Kivexa

abacavir / lamivudine

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This is a summary of the European public assessment report (EPAR) for Kivexa. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Kivexa.

What is Kivexa?

Kivexa is a medicine that contains two active substances, abacavir (600 mg) and lamivudine (300 mg). It is available as tablets.

What is Kivexa used for?

Kivexa is used in combination with at least one other antiviral medicine to treat adults and children weighing at least 25 kg who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).

The medicine can only be obtained with a prescription.

How is Kivexa used?

Kivexa should be prescribed by a doctor who has experience in the management of 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 Kivexa.

Kivexa is taken as one tablet once a day. It should only be given to patients who weigh at least 25 kg. Patients who need to adjust the dose of abacavir or lamivudine should take the medicines separately.

How does Kivexa work?

Both active substances in Kivexa, abacavir and lamivudine, are nucleoside reverse transcriptase inhibitors (NRTIs). They both work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses. Kivexa, taken in combination with at least one other HIV medicine, reduces the amount of HIV in the blood and keeps it at a low level. Kivexa does not cure HIV infection or AIDS, but can delay the damage to the immune system and the development of infections and diseases associated with AIDS.

Both active substances have been available in the European Union (EU) since the late 1990s: abacavir has been authorised as Ziagen since 1999, and lamivudine has been authorised as Epivir since 1996.

How has Kivexa been studied?

Kivexa has been studied in three main studies involving a total of 1,230 patients. At the time of Kivexa’s authorisation, abacavir was authorised at a dose of 300 mg twice a day. Therefore, the studies compared abacavir taken at a dose of 600 mg once a day and at a dose of 300 mg twice a day, in combination with lamivudine and one or two other antiviral medicines. Two studies used the active substances taken as separate medicines, while the third used a combination tablet for the once-daily dose. The main measure of effectiveness was the change in the level of HIV in the blood (viral load) after 24 or 48 weeks of treatment.

What benefit has Kivexa shown during the studies?

Both doses of abacavir, taken in combination with lamivudine and other antiviral medicines, were equally effective in reducing viral loads. In the first study, 66% (253 out of 384) of the patients taking abacavir once a day had viral loads below 50 copies/ml after 48 weeks of treatment, compared with 68% (261 out of 386) of the patients taking it twice a day. The combination tablet taken once a day was also as effective as the medicines taken separately twice a day in reducing viral loads over 24 weeks of treatment.

What is the risk associated with Kivexa?

The most common side effects with Kivexa (seen in between 1 and 10 patients in 100) are hypersensitivity (allergic reactions), rash, nausea (feeling sick), vomiting, diarrhoea, abdominal pain (stomach ache), headache, arthralgia (joint pain), muscle disorders, cough, nasal symptoms (nose problems, such as irritation and runny nose), fever, lethargy (lack of energy), tiredness, insomnia (difficulty sleeping), malaise (feeling unwell), loss of appetite and alopecia (hair loss). For the full list of all side effects reported with Kivexa, see the package leaflet.

Hypersensitivity reactions occur in patients taking Kivexa, usually within the first six 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 pain, dyspnoea (difficulty breathing), cough, lethargy, malaise, headache, signs of liver damage in the blood and myalgia (muscle pain). Treatment with Kivexa should be stopped promptly if the patient has a hypersensitivity reaction. For more information and the full list of restrictions, see the package leaflet.

Why has Kivexa been approved?

The CHMP decided that Kivexa’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Kivexa?

A risk management plan has been developed to ensure that Kivexa is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Kivexa, including the appropriate precautions to be followed by healthcare professionals and patients.

In addition, the company that makes Kivexa will provide educational material for all doctors who are expected to prescribe this medicine to increase awareness of the risk of hypersensitivity reactions and to provide guidance on how to manage it. Patients will also receive an alert card summarising key safety information on hypersensitivity reactions with this medicine.

Other information about Kivexa

The European Commission granted a marketing authorisation valid throughout the European Union for Kivexa on 17 December 2004.

For more information about treatment with Kivexa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Kivexa : EPAR - Summary for the public BG = bălgarski 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public ES = español 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public CS = čeština 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public DA = dansk 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public DE = Deutsch 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public ET = eesti keel 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public EL = elliniká 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public EN = English 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public FR = français 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public IT = italiano 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public LV = latviešu valoda 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public LT = lietuvių kalba 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public HU = magyar 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public MT = Malti 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public NL = Nederlands 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public PL = polski 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public PT = português 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public RO = română 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public SK = slovenčina 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public SL = slovenščina 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public FI = suomi 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public SV = svenska 14/01/2008 03/06/2016
Kivexa : EPAR - Summary for the public HR = Hrvatski 14/01/2008 03/06/2016

This EPAR was last updated on 03/06/2016 .

Authorisation details

Product details

Product details for Kivexa
NameKivexa
Agency product numberEMEA/H/C/000581
Active substance

abacavir / lamivudine

International non-proprietary name (INN) or common name

abacavir / lamivudine

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AR02

Publication details

Publication details for Kivexa
Marketing-authorisation holder

ViiV Healthcare UK Limited 

Revision26
Date of issue of marketing authorisation valid throughout the European Union17/12/2004

Contact address:

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

Product information

Product information

01/04/2016  Kivexa -EMEA/H/C/000581 -WS/0845

Name Language First published Last updated
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016
Kivexa : EPAR - Product Information HR = Hrvatski 16/07/2007 03/06/2016

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015
Kivexa : EPAR - All Authorised presentations HR = Hrvatski 26/02/2008 12/11/2015

Pharmacotherapeutic group

Antivirals for treatment of HIV infections, combinations

Therapeutic indication

Kivexa is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg.

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.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Kivexa : EPAR - Procedural steps taken and scientific information after authorisation HR = Hrvatski 16/07/2009 03/06/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Kivexa : EPAR - Procedural steps taken before authorisation HR = Hrvatski 07/08/2006  
Kivexa : EPAR - Scientific Discussion HR = Hrvatski 07/08/2006  

Authorised

This medicine is approved for use in the European Union

More information on Kivexa