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BayHep B® (hepatitis b immune globulin human) (Hepatitis B Immune Globulin (Human))
Hepatitis B Immune Globulin (Human)
BayHep B® (hepatitis b immune globulin human) treated with solvent/detergent is a sterile
solution of hepatitis B hyperimmune immune globulin for intramuscular
administration; it contains no preservative. BayHep B (hepatitis b immune globulin human) is prepared by cold
ethanol fractionation from the plasma of donors with high titers of antibody to
the hepatitis B surface antigen (anti-HBs). The immune globulin is isolated
from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a
final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% sodium
cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the
solution is heated to 30°C and maintained at that temperature for not less than
6 hours. After the viral inactivation step, the reactants are removed by
precipitation, filtration and finally ultrafiltration and diafiltration. BayHep
B is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine.
BayHep B (hepatitis b immune globulin human) is then incubated in the final container for 21–28 days at 20–27°C.
Each vial contains anti-HBs antibody equivalent to or exceeding the potency of
anti-HBs in a U.S. reference hepatitis B immune globulin (Center for Biologics
Evaluation and Research, FDA). The U.S. reference has been tested against the
World Health Organization standard Hepatitis B Immune Globulin and found to be equal
to 217 international units (IU) per mL.
The removal and inactivation of spiked model enveloped and
non-enveloped viruses during the manufacturing process for BayHep B (hepatitis b immune globulin human) has been
validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1),
was chosen as the relevant virus for blood products; Bovine Viral Diarrhea
Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV)
was chosen to model Hepatitis B virus and the Herpes viruses; and Reo virus
type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance
to physical and chemical inactivation. Significant removal of model enveloped
and non-enveloped viruses is achieved at two steps in the Cohn fractionation
process leading to the collection of Cohn Fraction II: the precipitation and
removal of Fraction III in the processing of Fraction II + IIIW suspension to
Effluent III and the filtration step in the processing of Effluent III to
Filtrate III. Significant inactivation of enveloped viruses is achieved at the
time of treatment of solubilized Cohn Fraction II with TNBP/sodium cholate.
Recommendations on post-exposure prophylaxis are based on
available efficacy data and on the likelihood of future HBV exposure for the
person requiring treatment. In all exposures, a regimen combining Hepatitis B
Immune Globulin (Human) with hepatitis B vaccine will provide both short- and
long-term protection, will be less costly than the two-dose Hepatitis B Immune
Globulin (Human) treatment alone, and is the treatment of choice.8
BayHep B (hepatitis b immune globulin (human)) is indicated for post-exposure prophylaxis in the
Acute Exposure to Blood Containing HBsAg
After either parenteral exposure, e.g., by accidental
“needlestick” or direct mucous membrane contact (accidental splash), or oral
ingestion (pipetting accident) involving HBsAg-positive materials such as blood,
plasma or serum. For inadvertent percutaneous exposure, a regimen of two doses
of Hepatitis B Immune Globulin (Human), one given after exposure and one a
month later, is about 75% effective in preventing hepatitis B in this setting.
