What is it and how is it used?

Ziagen is used to treat HIV (human immunodeficiency virus) infection.

Ziagen contains the active ingredient abacavir. Abacavir belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).

Ziagen does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases 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 Ziagen 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 Ziagen:

  • if you?re allergic(hypersensitive) to abacavir (or any other medicine containing abacavir ? such as Trizivir or Kivexa) or any of the other ingredients of Ziagen (listed in Section 6)Carefully read all the information about hypersensitivity reactions in Section 4.
  • if youhave severe liver diseaseCheck with your doctor if you think any of these apply to you.
Take special care with Ziagen

Some people taking Ziagen for HIV 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?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.

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.

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 Ziagen unless your doctor advises you to do so.

Look out for important symptoms

Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you?re taking Ziagen. Read the information ?Other possible side effects of combination therapy for HIV? 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). Ziagen 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.
  • Don?t risk blood transfer ? for example, don?t share needles.

Other medicines and Ziagen
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 Ziagen.

Some medicines interact with Ziagen

These include:

  • phenytoin, for treating epilepsy. Tell your doctor if you?re taking phenytoin. Your doctor may need to monitor you while you?re taking Ziagen.
  • methadone used as a heroin substitute. 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. Tell your doctor if you?re taking methadone.

Pregnancy
Ziagen is not recommended for use during pregnancy
. Ziagen and similar medicines may cause side effects in unborn babies. If you become pregnant while you?re taking Ziagen, 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 Ziagen, or other medicines for treating HIV infection, during your pregnancy.

Children whose mothers took NRTIs (medicines like Ziagen) 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
Don?t drive or operate machines
unless you?re feeling well.

Important information about some of the other ingredients of Ziagen oral solution

This medicine contains the sweetener sorbitol (approximately 5 g in each 15 ml dose), which may have a mild laxative effect. Don?t take medicines containing sorbitol if you have hereditary fructose intolerance. The calorific value of sorbitol is 2.6 kcal/g.

Ziagen also contains preservatives (parahydroxybenzoates) which may cause allergic reactions (possibly delayed).

How is it used?

Always take Ziagen exactly as your doctor has told you to. Check with your doctor or pharmacist if you?re not sure. Ziagen can be taken with or without food.

Stay in regular contact with your doctor

Ziagen helps to control your condition. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection. Keep in touch with your doctor, and don?t stop taking Ziagen without your doctor?s advice.

How much to take
Adults and adolescents over 12 years of age

The usual dose of Ziagen is 600 mg (30 ml) a day. This can be taken either as 300 mg (15 ml) twice a day or 600 mg (30 ml) once a day.

Children between three months and 12 years of age

The dose depends on the child?s body weight. The recommended dose is 8 mg/kg twice a day up to a maximum of 600 mg daily.

How to measure the dose and take the medicine

Use the oral dosing syringe supplied with the pack to measure your dose accurately. When full, the syringe contains 10 ml of solution.

1. Remove the bottle cap. Keep it safely.

2. Hold the bottle firmly. Push the plastic adapter into the neck of the bottle.

3. Insert the syringe firmly into the adapter.

4. Turn bottle upside down.

5. Pull out the syringe plunger until the syringe contains the first part of your full dose.

6. Turn the bottle the right way up. Remove the syringe from the adapter.

7. Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek. Slowly push the plunger in, allowing time to swallow. Don?t push too hard and squirt the liquid into the back of your throat, or you may choke.

8. Repeat steps 3 to 7 in the same way until you have taken your whole dose. For example, if your dose is 30 ml, you need to take 3 syringe-fulls of medicine.

9. Take the syringe out of the bottle and wash it thoroughly in clean water. Let it dry completely before you use it again.

10. Close the bottle tightly with the cap, leaving the adapter in place.

If you take too much Ziagen

If you accidentally take too much Ziagen, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.

If you forget to take Ziagen

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 Ziagen regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.

If you have stopped taking Ziagen

If you have stopped taking Ziagen 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 Ziagen, or any other medicine containing abacavir (e.g. Trizivir or Kivexa). It is important that you follow this advice.

If your doctor advises that you can start taking Ziagen 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, Ziagen 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 Ziagen or other medicines you are taking, or an effect of the HIV disease 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 in this leaflet in the panel headed ?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 Ziagen, other conditions can develop during combination therapy for HIV.
It is important to read the information later in this section under ?Other possible side effects of combination therapy for HIV?.

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

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).

Who gets these reactions?

Anyone taking Ziagen could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Ziagen.

You are more likely to develop such a reaction if you have the HLA-B*5701 gene (but you can get a reaction even if you don?t have this gene). You should have been tested for this gene before Ziagen was prescribed for you. If you know you have this gene, tell your doctor before you take Ziagen.

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 Ziagen, 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 Ziagen, 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.

If you are caring for a child who is being treated with Ziagen, it is important that you understand the information about this hypersensitivity reaction. If your child gets the symptoms described below it is essential that you follow the instructions given.

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 Ziagen.

Always carry your Alert Card while you are taking Ziagen.
If you have stopped taking Ziagen

If you have stopped taking Ziagen because of a hypersensitivity reaction, you must NEVER AGAIN take Ziagen, or any other medicine containing abacavir (e.g. Trizivir or Kivexa). If you do, within hours, your blood pressure could fall dangerously low, which could result in death.

If you have stopped taking Ziagen 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 Ziagen, or any other medicine containing abacavir (e.g. Trizivir or Kivexa). It is important that you follow this advice.

If your doctor advises that you can start taking Ziagen 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 Ziagen, return all your unused Ziagen oral solution for safe disposal. Ask your doctor or pharmacist for advice.

Common side effects

These may affect up to 1 in 10 people:

  • hypersensitivity reaction
  • feeling sick (nausea)
  • headache
  • being sick (vomiting)
  • diarrhoea
  • loss of appetite
  • tiredness, lack of energy
  • fever (high temperature)
  • skin rash

Rare side effects

These may affect up to 1 in 1,000 people:

  • lactic acidosis ( see the next section, ?Other possible side effects of combination therapy for HIV?)
  • inflammation of the pancreas (pancreatitis).

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.
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 combination therapy for HIV

Combination therapy including Ziagen 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 Ziagen:
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 Ziagen, 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

Combination therapy for HIV 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 Ziagen out of the reach and sight of children.

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

Do not store above 30°C.

Discard oral solution two months after first opening.

If you have any unwanted Ziagen oral solution, don?t dispose of it in your wastewater or household rubbish. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Ziagen contains

The active substance in Ziagen oral solution is 20 mg of abacavir (as sulfate) in each ml of the solution.

The other ingredients are sorbitol 70% (E420), saccharin sodium, sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), maltodextrin, lactic acid, glyceryl triacetate, natural and artificial strawberry and banana flavour, purified water.

What Ziagen looks like and contents of the pack

Ziagen oral solution is clear to yellowish in colour with strawberry/banana flavouring. It is supplied in cartons containing a white polyethylene bottle, with a child resistant cap. The bottle contains 240 ml (20 mg abacavir/ml) of solution. A 10 ml oral dosing syringe and a plastic adapter for the bottle are included in the pack.

Marketing Authorisation Holder and Manufacturer (s)
Marketing Authorisation Holder:
ViiV Healthcare UK Limited, 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom

Manufacturer: Glaxo Wellcome GmbH & Co. KG, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany

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

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Lietuva

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

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