What is it and how is it used?

Trizivir is used to treat HIV (human immunodeficiency virus) infection in adults.

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 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.

Not everyone responds to treatment with Trizivir in the same way. Your doctor will monitor the effectiveness of your treatment.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Don?t take Trizivir:

  • if you?re allergic(hypersensitive) to abacavir (or any other medicine containing abacavir ? Kivexa or Ziagen), lamivudine or zidovudine, or any of the other ingredients of Trizivir (listed in Section 6)Carefully read all the information about hypersensitivity reactions in Section 4.
  • if youhave liver problems
  • if youhave severe kidney problems
  • if you have a very low red blood cell count(anaemia) or a very low white blood cell count(neutropenia). Check with your doctor if you think any of these apply to you.
Take special care with Trizivir

Hypersensitivity reactions

About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have a gene called HLA-B*5701 developed a hypersensitivity reaction (a serious allergic reaction).

Carefully read all the information about hypersensitivity reactions in Section 4 of this leaflet.

Some people taking Trizivir are more at risk of serious side effects. You need to be aware of the extra risks:

  • if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, don?t stop Trizivir without your doctor?s advice, as your hepatitis may come back)
  • if you?re seriously overweight (especially if you?re a woman)
  • if you?re diabetic and using insulin. Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you?re taking your medicine. See Section 4 for more information.

Risk of heart attack

It cannot be excluded that abacavir may increase the risk of having a heart attack.
Tell your doctor if you have heart problems, if you smoke, or have other illnesses that may increase your risk of heart disease such as high blood pressure, or diabetes. Don?t stop taking Trizivir unless your doctor advises you to do so.

Look out for important symptoms

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?re taking Trizivir.
Read the information ?Other possible side effects of Trizivir? in Section 4 of this leaflet.

Protect other people

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). Trizivir will not stop you passing HIV infection on to other people. To protect other people from becoming infected with HIV:

  • Use a condom when you have oral or penetrative sex.
  • Avoid contact with other peoples? blood ? for example, don?t share needles.

Taking other medicines
Tell your doctor or pharmacist if you?re taking any other medicines
, or if you?ve taken any recently, including herbal medicines or other medicines you bought without a prescription.

Remember to tell your doctor or pharmacist if you begin taking a new medicine while you?re taking Trizivir.

These medicines should not be used with Trizivir:

  • stavudine or zalcitabine, to treat HIV infection
  • ribavirin, or injections of ganciclovir or foscarnet, to treat viral infections
  • high doses of co-trimoxazole, an antibiotic. Tell your doctor if you?re being treated with any of these.
Some medicines can make it more likely that you?ll have side effects, or make side effects worse These include:

  • sodium valproate, to treat epilepsy
  • interferon, to treat viralinfections
  • 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 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
  • methadone, used as a heroin substitute
  • vincristine, vinblastine or doxorubicin, to treat cancer. Tell your doctor if you?re taking any of these.

Some medicines interact with Trizivir

These include:

  • clarithromycin, an antibiotic If you?re taking clarithromycin, take your dose at least 2 hours before or after you take your Trizivir.
  • phenytoin, for treating epilepsy. Tell your doctor if you?re taking phenytoin. Your doctor may need to monitor you while you?re taking Trizivir.
Methadone and Trizivir

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.

Pregnancy
Trizivir is not recommended for use during pregnancy
. Trizivir and similar medicines may cause side effects in unborn babies. If you become pregnant while you?re taking Trizivir, your baby may be given extra check-ups (including blood tests) to make sure it is developing normally.

If you are pregnant, if you become pregnant, or if you?re planning to become pregnant: Talk to your doctor immediately about the risks and benefits of taking Trizivir during your pregnancy.

Children whose mothers took NRTIs (medicines like Trizivir) during pregnancy have a reduced risk of being infected with HIV. This benefit is greater than the risk of having side effects.

Breast-feeding
Women who are HIV-positive must not breast-feed
, because HIV infection can be passed on to the baby in breast milk.

If you?re breast-feeding, or thinking about breast-feeding:
Talk to your doctor immediately.

