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    Disease-Specific Immunoglobulins - Antiviral

    DEA CLASS

    Rx

    DESCRIPTION

    Purified gamma globulins containing anti-HBs antibodies with activity against hepatitis B virus surface antigen (HBsAg)
    Used for HBV postexposure prophylaxis after acute exposure to contaminated blood, sexual or household exposure to HBV, and perinatal exposure; HepaGam also used to prevent HBV recurrence after liver transplantation
    Combined treatment of HBIG and hepatitis B vaccine provides short (passive) and long-term (active) protection against HBV

    COMMON BRAND NAMES

    Hepagam B, HyperHEP S/D, Nabi-HB

    HOW SUPPLIED

    Hepagam B Intravenous Inj Sol: 1mL, 312U
    Hepagam B/HyperHEP S/D/Nabi-HB Intramuscular Inj Sol: 1mL, 5mL, 312U, 1560U

    DOSAGE & INDICATIONS

    For post-exposure hepatitis B prophylaxis.
    Prophylaxis after percutaneous (e.g., bite, needlestick) or mucosal exposure to HBsAg-positive blood or body fluids that contain blood.
    NOTE: Receipt of hepatitis immune globulin (HBIG) is not recommended for adults either vaccinated or unvaccinated against HBV following exposure to an unknown source or to a known source at low risk for HBsAg-positivity. Unvaccinated patients are recommended to get the hepatitis B vaccine series.
    Intramuscular dosage
    Adults not yet vaccinated against HBV following exposure to known positive HBsAg source

    0.06 mL/kg IM for 1 dose as soon as possible after exposure (preferably less than 24 hours after exposure but no later than 7 days after exposure). Initiate the hepatitis B vaccination series at a different site. For persons who refuse the hepatitis B vaccine or are known non-responders to the vaccine, a second dose of HBIG should be given 1 month after the first dose.[48198] [53234]

    Adults not yet vaccinated against HBV following exposure to known source at high risk for HBsAg-positivity

    Initiate the hepatitis B vaccination series. Test source for HBsAg. If positive, give 0.06 mL/kg IM for 1 dose. For persons who refuse the hepatitis B vaccine or are known non-responders to the vaccine, a second dose of HBIG should be given 1 month after the first dose.[48198] [53234]

    Adults vaccinated against HBV following exposure to known positive HBsAg source

    Test exposed person for anti-HBs antibodies. If inadequate antibody (i.e., less than 10 milli-International Units/mL anti-HBs by radioimmunoassay or negative by enzyme immunoassay), then 0.06 mL/kg IM for 1 dose immediately and hepatitis B vaccine booster dose at a different site or a second dose of HBIG 1 month after the first dose. Two doses of HBIG are preferred if no response after at least 4 doses of vaccine.[48198] [53234]

    Adults vaccinated against HBV following exposure to known source at high risk for HBsAg-positivity

    Test source for HBsAg only if exposed person is a vaccine nonresponder; if the source is HBsAg-positive, give 0.06 mL/kg IM for 1 dose immediately plus hepatitis B vaccine booster dose at a different site or a second dose of HBIG 1 month after the first dose. Two doses of HBIG are preferred if no response after at least 4 doses of vaccine.[48198] [53234] [53233]

    Infants, Children, and Adolescents

    0.06 mL/kg/dose IM as soon as possible after exposure (preferably less than 24 hours after exposure but no later than 7 days after exposure) plus hepatitis B vaccination series initiation or completion at a different site.

    Prophylaxis after perinatal exposure.
    Intramuscular dosage
    Neonates born to HBsAg-positive mothers and neonates less than 2 kg† born to mothers with unknown HBsAg status

    0.5 mL IM for 1 dose after physiologic stabilization of the infant and preferably within 12 hours of birth plus hepatitis B vaccination series initiation at a different site. If needed, test mother for HBsAg status. [53234] [53233]

