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.
WARNING: Important safety information is provided in a boxed warning in the
full CMI. Read before using this medicine.
1. Why am I taking TRIZIVIR?
TRIZIVIR contains the active ingredients abacavir, lamivudine and zidovudine. TRIZIVIR
is used, alone or in combination with other antiretrovirals, to slow down the progression
of human immunodeficiency virus (HIV) infection which can lead to Acquired Immune
Deficiency Syndrome (AIDS) and other related illnesses (e.g. AIDS-related Complex
(ARC)).
For more information, see Section
1. Why am I taking TRIZIVIR? in the full CMI.
2. What should I know before I take TRIZIVIR?
Do not use if you have ever had an allergic reaction to TRIZIVIR or any of the ingredients
listed at the end of the CMI.
IF YOU EXPERIENCE AN ALLERGIC REACTION TO TRIZIVIR IMMEDIATELY STOP TAKING THIS MEDICINE
AND SEEK MEDICAL ATTENTION. THIS MAY BE LIFE-THREATENING.
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 take TRIZIVIR? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with TRIZIVIR and affect how it works.
4. How do I take TRIZIVIR?
The usual dosage of TRIZIVIR tablets is one tablet twice a day. Swallow the tablets
with some water.
5. What should I know while taking TRIZIVIR?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are taking TRIZIVIR.
For as long as you are taking TRIZIVIR, your doctor will arrange for you to have regular
blood tests to check for side effects.
Keep in contact with your doctor and don’t stop taking TRIZIVIR without talking to
your doctor.
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Things you should not do
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Do not stop using this medicine or change the dose without talking to your doctor
unless you experience an allergic reaction.
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 TRIZIVIR
affects you.
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Looking after your medicine
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Store TRIZIVIR below 30°C in the pack out of direct light.
Keep this medicine in the pack until it is time to take it.
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6. Are there any side effects?
Side effects that have been reported include body odour, chills, increased sensitivity
to pain, back pain, chest pain, weakness, weight loss, loss of appetite, generally
feeling unwell, feeling faint, constipation, diarrhoea, difficulty in swallowing,
mouth ulcers, bleeding gums, heartburn, vomiting, nausea, muscle aches and spasms,
confusion, depression, nervousness, loss of mental clarity, dizziness, headache, sleeplessness,
cough, sore throat, hay fever, itchiness, vision problems, sensitivity to light, ,increased
frequency of urination, anaemia, neutropenia, allergic reactions, pancreatitis, lipoatrophy
and lactic acidosis.
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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WARNING: PATIENTS TAKING TRIZIVIR, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY
REACTION (SEROUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH
TRIZIVIR IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD
STOP TAKING TRIZIVIR 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, VOMITING, DIARRHOEA OR ABDOMINAL PAIN
- SEVERE TIREDNESS, ACHINESS OR GENERALLY FEELING UNWELL
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO TRIZIVIR TABLETS, NEVER
TAKE TRIZIVIR OR ANY OTHER MEDICINE CONTAINING ABACAVIR (Kivexa, Triumeq, Ziagen)
AGAIN AS YOU MAY DEVELOP A LIFE-THREATENING REACTION WHICH CAN BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE TRIZIVIR 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 2. WHAT SHOULD I KNOW BEFORE I TAKE TRIZIVIR.
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Active ingredients:
abacavir, lamivudine and zidovudine
Consumer Medicine Information (CMI)
This leaflet provides important information about using TRIZIVIR. 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 TRIZIVIR.
Where to find information in this leaflet:
1. Why am I taking TRIZIVIR?
TRIZIVIR contains the active ingredients abacavir, lamivudine and zidovudine. TRIZIVIR belongs to a group of medicines called antiretrovirals.
TRIZIVIR is used, alone or in combination with other antiretrovirals, to slow down
the progression of human immunodeficiency virus (HIV) infection which can lead to
Acquired Immune Deficiency Syndrome (AIDS) and other related illnesses (e.g. AIDS-related
Complex (ARC)).
TRIZIVIR does not cure AIDS or HIV infection however it slows down production of HIV
in the body. In this way it stops ongoing damage to the body’s immune system which
fights 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 TRIZIVIR 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.