Perinatal Exposure of Infants Born to HBsAg-positive Mothers
Infants born to HBsAg-positive mothers are at risk of being
infected with hepatitis B virus and becoming chronic carriers.5,8-10
This risk is especially great if the mother is HBeAg-positive.11-13
For an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive
mother, a regimen combining one dose of Hepatitis B Immune Globulin (Human) at
birth with the hepatitis B vaccine series started soon after birth is 85%–95%
effective in preventing development of the HBV carrier state.8,14 Regimens
involving either multiple doses of Hepatitis B Immune Globulin (Human) alone or
the vaccine series alone have 70%–90% efficacy, while a single dose of
Hepatitis B Immune Globulin (Human) alone has only 50% efficacy.8,15
Sexual Exposure to an HBsAg-positive Person
Sex partners of HBsAg-positive persons are at increased risk
of acquiring HBV infection. For sexual exposure to a person with acute
hepatitis B, a single dose of Hepatitis B Immune Globulin (Human) is 75%
effective if administered within 2 weeks of last sexual exposure.8
Household Exposure to Persons with Acute HBV Infection
Since infants have close contact with primary care-givers
and they have a higher risk of becoming HBV carriers after acute HBV infection,
prophylaxis of an infant less than 12 months of age with Hepatitis B Immune
Globulin (Human) and hepatitis B vaccine is indicated if the mother or primary
care-giver has acute HBV infection.8
Administration of Hepatitis B Immune Globulin (Human) either
preceding or concomitant with the commencement of active immunization with
Hepatitis B Vaccine provides for more rapid achievement of protective levels of
hepatitis B antibody, than when the vaccine alone is administered.16
Rapid achievement of protective levels of antibody to hepatitis B virus may be
desirable in certain clinical situations, as in cases of accidental
inoculations with contaminated medical instruments.16
Administration of Hepatitis B Immune Globulin (Human) either
1 month preceding or at the time of commencement of a program of active
vaccination with Hepatitis B Vaccine has been shown not to interfere with the
active immune response to the vaccine.16
Digestive Disorders: Common MisconceptionsSee Slideshow
DOSAGE AND ADMINISTRATION
Acute Exposure to Blood Containing HBsAg15
Table 1 summarizes prophylaxis for percutaneous (needlestick or bite), ocular,
or mucous-membrane exposure to blood according to the source of exposure and
vaccination status of the exposed person. For greatest effectiveness, passive
prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon
as possible after exposure (its value beyond 7 days of exposure is unclear).
If Hepatitis B Immune Globulin (Human) is indicated (see Table 1), an
injection of 0.06 mL/kg of body weight should be administered intramuscularly
(see PRECAUTIONS) as soon as possible after
exposure and within 24 hours, if possible. Consult Hepatitis B Vaccine package
insert for dosage information regarding that product.
Table 1 : (adapted from 20) Recommendations for
Hepatitis B Prophylaxis Following Percutaneous or Permucosal Exposure
Hepatitis B Immune Globulin (Human) X 1 immediately*
Initiate HB Vaccine Series†
Test exposed person for anti-HBs.
If inadequate antibody,‡ Hepatitis B Immune Globulin (Human)
(X1) immediately plus HB Vaccine booster dose, or 2 doses of HBIG,*
one as soon as possible after exposure and the second 1 month later.
Known Source (High Risk)
Initiate HB Vaccine Series
Test source for HBsAg. If positive, Hepatitis B Immune Globulin
(Human) X 1
Test Source for HBsAg only if exposed is vaccine nonresponder; if
source is HBsAg-positive, give Hepatitis B Immune Globulin (Human)
X 1 immediately plus HB Vaccine booster dose, or 2 doses of HBIG*,
one as soon as possible after exposure and the second 1 month later.
Low Risk HBsAg-Positive
Initiate HB Vaccine series
Initiate HB Vaccine series within 7 days of exposure
* Hepatitis B Immune Globulin (Human), dose
0.06 mL / kg IM.
† HB Vaccine dose 20 μg IM for adults; 10 μg IM for infants
or children under 10 years of age. First dose within 1 week; second and
third doses, 1 and 6 months later.
‡ Less than 10 sample ratio units (SRU) by radioimmunoassay (RIA),
negative by enzyme immunoassay (EIA).
For persons who refuse Hepatitis B Vaccine, a second dose of Hepatitis B Immune
Globulin (Human) should be given 1 month after the first dose.
Prophylaxis of Infants Born to HBsAg and HBeAg Positive Mothers
Efficacy of prophylactic Hepatitis B Immune Globulin (Human)
in infants at risk depends on administering Hepatitis B Immune Globulin (Human)
on the day of birth. It is therefore vital that HBsAg-positive mothers be
identified before delivery.
