300 mg film-coated tablets
abacavir
What Ziagen is and what it is used for
Ziagen is used to treat HIV infection ( infection with human immunodeficiency virus).
Ziagen contains the active substance abacavir. Abacavir belongs to a group of antiretroviral drugs called nucleoside analog reverse transcriptase inhibitors (NRTIs).
Ziagen does not completely cure HIV infection. It reduces the number of viruses in the body and keeps it at a low level. It also increases 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 Ziagen in the same way. Your doctor will check which treatment effect you get.
What you need to know before taking Ziagen
Do not take Ziagen:
- if you are allergic (hypersensitive) to abacavir (or to other medicines containing abacavir, eg Trizivir, Triumeq, or Kivexa ) or to any of the other ingredients of this medicine (see section 6). Be sure to read the full information about hypersensitivity reactions in section 4. Check with your doctor if you think any of this applies to you.
Be especially careful with Ziagen
Some patients who take Ziagen for HIV 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 any liver disease, including hepatitis B or hepatitis C
- if you are severely overweight (especially if you are a woman)
- if you have severe kidney disease
Talk to your doctor if any of these apply to you. 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 excluded that abacavir may increase the risk of myocardial infarction.
Tell your doctor if you have heart problems, if you smoke or if you have other diseases that can increase the risk of heart diseases such as high blood pressure or diabetes. Do not stop taking Ziagen unless your doctor advises you to do so.
Pay attention to important symptoms
Some patients who use drugs against HIV infection develop other conditions that can be serious. You need to know important signs and symptoms to look out for while taking Ziagen.
Read the information “Other possible side effects of combination anti-HIV therapy” in section 4 of this leaflet.
Other medicines and Ziagen
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 taking Ziagen.
Some medicines affect or are affected by Ziagen
These include:
- 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 Ziagen
- methadone, used as a heroin substitute. 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. Tell your doctor if you are taking methadone.
- 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.
Pregnancy
Ziagen is not recommended for use during pregnancy. Ziagen and similar medicines can cause side effects in the unborn child.
If you have taken Ziagen 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 transmitted to the baby through breast milk. A small amount of the ingredients in Ziagen 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
Do not drive or operate machinery if you are unwell.
Important information about some ingredients in Ziagen 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 Ziagen
Always take this medicine as directed by your doctor. Consult your doctor or pharmacist if you are unsure.
Swallow the tablets with a little water. Ziagen can be taken with or without food.
If you cannot swallow the tablet(s) whole, you can crush them and mix them in a small amount of food or drink and take the whole dose immediately.
Keep in regular contact with your doctor
Ziagen helps you keep your disease under control. You must take it every day to prevent the disease from getting worse. You can still develop other infections or diseases associated with HIV infection.
Keep in touch with your doctor and do not stop taking Ziagen without your doctor’s advice.
How much to take
Adults, adolescents, and children weighing at least 25 kg
The usual dose of Ziagen is 600 mg per day. Dose one can be taken either as one 300 mg tablet twice daily or as two 300 mg tablets once daily.
Children from the age of one who weighs less than 25 kg
The dose given is based on the child’s body weight. The recommended dose is:
- Children weighing at least 20 kg and less than 25 kg: Usual dose of Ziagen is 450 mg daily. This can be given as 150 mg (half a tablet) in the morning and 300 mg (a whole tablet) in the evening, or as 450 mg (one and a half tablets) once a day, according to the doctor’s prescription.
- Children weighing at least 14 kg and less than 20 kg: Usual dose of Ziagen is 300 mg daily. This can be given as 150 mg (half a tablet) twice a day, or as 300 mg (a whole tablet) once a day, according to the doctor’s prescription.
The tablet can be divided into two equal doses.
An oral solution (20 mg abacavir/ml) is also available for the treatment of children older than three months who weigh less than 14 kg or for patients who require a lower-than-normal dose or who cannot take tablets.
If you have taken too much Ziagen
If you accidentally take too much Ziagen, talk to your doctor or pharmacist, or contact the emergency department of your nearest hospital for further advice.
