Hepatitis B Surface Antigen (rDNA)

Hepatitis B Surface Antigen (rDNA) Uses, Dosage, Side Effects, Food Interaction and all others data.

Hepatitis B Vaccine is an ingredient in the EMA-withdrawn product Quintanrix. It is marketed in Canada as Engerix B. It is also a part of Twinrix (Hep A/Hep B vaccine) available also in Canada.The hepatitis B virus induces a severe form of viral hepatitis. Other causative agents are hepatitis A virus, and the non-A, non-B hepatitis viruses. Hepatitis D virus, a defective virus requiring the “keeper function” of the hepatitis B virus, occurs either as a co-infection or super-infection in a HBsAg carrier.

Transmission of the virus occurs through percutaneous contact with contaminated blood, serum or plasma. Infection may also occur by the exposure of mucous surfaces, or intact or damaged skin to other body fluids such as saliva, mucosal secretions and semen.

There is no specific treatment for hepatitis. The incubation period may be as long as 6 months, followed by a very complex clinical course of an acute or chronic nature, often leading to hospitalization.

Hepatitis B Surface Antigen (rDNA)
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Side Effect
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Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
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Interaction With other Medicine
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Trade Name	Hepatitis B Surface Antigen (rDNA)
Generic	Hepatitis B Vaccine (Recombinant)
Hepatitis B Vaccine (Recombinant) Other Names	HBSAG, Hepatitis B antigen, Hepatitis B surface antigen, Hepatitis B Surface Antigen (rDNA), Hepatitis B surface antigen (recombinant), Hepatitis B surface antigen vaccine, Hepatitis B surface antigens, Hepatitis B Vaccine, Hepatitis B virus hbsag surface protein antigen, Hepatitis-B surface antigen
Type
Protein binding	Evaluation of pharmacokinetic properties is not required for vaccines.
Groups	Approved, Withdrawn
Therapeutic Class
Manufacturer
Available Country
Last Updated:	September 19, 2023 at 7:00 am

Uses

Hepatitis B Surface Antigen (rDNA) is a solution of Hepatitis B surface antigen used to immunize patients against Hepatitis B.

Active immunization against hepatitis B virus infection.

The vaccine will not protect against infection caused by hepatitis A and non-A non-B hepatitis viruses. As hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection or carrier state, it can be expected that hepatitis D will also be prevented by vaccination with hepatitis B virus vaccine.

The vaccine can be administered at any age from birth onwards. It may be used to start a primary course of vaccination or as a booster dose. It may also be used to complete a primary course of vaccination started with plasma-derived or yeast-derived vaccines or as a booster dose in subjects who have previously received a primary course of vaccination with plasma-derived or yeast-derived vaccines.

In areas of low prevalence of hepatitis B, vaccination is strongly recommended in subjects who are at increased risk of infection. These include the following groups:

Health professionals: physicians and surgeons; oral surgeons and dentists; nurses, dental nurses, dental hygienists, podiatrists; IV teams and operating room personnel; paramedical personnel in close contact with patients; staff in hemodialysis, nephrology, hepatology, hematology and oncology units; laboratory personnel handling blood and other clinical specimens; blood bank and plasma fractionation workers; pathologists and morgue attendants; cleaning staff who handle waste in hospitals; emergency and first aid workers; ambulance staff; dental, medical and nursing students.
Patients: patients receiving frequent blood transfusion or clotting factor concentrates, such as those in oncology units and those with thalassemia, sickle-cell anemia, cirrhosis, hemophilia, etc.; patients on hemodialysis; patients with type 2 diabetes.
Personnel and residents of institutions: persons with frequent and/or close contacts with high-risk groups; prisoners and prison staff; residents and staff of institutions for the developmentally challenged (those who are in contact with aggressive biting residents being at highest risk).
Persons at increased risk due to their sexual practices: males having sexual contact with other males; others with multiple sexual partners or with a recent history of sexually transmitted disease.
Persons who use injectable drugs illicitly.
Travellers to areas of high endemicity and their close contacts.
Household contacts of any of the above groups and of patients with acute or chronic hepatitis B infection.
Infants born of HBsAg-positive mothers.
Chronic Liver Disease (CLD): subjects with chronic liver disease; subjects at risk of developing CLD (e.g. Hepatitis C virus carriers, persons who abuse alcohol).
Others: police; fire fighters; armed forces personnel; morticians and embalmers; those who through their work or personal lifestyle may be exposed to the hepatitis B virus.
In areas of both low and high prevalence, vaccination should be offered to all young children and neonates at risk, as well as to adult high risk groups.

Hepatitis B Surface Antigen (rDNA) is also used to associated treatment for these conditions: Hepatitis A, Viral Hepatitis B

How Hepatitis B Surface Antigen (rDNA) works

ENGERIX®-B induces specific humoral antibodies against HBsAg (anti-HBs antibodies). It is generally accepted that an anti-HBs titre greater than 10 IU/L correlates with protection against hepatitis B virus infection. More than 90% of healthy adults, children and neonates developed protective anti-HBs titres one month after completing a primary vaccination schedule of ENGERIX®-B (hepatitis B vaccine (recombinant)).

Toxicity

Cases of overdose have been reported during post-marketing surveillance. Adverse events reported following overdosage were similar to those reported with normal vaccine administration.