Europe — EMA
Hepatitis-B-Immunglobulin Behring (Human Hepatitis B Immunoglobulin)
Learn about Hepatitis-B-Immunglobulin Behring, a prescription human hepatitis B immunoglobulin for post‑exposure prophylaxis and newborn protection in the EU.
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What is Human Hepatitis B Immunoglobulin?
Hepatitis-B-Immunglobulin Behring is a human hepatitis B immunoglobulin preparation supplied as an injectable solution for intramuscular use. The product contains purified antibodies derived from human plasma and is classified as an immunoglobulin in the antiviral (passive immunization) therapeutic class. It is marketed in the European Union and requires a prescription. The preparation provides passive immunity against hepatitis B virus by neutralizing circulating viral particles.
What is Human Hepatitis B Immunoglobulin used for?
Hepatitis‑B‑Immunglobulin Behring is indicated for specific situations where immediate protection against hepatitis B virus is needed.
- Post‑exposure prophylaxis for individuals with recent potential exposure to hepatitis B virus. - Prevention of hepatitis B infection in newborn infants born to hepatitis B surface antigen‑positive mothers. - Supplementation of hepatitis B vaccine when rapid immunity is required, such as in immunocompromised patients. - Use in clinical settings where hepatitis B vaccine response is inadequate or delayed.
What are the side effects of Human Hepatitis B Immunoglobulin?
The safety profile of Hepatitis‑B‑Immunglobulin Behring reflects the typical reactions observed with intramuscular immunoglobulin preparations.
Common: - Injection‑site pain, redness or swelling. - Low‑grade fever. - Headache. - Fatigue or mild malaise. - Nausea.
Serious: - Severe allergic reaction (anaphylaxis) with difficulty breathing or swelling of the face. - Acute hemolytic transfusion reaction. - Serum sickness–like illness with rash, fever, joint pain. - Thromboembolic events such as deep‑vein thrombosis. - Renal impairment or acute kidney injury.
What precautions apply to Human Hepatitis B Immunoglobulin?
Before administering Hepatitis‑B‑Immunglobulin Behring, clinicians should consider several precautionary measures.
- Verify patient’s hepatitis B surface antigen and antibody status to avoid unnecessary treatment. - Assess for known hypersensitivity to human immunoglobulins or any component of the formulation. - Use caution in patients with a history of severe allergic reactions or anaphylaxis. - Monitor renal function in individuals with pre‑existing kidney disease. - Consider the risk of thromboembolic events in patients with cardiovascular disease or prolonged immobility. - Avoid intravascular administration; ensure proper intramuscular technique.
What does Human Hepatitis B Immunoglobulin interact with?
Hepatitis‑B‑Immunglobulin Behring may interact with other agents, influencing efficacy or safety.
Avoid: - Concurrent administration of live vaccines (e.g., measles‑mumps‑rubella) as passive antibodies can diminish vaccine response. - High‑dose immunoglobulin products given within 2 weeks, which may increase the risk of hyperviscosity.
Use with caution: - Anticoagulants (e.g., warfarin) because immunoglobulin can affect coagulation parameters. - Immunosuppressive therapies that may alter the patient’s ability to mount an active immune response. - Renal‑clearing drugs (e.g., aminoglycosides) in patients with compromised kidney function. - Blood pressure‑lowering agents, as volume load from the product may affect hemodynamics.