Hepatitis B Immune Globulin (Human) (0.5 mL) should be
administered intramuscularly (IM) to the newborn infant after physiologic
stabilization of the infant and preferably within 12 hours of birth. Hepatitis
B Immune Globulin (Human) efficacy decreases markedly if treatment is delayed
beyond 48 hours. Hepatitis B Vaccine should be administered IM in three doses
of 0.5 mL of vaccine (10 μg) each. The first dose should be given within 7
days of birth and may be given concurrently with Hepatitis B Immune Globulin
(Human) but at a separate site. The second and third doses of vaccine should be
given 1 month and 6 months, respectively, after the first. If administration of
the first dose of Hepatitis B Vaccine is delayed for as long as 3 months, then
a 0.5 mL dose of Hepatitis B Immune Globulin (Human) should be repeated at 3
months. If Hepatitis B Vaccine is refused, the 0.5 mL dose of Hepatitis B
Immune Globulin (Human) should be repeated at 3 and 6 months. Hepatitis B
Immune Globulin (Human) administered at birth should not interfere with oral polio and diphtheria-tetanuspertussis vaccines administered at 2 months of age.15
Sexual Exposure to an HBsAg-positive Person
All susceptible persons whose sex partners have acute
hepatitis B infection should receive a single dose of HBIG (0.06 mL/kg) and
should begin the hepatitis B vaccine series if prophylaxis can be started within
14 days of the last sexual contact or if sexual contact with the infected
person will continue (see Table 2 below). Administering the vaccine with HBIG
may improve the efficacy of postexposure treatment. The vaccine has the added
advantage of conferring long-lasting protection.8
Table 2 : (adapted from 21) Recommendations for
Postexposure Prophylaxis for Sexual Exposure to Hepatitis B
0.06 mL/kg IM†
Single dose within 14 days of last sexual contact
1.0 mL IM†
First dose at time of HBIG* treatment¶
* HBIG = Hepatitis B Immune Globulin (Human)
† IM = intramuscularly
¶ The first dose can be administered the same time as the HBIG dose
but at a different site; subsequent doses should be administered as recommended
for specific vaccine.
Household Exposure to Persons with Acute HBV Infection
Prophylactic treatment with a 0.5 mL dose of Hepatitis B
Immune Globulin (Human) and hepatitis B vaccine is indicated for infants < 12
months of age who have been exposed to a primary care-giver who has acute
hepatitis B. Prophylaxis for other household contacts of persons with acute HBV
infection is not indicated unless they have had identifiable blood exposure to
the index patient, such as by sharing toothbrushes or razors. Such exposures
should be treated like sexual exposures. If the index patient becomes an HBV
carrier, all household contacts should receive hepatitis B vaccine.8
Hepatitis B Immune Globulin (Human) may be administered at
the same time (but at a different site), or up to 1 month preceding Hepatitis B
Vaccination without impairing the active immune response from Hepatitis B
Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container permit.
Administer intramuscularly. Do not inject intravenously.
Hepatitis B Immune Globulin (Human) — BayHep B® (hepatitis b immune globulin (human)) is supplied
with a syringe and an attached UltraSafe® Needle Guard for your protection and
convenience. Please follow instructions below for proper use of syringe and
UltraSafe® Needle Guard.
Directions for Syringe Usage
Remove the prefilled syringe from the package. Lift syringe by barrel, not
Twist the plunger rod clockwise until the threads are seated.
With the rubber needle shield secured on the syringe tip, push the plunger
rod forward a few millimeters to break any friction seal between the rubber
stopper and the glass syringe barrel.
Remove the needle shield and expel air bubbles. [Do not remove the rubber
needle shield to prepare the product for administration until immediately
prior to the anticipated injection time.]
Proceed with hypodermic needle puncture.
Aspirate prior to injection to confirm that the needle is not in a vein
Inject the medication.
Keeping your hands behind the needle, grasp the guard with free hand and
slide forward toward needle until it is completely covered and guard clicks
into place. If audible click is not heard, guard may not be completely activated.
(See Diagrams A and B)
Place entire prefilled glass syringe with guard activated into an approved
sharps container for proper disposal. (See Diagram C)
A number of factors beyond our control could reduce the efficacy of this product
or even result in an ill effect following its use. These include improper storage
and handling of the product after it leaves our hands, diagnosis, dosage, method
of administration and biological differences in individual patients. Because
of these factors, it is important that this product be stored properly and that
the directions be followed carefully during use.
BayHep B (hepatitis b immune globulin (human)) is supplied in a 0.5 mL neonatal single dose
syringe with attached needle, a 1 mL single dose syringe with attached needle
and a 1 mL and a 5 mL single dose vial.
