Hepatitis B Immune Globulin (Monograph)

Brand names: HepaGam B, HyperHEP B, Nabi-HB
Drug class: Antitoxins and Immune Globulins
ATC class: J06BB04
VA class: IM100

Medically reviewed by Drugs.com on Sep 23, 2024. Written by ASHP.

Introduction

Specific immune globulin (hyperimmune globulin). Hepatitis B immune globulin (HBIG) contains antibody to hepatitis B surface antigen (anti-HBs) prepared from plasma of donors with high titers of anti-HBs and is used to provide temporary passive immunity to hepatitis B virus (HBV).

Uses for Hepatitis B Immune Globulin

Prevention of Perinatal Hepatitis B Virus (HBV) Infection

Prevention of perinatal HBV infection in neonates born to hepatitis B surface antigen-positive (HBsAg-positive) women.

A combined regimen that includes active immunization with hepatitis B vaccine (HepB vaccine) and passive immunization with hepatitis B immune globulin (HBIG) is 85–95% effective in preventing acute and chronic HBV infection in infants born to women positive for both HBsAg and HBeAg.

HBIG has been used alone for prevention of perinatal HBV infection in neonates born to HBsAg-positive women, but use of passive immunization alone is no longer recommended since a regimen that includes both HBIG and HepB vaccine is more effective.

ACIP and AAP recommend routine serologic screening of all pregnant women during an early prenatal visit (e.g., first trimester) to determine their HBsAg status, even if they were tested previously or have already been vaccinated against HBV. Women who were not tested prenatally, those who engage in behaviors that put them at high risk for HBV (e.g., >1 sex partner in the previous 6 months, HBsAg-positive sex partner, evaluation or treatment for sexually transmitted diseases (STDs), recent or current injection drug abuse) and those with clinical hepatitis should be tested for HBsAg status when admitted to the hospital for delivery.

To prevent perinatal HBV infection, ACIP and AAP recommend that all neonates born to HBsAg-positive women receive a dose of HBIG and a dose of HepB vaccine as soon as possible after birth (within 12 hours of birth), regardless of gestational age or birthweight. For neonates <2 kg, do not count the birth vaccine dose toward completion of the HepB vaccine series; begin usual 3-dose vaccine series when infant is 1 month of age.

If maternal HBsAg status is unknown at birth, give infant the first dose of HepB vaccine (within 12 hours of birth). Determine mother’s HBsAg status as quickly as possible and, if positive, give infant a dose of HBIG as soon as possible (no later than 7 days of age). For neonates weighing <2 kg, if the mother’s HBsAg status cannot be determined within 12 hours of birth, give a dose of HBIG as soon as possible (within 12 hours of birth) and do not count the birth vaccine dose toward completion of the HepB vaccine series; begin usual 3-dose vaccine series when infant is 1 month of age.

Postexposure Prophylaxis of Hepatitis B Virus (HBV) Infection

HBV postexposure prophylaxis (PEP) in certain individuals exposed to HBV or HBsAg-positive materials (e.g., health-care personnel, sexual or intimate contacts of HBsAg-positive individuals).

Depending on exposure circumstances, PEP regimen may include combined passive immunization with HBIG and active immunization with HepB vaccine to provide both short- and long-term protection.

Multiple-dose regimen of HBIG alone (e.g., first dose at time of exposure and second dose 1 month later) is about 75% effective in preventing HBV infection following percutaneous exposure. However, since health-care personnel and others at risk of HBV exposure are candidates for preexposure vaccination with HepB vaccine and since combined passive and active immunization is more effective than HBIG alone following perinatal HBV exposure, combined active and passive immunization is preferred when PEP is indicated following an exposure to HBsAg-positive material.

HBIG is most effective when administered as soon as possible after exposure (preferably within 24 hours) and may be ineffective if administered >7 days after a percutaneous exposure or >14 days after a sexual exposure.

HBIG not indicated for treatment of acute or chronic HBV infection.

PEP may be indicated in susceptible, unvaccinated health-care personnel following occupational exposure to blood and other body fluids that might contain HBV. If an occupational exposure to HBV occurs, review vaccination status and vaccine-response status (if known) of exposed individual and HBsAg status of source. (See Table 1.)

If exposed individual was not previously vaccinated against HBV, initiate HepB vaccine series as soon as possible (preferably within 24 hours). In addition, if source is found to be HBsAg-positive, give a dose of HBIG as soon as possible (preferably within 24 hours).