TRIZIVIR is a combination medicine and may be available separately in some countries:
abacavir alone is called ZIAGEN (tablets and oral solution), lamivudine alone is called
3TC (tablets and oral solution) and zidovudine alone is RETROVIR (tablets and oral
solution).
2. What should I know before I take TRIZIVIR?
Warnings
HYPERSENSITIVITY REACTION
Patients taking TRIZIVIR may develop a hypersensitivity reaction (serious allergic
reaction) which can be life-threatening if you continue to take TRIZIVIR. It is important
that you read the information on this reaction in this section of the leaflet. There
is also an alert card included in the TRIZIVIR pack to remind you and medical staff
about TRIZIVIR hypersensitivity. This card should be removed from the pack and kept
with you at all times.
The symptoms of this reaction include fever, nausea or vomiting or diarrhoea or abdominal
pain, skin rash or skin redness or itching, severe tiredness or body aches or generally
feeling unwell, shortness of breath or sore throat or cough.
If you develop any of these symptoms call your doctor IMMEDIATELY WHO WILL ADVISE
YOU WHETHER TO STOP TAKING TRIZIVIR. If your doctor is not available, you must urgently
seek other medicinal advice (e.g. by going to the Emergency Department at your nearest
hospital) before taking the next dose.
If you have had this reaction to TRIZIVIR, NEVER take TRIZIVIR or any other medicines
containing abacavir (Kivexa, Triumeq, Ziagen) again as WITHIN HOURS you may experience
a life-threatening lowering of your blood pressure or death.
Other symptoms may include joint or muscle pain, swelling of the neck or itchy skin.
Occasionally inflammation of the eye (conjunctivitis), ulcers in the mouth, tingling
or numbness of the hands or feet or low blood pressure may occur. The symptoms of
this allergic reaction can occur at any time during treatment. It usually occurs within
the first six weeks of treatment with abacavir, and gets worse with continued treatment.
Occasionally life-threatening hypersensitivity reactions have occurred when abacavir
was restarted in patients who reported only one of the symptoms on the Alert Card.
On very rare occasions, hypersensitivity has been reported when abacavir was re-started
in patients who had no symptoms of hypersensitivity before stopping.
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, it is still possible for you to get this reaction. If you know you have
this gene, be sure to tell your doctor before you take abacavir.
Do not use TRIZIVIR if:
you are allergic to abacavir (trade name Ziagen or any other abacavir containing products
Kivexa, Triumeq), lamivudine (trade name 3TC) or zidovudine (trade name Retrovir),
or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
TELL YOUR DOCTOR IMMEDIATELY IF YOU EXPERIENCE AN ALLERGIC REACTION.
YOU MUST NOT TAKE TRIZIVIR OR ANY OTHER MEDICINE CONTAINING ABACAVIR (Kivexa, Triumeq,
Ziagen) AGAIN.
you have a reduced red blood cell count (anaemia) or white blood cell count (neutropenia).
you have kidney disease or severe liver disease.
you are pregnant, think you may be pregnant or are breastfeeding.
Check with your doctor if you:
have any other medical conditions or illnesses and any not related to HIV infection
take any medicines for any other condition
are allergic to any other foods, dyes, preservatives or medicines
are taking riociguat (e.g. Adempas; a medicine used to treat high blood pressure in
the arteries that carry blood from the heart to the lungs) as your doctor may need
to reduce the dose of riociguat. Abacavir (one of the active ingredients in TRIZIVIR)
may increase the level of riociguat in your blood
have or have ever had a hepatitis B infection
have or have ever had liver problems (e.g. jaundice, hepatitis, a virus affecting
the liver, an enlarged liver, liver scarring (cirrhosis)) or if you have any risk
factors for liver problems (e.g. excessive alcohol intake, use illegal intravenous
drugs with shared equipment or have iron or copper storage disorders)
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
Talk to 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 TRIZIVIR whilst
pregnant or breastfeeding.
Children and adolescents
TRIZIVIR is not recommended for use in children or adolescents who weigh less than
40 kg. TRIZIVIR is a fixed dose combination tablet and- as such it cannot be adjusted
according to the size and weight of the patient.
