Hepatitis B Immunoglobin

Registered South African indications:

• Post-exposure prophylaxis
• Newborn of hepatitis B-carrier mother
• Absence of immune response after vaccination
• Immunoprophylaxis of hepatitis B in haemodialysed patients

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Hypersensitivity to human immunoglobulins

Cautions

• Pregnancy 
• Breastfeeding
• HBsAg carrier

Forms avail. in SA and covered in this monograph: inj

Post-exposure prophylaxis

• IM: 500 IU; Repeat after 28 days if non-immune or has not received hepatitis B vaccination

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Dosage should be given within 48hrs and not more than 7 days after exposure

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Immunoprophylaxis of hepatitis B in haemodialysed patients

• IM: 8-12 IU/kg, given every 2 months until seroconversion from vaccination; Max single dose: 500 IU

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Booster vaccination if absence of immune response after vaccination

• IM: 500 IU, given every 2 months

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A minimum protective antibody titre is considered to be 10 IU/L

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For all the indications give hepatitis B vaccination on the same day as initial injection of immunoglobulin; Inject at different anatomical site

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See additional prescribing points for administration directions

Paed. forms avail. in SA and covered in this monograph: inj

Post-exposure prophylaxis

Younger than 5 years

• IM: 200 IU; Repeat after 28 days if non-immune or has not received hepatitis B vaccination

Between 5-10 years

• IM: 300 IU; Repeat after 28 days if non-immune or has not received hepatitis B vaccination

Older than 10 years

• See adult dosage

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Dosage should be given within 48hrs and not more than 7 days after exposure

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Newborn babies born to HBsAg-positive mothers (especially those who are hepatitis B envelope antigen (HBeAg) positive)

• IM: 200 IU, as a single dose

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Dosage should be given as soon as possible after birth, preferrably within 24hrs

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May need to repeat doses until seroconversion from vaccination occurs

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Booster vaccination if absence of immune response after vaccination

• IM: 8 IU/kg, given every 2 months

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A minimum protective antibody titre is considered to be 10 IU/L

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For all the indications. give hepatitis B vaccination on the same day as initial injection of immunoglobulin; Inject at different anatomical site

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See additional prescribing points for administration directions

Pregnancy

• Caution
• The safety of this medicinal product for use in human pregnancy has not been established in controlled clinical trials. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the foetus and the neonate are to be expected

Breastfeeding

• Caution
• It is not known if hepatitis B immunoglobin is excreted in breastmilk. Caution is recommended when administrating to breastfeeding mothers

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended 

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Light-headedness
• Flushing
• Tremor
• Dizziness

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Nausea
• Glossitis
• Buccal ulceration

Musculoskeletal Disorders

• Arthralgia
• Backache

Skin and Subcutaneous Tissue Disorders 

• Cutaneous reactions
• Local reactions
• Pain and tenderness at injection site
• Local induration

Immune, Blood and Lymphatic System Disorders

• Anaphylactic reactions
• Interference with serological testing

Others

• Chills
• Chest pain
• Facial oedema

• Live attenuated viral vaccines  

None routine

Administration directions: IM

• Adults: Deltoid preferred
• Infants: Lateral aspect of thigh preferred
• If large volumes required (> 2ml infants, > 5ml adults) divide dosage and administer at different anatomical sites
• DO NOT administer into blood vessel

Hepatitis B immunoglobulin provides passive immunisation for individuals exposed to the hepatitis B virus by binding to the surface antigen and reducing the rate of hepatitis B infection.

Injection (per 1ml) 100iu

• Hebagam (National Bioproducts)