300 mg/150 mg/300 mg film-coated tablets
abacavir/lamivudine/zidovudine
What Trizivir is and what it is used for
Trizivir is used to treat HIV infection in adults.
Trizivir contains three active substances used to treat HIV infection ( human immunodeficiency virus infection): abacavir, lamivudine, and zidovudine. All these substances belong to a group of antiretroviral drugs called nucleoside analog reverse transcriptase inhibitors (NRTIs).
Trizivir helps control your disease. Trizivir does not cure HIV infection. It reduces the number of viruses in the body and keeps it at a low level. This helps your body increase the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that is important for the body to fight infection.
Not all patients respond to treatment with Trizivir in the same way. Your doctor will check which treatment effect you get.
What you need to know before you take Trizivir
Do not take Trizivir:
- if you are allergic (hypersensitive) to abacavir (or to other medicines containing abacavir – Kivexa, Triumeq, or Ziagen ), lamivudine or zidovudine, or to any of the other ingredients of this medicine (see section 6).
- Be sure to read the full information on hypersensitivity reactions in section 4.
- if you have severe kidney problems
- if you have a very low number of red blood cells (anemia) or a very low number of white blood cells ( neutropenia ).
Check with your doctor if you think any of these apply to you.
Take special care with Trizivir
Some patients taking Trizivir are at greater risk of serious side effects. You need to be aware of the additional risks:
- If you have moderate or severe liver disease
- if you have previously had liver disease, including hepatitis B or hepatitis C (if you have hepatitis B infection, do not stop taking Trizivir without consulting your doctor as your hepatitis may come back)
- if you are severely overweight (especially if you are a woman)
Talk to your doctor if any of these apply to you before using Trizivir. You may need extra checks, including blood tests, while you are taking medication. See section 4 for more information.
Hypersensitivity reaction to abacavir
Even patients who do not have the HLA-B*5701 gene can develop a hypersensitivity reaction (a severe allergic reaction ).
Be sure to read the full information on hypersensitivity reactions in section 4 of this leaflet.
Risk of heart attack
It cannot be ruled out that abacavir may increase the risk of a heart attack.
Tell your doctor if you have heart problems, if you smoke, or if you have other conditions such as high blood pressure or diabetes that may increase your risk of heart disease. Do not stop taking Trizivir unless your doctor advises you to do so.
Pay attention to important symptoms
Some people who use Trizivir develop other conditions that can be serious. You need to know important signs and symptoms to look out for while taking Trizivir.
Read the information “Other possible side effects of Trizivir” in section 4 of this leaflet.
Other medicines and Trizivir
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including over-the-counter medicines, herbal medicines, herbal medicines, or other natural products.
Remember to tell your doctor or pharmacist if you start taking a new medicine while you are taking Trizivir.
These medicines should not be taken with Trizivir:
- stavudine or emtricitabine to treat HIV infection
- medicines containing lamivudine, for the treatment of HIV infection or hepatitis B infection
- ribavirin or injection of ganciclovir for treatment of viral infection
- high doses of co-trimoxazole, an antibiotic.
- cladribine, which is used to treat hairy cell leukemia
Tell your doctor if you are being treated with any of these medicines.
Some medicines make you more likely to have side effects or make the side effects worse.
These include:
- sodium valproate, for the treatment of epilepsy
- interferon, for the treatment of viral infections
- pyrimethamine, for the treatment of malaria and other parasitic infections
- dapsone, to prevent pneumonia and treat skin infections
- fluconazole or flucytosine, for the treatment of fungal infections such as candida
- pentamidine or atovaquone, to treat parasitic infections such as Pneumocystis jirovecii – pneumonia (often called PCP)
- amphotericin or co-trimoxazole, to treat fungal and bacterial infections
- probenecid, for the treatment of gout and similar conditions, and which is given together with antibiotics to increase the effectiveness
- methadone, used as a heroin substitute
- vincristine, vinblastine, or doxorubicin, for the treatment of cancer.
Tell your doctor if you are using any of these medicines.
Some drugs interact with Trizivir
These include:
- clarithromycin, an antibiotic you are taking clarithromycin, take your dose at least 2 hours before or after you take Trizivir.
- phenytoin, for the treatment of epilepsy. Tell your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking Trizivir.
- medicines (usual liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol, and maltitol), if taken regularly. Tell your doctor or pharmacist if you are being treated with any of these medicines.