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 TRIZIVIR and affects how it works.
If you take ribavirin (e.g. Ibavyr) and TRIZIVIR together it may cause or worsen anaemia
(low red blood cells). Tell your doctor if you notice symptoms of anaemia such as
tiredness and shortness of breath.
Tell your doctor if you are taking any of the following medicines:
phenytoin, a medicine used to treat epilepsy
oxazepam, lorazepam; medicines used to treat anxiety and insomnia
aspirin, codeine, morphine, methadone, indomethacin, ketoprofen, naproxen – medicines
used to treat pain
cimetidine, a medicine used to treat heartburn, stomach ulcers
clofibrate, a medicine used to treat high cholesterol, high triglycerides
probenecid, a medicine used to treat gout
isoprinosine, ganciclovir, interferons, ribavirin; antiviral medicines
stavudine, emtricitabine; medicines used to treat HIV
pentamidine, atovaquone; antimicrobial medicines
pyrimethamine, dapsone; medicines used to treat parasite infections
flucytosine, a medicine used to treat fungal infections
clarithromycin, trimethoprim/sulfamethoxazole, medicines used to treat bacterial infections
vincristine, vinblastine, doxorubicin; medicines used in the treatment of cancer
sorbitol-containing medicines (usually liquids) which are used regularly
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TRIZIVIR.
4. How do I take TRIZIVIR?
How much to take
The usual dosage of TRIZIVIR tablets is one tablet twice a day.
If you have certain medical conditions, your doctor may advise that you take a lower
dose of abacavir, lamivudine and/or zidovudine, the active ingredients in TRIZIVIR.
Follow the instructions provided and use TRIZIVIR until your doctor tells you to stop.
How to take TRIZIVIR
Swallow the tablets whole with a drink of water.
If you forget to take TRIZIVIR
TRIZIVIR should be taken regularly at the same time each day.
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 TRIZIVIR
If you think that you have used too much TRIZIVIR, 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 TRIZIVIR?
Things you should do
Tell your doctor straight away if you:
have any sign of an allergic reaction or have experienced an allergic reaction in
the past to any medicine containing abacavir (e.g. Kivexa, Triumeq, Ziagen)
become pregnant or intend to become pregnant
have not taken TRIZIVIR as intended
Remind any doctor, dentist or pharmacist you visit that you are taking TRIZIVIR.
This is especially important for any medicines that might have an effect on your liver,
kidneys, red or white blood cells or other cells in the body.
Stay in regular contact with your doctor
TRIZIVIR 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
TRIZIVIR does not cure HIV infections, you may still develop other infections and
illnesses linked to HIV.
Whilst you are taking TRIZIVIR it is important to have blood tests when your doctor
asks you to. This enables them to check your health and monitor the levels of your
red and white blood cells. If you develop anaemia or neutropenia, your doctor may
reduce the dose or stop treatment with TRIZIVIR.
If you stop taking TRIZIVIR
If you have a long-standing infection of your liver (hepatitis B) it may flare up.
This can cause serious illness particularly if your liver is already not working very
well. If you have both HIV and hepatitis B, when you stop taking TRIZIVIR, your doctor
is likely to arrange tests to check how well your liver is working and to measure
virus levels.
Things you should not do
Do not stop taking this medicine or change the dose.
If you have stopped taking TRIZIVIR for any reason it is important that you contact
your doctor before restarting. This is very important if you think you are experiencing
side effects from other medicines or have another illness.
Your doctor will check whether any symptoms you had before stopping this medicine
may be related to a hypersensitivity reaction.
If your doctor thinks there was a possibility that they were related, you may be told
to never take TRIZIVIR or any other medicine containing abacavir (Kivexa, Triumeq,
Ziagen) again. It is important to follow this advice.
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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TRIZIVIR
affects you.
TRIZIVIR may cause headaches and tiredness in some people.
Looking after your medicine
Keep TRIZIVIR in the pack until it is time to take it.
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.
If you become concerned about any new symptoms, or any changes in your health after
starting HIV treatment, discuss with your doctor immediately.
