DOSAGE AND ADMINISTRATION
Acute Exposure To Blood Containing HBs Ag 
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
Table 1. (adapted from ) Recommendations for Hepatitis B Prophylaxis Following
Percutaneous or Permucosal Exposure
- Hepatitis B Immune Globulin
(Human) x1 immediately*
- Initiate HB Vaccine Series†
- Test exposed person for anti-
- 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
- Initiate HB Vaccine Series
- Test source for HBsAg. If
positive, Hepatitis B Immune
Globulin (Human) x1
- Test Source for HBsAg only if
exposed is vaccine nonresponder; if
source is HBsAg-positive, give
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
||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
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 HBs Ag 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 HBsAgpositive
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-tetanus-pertussis vaccines
administered at 2 months of age. 
Sexual Exposure To An HBs Ag-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. 
Table 2. (adapted from ) Recommendations for Postexposure Prophylaxis
for Sexual Exposure to Hepatitis B
|0.06 mL/kg IM†
||Single dose within 14
days of last sexual
||1.0 mL IM†
||First dose at time of
*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. 
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 Vaccination.
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) - HyperHEP B® S/D is supplied in a syringe with an attached
UltraSafe® Needle Guard for your protection and convenience, as well as in vials. 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 by plunger.
- 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 or artery.
- 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 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
HyperHEP B S/D 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. HyperHEP B S/D is
preservative-free and latex-free.
||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 expiration date.
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 97(2):305–8, 1980.
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; 433-5, 1981.
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, 1976.
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, 1977.
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,
15. Recommendation of the Immunization Practices Advisory Committee (ACIP): Recommendations for
protection against viral hepatitis. MMWR 34(22):313–35, 1985.
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.
Manufactured by: Grifols Therapeutics Inc. Research Triangle Park, NC 27709 USA. Revised: March 2018.