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.
Important safety information on TRIUMEQ hypersensitivity reaction is provided in the
full CMI. Read before using this medicine.
1. Why am I using TRIUMEQ?
TRIUMEQ contains three active ingredients dolutegravir, abacavir and lamivudine. TRIUMEQ
is used to treat human immunodeficiency virus (HIV) infection, which can lead to Acquired
Immune Deficiency Syndrome (AIDS) and other related illnesses (eg AIDS-related Complex
or ARC).
2. What should I know before I use TRIUMEQ?
Do not use if you have ever had an allergic reaction to dolutegravir, abacavir and
lamivudine 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.
For more information, see Section
2. What should I know before I use TRIUMEQ? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with TRIUMEQ and affect how it works.
4. How do I use TRIUMEQ?
The normal dose for adults and adolescents is one combined tablet, once a day.
TRIUMEQ tablets should be swallowed whole with water.
TRIUMEQ tablets do not have to be taken with food.
5. What should I know while using TRIUMEQ?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using TRIUMEQ.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine.
For as long as you're taking TRIUMEQ, your doctor will arrange regular blood tests
to check for side effects.
Keep in contact with your doctor, and don't stop taking TRIUMEQ without your doctor's
advice
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Things you should not do
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Do not stop using this medicine or lower the dosage without checking with your doctor.
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Driving or using machines
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Don't drive or use machines unless you are sure you're 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.
Do not store TRIUMEQ or any other medicine in the bathroom or near a sink. Do not
leave it on a windowsill or in the car.
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6. Are there any side effects?
The most common side effects are fever, skin rash, feeling sick (nausea and or vomiting),
stomach pain (abdominal pain), tiredness, headache and rash.
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.
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PATIENTS TAKING TRIUMEQ, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION
(SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH TRIUMEQ
IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP
TAKING TRIUMEQ IF:
1) YOU GET A SKIN RASH OR
2) YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING GROUPS:
- FEVER
- SHORTNESS OF BREATH, SORE THROAT OR COUGH
- NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN
- SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO TRIUMEQ TABLETS, NEVER TAKE
TRIUMEQ, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (TRIUMEQ, TRIZIVIR & ZIAGEN)
AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE TRIUMEQ PACK, TO REMIND YOU AND MEDICAL STAFF
ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED FROM THE PACK AND KEPT
WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER SECTION 5. WHAT SHOULD I KNOW WHILE USING TRIUMEQ? .
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Active ingredients:
dolutegravir (as sodium), abacavir (as sulfate) and lamivudine
Consumer Medicine Information (CMI)
This leaflet provides important information about using TRIUMEQ. 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 TRIUMEQ.
Where to find information in this leaflet:
1. Why am I using TRIUMEQ?
TRIUMEQ contains the active ingredients dolutegravir, abacavir and lamivudine. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors
(INIs). Abacavir and lamivudine belong to a group of anti-retroviral medicines called
nucleoside analogue reverse transcriptase inhibitors (NRTIs).
TRIUMEQ is used to treat Human Immunodeficiency Virus (HIV) infection in adults and
children over 12 years old.
TRIUMEQ does not cure HIV infection; it reduces the amount of virus in your body,
and keeps it at a low level. TRIUMEQ also increases the CD4 cell count in your blood.
CD4 cells are a type of white blood cells that are important in helping your body
to fight 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 any.
2. What should I know before I use TRIUMEQ?
Warnings
Do not use TRIUMEQ if:
you are allergic to abacavir, which is also included in medicines called KIVEXA, TRIZIVIR
and ZIAGEN.
you are allergic to the active ingredients dolutegravir or lamivudine, or any of the
ingredients listed at the end of this leaflet.
if you're taking another medicine called dofetilide, pilsicainide (to treat heart
conditions) or fampridine (used in multiple sclerosis).
if you have a serious liver disease TRIUMEQ may not be suitable for you.
Check with your doctor if you:
have a kidney problem. You may need extra check-ups, including blood tests, while
you're taking this medicine.
have any other medical conditions.
take any medicines for any other condition.
have allergies to any other medicines, foods, preservatives or dyes.