It is not known whether these side effects are due to taking TRIZIVIR or taking TRIZIVIR
whilst taking other medicines. Some of these side effects may occur as part of HIV
infection, AIDS or AIDS-related Complex.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Hypersensitivity reaction
TRIZIVIR contains abacavir (which is also an active ingredient in Kivexa, Triumeq
and Ziagen).
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. This reaction is described in the Section 2
What should I know before I take TRIZIVIR? It is important that you read and understand the information about this serious reaction.
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.
Less serious side effects
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Less serious side effects
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What to do
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Psychiatric disorders:
confusion, depression, nervousness, loss of mental clarity,
Nervous system disorders:
dizziness, seizures, headache, fainting, sleeplessness, fatigue, tiredness
unusual feelings in any part of the body, such as numbness, burning, tingling or pins
and needles
vision problems, sensitivity to light
Blood system disorders:
widening of blood vessels leading to low blood pressure and feeling faint
increased bruising or bleeding
Metabolic disorders:
weight loss, loss of appetite
Respiratory disorders:
cough, sore throat, hay fever, sinus problems, hoarseness
ear, nose, throat infections
Gastrointestinal disorders:
constipation, gas from the stomach or bowel, blood in the stool, diarrhoea, abdominal
discomfort and pain
vomiting, nausea
heartburn
difficulty in swallowing, mouth ulcers, bleeding gums
Skin disorders:
acne, itchiness, changes in nail, skin or mouth colour
Musculoskeletal disorders:
muscle aches or pains, muscle shaking or spasms or twitching
Urinary disorders:
passing too much urine or increased frequency of urination
General disorders:
generally feeling unwell
chills, fever
flu like symptoms
increased sensitivity to pain, back pain, enlarged glands, chest pain
discomfort and pain
Side effects that may show up in blood tests:
abnormal results of blood tests of liver function
reduction in blood cells
blood chemistry changes, with excess acidity of the blood
Other:
body odour
hearing loss
hair loss
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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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Blood system disorders:
reduced red blood cell count (anaemia)
reduced white blood cell count (neutropenia)
The frequency and severity of anaemia and neutropenia are greater in patients with
advanced HIV disease or in patients who start taking TRIZIVIR in the later stages
of HIV disease.
Allergic reactions:
serious skin reactions
swelling of the lips, tongue, wheezing or difficulty breathing, rash, hives on the
skin. These are all signs of an allergic reaction
Pancreatitis:
signs of an inflamed pancreas (pancreatitis) such as severe stomach pain or cramps,
nausea, vomiting
If you experience any of these symptoms soon after starting treatment with TRIZIVIR
stop taking this medicine and contact your doctor immediately.
Change in body shape:
Treatment with TRIZIVIR may cause a loss of fat from the legs, arms and face (lipoatrophy).
If this occurs tell your doctor and they will assess if you should stop taking TRIZIVIR
and your HIV treatment be changed. If you stop taking TRIZIVIR it may take several
months to see any lost fat return and you might not regain it all.
Lactic acidosis:
If you are taking medication for HIV and become unwell with fast breathing, stop taking
TRIZIVIR and talk to your doctor immediately. This might be a condition known as ‘lactic
acidosis’. The fast breathing is due to high acid levels in the blood. Your liver
may not be working properly and gets big and fatty and can be life threatening. This
illness occurs more often in women than men.
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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 TRIZIVIR contains
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Active ingredients
(main ingredients)
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abacavir (as sulfate)
lamivudine
zidovudine
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Other ingredients
(inactive ingredients)
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aluminium lake
hypromellose
indigo carmine CI73015
iron oxide yellow
macrogol 400
magnesium stearate
microcrystalline cellulose
sodium starch glycolate
titanium dioxide
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Do not take this medicine if you are allergic to any of these ingredients.
What TRIZIVIR looks like
TRIZIVIR tablets are blue/green capsule-shaped film-coated tablets, engraved with
"GX LL1" on one tablet face. Available in packs of 60 tablets.
AUST R 78348 (bottle)
AUST R 78349 (blister pack)
Who distributes TRIZIVIR
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 in December 2022.
Version 10.0