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.
1. Why am I taking JULUCA?
JULUCA contains the active ingredients dolutegravir and rilpivirine. JULUCA is used
to treat human immunodeficiency virus (HIV) infection.
2. What should I know before I take JULUCA?
Do not use if you have ever had an allergic reaction to JULUCA or any of the ingredients
listed at the end of the CMI.
Do not use JULUCA if you are taking any of the following medicines: dofetilide, pilsicainide,
fampridine, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampicin, rifapentine,
omeprazole, esomeprazole, lansoprazole, pantoprazole, rabeprazole, dexamethasone and
products containing St John’s wort.
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 JULUCA and affect how it works.
4. How do I use JULUCA?
The usual dosage of JULUCA is one tablet once a day with a meal.
If you taken certain other medications this will affect when you can take JULUCA.
Swallow the tablet whole with a glass of water.
5. What should I know while taking JULUCA?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking JULUCA.
For as long as you are taking JULUCA your doctor will arrange for you to have regular
blood tests to check for side effects.
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Things you should not do
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Do not stop using this medicine suddenly or change the dose without talking to your
doctor.
Do not take this medicine to treat any other complaints.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how JULUCA
affects you.
JULUCA may cause dizziness or make you feel less alert than normal.
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Looking after your medicine
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Store JULUCA in the bottle below 30°C.
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6. Are there any side effects?
Side effects that have been reported include headache, dizziness, nausea, vomiting,
stomach pains or discomfort, diarrhoea, increased wind (flatulence), decreased appetite,
weight gain, depression, anxiety, difficulty sleeping or falling asleep (insomnia),
abnormal dreams, sleep disorders, fatigue, a lack of energy, feeling drowsy, itching,
joint pain and muscle pain.
Serious side effects include allergic reactions, suicidal thoughts and behaviours
and liver failure. Urgent medical attention is required.
Active ingredient(s):
dolutegravir and rilpivirine (as hydrochloride)
Consumer Medicine Information (CMI)
This leaflet provides important information about using JULUCA. 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 JULUCA.
Where to find information in this leaflet:
1. Why am I taking JULUCA?
JULUCA contains the active ingredients dolutegravir and rilpivirine.
Dolutegravir belongs to a group of antiretroviral medicines called integrase inhibitors
(INIs). Rilpivirine belongs to a group of antiretroviral medicines called non-nucleoside
analogue reverse transcriptase inhibitors (NNRTIs).
JULUCA is used to treat human immunodeficiency virus (HIV) infection.
JULUCA does not cure HIV infection however it keeps 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.
You can still pass on HIV when taking this medicine through sexual activity or through
passing on blood or bodily secretions which carry the HIV virus, although the risk
is lowered by taking antiretroviral therapy.
You should use proper precautions to prevent this from occurring. Discuss with your
doctor the precautions needed to avoid infecting other people.
While taking JULUCA and/or any other therapy for HIV, you may continue to develop
other infections and other complications of HIV infection. You should keep in regular
contact with your doctor.
2. What should I know before I take JULUCA?
Warnings
Do not take JULUCA if:
you are allergic to dolutegravir, rilpivirine or any of the ingredients listed at
the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you take any of the following medicines:
dofetilide or pilsicainide, used to treat heart conditions
fampridine, used to treat multiple sclerosis
carbamazepine, oxcarbazepine, phenobarbital, phenytoin, medicines known as anticonvulsants
used to treat epilepsy and prevent seizures
rifampicin, rifapentine, medicines used to treat some bacterial infections such as
tuberculosis
omeprazole, esomeprazole, lansoprazole, pantoprazole or rabeprazole, proton pump inhibitor
medicines used to prevent and treat stomach ulcers, heartburn or acid reflux disease
dexamethasone, a corticosteroid medicine used in a variety of conditions such as inflammation
and allergic reactions
products containing St John’s Wort (hypericum perforatum), a herbal product used to
treat depression
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
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor can discuss with you the benefits and risks of taking JULUCA whilst pregnant
or breastfeeding.
It is important to use a reliable method of contraception to prevent pregnancy.
Taking dolutegravir (one of the components in JULUCA tablets) at the time of becoming
pregnant or during the first 12 weeks of pregnancy may increase the risk of a type
of birth defect known as neural tube defects such as spina bifida (a malformed spinal
cord).
Women who are HIV positive should not breastfeed as HIV infection can be passed onto
the baby through the breastmilk. Dolutegravir is known to pass into the breastmilk
in small amounts.
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 and so the body starts to fight infections.
Symptoms of infection and inflammation may develop, caused by either:
old, hidden infections flaring up at 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
medications to treat your HIV infection.
Symptoms may include:
muscle weakness and/or muscle pain
joint pain or swelling
weakness beginning in the hands or feet and moving towards the trunk of the body
palpitations or tremor
hyperactivity (excessive restlessness and movement)
If you get symptoms of infection or if you notice any of the symptoms above, tell
your doctor immediately. Do not take other medicines for the infection without your
doctor’s advice.