0.5 mL syringe
1 mL syringe
1 mL vial
5 mL vial
Store at 2–8°C (36–46°F). Do not freeze. Do not use after
U.S. federal law prohibits dispensing without prescription.
8. Recommendations of the Immunization Practices Advisory Committee
(ACIP): Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission
in the United States Through Universal Childhood Vaccination. Appendix A: Postexposure
Prophylaxis for Hepatitis B. MMWR 40(RR-13):21-25, 1991.
9. Stevens CE, Beasley RP, Tsui J, et al: Vertical transmission
of hepatitis B antigen in Taiwan. N Engl J Med 292(15):771-4, 1975.
10. Shiraki K, Yoshihara N, Kawana T, et al: Hepatitis B surface
antigen and chronic hepatitis in infants born to asymptomatic carrier mothers.
Am J Dis Child 131(6):644-7, 1977.
11. Recommendation of the Immunization Practices Advisory Committee
(ACIP): Immune globulins for protection against viral hepatitis. MMWR 30(34):423-8;
12. Okada K, Kamiyama I, Inomata M, et al: e antigen and anti-e
in the serum of asymptomatic carrier mothers as indicators of positive and negative
transmission of hepatitis B virus to their infants. N Engl J Med 294(14):746-9,
13. Beasley RP, Trepo C, Stevens CE, et al: The e antigen and
vertical transmission of hepatitis B surface antigen. Am J Epidemiol 105(2):94-8,
14. Beasley RP, Hwang LY, Lee GCY, et al: Prevention of perinatally
transmitted hepatitis B virus infections with hepatitis B immune globulin and
hepatitis B vaccine. Lancet 2(8359): 1099-102, 1983.
15. Recommendation of the Immunization Practices Advisory Committee
(ACIP): Recommendations for protection against viral hepatitis. MMWR 34(22):313–35,
16. Szmuness W, Stevens CE, Olesko WR, et al: Passive-active
immunisation against hepatitis B: immunogenicity studies in adult Americans.
Lancet 1:575–77, 1981.
20. Recommendations of the Immunization Practices Advisory Committee
(ACIP): Update on Adult Immunization. Table 9. Recommendations for postexposure
prophylaxis for percutaneous or permucosal exposure to hepatitis B, United States.
MMWR 40(RR-12):70, 1991.
21. Recommendations of the Immunization Practices Advisory Committee
(ACIP): Update on Adult Immunization. Table 10. Recommendations for postexposure
prophylaxis for perinatal and sexual exposure to hepatitis B, United States.
MMWR 40(RR-12):71, 1991.
Bayer Corporation, Pharmaceutical Division, Elkhart, IN 46515
USA. Rev. March 2004.
Side Effects & Drug Interactions
Local pain and tenderness at the injection site, urticaria
and angioedema may occur; anaphylactic reactions, although rare, have been
reported following the injection of human immune globulin preparations.19
Although administration of Hepatitis B Immune Globulin
(Human) did not interfere with measles vaccination,18 it is not
known whether Hepatitis B Immune Globulin (Human) may interfere with other live
virus vaccines. Therefore, use of such vaccines should be deferred until
approximately 3 months after Hepatitis B Immune Globulin (Human)
administration. Hepatitis B Vaccine may be administered at the same time, but
at a different injection site, without interfering with the immune response.16
No interactions with other products are known.
18. Beasley RP, Hwang LY: Measles vaccination not interfered
with by hepatitis B immune globulin. Lancet 1:161, 1982.
19. Ellis EF, Henney CS: Adverse reactions following administration
of human gamma globulin. J Allerg 43(1):45-54, 1969.
BayHep B (hepatitis b immune globulin (human)) is made from human plasma. Products made from
human plasma may contain infectious agents, such as viruses, that can cause
disease. The risk that such products will transmit an infectious agent has been
reduced by screening plasma donors for prior exposure to certain viruses, by
testing for the presence of certain current virus infections, and by inactivating
and/or removing certain viruses. Despite these measures, such products can
still potentially transmit disease. There is also the possibility that unknown
infectious agents may be present in such products. Individuals who receive
infusions of blood or plasma products may develop signs and/or symptoms of some
viral infections, particularly hepatitis C. ALL infections thought by a
physician possibly to have been transmitted by this product should be reported
by the physician or other healthcare provider to Bayer Corporation
The physician should discuss the risks and benefits of
this product with the patient, before prescribing or administering it to the
BayHep B (hepatitis b immune globulin (human)) should be given with caution to patients with a
history of prior systemic allergic reactions following the administration of
human immune globulin preparations. Epinephrine should be available.
