Monograph: |
Hepatitis B lmnmnoglobulin
Human Hepatitis B lmnmnoglobulin (Ph. Eur.) (Hepatitis
B Immunoglobulin (BP 1998); Immunoglobulinum Hu-
manum Hepatitidis B) is a liquid or freeze-dried preparation
containing immunoglobulins. mainly immunoglobulin G
(lgG). It is obtained from plasma from selected and/or immu-
nised donors having specific antibodies against hepatitis B
surface antigen. Normal immunoglobulin may be added. It
contains not less than 100 international units per mL. The liq-
uid preparation should be stored, protected from light, in a
sealed, colourless, glass container. The freeze-dried prepara-
tion should be stored, protected from light, in a colourless.
glass container, under vacuum or under an inert gas.
Human Hepatitis B Immunoglobulin for Intravenous Use
(Ph. Eur.) (Hepatitis B Immunoglobulin for Intravenous Use
(BP 1998); Immunoglobulinum Humanum Hepatitidis B ad
Usum Intravenosum) is a liquid or freeze-dried preparation
containing immunoglobulins. mainly immunoglobulin G
(lgG). It is obtained from plasma from selected and/or immu-
nised donors having antibodies against hepatitis B surface an-
tigen. Normal immunoglobulin for intravenous use may be
added. It contains not less than 50 international units per mL.
Storage requirements are similar to those for Hepatitis B Im-
munoglobulin. except that the freeze-dried preparation is
stored at a temperature not exceeding 25Β°.
Hepatitis B Immune Globulin (USP 23) is a sterile solution
consisting of globulins derived from the plasma of human do-
nors who have high titers of antibodies against hepatitis B sur-
face antigen. It contains 10 to 18% of protein, of which not
less than 80% is monomeric immunoglobulin G. It contains
glycine as a stabilising agent, and a suitable preservative. It
should be stored at 2Β° to 8Β°.
Adverse Effects and Precautions
As for immunoglobulins in general.
For a warning concerning possible lack of equivalence be-
tween different preparations of hepatitis B immunoglobulins
see under Uses and Administration, below.
Uses and Administration
Hepatitis B immunoglobulins are used for passive
immunisation of persons exposed or possibly ex-
posed to hepatitis B virus, including by sexual con-
tact. They are not appropriate for treatment. Active
immunisation with hepatitis B vaccine should al-
ways be commenced in conjunction with adminis-
tration of hepatitis B immunoglobulins in patients
exposed to hepatitis B virus.
In the UK a hepatitis B immunoglobulin containing
100 international units per mL is available for intra-
muscular use. The recommended dose in adults and
children over 10 years of age is a single dose of
500 international units by intramuscular injection
given preferably within 48 hours of exposure and
not more than I week after exposure. Children aged
5 to 9 years may be given 300 international units.
and children under 5 years 200 international units.
Hepatitis B immunoglobulin should also be given to
newborn infants at risk whose mothers are persistent
carriers of hepatitis B surface antigen or whose
mothers are HBsAg-positive as a result of recent in-
fection. The recommended dose is 200 international
units by intramuscular injection preferably at birth,
and certainly within 48 hours of birth.
There is now a UK and European standard for a
preparation for intravenous use containing not less
than 50 international units per mL.
In the USA a hepatitis B immunoglobulin contain-
ing 15 to 18% of protein is available for intramuscu-
lar use. The recommended dose for adults is
0.06 mL per kg body-weight. A dose of 0.5 mL is
given to infants perinatally exposed to hepatitis B;
this appears to be equivalent to approximately half
the dose employed in the UK.
The US Immunization Practices Advisory Committee has
issued recommendations on the use of hepatitis B vaccines
and hepatitis B immunoglobulins.
The content of hepatitis B immunoglobulin may vary between
countries and between manufacturers. Care should be taken in
interpreting dosage recommendations which are not given in
terms of international units' Products available in the USA
have their strength expressed with reference to an FDA stand-
ard but are considered to contain the equivalent of at least 200
international units per mL.
Monoclonal antibodies. The name tuvirurnab is applied to
a human hepatitis B monoclonal antibody. A murine mono-
clonal antibody has been tried in a few patients with primary
antibody deficiency.
Organ transplantation. A study' in 110 patients positive
for hepatitis B surface antigen undergoing liver transplanta-
tion suggested that long-term passive immunization with hep-
atitis B immunoglobulin could reduce hepatitis B re-infection
and improve survival in these patients.
Post exposure prophylaxis. For discussion of the use of
hepatitis B immunoglobulins in patients exposed to hepatitis
B virus, see under Hepatitis B Vaccines.
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