    Neonates at least 2 kg born to mothers with unknown HBsAg status†

    0.5 mL IM for 1 dose if evidence is suggestive of maternal HBV infection (e.g., presence of HBV DNA, HBeAg-positive, or mother known to be chronically infected with HBV). Otherwise, immediately test the mother for HBsAg status, and if the mother is HBsAg-positive, administer 0.5 mL IM for 1 dose as soon as possible but no later than 7 days after birth. Also, initiate the hepatitis B vaccination series within 12 hours of birth.[48198] [53026] [53230] [53234] [53233] [62840]

    Prophylaxis after sexual exposure to HBsAg-positive persons.
    Intramuscular dosage
    Adults

    0.06 mL/kg IM for 1 dose to all susceptible persons whose sexual partners have acute viral infection with hepatitis B. In addition, these persons should begin the hepatitis B vaccination series, if not contraindicated, within 14 days of the sexual contact or if sexual contact with the infected person will continue. Administering the hepatitis B vaccine with HBIG, but at a different site, may improve the efficacy of post-exposure treatment.[48198] [53234] [53233]

    Children and Adolescents

    0.06 mL/kg/dose IM as soon as possible after exposure (preferably less than 24 hours after exposure but no later than 14 days after exposure or if sexual contact will continue) plus hepatitis B vaccination series initiation or completion at a different site. [53234] [53233]

    Prophylaxis with household exposure to persons with acute HBV infection.
    Intramuscular dosage
    Adults

    Prophylaxis of household contacts of persons with acute viral infection with hepatitis B is not indicated unless they have an identifiable blood exposure to the index patient such as by sharing toothbrushes or razors. These patients should be given 0.06 mL/kg IM for 1 dose and begin the hepatitis B vaccination series within 14 days of contact or if contact will continue. If the index patient becomes a carrier of hepatitis B, all household contacts should receive the hepatitis B vaccine series.[48198] [53234] [53233]

    Children and Adolescents who have an identifiable blood exposure to the index patient such as through sharing toothbrushes or razors

    Prophylaxis of household contacts of persons with acute viral infection with hepatitis B is not indicated unless they have an identifiable blood exposure to the index patient such as by sharing toothbrushes or razors. These patients should be given 0.06 mL/kg/dose IM for 1 dose and begin the hepatitis B vaccination series within 14 days of contact or if contact will continue. If the index patient becomes a carrier of hepatitis B, all household contacts should receive the hepatitis B vaccine series. [53234] [53233]

    Neonates and Infants whose primary caregiver has acute HBV infection

    0.5 mL IM for 1 dose as soon as possible after exposure plus hepatitis B vaccination series initiation or completion at a different site. [53234] [53233]

    For prevention of hepatitis B infection recurrence after liver transplantation in HBsAg-positive liver transplant patients.
    NOTE: HepaGam B is most effective in patients with absent or low concentrations of HBV replication at the time of transplantation.
    NOTE: Use of antiviral therapy in conjunction with HepaGam B after transplantation has not been evaluated.
    NOTE: After the transplant, regularly monitor serum anti-HBs antibody concentration. Patients who are particularly susceptible to extreme loss of circulated anti-HBs include those with surgical bleeding or abdominal fluid drainage of more than 500 mL and patients who are undergoing plasmapheresis.[48198]
    Intravenous infusion dosage (HepaGam B only)
    Adults

    20,000 International Units via intravenous (IV) infusion at a rate of 2 mL/minute (decrease to at least 1 mL/min if infusion-related reactions develop). The first dose should be given concurrently with grafting of the transplanted liver. Subsequent doses should be given on the following schedule: once daily on postoperative days 1 through 7, then every 2 weeks starting on postoperative day 14, then every month starting on month 4. The target serum anti-HBs antibody concentration is greater than 500 International Units/L. Regularly monitor the serum anti-HBs concentration before an infusion to track response and to allow for treatment adjustment. If the serum anti-HBs concentration is less than 500 International Units/L within the first week of transplantation, increase the dose to 10,000 International Units IV every 6 hours until the target anti-HBs concentration is reached.[48198]

    MAXIMUM DOSAGE

    Adults

    0.06 mL/kg/dose IM for hepatitis B prophylaxis; 20,000 International Units/dose IV for prevention of hepatitis B recurrence.