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.
Taking dolutegravir (one of the components of TRIUMEQ) at the time of becoming pregnant,
or during the first twelve weeks of pregnancy, may increase the risk of a type of
birth defect, called neural tube defect, such as spina bifida (malformed spinal cord).
Your doctor can discuss with you the risks and benefits involved.
Abacavir and lamivudine belong to a group of anti-retroviral medicines called nucleoside
analogue reverse transcriptase inhibitors (NRTIs). In babies and infants exposed to
NRTIs during pregnancy or labour small temporary increases in blood levels of a substance
called lactate have been observed. Additionally, there have been very rare reports
of diseases that affect the nervous system such as a delayed development and seizures.
Overall, in children whose mothers took NRTIs during pregnancy, the benefit from the
reduced chance of being infected with HIV is likely to be greater than the risk of
suffering from side effects.
Where possible, women who are HIV-positive should not breast feed. This is because
HIV infection can be passed on to the baby in breast milk. If formula feeding is not
possible, you should get advice from your doctor.
A small amount of the ingredients in TRIUMEQ can also pass into your breast-milk.
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 and feet and moving up 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.
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 TRIUMEQ and affect how it works.
Do not take TRIUMEQ with these medicines:
dofetilide or pilsicainide, to treat heart conditions
fampridine, used in multiple sclerosis.
These medicines should not be used with TRIUMEQ:
emtricitabine, to treat HIV infection
sorbitol-containing medicines (usually liquids) used regularly.
Tell your doctor if you are taking:
metformin, to treat diabetes
medicines called antacids, to treat indigestion and heartburn. Do not take an antacid
that contains aluminium, calcium or magnesium during the 6 hours before you take TRIUMEQ,
or for at least 2 hours after you take it. These antacids, readily available over
the counter, will decrease the effectiveness of TRIUMEQ if taken at the same time
as TRIUMEQ.
calcium and iron supplements. Do not take a calcium or iron supplement during the
6 hours before you take TRIUMEQ, or for at least 2 hours after you take it. If you
take food with your medicine you can take a calcium or iron supplement at the same
time as TRIUMEQ.
etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir,
to treat HIV infection
rifampicin, to treat tuberculosis (TB) and other bacterial infections
co-trimoxazole, an antibiotic used to treat Pneumocystis jiroveci pneumonia (often
referred to as PCP) or toxoplasmosis
phenytoin and phenobarbital, to treat epilepsy
carbamazepine, to treat epilepsy and bipolar disorder
St. John's wort, (Hypericum perforatum), a herbal remedy to treat depression.
If you are taking methadone, your doctor may need to adjust your methadone dose, as
abacavir (one of the active substances in TRIUMEQ) increases the rate at which methadone
leaves your body. This is unlikely to affect most methadone users.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TRIUMEQ.
4. How do I take TRIUMEQ?
How much to take
The usual dose of TRIUMEQ in adults and in children over the age of 12 years weighing
at least 40 kg is one combined tablet (50 mg dolutegravir, 600 mg abacavir, 300 mg
lamivudine) taken once a day.
If you weigh less than 40kg, you cannot take TRIUMEQ, because the dose of each component
of this medicine cannot be adjusted to your weight. Your doctor might prescribe the
components separately for you.
Follow the instructions provided and use TRIUMEQ until your doctor tells you to stop.
When to take TRIUMEQ
TRIUMEQ should be taken at the same time each day. This will help you remember when
to take it.
How to take TRIUMEQ
TRIUMEQ should be swallowed whole with water. TRIUMEQ tablets do not have to be taken
with food.
If you forget to take TRIUMEQ
TRIUMEQ should be taken regularly at the same time each day. If you miss your dose
at the usual time, take it as soon as you remember, and then continue as before.
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 TRIUMEQ
If you think that you have taken too much TRIUMEQ, 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 TRIUMEQ?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking TRIUMEQ.