If exposed individual was previously vaccinated against HBV and is a known responder (serum anti-HBs ≥10 mIU/mL), PEP is not necessary. If exposed individual was previously vaccinated but is a known nonresponder (serum anti-HBs <10 mIU/mL), PEP is not necessary if source is HBsAg-negative. However, if source is HBsAg-positive or known to be high-risk for HBV, give exposed individual a dose of HBIG and initiate a second HepB vaccine series as soon as possible after exposure. A 2-dose regimen of HBIG (without HepB vaccine) is preferred in individuals who already previously failed to respond to a second vaccine series.

If antibody status of exposed individual is unknown, test them for anti-HBs prior to initiation of PEP. If exposed individual is found to be a responder (serum anti-HBs ≥10 mIU/mL), PEP is not necessary. If exposed individual is found to be a nonresponder (anti-HBs levels <10 mIU/mL) and source is HBsAg-positive, give a dose of HBIG and a booster dose of HepB vaccine. If exposed individual is found to be a nonresponder and source is unknown or not available for testing, give a booster dose of HepB vaccine and recheck antibody titer in 1–2 months.

ACIP and CDC recommend PEP with HepB vaccine with or without HBIG for victims of sexual assault (adult, adolescent, child) who are susceptible to HBV. PEP after a sexual assault is not necessary in those who previously received the complete HepB vaccine series. If victim is unvaccinated or incompletely vaccinated and perpetrator is HBsAg-positive, give a dose of HBIG within 14 days of the assault (preferably within 24 hours) and initiate or complete HepB vaccine series.

ACIP and CDC recommend that previously unvaccinated sexual partners of individuals HbsAg-positive individuals receive PEP with a dose of HBIG and the initial dose of the HepB vaccine series (within 14 days of the most recent sexual contact). Completion of the vaccine series confers long-term protection in case the individual with acute HBV infection becomes chronically infected.

AAP recommends that unvaccinated infants <12 months of age in close contact with a mother or other primary care-giver who has acute HBV infection receive combined passive immunization with HBIG and active immunization with HepB vaccine. If the infant previously received a single dose of HepB vaccine, give the second vaccine dose if the interval is appropriate or, if it is too soon to give a vaccine dose, give a dose of HBIG. HBIG is not required if, at the time of exposure, the infant has already received ≥2 doses of HepB vaccine.

Other nonsexual household contacts of individuals with acute HBV infection are not at increased risk for infection unless they have other risk factors or are exposed to the blood of the infected patient (e.g., by sharing a toothbrush or razor). However, encourage all household contacts of patients with acute HBV infection to receive HepB vaccine. If the patient with acute HBV infection becomes chronically infected (i.e., remains HBsAg-positive after 6 months), all household contacts should be vaccinated with HepB vaccine.

ACIP and CDC recommend PEP with HepB vaccine for sexual or needle-sharing partners and nonsexual household contacts of individuals with chronic HBV infection. Because most HBsAg-positive individuals are identified during routine screening (e.g., blood donation, prenatal evaluation) or clinical evaluation and it may be difficult to identify the time of last contact, HBIG is not considered necessary for PEP in contacts of such individuals. A dose of HBIG may be indicated if the most recent sexual exposure to an HBsAg-positive individual occurred within the last 14 days.

CDC recommends that individuals wounded in bombings or other mass casualty settings who are unvaccinated or have an uncertain vaccination history receive postexposure vaccination with HepB vaccine (without HBIG). Responders and other personnel in mass casualty settings should be managed using PEP regimens recommended for occupational exposures to HBV. (See Table 1.)

PEP not necessary in individuals who previously received primary immunization with HepB vaccine and have serologic evidence of adequate levels of anti-HBs (≥10 mIU/mL).

PEP not necessary in individuals previously infected with HBV; such individuals are immune to reinfection.

Prevention of Hepatitis B Virus (HBV) Recurrence in Liver Transplant Recipients

Prevention of HBV recurrence in liver transplant recipients who are HBsAg-positive.

HBIG has been used alone or in conjunction with an antiviral (e.g., lamivudine, adefovir) to suppress HBV replication and prevent recurrence of HBV infection in patients with chronic HBV infection undergoing liver transplantation. Optimum regimens for such prophylaxis (i.e., dosage, route, and duration of HBIG; specific antiviral for a combined regimen) not established.

HepaGam B given by IV infusion is labeled by the FDA for prevention of HBV recurrence in liver transplant recipients based on interim results of a clinical study in HBsAg-positive, HBeAg-negative transplant recipients who had only low or undetectable levels of HBV replication at time of transplant.

