hepatitis B immune globulin (HBIG)

Action and Spectrum

Actions and Spectrum 

Action: 

Passive Immunization: drug works by providing passive immunity against the hepatitis B virus.   

Immediate Protection: When administered promptly after exposure to HBV, drug provides immediate protection against the virus. The antibodies present in drug can bind to the virus particles, preventing their attachment and entry into liver cells. 

Spectrum: 

Post-Exposure Prophylaxis: drug is primarily used for post-exposure prophylaxis in individuals exposed to HBV. It is administered to individuals who have had a recent high-risk exposure, such as needlestick injuries, sexual contact with an infected individual, or contact with infected blood or body fluids.  

Perinatal Prevention: drug is also used in newborns of HBV-infected mothers to prevent vertical transmission of the virus. It is typically given within 12 hours of birth, along with the hepatitis B vaccine, to provide immediate protection to the infant. 

Drug Interaction

Adverse Reaction

Frequency defined  

>10% 

Erythema (12%) 

Headache (14%) 

1-10% 

Ecchymosis (2%) 

Vomiting (2%) 

Myalgia (10%) 

Generalized pain, injection site pain (4%) 

Nausea (4%) 

Malaise (6%) 

Vomiting (2%) 

<1% 

Nephrotic syndrome (rare) 

Fever 

Chest tightness 

Anaphylaxis 

Angioneurotic edema 

Lethargy 

Black Box Warning

Black Box Warning: 

None  

Contraindication / Caution

Contraindication/Caution:  

Hypersensitivity: The drug should not be administered to individuals with a known hypersensitivity or severe allergic reaction to human immunoglobulin or any other product component. 

IgA Deficiency: drug contains small amounts of immunoglobulin A (IgA). Individuals with selective IgA deficiency may have antibodies against IgA, which could lead to an allergic reaction. In such cases, drug should be used with caution, and the potential benefits and risks should be evaluated. 

Previous Severe Reaction: If a person has experienced a severe hypersensitivity reaction to a previous dose of drug, the medication should be avoided. 

Pregnancy / Lactation

Pregnancy warnings:     

Pregnancy category: C 

Lactation: Excreted into human milk is unknown 

Pregnancy Categories:         

Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester. 

Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments.   

Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.    

Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   

Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.    

Category N: There is no data available for the drug under this category

Pharmacology

Pharmacology:  

hepatitis B immune globulin is a blood-derived product that contains antibodies against the hepatitis B virus. It is used for both prophylaxis and treatment of hepatitis B infection. 

Pharmacodynamics:  

Drug works by providing passive immunity against HBV. It contains high levels of immunoglobulin G (IgG) antibodies that target the surface antigen of the virus (HBsAg). These antibodies bind to the HBsAg, neutralize the virus, and prevent its entry into liver cells. drug does not directly eliminate the virus from infected cells but helps in reducing viral replication.   

Pharmacokinetics: 

Absorption 

drug is administered intramuscularly (IM) or intravenously (IV). When given IM, the absorption is slower compared to IV administration. 

Distribution 

 drug antibodies are distributed throughout the body, including the liver. 

Metabolism 

drug is mainly metabolized by the reticuloendothelial system.  

Excretion and Elimination 

 The exact elimination half-life of drug may vary depending on the product used, but it generally ranges from a few days to a few weeks. The antibodies are primarily eliminated through catabolism in the liver. 

Adminstartion

Administration:  

Dosage: The dosage of drug may vary depending on the specific situation and the individual’s weight. It is typically administered intramuscularly (into a muscle) or intravenously (into a vein).  

The dose may be a single injection or multiple doses given over a specific period. The exact dosage and administration regimen should be determined by a healthcare professional. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: hepatitis B immune globulin (HBIG) 

Why do we use hepatitis B immune globulin (HBIG)?  

Post-exposure prophylaxis: drug is administered to individuals who have been recently exposed to HBV and are at risk of developing an infection. This can include newborn infants born to HBV-positive mothers, healthcare workers after a needlestick injury, and individuals who have had unprotected sexual contact with an HBV-infected person. drug provides immediate passive immunity against the virus, helping to prevent or minimize the establishment of infection. 

Perinatal prophylaxis: drug is given to infants born to HBV-infected mothers to reduce the risk of mother-to-child transmission of the virus. It is typically administered within 12 hours of birth, along with the hepatitis B vaccine. This combination approach significantly reduces the likelihood of vertical transmission of HBV. 

Pre-liver transplant prophylaxis: drug is used in individuals undergoing liver transplantation for chronic hepatitis B. It is given before and after the transplant procedure to prevent reinfection of the transplanted liver. drug provides temporary passive immunity until the patient’s own immune system can mount an effective response against the virus. 

Treatment of acute hepatitis B: In some cases, drug may be used as a therapeutic intervention in individuals with acute hepatitis B.