Hepatitis B immunoglobulin

Generic name
Hepatitis B immunoglobulin
Brand name
ATC Code
J06BB04
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Hepatitis B immunoglobulin

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

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Prophylaxis for hepatitis B in newborns of HBsAg-positive mothers
  • Intramuscular
    • Term neonate
      • 150 - 180 IU/dose, once only.
        • Administer immediately after the birth combined with vaccination for hepatitis B, followed by active immunization as per the National Vaccination Programme (see the monograph on DPTP-HiB-HepB)
        • Administration can be repeated until the active production of antibodies is observed after vaccination (titre at least 10 mIU/ml)
  • Intravenous
    • Term neonate
      • Hepatect: 30 - 100 IU/kg/dose, once only.
        • In children of HBsAg-positive mothers: immediately after the birth combined with vaccination with a hepatitis B vaccine, followed by active immunization as per the National Vaccination Programme (see the monograph on DPTP-HiB-HepB)
        • Administration can be repeated until the active production of antibodies is observed after vaccination (titre at least 10 mIU/ml)
Prophylaxis for hepatitis B reinfection after liver transplant
  • Intravenous
    • 1 month up to 18 years
      [2]
      • Hepatect: Start on the day of the transplant:
        5.780.3         IU/m²/day in 1 dose once only. Then daily for 1 week and as long as necessary to achieve a serum concentration of 100-150 IU/litre in patients who are negative for HBV DNA and above 500 IU/litre in patients who are positive for HBV DNA.
    • 1 month up to 18 years
      • Hepatect: Start on the day of the transplant:
        5.780.3         IU/m²/day in 1 dose once only. Then daily for 1 week and as long as necessary to achieve a serum concentration of 100-150 IU/litre in patients who are negative for HBV DNA and above 500 IU/litre in patients who are positive for HBV DNA.
Prophylaxis for hepatitis B after accidental exposure
  • Intramuscular
    • 1 month up to 18 years

      • HEPBQUIN:

        Exposure to a SMALL quantity of HBsAg-positive blood

        • Vaccinated, titre sufficient: no action necessary

        • Vaccinated, titre < 10 mIU/ml: 8 IU/kg + booster vaccination OR 2x 8 IU/kg

        • Vaccinated, titre unknown: 8 IU/kg and determine the titre after 3 months
        • Not vaccinated: 8 IU/kg + vaccination series
        • Vaccination not possible: 8 IU/kg; repeat after 2 and 4 months

        Exposure to a LARGE quantity of HBsAg-positive blood

        • Vaccinated, titre sufficient: no action necessary
        • Vaccinated, titre < 10 mIU/ml: 50 IU/kg + booster vaccination
        • Vaccinated, titre unknown: 50 IU/kg and determine the titre after 3 months
        • Not vaccinated: 50 IU/kg + vaccination series
        • Vaccination not possible:  8 IU/kg; repeat after 2 and 4 months
Prophylaxis for hepatitis B on continuous infection risk
  • Intravenous
    • 1 month up to 18 years
      • Hepatect: 8 IU/kg/dose Repeat every 2 months.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects

No information is present at this moment.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

IMMUNOGLOBULINS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Immunoglobulins, normal human
J06BA02
J06BA01
Specific immunoglobulins
J06BB01
J06BB02
J06BB03
Antibacterial monoclonal antibodies
J06BC03
IMMUNOGLOBULINS, NORMAL HUMAN
J06BA02
J06BA01
Antiviral monoclonal antibodies
J06BD07
J06BD08
J06BD01

References

  1. Sanquin, SPC HepBQuin (RVG 16926) 28-04-2014, www.geneesmiddeleninformatiebank.nl
  2. Biotest Pharma GmbH, SPC Hepatect (RVG 27115), www.cbg-meb.nl, Geraadpleegd 25/11/13, http://db.cbg-meb.nl/IB-teksten/h27115.pdf
  3. LCI, Guideline Hepatitis B, www.rivm.nl, July 2017
  4. RIVM, Draaiboek Prenatale Screening Infectieziekten en Erytrocytenimmunisatie, https://www.rivm.nl/documenten/draaiboek-prenatale-screening-infectieziekten-en-erytrocytenimmunisatie, Versie 6.0, april 2018

Changes

Therapeutic Drug Monitoring


Overdose