Although safety and efficacy not established, other HBIG preparations have been administered IM or IV^{† [off-label]} for prevention of HBV recurrence in liver transplant recipients and have been used alone or in conjunction with an antiviral active against HBV.

Hepatitis B Immune Globulin Dosage and Administration

Administration

IM Administration

HepaGam B, HyperHEP B, and Nabi-HB: Administer by IM injection for prevention of perinatal HBV infection and for postexposure prophylaxis of HBV infection. Do not administer IV for this indication.

Inspect visually for particulate matter and discoloration.

Administer undiluted. Do not mix with any other drug or solution.

Depending on patient age, administer IM into the deltoid muscle or anterolateral thigh. To ensure delivery into muscle, IM injections should be made at a 90° angle to the skin using a needle length appropriate for the individual’s age and body mass, the thickness of adipose tissue and muscle at the injection site, and the injection technique.

For neonates and young children (up to 12 months of age), IM injections should be made into the anterolateral aspect of the thigh. For children 1–2 years of age, IM injections should preferably be administered into the anterolateral thigh; deltoid muscle is an alternative if muscle mass is adequate. For children and adolescents 3–18 years of age and adults, deltoid muscle is preferred, although anterolateral thigh is an alternative.

Because of the risk of injection-associated injury to the sciatic nerve, use gluteal region only when necessary (e.g., when a large volume or multiple doses are indicated). If use of gluteal area is considered necessary, use only the upper, outer quadrant; avoid central region.

Although some manufacturers recommend that aspiration (i.e., pulling back on the syringe plunger after needle insertion and before injection) should be performed to ensure that a blood vessel has not been entered, ACIP and AAP state this procedure is not required because large blood vessels are not present at recommended IM injection sites.

May be given simultaneously with HepB vaccine (using different syringes and different injection sites) when passive immunization is considered necessary in addition to active immunization with the vaccine (e.g., in neonates born to HBsAg-positive women, PEP regimen in certain individuals exposed to HBV or HBsAg-positive materials).

IV Infusion

HepaGam B: Administer by IV infusion for prevention of HBV recurrence in liver transplant recipients. Although safety and efficacy not established, other HBIG preparations have been administered by IV infusion^{† [off-label]} for this use.

Do not mix with any other drug or solution. Administer using a separate IV line using an IV administration set via infusion pump.

Do not shake vial; avoid foaming.

Rate of Administration

HepaGam B: Administer by IV infusion at a rate of 2 mL/minute. Decrease to ≤1 mL/minute if patient develops discomfort or infusion-related adverse effects or if there is concern about the rate of infusion.

Dosage

Pediatric Patients

Prevention of Perinatal Hepatitis B Virus (HBV) Infection

Neonates Born to HBsAg-positive Women

IM

Combined passive immunization with HBIG and active immunization with HepB vaccine is indicated.

Give 0.5 mL of HBIG and a dose of monovalent HepB vaccine within 12 hours of birth (using different syringes and different injection sites).

If first dose of HepB vaccine is delayed for ≥3 months, manufacturer of HyperHEP B recommends a second 0.5-mL dose of HBIG at 3 months of age. If HepB vaccine is contraindicated or not available, this manufacturer recommends second and third 0.5-mL doses of HBIG at 3 and 6 months of age, respectively.

Neonates Born to Women with Unknown HBsAg Status

IM

Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.

Give a dose of monovalent HepB vaccine within 12 hours of birth. Determine HBsAg status of the mother as soon as possible.

If mother is found to be HBsAg-positive, give neonate 0.5 mL of HBIG as soon as possible (no later than 1 week of age).

If neonate was preterm and weighed <2 kg at birth, give neonate 0.5 mL of HBIG within 12 hours of birth if mother is found to be HBsAg-positive or if results are not available.

Postexposure Prophylaxis of Hepatitis B Virus (HBV) Infection

Unvaccinated or Incompletely Vaccinated Infants <12 Months of Age Exposed to Acute HBV Infection

IM

Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.

If mother or other primary care-giver has acute HBV infection, give 0.5 mL of HBIG and initiate or complete primary immunization with HepB vaccine. HBIG is not necessary if infant already received ≥2 doses of HepB vaccine.

Unvaccinated or Incompletely Vaccinated Sexual Assault Victims

IM

Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.

If perpetrator is HBsAg-positive, give 0.06 mL/kg of HBIG within 14 days of the assault (preferably within 24 hours). Initiate or complete primary immunization with HepB vaccine.