    Geriatric

    0.06 mL/kg/dose IM for hepatitis B prophylaxis.

    Adolescents

    0.06 mL/kg/dose IM for hepatitis B prophylaxis.

    Children

    0.06 mL/kg/dose IM for hepatitis B prophylaxis.

    Infants

    0.5 mL/dose IM for hepatitis B prophylaxis.

    Neonates

    0.5 mL/dose IM for hepatitis B prophylaxis.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

     
    NOTE: Each vial of HepaGam B or of Nabi-HB has at least 312 International Units anti-HBs/mL. The measured potency of each lot of HepaGam B is stamped on the vial label.

    Injectable Administration

    Hepatitis B immune globulin is administered intramuscularly for postexposure prophylaxis or intravenously for prevention of hepatitis B recurrence after liver transplantation in HBsAg-positive patients (NOTE: ONLY HepaGam B is approved for intravenous administration).
    Hepatitis B immune globulin should not be given in the same syringe or injected at the same site as hepatitis B virus vaccine.
    A separate syringe and needle should be used for each person receiving HBIG.
    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if particulate matter is present or if the product is not clear to opalescent. Do not shake vials, avoid foaming.

    Intravenous Administration

    HepaGam B only:
    Calculate the volume needed for each 20,000 IU dose by using the measured potency of the HepaGam B lot. The potency is stamped on the vial label. Aseptically prepare the dose.
    Promptly use the product after the vial has been entered; use within 6 hours of vial entry. No preservatives are in the single-dose vials; discard any unused product in a vial that has been entered.
    Administer at 2 ml/minute through a separate intravenous line using an intravenous administration set via infusion pump. Decrease the rate to 1 ml/minute or less if the patient gets uncomfortable, if the patient has infusion-related adverse events, or if concern about the infusion speed exists.

    Intramuscular Administration

    Promptly use the product after the vial has been entered; use within 6 hours of vial entry. No preservatives are in the single-dose vials; discard any unused product in a vial that has been entered.
    In adults and children: Intramuscular injections should be made into the deltoid muscle or the anterolateral muscles of the thigh. To avoid injury to the sciatic nerves, injection into the upper outer quadrant of the gluteus maximus should be used only if large volumes are administered or when large doses must be divided into multiple IM injections. If the gluteal region is used, only inject into the upper outer quadrant; avoid the central region.
    In neonates, infants, and small children: Intramuscular injections should be made into the anterolateral muscles of the thigh.

    STORAGE

    Hepagam B:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Refrigerate (between 36 and 46 degrees F)
    - Store product in refrigerator (36 to 46 degrees F) and use within 6 hours after opening
    HyperHEP S/D:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Protect from freezing
    - Refrigerate (between 36 and 46 degrees F)
    Nabi-HB:
    - Do not freeze
    - Refrigerate (between 36 and 46 degrees F)
    - Store product in refrigerator (36 to 46 degrees F) and use within 6 hours after opening

    CONTRAINDICATIONS / PRECAUTIONS

    Laboratory test interference

    Antibodies present in hepatitis B immune globulin (HBIG) may cause laboratory test interference. After administration of immune globulins, a transitory increase of passively transferred antibodies in the patient's blood may cause misleading positive results in serological testing (e.g., Coombs' test).[48198] [53234] [53233]

    Intravenous administration

    The only indication for which hepatits B immune globulin (HBIG) is given by intravenous administration is to prevent the recurrence of hepatitis B virus (HBV) infection in HBsAg-positive patients who have undergone a liver transplant. The only formulation approved for intravenous administration is HepaGam B. Intramuscular administration is recommended for all other formulations and indications. Patients receiving HepaGam B by intravenous infusion must be closely monitored during and immediately following each dose, as certain adverse reactions may be related to the rate of infusion.[48198] [53234] [53233]

