Hepatitis B Immunoglobulin

Introduction: Hepatitis B Immunoglobulin contains specific neutralising antibodies (mainly IgG) that provide passive immunisation for individuals exposed to the hepatitis B virus. It is used for post-exposure prophylaxis in persons who are not vaccinated, or whose prior vaccination regimen is incomplete or when the antibody level is <10 IU/ml.

How it works: Hepatitis B Immunoglobulin contains specific neutralising antibodies that provide immediate passive protection against hepatitis B virus by neutralizing the virus and preventing infection.

Important Information: Intramuscular (IM) or intravenous (IV) administration. Should be given within 48 hours of exposure.

• Passive immunisation against hepatitis B infection
• Prophylaxis of hepatitis B recurrence after liver transplantation

Vaccines, Anti-sera & Immunoglobulin

Passive Immunisation

Hepatitis B immunoglobulins contain specific neutralising antibodies (mainly IgG) that provide passive immunisation for individuals exposed to the hepatitis B virus. It is used for post-exposure prophylaxis in persons who are not vaccinated, or whose prior vaccination regimen is incomplete or when the antibody level is <10 IU/ml. It may also be used in haemodialysis patients and receptors of certain blood products who are unable to develop adequate immune protection.

Hepatitis B Immunoglobulin provides immediate passive protection against hepatitis B virus by supplying antibodies that neutralize the virus and prevent infection.

Adult Dose (IM):

• Passive immunisation: 500 IU as a single dose (within 48 hours of exposure, not >1 week)

Adult Dose (IV - Liver Transplantation):

• 20,000 IU/dose
• Initially: 1 dose with liver transplant
• 1st week: 1 dose daily (day 1-7)
• Week 2-12: 1 dose every 2 weeks
• From 4th month: 1 dose monthly

Child Dose (IM):

• <5 years: 200 IU
• 5-9 years: 300 IU
• >10 years: 500 IU
• Newborn (HBsAg-positive mother): 200 IU at birth or within 24 hours

* Use as directed by the registered physician

Intramuscular (IM) or intravenous (IV) injection. Do not give IV injection (except for liver transplantation). For large volumes (>2 ml children or >5 ml adults), administer in divided doses at different sites.

If you miss a dose, consult your doctor.

Common Side Effects:

• Headache
• Lightheadedness
• Malaise
• Pain, erythema and tenderness at injection site
• Nausea
• Vomiting
• Arthralgia
• Myalgia

Serious: Anaphylaxis, Angioedema

Precautions:

• Caution in patients with thrombocytopenia or coagulation disorders
• Hepatitis B immunoglobulin should not be given via IV injection (except liver transplantation)
• May cause drowsiness
• Caution in pregnancy and lactation

Contraindications:

• Hypersensitivity
• Severe allergy to gamma globulin or anti-immunoglobulin therapies
• IM injection in patients with thrombocytopenia or coagulation disorders

Drug Interactions:

• May interfere with immune response when used with live vaccines
• Live vaccines should be given only 3 months after immunoglobulin administration

Food Interactions: No interaction found/established.

Use in Pregnancy: Safety during pregnancy has not been established. Use with caution.

Use in Lactation: Immunoglobulins are excreted into milk and may contribute to transfer of protective antibodies to the neonate. Use with caution.

Pediatric Use: Dosage available from neonates to 10 years.

Geriatric Use: Use as per doctor's advice for elderly patients.

Renal & Hepatic Impairment: Specific dosage recommended for haemodialysis patients.

Overdose: Consequences of overdose are not known. Employ usual supportive measures.

Storage: Store in a refrigerator (2-8°C). Keep in outer carton to protect from light. Do not freeze.

Hepatitis B Immunoglobulin