In patients who have severe thrombocytopenia or any
coagulation disorder that would contraindicate intramuscular injections, Hepatitis
B Immune Globulin (Human) should be given only if the expected benefits
outweigh the risks.
BayHep B (hepatitis b immune globulin (human)) should not be administered intravenously because of
the potential for serious reactions. Injections should be made intramuscularly,
and care should be taken to draw back on the plunger of the syringe before
injection in order to be certain that the needle is not in a blood vessel.
Intramuscular injections are preferably administered in the
anterolateral aspects of the upper thigh and the deltoid muscle of the upper
arm. The gluteal region should not be used routinely as an injection site
because of the risk of injury to the sciatic nerve. An individual decision as
to which muscle is injected must be made for each patient based on the volume
of material to be administered. If the gluteal region is used when very large
volumes are to be injected or multiple doses are necessary, the central region
MUST be avoided; only the upper, outer quadrant should be used.17
Pregnancy Category C
Animal reproduction studies have not been conducted with
BayHep B (hepatitis b immune globulin (human)) . It is also not known whether BayHep B (hepatitis b immune globulin (human)) can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. BayHep B (hepatitis b immune globulin (human))
should be given to a pregnant woman only if clearly needed.
Safety and effectiveness in the pediatric population have
not been established.
Overdosage & Contraindications
Although no data are available, clinical experience with
other immunoglobulin preparations suggests that the only manifestations would
be pain and tenderness at the injection site.
Hepatitis B Immune Globulin (Human) provides passive
immunization for individuals exposed to the hepatitis B virus (HBV) as
evidenced by a reduction in the attack rate of hepatitis B following its use.1-6
The administration of the usual recommended dose of this immune globulin
generally results in a detectable level of circulating anti-HBs which persists
for approximately 2 months or longer. The highest antibody (IgG) serum levels
were seen in the following distribution of subjects studied: 7
% OF SUBJECTS
Mean values for half-life were between 17.5 and 25 days,
with the shortest being 5.9 days and the longest 35 days.7
Cases of type B hepatitis are rarely seen following exposure
to HBV in persons with preexisting anti-HBs. No confirmed instance of
transmission of hepatitis B has been associated with this product. In a
clinical study in eight healthy human adults receiving another hyperimmune
immune globulin product treated with solvent/detergent, Rabies Immune Globulin
(Human), BayRab®, prepared by the same manufacturing process, detectable
passive antibody titers were observed in the serum of all subjects by 24 hours
post injection and persisted through the 21 day study period. These results
suggest that passive immunization with immune globulin products is not affected
by the solvent/detergent treatment.
1. Grady GF, Lee VA: Hepatitis B immune globulin — prevention
of hepatitis from accidental exposure among medical personnel. N Engl J Med
2. Seeff LB, Zimmerman HJ, Wright EC, et al: Efficacy of hepatitis
B immune serum globulin after accidental exposure. Lancet 2(7942):939-41, 1975.
3. Krugman S, Giles JP: Viral hepatitis, type B (MS-2-strain).
Further observations on natural history and prevention. N Engl J Med 288(15):755-60,
4. Current trends: Health status of Indochinese refugees: malaria
and hepatitis B. MMWR 28(39):463-4; 469-70, 1979.
5. Jhaveri R, Rosenfeld W, Salazar JD, et al: High titer multiple
dose therapy with HBIG in newborn infants of HBsAg positive mothers. J Pediatr
6. Hoofnagle JH, Seeff LB, Bales ZB, et al: Passive-active immunity
from hepatitis B immune globulin. Ann Intern Med 91(6):813-8, 1979.
7. Scheiermann N, Kuwert EK: Uptake and elimination of hepatitis
B immunoglobulins after intramuscular application in man. Dev Biol Stand 54:347-55,
No information provided. Please refer to the WARNINGS
and PRECAUTIONS sections.