    IgA deficiency

    Patients with IgA deficiency often develop antibodies against IgA and are more likely to have anaphylactic or immune-mediated adverse reactions to pooled immunoglobulin products such as hepatitis B immune globulin (HBIG). Both HepaGam B and Nabi-HB contain trace amounts (less than 40 mcg/mL) of IgA. HepaGam B is contraindicated for use in IgA deficient patients with antibodies against IgA and a history of hypersensitivity reactions. Nabi-HB should be used with caution in IgA deficient patients, with careful consideration of the potential benefit of HBIG receipt and the potential for hypersensitivity reactions. Administer HBIG in a setting with appropriate equipment, medication (i.e., epinephrine, antihistamines), and personnel trained in the management of hypersensitivity, anaphylaxis, and shock.[48198] [53234] [53233]

    Coagulopathy, hemophilia, thrombocytopenia

    Intramuscular (IM) injections of hepatitis B immune globulin (HBIG) can cause injury at the injection site and should be used cautiously in patients with thrombocytopenia or coagulopathy (e.g., hemophilia). In patients who have severe thrombocytopenia or any coagulation disorder that would potentially contraindicate IM administration, HBIG should be given only if the expected benefits of treatment outweigh the potential risk associated with IM administration.[48198] [53234] [53233]

    Pregnancy

    Hepatitis B immune globulin (HBIG) is an FDA pregnancy category C drug. The ability of HBIG to cause fetal harm or to affect reproductive capacity is unknown. Administer HBIG to a pregnant woman only if clearly indicated. Studies concerning its effects on the fetus have not been done; however, other immunoglobulins have been used safely during pregnancy. Consult current CDC and American College of Obstetrician and Gynecology guidelines prior to use in pregnant patients; many guidelines recommend the use of HBIG during pregnancy for HBV post-exposure prophylaxis when indicated. [53234] [53233]

    Breast-feeding

    Excretion of hepatitis B immune globulin (HBIG) into breast milk is unknown; administer cautiously to women who are breast-feeding. Case reports of 2 nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA. [53234] [53233]

    Vaccination

    Hepatitis B immune globulin (HBIG) may impair the efficacy of live attenuated virus vaccines. Therefore, vaccinations with live virus vaccines should be delayed until 3 months after HBIG administration. Persons who received HBIG less than 14 days after a live virus vaccination should be revaccinated 3 months after administration of the immune globulin unless serologic tests indicate that antibodies were produced. HBIG and hepatitis B vaccine may be given at the same time, but at a different site, without interfering with the immune response.[48198] [53234] [53233]

    Hyperglycemia

    Blood glucose testing systems based on the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) method falsely interpret the maltose contained in HepaGam B as glucose. Falsely elevated glucose readings (false hyperglycemia) have led to life-threatening hypoglycemia because of inappropriate administration of insulin. Falsely elevated glucose readings could also mask true cases of hypoglycemia. Measurement of blood glucose must be done with a glucose-specific method if a patient takes a parenteral product that contains maltose. Read the product information of the blood glucose testing system including the information about the test strips to determine if the system is appropriate for use with maltose-containing parenteral products. If any uncertainty exists, contact the manufacturer of the testing system.[48198]

    Viral infection

    As with other products derived from or purified with human blood components, the possibility of transmission of viral or bacterial infections exists in patients receiving hepatitis B immune globulin (HBIG). Screening plasma donors for prior exposure to certain viruses, testing for the presence of viruses, and inactivating or reducing viruses has reduced the risk of transmission of infectious agents. Additionally, the manufacturing processes are designed to reduce the risk of transmitting viral infection; however, none of the processes are completely effective. There is also the possibility that unknown infectious agents may be present in this product.[48198] [53234] [53233]

    Geriatric, hypertriglyceridemia

    Thrombotic events may occur during or after treatment with intravenous immune globulins, such as HepaGam B. Patients at increased risk include those with a history of atherosclerosis, cardiovascular disease or impaired cardiac output, coagulation disorders, prolonged immobilization, hyperviscosity, and geriatric patients. To reduce the risk for thrombotic events, at-risk patients should receive HepaGam B at the lowest possible infusion rate. In addition, consider baseline assessment of blood viscosity in patients at risk for hyperviscosity including those with cryoglobulins, hypertriglyceridemia, or monoclonal gammopathies.[48198]

