Hepatitis B Immuneglobulin

Introduction: Hepatitis B Immuneglobulin 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 Immuneglobulin 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 24-72 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 Immuneglobulin provides immediate passive protection against hepatitis B virus by supplying antibodies that neutralize the virus and prevent infection.

Adult Dose (IM - Exposure Prevention):

• At least 500 IU (depending on intensity of exposure)
• As soon as possible after exposure, preferably within 24-72 hours

Adult Dose (IV - Liver Transplantation):

• 2000 IU IM every 15 days after transplantation (excluding first week)
• HBV-DNA negative: maintain anti-HBs >100 IU/L
• HBV-DNA positive: maintain anti-HBs >500 IU/L

Haemodialysis Patients:

• 8-12 IU/kg (max 500 IU) every 2 months

Newborn (HBsAg-positive mother):

• 30-100 IU/kg at birth or as soon as possible after birth

No immune response after vaccination:

• Adults: 500 IU every 2 months
• Children: 8 IU/kg every 2 months

* Use as directed by the registered physician

Intramuscular (IM) route - bring to room or body temperature before use. Use clear, colorless or pale-yellow or light brown solution. 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:

• Hypersensitivity
• Anaphylactic shock
• Headache
• Tachycardia
• Hypotension
• Vomiting
• Erythema
• Itching
• Malaise

Precautions:

• Product should not be administered into a blood vessel (may cause shock)
• If you are HBsAg carrier, there is no benefit in administering this product
• Serious allergic reactions are rare
• If allergic/anaphylactic reaction is suspected, stop administration immediately
• Product contains 3.9 mg sodium per ml (consider if on low salt diet)

Contraindications:

• Hypersensitivity to human immunoglobulins or any ingredients
• IgA deficiency (may have anti-IgA antibodies - severe allergic reactions possible)

Drug Interactions:

• Hepatitis B Immuneglobulin must not be mixed with other medicinal products

Food Interactions: No interaction found/established.

Use in Pregnancy: Safety during pregnancy has not been established. Use with caution. Clinical experience suggests no harmful effects on pregnancy course or fetus/neonate.

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

Pediatric Use: No relevant use in pediatric population for liver transplantation. Specific dosage for newborns available.

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

Renal & Hepatic Impairment: Specific dosage for haemodialysis patients (8-12 IU/kg every 2 months, max 500 IU).

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. Keep out of reach of children.

Hepatitis B Immuneglobulin