If you forget to take Ziagen
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 Ziagen regularly, as irregular intake can increase the risk of a hypersensitivity reaction.
If you have stopped taking Ziagen
If you have stopped taking Ziagen 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 Ziagen or other medicines containing abacavir (eg Triumeq, Trizivir, or Kivexa) again. You must follow this advice.
If your doctor advises you to start taking Ziagen again, you may be asked to take the first doses in a place 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.
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 Ziagen or other drugs are taken at the same time. 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 as the side effects mentioned below for Ziagen, other conditions may develop during combination anti-HIV therapy.
It is important to read the information later in this section under “Other possible side effects in combination treatment against HIV”.
| Hypersensitivity reaction Ziagen contains abacavir (which is also an active substance in Trizivir, Triumeq, and Kivexa ). 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 Ziagen can develop a hypersensitivity reaction to abacavir, which can be life-threatening if they continue to take Ziagen. 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 Ziagen was prescribed to you. If you know you carry this gene, talk to your doctor before taking Ziagen. About 3-4 out of every 100 patients who were treated with abacavir in a clinical trial and 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, and tingling or numbness in the hands or feet. When do these symptoms appear? Hypersensitivity reactions can occur at any time during treatment with Ziagen but are more likely to occur during the first six weeks of treatment. If you are caring for a child treated with Ziagen, you must understand the information about this hypersensitivity reaction. If your child develops symptoms such as those described below, you must follow the instructions given. Contact your doctor immediately: if you get a rash, 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 Ziagen. If you have stopped taking ZiagenIf you have stopped taking Ziagen because of a hypersensitivity reaction, you must NEVER AGAIN take Ziagen or any other medicine containing abacavir (eg Trizivir, Triumeq, or Kivexa). If you do, you can experience a dangerous drop in blood pressure within hours, which can result in death. If you have stopped taking Ziagen 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 Ziagen or other medicines containing abacavir (eg Trizivir, Triumeq, or Kivexa) 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 Ziagen again, you may be asked to take the first doses in a place where you have access to medical care if needed. If you are hypersensitive to Ziagen, return all unused Ziagen tablets for destruction. Consult your doctor or pharmacist. The packaging of Ziagen 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. |
Common side effects are
These may affect up to 1 in 10 users:
- hypersensitivity reaction
- vomiting
- headache
- nausea
- diarrhea
- loss of appetite
- fatigue, listlessness
- fever (high temperature)
- rash.
Rare side effects ar
These may affect up to 1 in 1,000 users:
- inflammation of the pancreas ( pancreatitis ).
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 )
- lactic acidosis (excess lactic acid in the blood)
If you notice any of these symptoms, see a doctor immediately.
If you get a side effect ar
Tell your doctor or pharmacist if any of these side effects become severe or bothersome, or if you notice any side effects not mentioned in this information.
Other possible side effects are with combination treatment against HIV
Combination therapy with Ziagen may 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 Ziagen:
Talk to your doctor immediately. Do not take any other anti-infection medicines without consulting your doctor.
You may have problems with the skeleton
Some patients treated with combination anti-HIV therapy 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.
How Ziagen should be stored
Keep this medicine out of the sight and reach of children.
Use before the expiry date (EXP) stated on the packaging. The expiration date is the last day of the specified month.
Store at a maximum of 30 ºC.
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 substance in each Ziagen film-coated, scored tablet is 300 mg of abacavir (as sulfate).
Other ingredients in the tablet core are microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and colloidal anhydrous silica. The film coating surrounding the tablet contains triacetin, hypromellose, titanium dioxide, polysorbate 80, and yellow iron oxide.
Appearance and package sizes of the medicine
Ziagen film-coated tablets are engraved with “GX 623” on both sides. The scored tablets are yellow and capsule-shaped and supplied in blister packs of 60 tablets.
| Manufacturer | Marketing Authorisation Holder |
| Delpharm Poznań Spółka Akcyjnaul. Grunwaldzka 18960-322 PoznańPoland | ViiV Healthcare BVVan Asch van Wijckstraat 55H3811 LP AmersfoortNetherlands |
Contact the representative of the marketing authorization holder if you want to know more about this medicine.
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