- riociguat, to treat high blood pressure in the blood vessels (pulmonary arteries) that carry blood from the heart to the lungs.
Your doctor may need to lower your riociguat dose because abacavir can increase riociguat blood levels.
Methadone and Trizivir
Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you will be monitored for withdrawal symptoms. Your methadone dose may need to be changed.
Pregnancy
If you are pregnant, become pregnant, or plan to become pregnant, talk to your doctor about the risks and benefits for you and your baby of taking Trizivir during your pregnancy.
Trizivir and similar medicines can cause side effects in the fetus.
If you have taken Trizivir during your pregnancy, the doctor may request regular blood tests and other diagnostic tests to check the baby’s development. For children of a mother who took NRTIs during pregnancy, the benefit of protection against HIV is greater than the risk of side effects.
Breast-feeding
Breastfeeding is not recommended for women living with HIV because HIV – infection
can be transferred to the baby through breast milk.
A small amount of the ingredients in Trizivir can also pass into breast milk.
If you are breastfeeding or thinking about starting to breastfeed, discuss this with your doctor as soon as possible.
Driving ability and use of machinery
Trizivir can make you dizzy and has other side effects that can make you less alert.
Do not drive or operate machinery if you are unwell.
Important information about any ingredient in Trizivir tablets
This medicine contains less than 1 mmol (23 mg) of sodium per dose unit, i.e. it is almost ‘sodium-free’.
How to take Trizivir
Always take this medicine as directed by your doctor. Consult your doctor or pharmacist if you are unsure.
Keep in touch with your doctor and do not stop taking Trizivir without your doctor’s advice.
How much to take
The usual dose of Trizivir for adults is one tablet twice daily.
Take the tablets at regular times with approximately 12 hours between each dose.
Swallow the tablets whole with a little water. Trizivir can be taken with or without food.
If you have taken too much Trizivir
If you accidentally take too much Trizivir, talk to your doctor or pharmacist, or contact the emergency department of your nearest hospital for further advice.
If you forget to take Trizivir
If you have forgotten to take a dose, take it as soon as you remember. Then continue with the treatment as before. Do not take a double dose to make up for a missed dose.
You must take Trizivir regularly, because an irregular intake may mean that the drug does not continue to work against HIV – infection, and the risk of a hypersensitivity reaction increases.
If you have stopped taking Trizivir
If you have stopped taking Trizivir for any reason – especially when you think you may have had side effects or because of another illness:
Talk to your doctor before you start taking the medicine again. Your doctor will investigate whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks there is a connection, you will be asked to never take Trizivir or other medicines containing abacavir (Kivexa, Triumeq, or Ziagen) ever again. You must follow this advice.
If your doctor advises you to start taking Trizivir again, you may be asked to take the first dose one at a time where you have access to medical care if needed.
Possible side effects
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but in the case of blood lipids, there can sometimes be a connection with HIV drugs. The doctor will perform tests to find such changes.
Treatment with Trizivir often causes loss of fat on the legs, arms, and face (lipoatrophy). It has been shown that such loss of body fat may not fully reverse after zidovudine treatment is stopped. Your doctor will look for signs of lipoatrophy. Tell your doctor if you notice a decrease in the amount of fat on your legs, arms, and face. When such signs appear, you should stop taking Trizivir and get other HIV treatment.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
When treating an HIV infection, it is not always possible to distinguish disease symptoms from drug side effects caused by Trizivir or other drugs are taken at the same time or symptoms of HIV infection per se. For this reason, you must talk to your doctor about any changes in your health.
Even patients who do not have the HLA-B*5701 gene can develop a hypersensitivity reaction (a severe allergic reaction ), described in this leaflet under the heading “Hypersensitivity reactions”. You must read and understand the information about this serious reaction.
As well to the side effects mentioned below for Trizivir, other conditions may develop during treatment.
