Trizivir
abacavir (as sulfate) / lamivudine / zidovudine
abacavir/lamivudine/zidovudine
Keep this leaflet. You may need to read it again.
If you have any further questions ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
The Trizivir pack includes an Alert Card, to remind you and medical staff about abacavir hypersensitivity. Detach this card and keep it with you at all times.
What Trizivir is and what it is used for
What you need to know before you take Trizivir
How to take Trizivir
Possible side effects
How to store Trizivir
Contents of the pack and other information
Trizivir contains three active ingredients that are used to treat HIV infection: abacavir, lamivudine and zidovudine. All of these belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Trizivir helps to control your condition. Trizivir does not cure HIV infection; it reduces the amount of virus in your body and keeps it at a low level. This helps your body to increase the CD4 cell count in your blood. CD4 cells are a type of white blood cell that are important in helping your body to fight infection.
Not everyone responds to treatment with Trizivir in the same way. Your doctor will monitor the effectiveness of your treatment.
if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir
— Kivexa, Triumeq or Ziagen), lamivudine or zidovudine, or any of the other ingredients of this medicine (listed in Section 6)
if you have severe kidney problems
if you have a very low red blood cell count (anaemia) or a very low white blood cell count (neutropenia)
Some people taking Trizivir are more at risk of serious side effects. You need to be aware of the extra risks:
if you have moderate or severe liver disease
if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Trizivir without your doctor’s advice, as your hepatitis may come back)
if you are seriously overweight (especially if you are a woman)
You may need extra check-ups, including blood tests, while you are taking your medicine. See Section 4 for more information.
Even patients who don’t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction).Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.
It cannot be excluded that abacavir may increase the risk of having a heart attack.
Trizivir unless your doctor advises you to do so.
Some people taking Trizivir develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you are taking Trizivir.
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). You can still pass on HIV when taking this
medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the
precautions needed to avoid infecting other people.
Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Trizivir.
stavudine or emtricitabine, to treat HIV infection
other medicinal products containing lamivudine, used to treat HIV infection or hepatitis B infection
ribavirin or injections of ganciclovir to treat viral infections
high doses of co-trimoxazole, an antibiotic
cladribine, used to treat hairy cell leukaemia
sodium valproate, to treat epilepsy
interferon, to treat viral infections
pyrimethamine, to treat malaria and other parasitic infections
dapsone, to prevent pneumonia and treat skin infections
fluconazole or flucytosine, to treat fungal infections such as candida
pentamidine or atovaquone, to treat parasitic infections such as Pneumocystis jirovecii
pneumonia (often referred to as PCP)
amphotericin or co-trimoxazole, to treat fungal and bacterial infections
probenecid, to treat gout and similar conditions, and given with some antibiotics to make them more effective
vincristine, vinblastine or doxorubicin, to treat cancer Tell your doctor if you’re taking any of these.
These include:
If you are taking clarithromycin, take your dose at least 2 hours before or after you take your Trizivir.
medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
Your doctor may need to reduce your riociguat dose, as abacavir may increase riociguat blood levels.
Abacavir increases the rate at which methadone is removed from the body. If you are taking methadone, you will be checked for any withdrawal symptoms. Your methadone dose may need to be changed.
Trizivir and similar medicines may cause side effects in unborn babies.
If you have taken Trizivir during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
If you are breast-feeding, or thinking about breast-feeding:
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
Take the tablets at regular times, leaving approximately 12 hours between each tablet. Swallow the tablets whole, with some water. Trizivir can be taken with or without food.
If you accidentally take too much Trizivir, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. Do not take a double dose to make up for a forgotten dose.
It is important to take Trizivir regularly, because if you take it at irregular intervals it may not continue to work against the HIV infection, and you may be more likely to have a hypersensitivity reaction.
If you have stopped taking Trizivir for any reason — especially because you think you are having side effects, or because you have other illness:
If your doctor advises that you can start taking Trizivir again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Treatment with Trizivir often causes a loss of fat from legs, arms and face (lipoatrophy). This loss of body fat has been shown to be not fully reversible after discontinuation of zidovudine. Your doctor should monitor for signs of lipoatrophy. Tell your doctor if you notice any loss of fat from your legs, arms, and face. When these signs occur, Trizivir should be stopped and your HIV treatment changed.
Like all medicines, this medicine can cause side effects, although not everyone gets them. When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of
Trizivir or other medicines you are taking, or an effect of the HIV infection itself. So it is very important to talk to your doctor about any changes in your health.
Even patients who don’t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction), described in this leaflet in the panel headed ‘Hypersensitivity reactions’.
It is important to read the information on the other side of this leaflet under ‘Other possible side effects of Trizivir’.
Anyone taking Trizivir could develop a hypersensitivity reaction to abacavir, which could 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 get a reaction even if you do not have this gene). You should have been tested for this gene before Trizivir was prescribed for you. If you know you have this gene, tell your doctor before you take Trizivir.
About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have the HLA- B*5701 gene developed a hypersensitivity reaction.
The most common symptoms are:
Other common symptoms are:
nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness
Other symptoms include:
Pains in the joints or muscles, swelling of the neck, shortness of breath, sore throat, cough, occasional headaches, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure, tingling or
numbness of the hands or feet.
Hypersensitivity reactions can start at any time during treatment with Trizivir, but are more likely during the first 6 weeks of treatment.
fever
shortness of breath, sore throat or cough
nausea or vomiting, diarrhoea or abdominal pain
severe tiredness or achiness, or generally feeling ill
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, within hours, your blood pressure could fall dangerously low, which could result in death.