Driving and using machines
Trizivir can make you dizzy
and have other side effects that make you less alert.
Don?t drive or operate machines unless you?re feeling well.

How is it used?

Always take Trizivir exactly as your doctor has told you to. Check with your doctor or pharmacist if you?re not sure.

Keep in touch with your doctor, and don?t stop taking Trizivir without your doctor?s advice.

How much to take
The usual dose of Trizivir for adults is one tablet twice a day
.

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 take too much Trizivir

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 Trizivir

If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. Don?t take a double dose to make up for a missed 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

If you have stopped taking Trizivir for any reason ? especially because you think you are having side effects, or because you have other illness:
Talk to your doctor before you start taking it again. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If the doctor thinks they may have been related, you will be told never again to take Trizivir, or any other medicine containing abacavir (Kivexa or Ziagen). It is important that you follow this advice.

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.

What are possible side effects?

Like all medicines, Trizivir can cause side effects, but not everyone gets them.

When you?re 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.

About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have a gene called HLA-B*5701 developed a hypersensitivity reaction (a serious allergic reaction), described on the other side of this leaflet under ?Hypersensitivity reactions?. It is very important that you read and understand the information about this serious reaction.

As well as the side effects listed below for Trizivir, other conditions can 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 reactions

Trizivir contains abacavir (which is also an active ingredient in Kivexa and Ziagen).

Who gets these reactions?

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 don?t 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.

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. Other symptoms include:
  • pains in the joints or muscles, swelling of the neck, shortness of breath, sore throat, cough, headache
  • occasionally, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure. If you continue to take Trizivir, the symptoms will get worse, and may be life-threatening.

When do these reactions happen?

Hypersensitivity reactions can start at any time during treatment with Trizivir, but are more likely during the first 6 weeks of treatment.

Occasionally, reactions have developed in people who start taking abacavir again, and had only one symptom on the Alert Card before they stopped taking it.

Very rarely, reactions have developed in people who start taking abacavir again, but who had no symptoms before they stopped taking it.

Contact your doctor immediately:
1 if you get a skin 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, diarrhoea or abdominal pain
  • severe tiredness or achiness, or generally feeling ill. Your doctor may advise you to stop taking Trizivir.

Always carry your Alert Card while you are 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 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:

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 Trizivir, or any other medicine containing abacavir (Kivexa or Ziagen). It is important that you follow this advice.

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.

If you are hypersensitive to Trizivir, return all your unused Trizivir tablets for safe disposal. Ask your doctor or pharmacist for advice.

Very common side effects

These may affect more than 1 in 10 people:

  • headache
  • feeling sick (nausea).

Common side effects

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 leucopenia)
  • 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.

Uncommon side effects

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).

Rare side effects

These may affect up to 1 in 1000 people:

  • liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
  • lactic acidosis ( 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).

Very rare side effects

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). If you notice any of these symptoms contact a doctor urgently. A very rare side effect that may show up in blood tests is: a failure of the bone marrow to produce new red or white blood cells ( aplastic anaemia).
If you get side effects

Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.

Other possible side effects of Trizivir

Trizivir may cause other conditions to develop during HIV treatment.

Old infections may flare up

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.
If you get any symptoms of infection while you?re taking Trizivir:
Tell your doctor immediately. Don?t take other medicines for the infection without your doctor?s advice.

Your body shape may change

People taking combination therapy for HIV may find that their body shape changes, because of changes in fat distribution:

  • Fat may be lost from the legs, arms or face.
  • Extra fat may build up around the tummy (abdomen), or on the breasts or internal organs.
  • Fatty lumps (sometimes called buffalo hump) may appear on the back of the neck. It is not yet known what causes these changes, or whether they have any long-term effects on your health. If you notice changes in your body shape: Tell your doctor.
Lactic acidosis is a rare but serious side effect

Some people taking Trizivir, 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, or in obese (very overweight) people, especially 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. 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: See your doctor as soon as possible.
You may have problems with your bones

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. Signs of osteonecrosis include:
  • stiffness in the joints
  • aches and pains (especially in the hip, knee or shoulder)
  • difficulty moving. If you notice any of these symptoms: Tell your doctor.
Other effects may show up in blood tests

Trizivir can also cause:

  • increased levels of lactic acid in the blood, which on rare occasions can lead to lactic acidosis
  • increased levels of sugar and fats (triglycerides and cholesterol) in the blood
  • resistance to insulin (so if you?re diabetic, you may have to change your insulin dose to control your blood sugar).