It is important to read the information on the other side of this leaflet under “Other possible side effects of Trizivir”
| Hypersensitivity reaction Trizivir contains abacavir (which is also an active substance in Kivexa, Triumeq, and Ziagen ). Abacavir can cause a serious allergic reaction, a so-called hypersensitivity reaction. These hypersensitivity reactions have been seen more often in people taking medicines containing abacavir. Who can get these reactions? Anyone taking Trizivir can develop a hypersensitivity reaction to abacavir, which can be life-threatening if they continue to take Trizivir. You are more likely to develop such a reaction if you have a gene called HLA-B*5701 (but you can react even if you do not have this gene). You should have been tested for this gene before Trizivir was prescribed to you. If you know you carry this gene, talk to your doctor before taking Trizivir. About 3-4 out of every 100 patients treated with abacavir in a clinical trial who did not carry the HLA-B*5701 gene developed a hypersensitivity reaction. What are the symptoms? The most common symptoms are fever (high temperature) and skin rash. Other common symptoms are nausea, vomiting, diarrhea, abdominal pain, and pronounced fatigue. Other symptoms are joint or muscle pain, swollen throat, shortness of breath, sore throat, cough, temporary headache, eye inflammation ( conjunctivitis ), mouth sores, low blood pressure, tingling, or numbness in the hands or feet. When do these symptoms appear? Hypersensitivity reactions can occur at any time during treatment with Trizivir but are more likely during the first six weeks of treatment. |
| Contact your doctor immediately: | |
| 1 | if you get a rash, OR |
| 2 | if you get symptoms from at least 2 of the following groups:fever shortness of breath, sore throat or cough nausea or vomiting, diarrhea or abdominal pain pronounced fatigue or diffuse aches or general malaise. Your doctor may advise you to stop taking Trizivir. |
| If you have stopped taking Trizivir | |
| If you have stopped taking Trizivir because of a hypersensitivity reaction, you must NEVER AGAIN take Trizivir or any other medicine containing abacavir (Kivexa, Triumeq, or Ziagen). If you do, you can experience a dangerous drop in blood pressure within hours, which can result in death. | |
| If you have stopped taking Trizivir for any reason – especially when you think you may have had side effects or because of another illness: | |
| Talk to your doctor before you start taking the medicine again. Your doctor will investigate whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks there is a connection, you will be asked to never take Trizivir or other medicines containing abacavir (Kivexa, Triumeq, or Ziagen) ever again. You must follow this advice. | |
| Occasionally, hypersensitivity reactions have developed in patients restarting abacavir who had only one of the symptoms listed on the warning card before stopping the drug. In very rare cases, hypersensitivity reactions have developed in patients who restart abacavir but who had no symptoms before stopping the drug. If your doctor advises you to start taking Trizivir again, you may be asked to take the first dose one at a time where you have access to medical care if needed. If you are allergic to Trizivir, return all unused Trizivir tablets for destruction. Consult your doctor or pharmacist. The package of Trizivir contains an alert card to remind you and the healthcare professional about the hypersensitivity reaction. Tear off this card and carry it with you at all times. |
Very common side effects are
These may affect more than 1 in 10 users:
- headache
- nausea.
Common side effects are
These may affect up to 1 in 10 users:
- hypersensitivity reaction
- vomiting
- diarrhea
- abdominal pain
- loss of appetite
- dizziness
- fatigue, listlessness
- fever (high temperature)
- general (general) malaise
- sleep difficulties ( insomnia )
- muscle pain and discomfort
- joint pain
- cough
- irritated or runny nose
- rash
- hair loss
Common side effects that can be detected in blood tests are:
- low red blood cell count ( anemia ) or low white blood cell count ( neutropenia or leukopenia )
- increase in liver enzyme levels
- increase in the level of bilirubin (a substance produced by the liver) in the blood, which can turn your skin yellow
Less common side effects are
These may affect up to 1 in 100 users:
- shortness of breath
- gas in the stomach ( flatulence )
- itching
- muscle weakness
A less common side effect that can be detected in blood tests is:
- a decrease in the number of blood cells involved in blood clotting ( thrombocytopenia ) or of all types of blood cells (pancytopenia).
Rare side effects ar
These may affect up to 1 in 1,000 users:
- liver diseases, such as jaundice, enlarged liver or fatty liver, inflammation ( hepatitis )
- lactic acidosis (excess of lactic acid in the blood; see the next section under “Possible side effects of Trizivir” )
- inflammation of the pancreas ( pancreatitis )
- chest pain; disease of the heart muscle ( cardiomyopathy )
- convulsions
- depression or anxiety, difficulty concentrating, drowsiness
- poor digestion, taste changes
- discoloration of the nails, skin, or mucous membrane inside the mouth
- flu-like symptoms – chills and sweating
- numbness and tingling in the skin
- the feeling of weakness in arms and legs
- breakdown of muscle tissue
- numbness
- increased frequency of urination
- breast augmentation in men
Rare side effects that can be detected in blood tests are:
- increase in an enzyme called amylase
- failure of the bone marrow’s ability to form new red blood cells (erythroblastopenia)
Very rare side effects
These may affect up to 1 in 10,000 users:
- skin rash, which may blister and look like small targets (dark spot in the center surrounded by a lighter area and a dark ring along the edge) (erythema multiforme)
- widespread skin rash with blisters and peeling skin, occurring especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome ), and a more severe form that causes skin peeling on more than 30% of the body surface ( toxic epidermal necrolysis )
If you notice any of these symptoms, see a doctor immediately.
