Hyper Hep B

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 iu/mL.
Hyper Hep B treated with solvent/detergent is a sterile solution of hepatitis B hyperimmune immune globulin for IM administration; it contains no preservative. Hyper Hep B 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 hrs. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally, ultrafiltration and diafiltration. Hyper Hep B is formulated as a 15-18% protein solution at a pH of 6.4-7.2 in 0.21-0.32 M glycine. Hyper Hep B is then incubated in the final container for 21-28 days at 20-27°C.
The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for Hyper Hep B 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 reovirus 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 2 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.

Pharmacology: 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. 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. The highest antibody (IgG) serum levels were seen in the following distribution of subjects studied: Day 3: 38%; day 7: 41.7%; day 14: 11.1%; day 21: 8.3%. Mean values of half-life were between 17.5 and 25 days, with the shortest being 5.9 days and the longest 35 days.
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 Hyper Hep B.
In a clinical study in 8 healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, rabies human immune globulin, BayRab, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hrs 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.

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 2-dose hepatitis B immune globulin (human) treatment alone, and is the treatment of choice.
Post-exposure prophylaxis in the following situations:
Acute Exposure to Blood Containing HBsAg: After either parenteral exposure eg, by accidental 'needlestick' or direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident) involving HBsAg-positive materials eg, blood, plasma or serum. For inadvertent percutaneous exposure, a regimen of 2 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. This risk is especially great if the mother is HBeAg-positive. For an infant with perinatal exposure to an HBsAg- and HBeAg-positive mother, a regimen combining 1 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. 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.
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.
Household Exposure to Persons with Acute HBV Infection: Since infants have close contact with primary caregivers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant <12 months with hepatitis B immune globulin and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection.
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. 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.
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.

Acute Exposure to Blood Containing HBsAg: 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 IM (see Precautions) as soon as possible after exposure and within 24 hrs, if possible.

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For persons who refuse hepatitis B vaccine, a 2nd dose of Hyper Hep B should be given 1 month after the 1st 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 IM to the newborn infant after physiologic stabilization of the infant and preferably within 12 hrs of birth. Hepatitis B immune globulin (human) efficacy decreases markedly if treatment is delayed beyond 48 hrs. Hepatitis B vaccine should be administered IM in 3 doses of 0.5 mL of vaccine (10 mcg) each. The 1st 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 2nd and 3rd doses of vaccine should be given 1 month and 6 months, respectively, after the first. If administration of the 1st dose of hepatitis B vaccine is delayed for as long as 3 months, then a 0.5-mL dose of hepatitis B immune globulin (HyperHep) should be repeated at 3 months. If hepatitis 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 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).
Administering the vaccine with HBIG may improve the efficacy of post-exposure treatment. The vaccine has the added advantage of conferring long-lasting protection.

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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 who have been exposed to a primary caregiver 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 eg, 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.
Administration: Administer IM. Do not inject IV.
Directions for Syringe Usage:
Remove the pre-filled 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.
Proceed with hypodermic needle puncture.
Aspirate prior to injection to confirm that the needle is not in a vein or artery.
Inject the medication.
Withdraw the needle and dispose or destroy it.

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.

None known.

Hyper Hep B is made from human plasma. Products made from human plasma may contain infectious agents eg, 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.
The physician should discuss the risks and benefits of Hyper Hep B with the patient, before prescribing or administering it to the patient.
Hyper Hep B 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 IM injections, hepatitis B immune globulin (human) should be given only if the expected benefits outweigh the risks.

Hepatitis B immune globulin (human) should not be administered IV because of the potential for serious reactions. Injections should be made IM, 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.
IM 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.
Laboratory Tests: None required.
Use in pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with Hyper Hep B. It is also not known whether Hyper Hep B can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyper Hep B should be given to a pregnant woman only if clearly needed.
Use in children: Safety and effectiveness in the pediatric population have not been established.

Use in pregnancy: Pregnancy Category C: Animal reproduction studies have not been conducted with Hyper Hep B. It is also not known whether Hyper Hep B can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hyper Hep B should be given to a pregnant woman only if clearly needed.
Use in children: Safety and effectiveness in the pediatric population have not been established.

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.

Although administration of hepatitis B immune globulin (human) did not interfere with measles vaccination, 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. No interactions with other products are known.

Store at 2-8°C (36-46°F). Do not freeze.

Vaccines, Antisera & Immunologicals

J06BB04 - hepatitis B immunoglobulin ; Belongs to the class of specific immunoglobulins. Used in passive immunizations.

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