Tell any other doctors, dentists, and pharmacists who treat you that you are taking
this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
this medicine. It may affect other medicines used during surgery.
Keep all of your doctor's appointments so that your progress can be checked.
If you have stopped taking TRIUMEQ tablets for any reason, it is important that you
contact your doctor before restarting. This is especially so if you think you are
having side-effects or have another illness. In some cases your doctor will ask you
to restart TRIUMEQ tablets where medical care can be readily accessed by yourself
or others.
Call your doctor straight away if you:
Become pregnant while taking this medicine.
Things you should not do
Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
If you have hepatitis B infection, you should not stop TRIUMEQ tablets without instructions
from your doctor, as you may have a recurrence of your hepatitis. This may occur due
to you suddenly stopping lamivudine.
Fat loss or fat gain
Fat loss or fat gain has been observed with combined antiretroviral therapy. A causal
relationship for this has not been established. Should any change in body shape be
noticed, seek medical advice.
Hypersensitivity reaction
TRIUMEQ contains abacavir. Abacavir can cause a serious allergic reaction known as
a hypersensitivity reaction, which can be life-threatening if treatment with abacavir
containing products is not stopped.
Research has found that people with a gene called HLA-B (type 5701) are more likely
to have a hypersensitivity reaction to abacavir. However, even if you do not have
this gene type it is still possible for you to get this reaction. If you know you
have this gene type, be sure to tell your doctor before you take abacavir.
What are the symptoms?
The most common symptoms are:
fever (high temperature) and skin rash.
Other common symptoms are:
nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain,
severe tiredness, shortness of breath, cough, headache, muscle pain and discomfort.
Other less common symptoms can include:
pains in the joints, swelling of the neck, serious breathing problems, sore throat
occasionally, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure,
tingling or numbness of the hands or feet.
When do these reactions happen?
Hypersensitivity reactions can start at any time during treatment with TRIUMEQ but
are more likely during the first 6 weeks of treatment.
Contact your doctor immediately:
if you get a skin rash, OR
if you get symptoms from at least 2 of the following groups:
fever
shortness of breath, sore throat or cough
nausea or vomiting, diarrhoea or stomach pain
severe tiredness or achiness, or generally feeling ill.
Always carry your Alert Card while you are taking TRIUMEQ.
If you have stopped taking TRIUMEQ:
If you have stopped taking TRIUMEQ because of a hypersensitivity reaction, you must
NEVER AGAIN take TRIUMEQ, or any other medicine containing abacavir (ZIAGEN, KIVEXA
or TRIZIVIR). If you do, within hours, your blood pressure could fall dangerously
low, which could result in death. You should also never again take medicines containing
dolutegravir.
Talk to your doctor before you start again. Your doctor will check whether your symptoms
were related to a hypersensitivity reaction. If the doctor thinks they may have been,
you will then be told never again to take TRIUMEQ, or any other medicine containing
abacavir. You may also be told never again to take any other medicine containing dolutegravir.
It is important that you follow this advice.
If you are hypersensitive to TRIUMEQ tablets you should return all of your unused
TRIUMEQ tablets to your doctor or pharmacist for proper disposal.
You will need regular blood tests
For as long as you're taking TRIUMEQ, your doctor will arrange regular blood tests
to check for side effects.
Stay in regular contact with you doctor
TRIUMEQ helps 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
TRIUMEQ does 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 TRIUMEQ
without your doctor's advice.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TRIUMEQ
affects you.
TRIUMEQ may make you dizzy or other side effects that may make you less alert.
Don't drive or use machines unless you're not affected.
Looking after your medicine
Store in the original package in order to protect from moisture. Keep the bottle tightly
closed. Do not remove the desiccant.
Keep your tablets in a cool dry place where the temperature stays below 30°C.
Do not store TRIUMEQ or any other medicine in the bathroom or near a sink. Do not
leave it on a window sill or in the car.
Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half
metres above the ground is a good place to store medicines
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.