A very rare side effect that can be detected in blood tests is:
- failure of the bone marrow’s ability to form new red and white blood cells ( aplastic anemia )
If you get a side effect ar
Tell your doctor or pharmacist if any of these side effects become serious or bothersome, or if you notice any side effects not mentioned in this information.
Other possible side effects of Trizivir
Trizivir can cause other conditions to develop during HIV treatment.
Symptoms of infection and inflammation
Old infections can flare up
Patients with advanced HIV infection ( AIDS ) have a weakened immune system and are more likely to develop serious infections (opportunistic infections ). When these patients start treatment, it happens that old, hidden infections can flare up and cause signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system getting better and the body starts to fight these infections. Symptoms usually include fever and any of the following:
- headache
- gripe
- breathing difficulties
In rare cases, when the immune system becomes stronger, it can also attack healthy body tissue (autoimmune diseases). The symptoms of autoimmune diseases can develop several months after you start taking medicines for your HIV infection. Symptoms may include:
- palpitations (fast or irregular heartbeats) or tremors
- hyperactivity (excessive restlessness and excessive movements)
- weakness that starts in the hands and feet and moves up the trunk
If you notice any symptoms of infection while taking Trizivir:
Talk to your doctor immediately. Do not take any other anti-infection medicines without consulting your doctor.
Lactic acidosis is a rare but serious side effect
Some patients taking Trizivir to develop a condition called lactic acidosis, combined with an enlarged liver.
Lactic acidosis is caused by a build-up of lactic acid in the body. This condition is rare and if it does occur it usually develops after a few months of treatment. It can be life-threatening and cause internal organ failure.
The risk of developing lactic acidosis is greater in patients who have liver disease, or if they are severely overweight, especially in women.
Symptoms of lactic acidosis include:
- nausea, vomiting
- abdominal pain
- general malaise
- decreased appetite, weight loss
- deep, rapid, labored breathing
- numbness or weakness in the arms and legs.
During treatment, the doctor will closely monitor signs of lactic acidosis. If you have any of the symptoms mentioned above, or other symptoms that worry you:
See your doctor as soon as possible.
You may have problems with the skeleton
Some patients treated with combination therapy for HIV develop a condition called osteonecrosis. In this condition, parts of the bone tissue die due to reduced blood supply. Patients may be at greater risk of developing this condition:
- if they have been treated with combination therapy for a long time
- if they also take anti-inflammatory medicines called corticosteroids
- if they drink alcohol
- if their immune system is very weak
- if they are overweight
Signs of osteonecrosis include:
- stiffness in the joints
- aches and pains (especially in the hips, knees, or shoulders)
- movement difficulty
If you notice any of these symptoms:
Tell your doctor.
Other effects that can be detected in blood tests
Trizivir can also cause:
- increased levels of lactic acid in the blood, which in rare cases can lead to lactic acidosis
How to store Trizivir
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the carton. The expiration date is the last day of the specified month.
Store at a maximum of 30 °C.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
The active substances in each Trizivir film-coated tablet are 300 mg abacavir (as sulfate), 150 mg lamivudine, and 300 mg zidovudine.
Other ingredients in the tablet core are microcrystalline cellulose, sodium starch glycolate, and magnesium stearate. The film coating surrounding the tablet contains hypromellose, titanium dioxide, polyethylene glycol, indigo carmine, and yellow iron oxide.
Appearance and package sizes of the medicine
Trizivir film-coated tablets are engraved with “GX LL1” on one side. They are blue/green and capsule shaped. The tablets are supplied in blister packs of 60 tablets or child-resistant sealed jars of 60 tablets.
Marketing Authorisation Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands
Manufacturer
Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189, 60-322 Poznan, Poland.
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
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