    ADVERSE REACTIONS

    Severe

    angioedema / Rapid / Incidence not known

    Moderate

    elevated hepatic enzymes / Delayed / 2.0-2.0
    erythema / Early / Incidence not known
    hypotension / Rapid / Incidence not known

    Mild

    headache / Early / 14.0-14.0
    injection site reaction / Rapid / 4.0-12.0
    myalgia / Early / 10.0-10.0
    malaise / Early / 6.0-6.0
    nausea / Early / 4.0-4.0
    ecchymosis / Delayed / 2.0-2.0
    arthralgia / Delayed / 2.0-2.0
    vomiting / Early / 2.0-2.0
    urticaria / Rapid / Incidence not known
    dizziness / Early / Incidence not known
    infection / Delayed / Incidence not known

    DRUG INTERACTIONS

    Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Haemophilus influenzae type b Conjugate Vaccine; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV: (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine.
    Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Hepatitis B Vaccine, Recombinant; Inactivated Poliovirus Vaccine, IPV : (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine.
    Haemophilus influenzae type b Conjugate Vaccine; Hepatitis B Vaccine, Recombinant: (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine.
    Hepatitis A Vaccine, Inactivated; Hepatitis B Vaccine, Recombinant: (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine.
    Hepatitis B Vaccine, Recombinant: (Minor) Administration of hepatitis B virus vaccines (e.g., hepatitis B vaccine, recombinant) at the same site or in the same syringe as hepatitis B immune globulin, HBIG can result in neutralization. Hepatitis B Immune Globulin (human) may be administered at the same time (but at a different site) or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine.
    Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) Do not give immune globulin including concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations. (Major) The manufacturers advise deferral of live virus vaccine receipt such as measles/mumps/rubella vaccines, MMR and varicella virus vaccine live until approximately 3 months after hepatitis B immune globulin, HBIG administration. Of note, the Advisory Committee on Immunization Practices states that Ty21a typhoid; yellow fever; live, attenuated influenza vaccine; zoster; and rotavirus vaccines may be administered at any time before, concurrent with, or after administration of HBIG. For all other live vaccines, do not administer simultaneously with HBIG, as HBIG may interfere with live virus vaccines. If simultaneous administration of measles-containing vaccine or varicella-containing vaccine (except zoster) is unavoidable, administer the products at different sites and revaccinate or test for seroconversion after recommended interval of at least 3 months between HBIG administration and any measles or varicella-containing vaccine except the zoster vaccine. It may be necessary to revaccinate persons who received HBIG shortly after live virus vaccination. If HBIG was administered less than 14 days after live virus vaccination, revaccinate 3 months after HBIG administration unless serologic test results indicate antibody production. Administering inactivated vaccines and toxoids either simultaneously with or at any interval before or after receipt of an antibody-containing product should not substantially impair development of a protective antibody response. Administer the inactivated vaccine or toxoid and HBIG at different sites using the standard recommended doses.
    Measles/Mumps/Rubella Vaccines, MMR: (Major) The manufacturers advise deferral of live virus vaccine receipt such as measles/mumps/rubella vaccines, MMR and varicella virus vaccine live until approximately 3 months after hepatitis B immune globulin, HBIG administration. Of note, the Advisory Committee on Immunization Practices states that Ty21a typhoid; yellow fever; live, attenuated influenza vaccine; zoster; and rotavirus vaccines may be administered at any time before, concurrent with, or after administration of HBIG. For all other live vaccines, do not administer simultaneously with HBIG, as HBIG may interfere with live virus vaccines. If simultaneous administration of measles-containing vaccine or varicella-containing vaccine (except zoster) is unavoidable, administer the products at different sites and revaccinate or test for seroconversion after recommended interval of at least 3 months between HBIG administration and any measles or varicella-containing vaccine except the zoster vaccine. It may be necessary to revaccinate persons who received HBIG shortly after live virus vaccination. If HBIG was administered less than 14 days after live virus vaccination, revaccinate 3 months after HBIG administration unless serologic test results indicate antibody production. Administering inactivated vaccines and toxoids either simultaneously with or at any interval before or after receipt of an antibody-containing product should not substantially impair development of a protective antibody response. Administer the inactivated vaccine or toxoid and HBIG at different sites using the standard recommended doses.
    Rotavirus Vaccine: (Major) Defer vaccination with live virus vaccines such as Rotavirus Vaccine until approximately 3 months after Hepatitis B immune globulin administration. Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines such as Rotavirus Vaccine may be impaired by Hepatitis B immune globulin administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines.
    Rubella Virus Vaccine Live: (Major) The manufacturers advise deferral of live virus vaccine receipt such as measles/mumps/rubella vaccines, MMR and varicella virus vaccine live until approximately 3 months after hepatitis B immune globulin, HBIG administration. Of note, the Advisory Committee on Immunization Practices states that Ty21a typhoid; yellow fever; live, attenuated influenza vaccine; zoster; and rotavirus vaccines may be administered at any time before, concurrent with, or after administration of HBIG. For all other live vaccines, do not administer simultaneously with HBIG, as HBIG may interfere with live virus vaccines. If simultaneous administration of measles-containing vaccine or varicella-containing vaccine (except zoster) is unavoidable, administer the products at different sites and revaccinate or test for seroconversion after recommended interval of at least 3 months between HBIG administration and any measles or varicella-containing vaccine except the zoster vaccine. It may be necessary to revaccinate persons who received HBIG shortly after live virus vaccination. If HBIG was administered less than 14 days after live virus vaccination, revaccinate 3 months after HBIG administration unless serologic test results indicate antibody production. Administering inactivated vaccines and toxoids either simultaneously with or at any interval before or after receipt of an antibody-containing product should not substantially impair development of a protective antibody response. Administer the inactivated vaccine or toxoid and HBIG at different sites using the standard recommended doses.
    Varicella-Zoster Virus Vaccine, Live: (Major) Do not give immune globulin including concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations.

