Synagis

palivizumab

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

What is Synagis?

Synagis is a powder and solvent that are made up into a solution for injection. It contains the active substance palivizumab.

What is Synagis used for?

Synagis is used to prevent serious lower respiratory tract (lung) disease caused by respiratory syncytial virus (RSV) that would require hospitalisation. It is used in the following groups of children, who are at high risk for this disease:

• children who are less than six months old and were born five or more weeks prematurely (at 35 weeks gestation or less);
• children who are less than two years of age and have had treatment for bronchopulmonary dysplasia (abnormal lung tissue, usually seen in babies born prematurely) within the last six months;
• children who are less than two years of age and were born with a serious heart disease.

The medicine can only be obtained with a prescription.

How is Synagis used?

Synagis is given once a month when there is a risk of RSV infection in the community: in the northern hemisphere, this is from November to April. If possible, the first dose should be given before this season starts. Patients generally receive a total of five monthly injections into the thigh muscle.

How does Synagis work?

The active substance in Synagis, palivizumab, is a monoclonal antibody. A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen). Palivizumab has been designed to attach to a protein called ‘fusion protein A’ on the surface of RSV. When palivizumab is attached to this protein, the virus becomes unable to enter the body’s cells, especially those in the lungs. This helps to prevent RSV infection.

How has Synagis been studied?

The main study of Synagis was carried out in 1,502 high-risk children and compared Synagis with placebo (a dummy treatment) during one RSV season. Another study was also carried out comparing Synagis with placebo in 1,287 children who were born with heart disease. In both studies, the main measure of effectiveness was the number of children who had to be admitted to hospital because of RSV infection.

What benefit has Synagis shown during the studies?

Synagis was more effective than placebo in reducing RSV-related hospitalisations: 5% of the children who received Synagis were admitted to hospital for RSV infection during the study, compared with 11% of those who received placebo. This was a reduction of 55%. In children born with heart disease, there was a reduction of 45%.

What is the risk associated with Synagis?

The most common side effects with Synagis (seen in between 1 and 10 patients in 100) are diarrhoea, fever, injection site reactions (pain and inflammation at the site of injection) and nervousness. For the full list of all side effects reported with Synagis, see the package leaflet.

Synagis should not be used in people who may be hypersensitive (allergic) to palivizumab, any of the other ingredients or other ‘humanised’ monoclonal antibodies.

Why has Synagis been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Synagis’s benefits are greater than its risks for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by RSV in children at high risk for RSV disease. The Committee recommended that Synagis be given marketing authorisation.

Other information about Synagis:

The European Commission granted a marketing authorisation valid throughout the European Union for Synagis to Abbott Laboratories Limited on 13 August 1999. The marketing authorisation was renewed on 13 August 2004 and on 13 August 2009.

This EPAR was last updated on 19/01/2012 .

More detail is available in the summary of product characteristics

Product details

Publication details

Product information

19/12/2011  Synagis -EMEA/H/C/000257 -II/0065

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.

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

Synagis is indicated for the prevention of serious lower respiratory tract disease requiring hospitalisation caused by respiratory syncytial virus (RSV) in children at high risk for RSV disease:

• Children born at 35 weeks of gestation or less and less than 6 months of age at the onset of the RSV season.
• Children less than 2 years of age and requiring treatment for bronchopulmonary dysplasia within the last 6 months.
• Children less than 2 years of age and with haemodynamically significant congenital heart disease.

Changes since initial authorisation of medicine

Initial marketing-authorisation documents