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 JULUCA and affect how it works.
metformin, a medicine used to treat diabetes
medicines known as antacids which are used to treat indigestion and heartburn
famotidine, cimetidine, nizatidine, ranitidine (H2-receptor antagonists) used to treat
indigestion and heartburn
calcium and iron supplements (non-antacids)
rifabutin, a medicine used to treat some bacterial infections such as tuberculosis
clarithromycin, erythromycin, antibiotics used to treat bacterial infections
methadone, a medicine used for pain
efavirenz, etravirine, nevirapine, non-nucleoside reverse transcriptase inhibitors
(NNRTIs) used to treat HIV infection
any other medicines used to treat HIV infection
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect JULUCA.
4. How do I take JULUCA?
How much to take
The usual dosage of JULUCA is one tablet taken once a day with a meal.
Follow the instructions provided and use JULUCA until your doctor tells you to stop.
When to take JULUCA
Your doctor or pharmacist will tell you when to take JULUCA each day.
If you take an antacid medicine to treat indigestion or heartburn, you must take JULUCA
at least 4 hours before or 6 hours after you take the antacid.
Talk to your doctor or pharmacist for further advice on taking antacid medicines with
JULUCA.
If you take H2-receptor antagonists to treat indigestion and heartburn (e.g. famotidine,
cimetidine, nizatidine, ranitidine) you should take JULUCA at least 4 hours before
or 12 hours after you take the H2-receptor antagonist.
If you take calcium or iron supplements, you must take JULUCA at least 4 hours before
or 6 hours after you take a calcium or iron containing supplement. However, provided
you take JULUCA with a meal, you can take calcium and iron supplements at the same
time as JULUCA.
If you take rifabutin to treat bacterial infections such as tuberculosis, you must
also take a 25 mg dose of rilpivirine at the same time as you take JULUCA.
How to take JULUCA
Swallow the tablet whole with a drink of water.
It is important to take JULUCA with a meal. A protein-rich nutritional drink alone
does not replace a meal.
If you forget to take JULUCA
JULUCA should be taken regularly at the same time each day.
If it is less than 12 hours before your next dose, skip the dose you missed and take
your next dose when you are meant to.
Otherwise take it as soon as you remember and then go back to taking JULUCA as you
would normally.
Do not take a double dose to make up for the dose you missed.
If you take too much JULUCA
If you think that you have taken too much JULUCA, 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 taking JULUCA?
Things you should do
Ensure you have blood tests when you are meant to. It is important that your doctor
monitors your health.
Tell your doctor straight away if you:
become pregnant or intend to become pregnant
have not taken JULUCA as intended
Remind any doctor, dentist or pharmacist you visit that you are taking JULUCA.
Things you should not do
Do not stop using this medicine suddenly or change the dose.
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
Do not use this medicine to treat any other complaints unless your doctor tells you
to.
Stay in regular contact with your doctor
JULUCA helps to control your condition, but it is not a cure for HIV infection. You
need to keep taking it everyday to stop your illness from getting worse. Because JULUCA
does not cure HIV infections, you may still develop other infections and illnesses
linked to HIV.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how JULUCA
affects you.
JULUCA may cause dizziness or make you feel less alert than normal.
Looking after your medicine
Follow the instructions on the bottle on how to take care of your medicine properly.
Store it in a cool dry place (below 30°C) 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.
Within the first few weeks of treatment with anti-HIV medicines, some people, particularly
those that have been HIV positive for some time, may develop inflammatory reactions
(e.g. pain, redness, swelling, high temperature) which may resemble an infection and
may be severe. It is thought that these reactions are caused by a recovery in the
body's ability to fight infections, previously suppressed by HIV.
If you become concerned about any new symptoms, or any changes in your health after
starting HIV treatment, discuss with your doctor immediately.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Some side effects will only show up following a blood test. These include:
inflammation in the liver
increase in the level of liver enzymes
increase in bilirubin levels (a substance produced by the liver)
increase in the level of enzymes produced in the muscles (creatine phosphokinase,
creatinine)
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 JULUCA contains
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Active ingredient
(main ingredients)
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dolutegravir
rilpivirine (as hydrochloride)
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Other ingredients
(inactive ingredients)
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croscarmellose sodium
iron oxide red
iron oxide yellow
lactose monohydrate
macrogol 3350
magnesium stearate
mannitol
microcrystalline cellulose
polysorbate 20
polyvinyl alcohol
povidone
purified talc
silicified microcrystalline cellulose
sodium starch glycollate type A
sodium stearylfumarate
titanium dioxide
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Potential allergens
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lactose monohydrate
mannitol
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Do not take this medicine if you are allergic to any of these ingredients.
What JULUCA looks like
JULUCA tablets are pink, film coated, oval, biconvex shaped debossed with "SV J3T"
on one side.
JULUCA is available in bottles of 30 tablets. The bottle contains a desiccant. Once
the bottle is opened, keep the desiccant in the bottle.
AUST R 291356
Who distributes JULUCA
ViiV Healthcare Pty Ltd
Level 4, 436 Johnson Street
Abbotsford VIC 3067
Australia
Trademarks are owned by or licenced to the ViiV Healthcare group of companies.
© 2022 ViiV Healthcare group of companies or its licensor.
This leaflet was prepared on 13 December 2022.
Version 4.0