Ziagen
abacavir
Abacavir
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 Ziagen 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 Ziagen is and what it is used for
What you need to know before you take Ziagen
How to take Ziagen
Possible side effects
How to store Ziagen
Contents of the pack and other information
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.
if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir –such as Trizivir, Triumeq or Kivexa) or any of the other ingredients of this medicine (listed in Section 6)
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 moderate or severe liver disease
if you have ever had liver disease, including hepatitis B or C
if you are seriously overweight (especially if you are a woman)
if you have severe kidney disease
Abacavir hypersensitivity reactions
Even patients who don’t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction).
Risk of heart attack
It cannot be excluded that abacavir may increase the risk of having a heart attack.
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 are taking Ziagen.
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). 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.
These include:
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’.
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the tablets with some water. Ziagen can be taken with or without food.
If you cannot swallow the tablet(s), you may crush and combine them with a small amount of food or drink, and take all the dose immediately.
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.
The dose given depends on the body weight of your child. The recommended dose is:
The tablet can be divided into equal doses.
An oral solution (20 mg abacavir/ml) is also available for the treatment of children over three months of age and weighing less than 14 kg, or for people who need a lower than usual dose, or who cannot take tablets.
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 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 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 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 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.
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.
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 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.
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 later in this section under ‘Other possible side effects of combination therapy for HIV’.
These hypersensitivity reactions have been seen more frequently in people taking medicines that contain abacavir.
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 do not 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. 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 Ziagen, 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 Ziagen because of a hypersensitivity reaction, you must NEVER AGAIN take Ziagen, or any other medicine containing abacavir (e.g. Trizivir, Triumeq 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:
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 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.
The Ziagen 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 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
These may affect up to 1 in 1,000 people:
inflammation of the pancreas (pancreatitis)
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)
lactic acidosis (excess lactic acid in the blood)
Combination therapy including Ziagen 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 are taking Ziagen:
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:
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 which is stated 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 substance in each Ziagen film-coated, scored tablet is 300 mg of abacavir (as sulfate).
The other ingredients are microcrystalline cellulose, sodium starch glycollate, magnesium stearate and colloidal anhydrous silica in the core of the tablet. The tablet coating contains triacetin, methylhydroxypropylcellulose, titanium dioxide, polysorbate 80 and iron oxide yellow.
Ziagen film-coated tablets are engraved with ‘GX 623’ on both sides. The scored tablets are yellow and capsule-shaped and are provided in blister packs containing 60 tablets.
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 BV Tel: + 370 80000334
ViiV Healthcare BV Teл.: + 359 80018205
Tél/Tel: + 32 (0) 10 85 65 00
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
VIIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01
ViiV Healthcare BV Tel: + 40 800672524
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