Zerit

stavudine

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This is a summary of the European public assessment report (EPAR) for Zerit. 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 Zerit.

What is Zerit?

Zerit is a medicine containing the active substance stavudine. It is available as capsules containing 15 mg (red and yellow), 20 mg (brown), 30 mg (light and dark orange) and 40 mg (dark orange) stavudine. Zerit is also available as a powder to make up into an oral solution.

What is Zerit used for

Zerit is an antiviral medicine. It is used in combination with other antiviral medicines to treat adults and children who are infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS).

Zerit is used for as short a time as possible and only when other antiviral medicines cannot be used.

The medicine can only be obtained with a prescription.

How is Zerit used?

Treatment with Zerit should be initiated by a doctor who has experience in the treatment of HIV infection. The dose to use is calculated based on the age and weight of the patient. Adults weighing less than 60 kg and children weighing over 30 kg take a dose of 30 mg, and adults over 60 kg take 40 mg. Children over the age of 14 days receive 1 mg per kilogram body weight, unless they weigh more than 30 kg. Babies less than 13 days old should be given 0.5 mg/kg body weight. All doses should be taken every 12 hours.

Zerit should be taken on an empty stomach, at least one hour before a meal. If this is not possible, it may be taken with a light meal. The capsules should be swallowed whole or opened carefully and their contents mixed with food. The oral solution should be used in patients below three months of age. The dose may need to be adjusted in patients who have problems with their kidneys or certain side effects.

Zerit is to be used for as short a time as possible and the patients switched to appropriate alternatives whenever possible. Patients taking Zerit should be assessed frequently. For more information, see the summary of product characteristics (also part of the EPAR).

How does Zerit work?

The active substance in Zerit, stavudine, is a nucleoside reverse-transcriptase inhibitor (NRTI). It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses. By blocking this enzyme, Zerit, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. Zerit does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.

How has Zerit been studied?

The effectiveness of Zerit was assessed in four main studies. The first study compared the effects of Zerit taken alone with those of zidovudine (another antiviral medicine) in 822 HIV-infected patients who had been taking zidovudine for at least six months. Its main measure of effectiveness was how long it took for the patients to develop a disease associated with AIDS or to die. The second study compared two doses of Zerit in over 13,000 patients who did not respond to, or could not take, other types of antiviral medicine. This study measured survival rates.

Two further studies assessed the effectiveness of Zerit, taken in combination with lamivudine and efavirenz (other antiviral medicines) in 467 treatment-naïve patients (who had not taken treatment for HIV infection before). The main measures of effectiveness were the levels of HIV in the blood (viral load) and the number of CD4 T cells in the blood (CD4 cell count) after 48 weeks of treatment. CD4 T cells are white blood cells that are important in helping to fight infections, but which are killed by HIV.

What benefit has Zerit shown during the studies?

The studies showed that Zerit could reduce the rates of disease progression in HIV-infected patients. Patients taking Zerit alone developed an AIDS-related disease or died at a similar rate to those taking zidovudine. Patients taking either of two doses of Zerit also had similar survival rates over 22 weeks.

When taken in combination with lamivudine and efavirenz, around 70% of the patients taking Zerit had viral loads below 400 copies/ml after 48 weeks. The patients’ CD4 cell counts also rose from around 280 cells/mm3 before treatment by an average of around 185 cells/mm3.

What is the risk associated with Zerit?

The most common side effects when taking Zerit (seen in between 1 and 10 patients in 100) are peripheral neuropathy (damage to the nerves in the extremities causing tingling, numbness and pain in the hands and feet), diarrhoea, nausea, abdominal (tummy) pain, dyspepsia (heartburn), fatigue (tiredness), lipodystrophy (redistribution of body fat), lipoatrophy (a loss of fat in some areas of the body which can cause disfigurement), dizziness, insomnia (difficulty sleeping), abnormal thinking, somnolence (sleepiness), depression, rash, pruritus (itching) and hyperlactataemia (elevated lactic acid levels in the blood).

Three side effects are possibly related to the medicine’s toxic effect on mitochondria (the energy-producing components within cells): lipoatrophy, lactic acidosis (a build-up of lactic acid in the body) and peripheral neuropathy. These side effects are serious, usually appear with long-term use and are more commonly seen with Zerit than with other NRTI medicines.

For the full list of side effects reported with Zerit, see the package leaflet.

Zerit should not be used in people who may be hypersensitive (allergic) to stavudine or any of the other ingredients.

Why has Zerit been approved?

The CHMP decided that Zerit’s benefits are greater than its risks and recommended that it be given marketing authorisation. Since its authorisation, post-marketing reports and published literature regarding the side effects of Zerit have led the CHMP to update the prescribing information for Zerit, recommending that it should be used for as short a time as possible and only when other antiviral medicines cannot be used.

Other information about Zerit

The European Commission granted a marketing authorisation valid throughout the European Union for Zerit to Bristol-Myers Squibb Pharma EEIG on 8 May 1996. The marketing authorisation is valid for an unlimited period.

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

Name Language First published Last updated
Zerit : EPAR - Summary for the public BG = bălgarski 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public ES = español 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public CS = čeština 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public DA = dansk 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public DE = Deutsch 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public ET = eesti keel 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public EL = elliniká 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public EN = English 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public FR = français 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public IT = italiano 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public LV = latviešu valoda 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public LT = lietuvių kalba 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public HU = magyar 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public MT = Malti 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public NL = Nederlands 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public PL = polski 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public PT = português 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public RO = română 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public SK = slovenčina 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public SL = slovenščina 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public FI = suomi 06/02/2008 27/05/2011
Zerit : EPAR - Summary for the public SV = svenska 06/02/2008 27/05/2011

This EPAR was last updated on 11/02/2016 .

Authorisation details

Product details

Product details for Zerit
NameZerit
Agency product numberEMEA/H/C/000110
Active substance

stavudine

International non-proprietary name (INN) or common name

stavudine

Therapeutic area HIV Infections
Anatomical therapeutic chemical (ATC) code J05AF04

Publication details

Publication details for Zerit
Marketing-authorisation holder

Bristol-Myers Squibb Pharma EEIG

Revision27
Date of issue of marketing authorisation valid throughout the European Union08/05/1996

Contact address:

Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge
UB8 1DH
United Kingdom

Product information

Product information

14/01/2016  Zerit -EMEA/H/C/000110 -IB/0098/G

Name Language First published Last updated
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016
Zerit : EPAR - Product Information SV = svenska 16/11/2009 11/02/2016

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
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  
Zerit : EPAR - All Authorised presentations SV = svenska 11/08/2006  

Pharmacotherapeutic group

Antivirals for systemic use

Therapeutic indication

Hard capsules

Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (over the age of three months) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.

Powder for oral solution

Zerit is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-infected adult patients and paediatric patients (from birth) only when other antiretrovirals can not be used. The duration of therapy with Zerit should be limited to the shortest time possible.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Zerit : EPAR - Procedural steps taken before authorisation SV = svenska 11/08/2006  
Zerit : EPAR - Scientific Discussion SV = svenska 11/08/2006  

Authorised

This medicine is approved for use in the European Union

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