your
dose at the usual time, take it as soon as you remember.
If it is almost time for your next dose, skip the dose you missed and take your next
dose when you are meant to.
Do not take a double dose to make up for the dose you missed.
If you take too much
If you think that you have taken too many tablets you may need urgent medical attention.
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 VOCABRIA?
Things you should do
Have regular blood tests
For as long as you're taking VOCABRIA TABLETS, your doctor will arrange regular blood
tests to check for side effects.
Stay in regular contact with your doctor
VOCABRIA TABLETS help to control your condition, but it is not a cure for HIV infection.
You need to keep taking it every day to stop your illness from getting worse. Because
VOCABRIA TABLETS do not cure HIV infection, you may still develop other infections
and illnesses linked to HIV infection.
Keep in contact with your doctor, and don't stop taking VOCABRIA TABLETS without your
doctor's advice.
Protect other people
HIV infection is spread by sexual contact with someone who has the infection, or by
transfer of infected blood (for example, by sharing injection needles). VOCABRIA TABLETS
may not stop you passing HIV infection on to other people. To protect other people
from becoming infected with HIV:
Use a condom when you have oral or penetrative sex.
Don't risk blood transfer - for example, don't share needles.
Call your doctor straight away if you:
Become pregnant while taking VOCABRIA TABLETS.
Remind any doctor, dentist or pharmacist you visit that you are using VOCABRIA.
Things you should not do
Do not stop using this medicine or lower the dosage without checking with your doctor.
Do not take VOCABRIA TABLETS to treat any other complaints unless your doctor tells
you to.
Do not give your medicine to anyone else, even if they have the same condition as
you.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how VOCABRIA
TABLETS affect you.
VOCABRIA TABLETS may cause dizziness in some people or have other side effects that
make you less alert.
Don't drive or operate machinery unless you are sure you're not affected.
Looking after your medicine
Keep your tablets in the bottle until it is time to take them.
Keep your tablets in a cool, dry place where the temperature stays below 30°C.
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.
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.
When you're being treated for HIV, it can be hard to tell whether a symptom is a side
effect of VOCABRIA TABLETS or other medicines you are taking, or an effect of the
HIV disease itself. So, it is very important to talk to your doctor about any changes
in your health.
Some side effects may only be seen in your blood tests and may not appear immediately
after you start taking VOCABRIA TABLETS. If you get any of these effects, and if they
are severe, your doctor may advise you to stop taking VOCABRIA TABLETS.
As well as the effects listed below for VOCABRIA TABLETS, other conditions can develop
during combination therapy for HIV.
Less serious side effects
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Less serious side effects
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What to do
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Nervous system and psychiatric disorders:
Very common*
Headache
Common**
Dizziness
Depression (feelings of deep sadness and unworthiness)
Anxiety
Abnormal dreams
Difficulty in sleeping (insomnia)
Uncommon***
Feeling drowsy (somnolence)
Gastrointestinal disorders:
Common
Diarrhoea
Feeling sick (nausea)
Being sick (vomiting)
Stomach (abdominal) pain or discomfort
Wind (flatulence)
General disorders:
Very common
Feeling hot (pyrexia)
Common
Lack of energy (fatigue)
Feeling weak (asthenia)
Generally feeling unwell (malaise)
Other:
Common
Rash
Muscle pain (myalgia)
Uncommon
Weight gain
Side effects that may show up in blood tests:
increase in bilirubin (a substance produced by the liver) in the blood
an increase in lipase (an enzyme produced by the pancreas).
an increase in the level of enzymes produced in the muscles (creatine phosphokinase,
creatinine)
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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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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Allergic reaction:
Rash, itching or hives on skin
High temperature (fever)
Lack of energy (fatigue)
Swelling of the face, lips, tongue or other parts of the body
Wheezing or difficulty breathing
Shortness of breath
Muscle or joint aches
Liver disorders:
Uncommon***
Changes in liver blood tests (increase in transaminases)
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.
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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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***Uncommon: may affect up to 1 in 100 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 VOCABRIA TABLETS contain
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Active ingredient
(main ingredient)
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Cabotegravir (as cabotegravir sodium). Each tablet contains 30 mg cabotegravir.
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Other ingredients
(inactive ingredients)
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lactose monohydrate
microcrystalline cellulose
hypromellose
sodium starch glycolate
magnesium stearate
titanium dioxide
macrogol
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Do not take this medicine if you are allergic to any of these ingredients.
What VOCABRIA TABLETS look like
VOCABRIA TABLETS are white, oval, film-coated tablets, debossed with 'SV CTV' on one
side.
AUST R 323721
Who distributes VOCABRIA TABLETS
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.
© 2023 ViiV Healthcare group of companies or its licensor.
This leaflet was prepared on 18 September 2023.
Version 4.