If you have stopped taking Trizivir for any reason — especially because you think you are having side effects, or because you have other illness:
Occasionally, hypersensitivity reactions have developed in people who start taking abacavir containing products again, but who had only one symptom on the Alert Card before they stopped taking it.
Very rarely, patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.
If your doctor advises that you can start taking Trizivir again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
Ask your doctor or pharmacist for advice.
The Trizivir pack includes an Alert Card, to remind you and medical staff about hypersensitivity reactions. Detach this card and keep it with you at all times.
These may affect more than 1 in 10 people:
headache
feeling sick (nausea)
These may affect up to 1 in 10 people:
hypersensitivity reaction
being sick (vomiting)
diarrhoea
stomach pains
loss of appetite
feeling dizzy
tiredness, lack of energy
fever (high temperature)
general feeling of being unwell
difficulty in sleeping (insomnia)
muscle pain and discomfort
joint pain
cough
irritated or runny nose
skin rash
hair loss
Common side effects that may show up in blood tests are:
a low red blood cell count (anaemia) or low white blood cell count (neutropenia or leukopenia)
an increase in the level of liver enzymes
an increased amount in the blood of bilirubin (a substance produced in the liver) which may make your skin appear yellow
These may affect up to 1 in 100 people:
feeling breathless
wind (flatulence)
itching
muscle weakness
An uncommon side effect that may show up in blood tests is:
a decrease in the number of cells involved in blood clotting (thrombocytopenia), or in all kinds of blood cells (pancytopenia)
These may affect up to 1 in 1000 people:
liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
lactic acidosis (excess lactic acid in the blood ; see the next section, ‘Other possible side effects of Trizivir’)
inflammation of the pancreas (pancreatitis)
chest pain; disease of the heart muscle (cardiomyopathy)
fits (convulsions)
feeling depressed or anxious, not being able to concentrate, feeling drowsy
indigestion, taste disturbance
changes in the colour of your nails, your skin, or the skin inside your mouth
a flu-like feeling — chills and sweating
tingly feelings in the skin (pins and needles)
sensation of weakness in the limbs
breakdown of muscle tissue
numbness
passing urine more often
enlarged breasts in men
Rare side effects that may show up in blood tests are:
increase in an enzyme called amylase
a failure of the bone marrow to produce new red blood cells (pure red cell aplasia)
These may affect up to 1 in 10,000 people:
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)
a 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)
a failure of the bone marrow to produce new red or white blood cells (aplastic anaemia)
Trizivir may cause other conditions to develop during HIV treatment.
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation. These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections. Symptoms usually include fever, plus some of the following:
headache
stomach ache
difficulty breathing
In rare cases, as the immune system becomes stronger, it can also attack 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:
palpitations (rapid or irregular heartbeat) or tremor
hyperactivity (excessive restlessness and movement)
weakness beginning in the hands and feet and moving up towards the trunk of the body
If you get any symptoms of infection while you’re taking Trizivir:
Some people taking Trizivir 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, or in obese (very overweight) people, especially women.
feeling sick (nausea), being sick (vomiting)
stomach pain
generally feeling unwell
loss of appetite, weight loss
deep, rapid, difficult breathing
numbness or weakness in the limbs
During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed above or any other symptoms that worry you:
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:
if they have been taking combination therapy for a long time
if they are also taking anti-inflammatory medicines called corticosteroids
if they drink alcohol
if their immune systems are very weak
if they are overweight
stiffness in the joints
aches and pains (especially in the hip, knee or shoulder)
difficulty moving
If you notice any of these symptoms:
Trizivir can also cause:
increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the carton. The expiry date refers to the last day of that month.
Do not store above 30°C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures help protect the environment.
The active substances in each Trizivir film-coated tablet are 300 mg of abacavir (as sulfate), 150 mg lamivudine and 300 mg zidovudine.
The other ingredients are microcrystalline cellulose, sodium starch glycollate and magnesium stearate in the core of the tablet. The tablet coating contains hypromellose, titanium dioxide, polyethylene glycol, indigo carmine aluminium lake, iron oxide yellow.
Trizivir film-coated tablets are engraved with ‘GX LL1’ on one side. They are blue/green and capsule- shaped and are provided in blister packs containing 60 tablets or bottles containing 60 tablets with
child-resistant tops.
ViiV Healthcare BV
Van Asch van Wijckstraat 55H 3811 LP Amersfoort Netherlands
GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189 , 60-322 Poznan, Poland
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
ViiV Healthcare srl/bv
Tél/Tel: + 32 (0) 10 85 65 00
ViiV Healthcare BV Tel: + 370 80000334
ViiV Healthcare BV Teл.: + 359 80018205
ViiV Healthcare srl/bv
Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 65 00
ViiV Healthcare BV Tel.: + 36 80088309
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
ViiV Healthcare BV Tel: + 356 80065004
ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10
viiv.med.info@viivhealthcare.com
ViiV Healthcare BV Tel: + 31 (0) 33 2081199
ViiV Healthcare BV Tel: + 372 8002640
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
Laboratorios ViiV Healthcare, S.L.
Tel: +34 900 923 501
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969
ViiV Healthcare BV Tel: + 385 800787089
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tel: + 351 21 094 08 01
ViiV Healthcare BV Tel: + 40800672524
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
ViiV Healthcare BV Tel: + 386 80688869
Vistor hf.
Sími: +354 535 7000
ViiV Healthcare S.r.l Tel: + 39 (0)45 7741600
ViiV Healthcare BV
Τηλ: + 357 80070017
ViiV Healthcare BV Tel: + 371 80205045
ViiV Healthcare BV Tel: + 44 (0)800 221441