Less serious side effects
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Less serious side effects
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What to do
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Very common side effects
These may affect more than 1 in 10 people:
Gastrointestinal:
diarrhoea
feeling sick (nausea)
Nervous system:
headache
Common side effects
These may affect at least 1 in 10 people:
Gastrointestinal:
diarrhoea
being sick (vomiting)
stomach pains (abdominal pain) and bloating (abdominal distension)
stomach (abdominal) discomfort
wind (flatulence)
indigestion (dyspepsia)
gastro-oesophageal reflux disease
loss of appetite
General:
weight gain
feeling drowsy
tiredness, lack of energy
general feeling of being unwell
Musculoskeletal:
joint pain
muscle pain and discomfort
Nervous system:
high temperature (fever)
dizziness
Psychiatric:
nightmares and abnormal dreams
sleep disorder
depression (feelings of deep sadness and unworthiness)
anxiety
Skin related:
hair loss
skin rash
itching (pruritis)
From blood tests:
increase in triglycerides (type of fat) in the blood
increase in glucose (sugar) in the blood
Uncommon side effects
These may affect up to 1 in 100 people:
General:
inflammation of liver (hepatitis)
Psychiatric:
suicidal thoughts and behaviours (mainly in patients who have had depression or mental
health problems before)
From blood tests:
a low red blood cell count (anaemia) or low white blood cell count (neutropenia)
a decrease in the number of cells involved in blood clotting (thrombocytopenia)
an increase in the level of liver enzymes
Rare side effects
These may affect up to 1 in 1000 people:
General:
inflammation of the pancreas (pancreatitis)
liver failure (signs may be yellowing of the skin and the whites of the eyes or unusually
dark urine)
Musculoskeletal:
breakdown of muscle tissue.
From blood tests:
increase in an enzyme called amylase.
Very rare side effects
These may affect up to 1 in 10,000 people:
Nervous system:
tingling or numbness of the hands and feet (paraesthesiae)
tingling, numbness or weakness of the arms and legs (peripheral neuropathy)
Skin related:
skin rash, which may form blisters and looks like small targets (central dark spots
surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
widespread rash with blisters and peeling skin, particularly around the mouth, nose,
eyes and genitals (Stevens-Johnson syndrome), and a more severe form causing skin
peeling in more than 30% of the body surface (toxic epidermal necrolysis).
inflammation of the pancreas (pancreatitis)
From blood tests:
failure of bone marrow to produce new red blood cells
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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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Serious side effects
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Serious side effects
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What to do
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Lactic Acidosis
Some people taking TRIUMEQ, or other medicines like it (NRTIs), develop a condition
called lactic acidosis, together with an enlarged liver.
Lactic acidosis is caused by a build-up of lactic acid in the body. It is rare; if
it happens, it usually develops after a few months of treatment. It can be life-threatening,
causing failure of internal organs.
Lactic acidosis is more likely to develop in people who have liver disease, especially
in women.
Signs of lactic acidosis include:
deep, rapid, difficult breathing
drowsiness
numbness or weakness in the limbs
feeling sick (nausea), being sick (vomiting)
stomach pain.
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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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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 TRIUMEQ contains
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Active ingredient
(main ingredient)
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50 mg of dolutegravir (as dolutegravir sodium), 600 mg of abacavir (as abacavir sulfate)
and 300 mg lamivudine as the active ingredients.
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Other ingredients
(inactive ingredients)
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mannitol
microcrystalline cellulose
povidone
sodium starch glycolate
magnesium stearate
polyvinyl alcohol
titanium dioxide
macrogol 3350
talc
iron oxide red
iron oxide black
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Do not take this medicine if you are allergic to any of these ingredients.
What TRIUMEQ looks like
TRIUMEQ tablets are purple, oval, biconvex film-coated tablets debossed with '572
Trı' on one side.
(AUST R 218644)
TRIUMEQ tablets are available in bottles of 30 tablets with child-resistant closure.
Who distributes TRIUMEQ
ViiV Healthcare Pty Ltd
Level 4, 436 Johnston St,
Abbotsford, Victoria, 3067
Australia.
Trade marks 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 20 March 2024.
Version 13.0