PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is ImmunoGam?
ImmunoGam is a solution for injection containing the active substance human hepatitis B immunoglobulin.
What is ImmunoGam used for?
ImmunoGam is used to guarantee protection from the hepatitis B virus. ImmunoGam confers a 'passive' protection, ie it provides the antibodies that the body needs to fight the virus, rather than stimulate the body to produce its own. ImmunoGam can be used in the following subjects that need immediate protection:
• people accidentally exposed to the virus whose vaccination could be incomplete;
• patients who have undergone hemodialysis (a blood purification technique used in people with kidney problems). In these patients the product is used until the vaccination against the virus becomes effective;
• newborns of mothers carrying the virus;
• subjects continuously at risk of becoming infected with hepatitis B who have not responded to vaccination.
The medicine can only be obtained with a prescription.
How is ImmunoGam used?
ImmunoGam is given as an intramuscular injection (in a muscle). It is strongly recommended that all people receiving ImmunoGam also receive a hepatitis B vaccine.
Persons accidentally exposed to the virus must receive at least 500 international units (IU) as soon as possible and preferably within 24-72 hours of exposure. Hemodialysis patients must receive between 8 and 12 IU per kilogram of body weight up to a maximum of 500 IU every two months. Infants of mothers carrying the hepatitis B virus must receive between 30 and 100 IU / kg at birth or as soon as possible after birth. It may be necessary to repeat the dose until the children show an immune response against the virus after vaccination. Finally, people continuously at risk of hepatitis B infection who have not shown an immune response after vaccination can receive 500 IU (in adults) or 8 IU / kg (in children) every two months.
Physicians should also consider other official guidelines in dose selection and dosage for ImmunoGam
How does ImmunoGam work?
The active substance in ImmunoGam, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood. Antibodies are proteins in the blood that help the body fight infections and other diseases. ImmunoGam protects against the hepatitis B virus by maintaining high levels of human hepatitis B immunoglobulins in the blood, so that they can bind to the virus and stimulate the immune system to destroy it.
Medicinal products containing human hepatitis B immunoglobulins have been used in the European Union (EU) for many years.
What studies have been carried out on ImmunoGam?
Although ImmunoGam itself has not been tested in experimental models, the applicant has presented sufficient data from studies of similar medicines.
ImmunoGam was tested in only one main study of 253 newborns of mothers carrying the virus and 42 adults potentially exposed to the virus. All people receiving ImmunoGam were also given a hepatitis B vaccine. The main measure of effectiveness was the number of people who remained without hepatitis B infection. Patient follow-up lasted for up to a year. Since only a small number of adults participated in the study, the evaluation of the benefits of the medicine was mainly based on the results obtained in children.
What benefit has ImmunoGam shown during the studies?
ImmunoGam provided effective protection against hepatitis B virus infection. Of the 178 children who completed the study, 174 (98%) remained free of hepatitis B infection. This result is comparable with the percentage of protection observed with similar treatments in the published literature. Results in adults also provided some supporting data showing that ImmunoGam protects against infection with hepatitis B virus.
What are the risks associated with ImmunoGam?
The side effects of ImmunoGam are not common. However, the following side effects are observed in between 1 and 10 patients in 1 000: headache, dizziness, nausea, arthralgia (joint pain), back pain, myalgia (muscle pain), fatigue (tiredness) ), hardening of the injection site, feeling sick, pain at the injection site and pyrexia (fever).
ImmunoGam should not be used in people who may be hypersensitive (allergic) to the active substance, to any of the other substances or to human immunoglobulins, especially if they have a deficiency (very low levels) of immunoglobulin A (IgA) and if they have antibodies against 'IgA.
Why has ImmunoGam been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that ImmunoGam's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on ImmunoGam
On March 16, 2010, the European Commission granted a marketing authorization valid for the ImmunoGam, valid throughout the European Union, to Cangene Europe Limited. The marketing authorization is valid for five years after which it can be renewed.
For the full EPAR of ImmunoGam, click here. For more information on ImmunoGam therapy, read the package leaflet (included with EPAR).
Last update of this summary: 01-2010.