How should it be stored?

Keep Trizivir out of the reach and sight of children.

Do not take Trizivir after the expiry date shown on the carton.

Do not store above 30°C.

If you have any unwanted Trizivir tablets, don?t dispose of them in your waste water or your household rubbish. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Trizivir contains

The active substances in each Trizivir film-coated tablet are 300 mg of abacavir (as sulphate), 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.

What Trizivir looks like and contents of the pack

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.

Marketing Authorisation Holder

ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Manufacturer: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), Priory Street, Ware, Hertfordshire, SG 12 0DJ, United Kingdom.

or

GlaxoSmithKline Pharmaceuticals S.A., ul. Grunwaldzka 189 , 60-322 Poznan, Poland

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

BelgiëBelgiqueBelgien ViiV Healthcare sprlbvba TélTel 32 02 656 25 11 LuxembourgLuxemburg ViiV Healthcare sprlbvba BelgiqueBelgien TélTel 32 02 656 25 11

Te. 359 2 953 10 34 Magyarország GlaxoSmithKline Kft. Tel. 36 1 225 5300

Malta GlaxoSmithKline Malta Tel 356 21 238131 eská republika GlaxoSmithKline s.r.o. Tel 420 222 001 111 gsk.czmailgsk.com

Danmark GlaxoSmithKline Pharma AS Tlf 45 36 35 91 00 dk-infogsk.com Nederland ViiV Healthcare BV Tel 31 030 6986060 contact-nlviivhealthcare.co

Deutschland ViiV Healthcare GmbH Tel. 49 089 203 0038-10 viiv.med.infoviivhealthcare.com Norge GlaxoSmithKline AS Tlf 47 22 70 20 00 firmapostgsk.no

Eesti GlaxoSmithKline Eesti OÜ Tel 372 6676 900 estoniagsk.com Österreich GlaxoSmithKline Pharma GmbH Tel 43 01 97075 0 at.infogsk.com

GlaxoSmithKline A.E.B.E. 30 210 68 82 100 Polska GSK Commercial Sp. z o.o. Tel. 48 022 576 9000

España GlaxoSmithKline, S.A. Tel 34 902 202 700 es-cigsk.com Portugal VIIV HEALTHCARE, UNIPESSOAL, LDA Tel 351 21 094 08 01 FI.PTgsk.com

România GlaxoSmithKline GSK S.R.L. Tel 4021 3028 208 France ViiV Healthcare SAS Tél. 33 01 39 17 6969 Infomedviivhealthcare.com

Ireland GlaxoSmithKline Ireland Limited Tel 353 01 4955000 Slovenija GlaxoSmithKline d.o.o. Tel 386 01 280 25 00 medical.x.sigsk.com

Ísland GlaxoSmithKline ehf. Sími 354 530 3700 Slovenská republika GlaxoSmithKline Slovakia s. r. o. Tel 421 02 48 26 11 11 recepcia.skgsk.com

Italia ViiV Healthcare S.r.l Tel 39 045 9212611 SuomiFinland GlaxoSmithKline Oy PuhTel 358 010 30 30 30 Finland.tuoteinfogsk.com

GlaxoSmithKline Cyprus Ltd 357 22 39 70 00 Sverige GlaxoSmithKline AB Tel 46 08 638 93 00 info.produktgsk.com

Latvija GlaxoSmithKline Latvia SIA Tel 371 67312687 lv-epastsgsk.com United Kingdom ViiV Healthcare UK Limited Tel 44 0800 221441 customercontactukgsk.com

Lietuva

GlaxoSmithKline Lietuva UAB
Tel: + 370 5 264 90 00
info.lt@gsk.com

This leaflet was last approved in

Cookies help us deliver our services. By using our services, you agree to our use of cookies. OK