Basic Information
J05AF06
abacavir
Antivirals for systemic use
Therapeutic indication
Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children.
The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy.
Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Overview Summary
Ziagen is used with other antiviral medicines to treat patients who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).
Ziagen contains the active substance abacavir.
Active Substances (1)
abacavir
Documents (13)
Ziagen : EPAR - Medicine overview
July 14, 2009
OVERVIEW_DOCUMENT
Ziagen : EPAR - Procedural steps taken and scientific information after authorisation
December 7, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
Ziagen : EPAR - Steps taken after authorisation when a cutoff date has been used
April 29, 2009
CHANGES_SINCE_INITIAL_AUTHORISATION
Ziagen : EPAR - All Authorised presentations
November 20, 2005
AUTHORISED_PRESENTATIONS
Ziagen-H-C-252-II-0005 : EPAR - Scientific Discussion - Variation
November 20, 2005
CHANGES_SINCE_INITIAL_AUTHORISATION
Ziagen : EPAR - Procedural steps taken before authorisation
November 20, 2005
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Ziagen-H-C-252-P45-0075 : EPAR - Assessment Report
December 17, 2012
CHANGES_SINCE_INITIAL_AUTHORISATION
Ziagen : EPAR - Scientific Discussion
November 20, 2005
CHANGES_SINCE_INITIAL_AUTHORISATION
Ziagen : EPAR - Procedural steps taken before authorisation
November 20, 2005
CHANGES_SINCE_INITIAL_AUTHORISATION
Ziagen-H-C-PSUSA-00000010-202212 - EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
December 15, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Ziagen : EPAR - Product Information
December 11, 2009
DRUG_PRODUCT_INFORMATION
Ziagen-H-C-252-R-0025 : EPAR - Scientific Discussion - Renewal
November 20, 2005
CHANGES_SINCE_INITIAL_AUTHORISATION
Ziagen : EPAR - Scientific Discussion
November 20, 2005
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Overview Q&A (7)
Question
How is Ziagen used?
Answer
Ziagen can only be obtained with a prescription and should be prescribed by a doctor who has experience in managing HIV infection.
Before starting treatment with abacavir, all patients should have a test to find out if they have a gene called ‘HLA?B (type 5701)’. Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Ziagen.
Ziagen is available as tablets (300 mg) and as an oral solution (20 mg/ml). The recommended dose for adults and children weighing at least 25 kg is 600 mg daily. This can be taken either as a single daily dose or divided into 300 mg twice a day.
In children weighing less than 25 kg the recommended dose depends on body weight.
For more information about using Ziagen, see the package leaflet or contact your doctor or pharmacist.
Question
How does Ziagen work?
Answer
The active substance in Ziagen, abacavir, is a nucleoside reverse transcriptase inhibitor (NRTI). It works by blocking the activity of reverse transcriptase, an enzyme produced by HIV to make more copies of itself in the cells it has infected and so spread in the body. Ziagen, taken with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. It does not cure HIV infection, but it holds off damage to the immune system and the development of infections and diseases associated with AIDS.
Question
What benefits of Ziagen have been shown in studies?
Answer
Six main studies found that Ziagen was more effective than placebo (a dummy treatment) and was as effective as other antiviral medicines at keeping HIV infection under control. The studies included 1,843 HIV-infected adults (aged 18 years and over). Ziagen was taken alone or added to the combination of lamivudine and zidovudine (other antiviral medicines) or the patients’ existing HIV treatment. The main measures of effectiveness were changes in the level of HIV in the blood (viral load) and the number of CD4 T?cells in the blood (CD4 cell count). CD4 T?cells are white blood cells that help fight infections and are killed by HIV.
In all studies, Ziagen caused a decrease in viral loads in all age groups, particularly when taken with other antiviral medicines. In one of the studies, 77% of the patients taking Ziagen with lamivudine and zidovudine had viral loads below 400 copies/ml after 16 weeks (67 out of 87), compared with 38% of the adults taking lamivudine and zidovudine without Ziagen (33 out of 86). Another study compared the effects of Ziagen taken once and twice a day in combination with lamivudine and efavirenz (other antiviral medicines) in 784 patients. Once daily and twice daily Ziagen had similar effects on viral load. Patients receiving Ziagen also had increases in their CD4 cell counts.
Studies were also carried out in HIV-infected patients aged between 3 months and 18 years. One study found that in patients aged over 1 year, Ziagen combined with either lamivudine or zidovudine was more effective than treatment with a combination of lamivudine and zidovudine.
In addition, studies were carried out to examine once daily versus twice daily dosing in children and found that once daily and twice daily Ziagen had similar effects on viral load.
Question
What are the risks associated with Ziagen?
Answer
The most common side effects with Ziagen (which may affect up to 1 in 10 people) are loss of appetite, headache, nausea (feeling sick), vomiting, diarrhoea, rash, fever, lethargy (lack of energy) and tiredness.
Hypersensitivity reactions (allergic reactions) occur in patients taking Ziagen, usually within the first 6 weeks of treatment, and can be life-threatening. The risk of hypersensitivity is higher in patients who have the HLA?B (type 5701) gene. Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal (belly) pain, dyspnoea (difficulty breathing), cough, fever, lethargy, feeling unwell, headache, blood tests showing signs of liver damage and muscle pain. Treatment with Ziagen should be stopped promptly if the patient has a hypersensitivity reaction.
For the full list of side effects and restrictions with Ziagen, see the package leaflet.
Question
Why is Ziagen authorised in the EU?
Answer
The European Medicines Agency noted that the demonstration of the benefit of Ziagen was based on the results of studies mainly with the medicine taken twice a day in combination with other medicines. The Agency decided that Ziagen’s benefits are greater than its risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Ziagen?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ziagen have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Ziagen are continuously monitored. Side effects reported with Ziagen are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Ziagen
Answer
Ziagen received a marketing authorisation valid throughout the EU on 8 July 1999.