    PREGNANCY AND LACTATION

    Pregnancy

    Hepatitis B immune globulin (HBIG) is an FDA pregnancy category C drug. The ability of HBIG to cause fetal harm or to affect reproductive capacity is unknown. Administer HBIG to a pregnant woman only if clearly indicated. Studies concerning its effects on the fetus have not been done; however, other immunoglobulins have been used safely during pregnancy. Consult current CDC and American College of Obstetrician and Gynecology guidelines prior to use in pregnant patients; many guidelines recommend the use of HBIG during pregnancy for HBV post-exposure prophylaxis when indicated. [53234] [53233]

    Excretion of hepatitis B immune globulin (HBIG) into breast milk is unknown; administer cautiously to women who are breast-feeding. Case reports of 2 nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA. [53234] [53233]

    MECHANISM OF ACTION

    Anti-HBs antibodies present in hepatitis B immune globulin (HBIG) neutralize the hepatitis B virus (HBV) by opsonization, resulting in complement activation and stimulation of cell-mediated immunity. In individuals exposed to HBV, HBIG provides passive immunity by binding to the hepatitis B virus surface antigen (HBsAg). In postexposure prophylaxis, HBIG may provide temporary protection from HBV infection for 3 to 6 months. Combined treatment of HBIG and hepatitis B vaccine provides short and long-term protection against HBV. HBIG does not appear to suppress the active immunity induced by the hepatitis B vaccination.[48198] [53234] [53233]

    PHARMACOKINETICS

    Hepatitis B Immune Globulin (HBIG) is administered intramuscularly and intravenously (HepaGam B only). The distribution of HBIG has not been described; however, it is probable that HBIG crosses the placenta and may be distributed into breast milk. The volume of distribution ranges from approximately 7.5 to 11 liters. The mean half-life of HBIG is 17.5 to 25 days.[48198] [53234] [53233]
     
    Standard doses of HBIG provide passively acquired antibodies to the hepatitis B surface antigen (HBsAg) and, thus, temporary protection (i.e., 3 to 6 months).

    Intramuscular Route

    After IM administration of Nabi-HB to adults, the maximum concentration occurred at 6.5 +/- 4.3 days. After a 0.06 ml/kg/dose IM of HepaGam B to adults, the maximum concentration occurred within 4 to 5 days.