Adults

Postexposure Prophylaxis of Hepatitis B Virus (HBV) Infection

Occupational Exposure in Susceptible Health-care Personnel

IM

When source is known to be HBsAg-positive and exposed individual is unvaccinated or a known nonresponder to HepB vaccine (anti-HBs <10 mIU/mL), combined active immunization with HepB vaccine and passive immunization with HBIG is indicated. (See Table 1 under Uses.)

Give 0.06 mL/kg of HBIG within 24 hours of the exposure and initiate or complete primary immunization with HepB vaccine.

In those who previously failed to respond to a second HepB vaccine series, give 0.06 mL/kg of HBIG within 24 hours of the exposure and 0.06 mL/kg 1 month later.

Unvaccinated or Incompletely Vaccinated Sexual Assault Victims

IM

Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.

If perpetrator is HBsAg-positive, give 0.06 mL/kg of HBIG within 14 days of the assault (preferably within 24 hours). Initiate or complete primary immunization with HepB vaccine.

Sexual or Intimate Exposure to Individuals with Acute HBV Infection

IM

Active immunization with HepB vaccine is indicated; passive immunization with HBIG also may be indicated.

Give 0.06 mL/kg of HBIG within 14 days of the last sexual or intimate exposure and initiate or complete primary immunization with HepB vaccine.

Prevention of HBV Recurrence in Liver Transplant Recipients (HepaGam B)

IV

Give initial dose of 20,000 international units concurrently with grafting of transplanted liver (anhepatic phase). Give 20,000 international units once daily on postoperative days 1–7, once every 2 weeks during postoperative weeks 2–12, and once monthly beginning at postoperative month 4.

Track treatment response by monitoring serum HBsAg and anti-HBs antibody levels.

Dosage is designed to provide serum anti-HBs levels >500 international units/L. Adjust dosage if anti-HBs levels do not increase to ≥500 international units/L within the first postoperative week. In such cases, increase dosage to 10,000 international units every 6 hours until target anti-HBs level is reached. Individuals with surgical bleeding or abdominal fluid drainage (>500 mL) and those undergoing plasmapheresis are particularly susceptible to extensive loss of circulating anti-HBs.

Cautions for Hepatitis B Immune Globulin

Contraindications

• HepaGam B: Individuals with history of anaphylactic or severe systemic reactions to parenteral human immune globulin.

• HyperHEP B: Manufacturer states no known contraindications.

• Nabi-HB: Individuals with history of anaphylactic or severe systemic reactions to human immune globulin.

Warnings/Precautions

Warnings

Risk of Transmissible Agents in Plasma-derived Preparations

Because HBIG is prepared from pooled human plasma, it is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of Creutzfeldt-Jakob disease (CJD) or variant CJD (vCJD).

Improved donor screening, viral-inactivation procedures (e.g., solvent/detergent treatment), and/or filtration procedures have reduced, but not completely eliminated, risk of pathogen transmission with plasma-derived preparations.

Solvent/detergent inactivation processes apparently can inactivate lipid-enveloped viruses (e.g., HBV, hepatitis C virus [HCV], HIV type 1 and type 2 [HIV-1 and HIV-2]), but are less effective against viruses that do not have a lipid envelope (e.g., hepatitis A virus [HAV], parvovirus B-19). Certain filtering procedures are effective in reducing levels of some enveloped and non-enveloped viruses.

Because no purification method has been shown to be totally effective in removing the risk of viral infectivity from plasma-derived preparations and because new blood-borne viruses or other disease agents may emerge which may not be inactivated by the manufacturing process or the chemical (solvent/detergent) treatment procedures currently used, administer HBIG only when a benefit is expected.

Any infection believed to have been transmitted by HBIG should be reported to the manufacturer.

Individuals with Bleeding Disorders

Because bleeding may occur following IM administration in individuals with thrombocytopenia or a bleeding disorder (e.g., hemophilia) or in those receiving anticoagulant therapy, use caution in such individuals. Administer IM in these patients only if expected benefits outweigh potential risks.

ACIP states that IM injections can be used in individuals who have bleeding disorders or are receiving anticoagulant therapy if a clinician familiar with the patient’s bleeding risk determines that the injection can be administered with reasonable safety. In these cases, use a fine needle (23 gauge) to administer the dose and apply firm pressure to the injection site (without rubbing) for ≥2 minutes. If patient is receiving antihemophilia therapy, administer the IM dose shortly after a scheduled dose of such therapy.

Advise individual and/or their family about the risk of hematoma from IM injections.

Blood Glucose Testing

HBIG preparations that contain maltose (HepaGam B) may cause falsely elevated results in blood glucose determinations that use glucose dehydrogenase pyrroloquinequinone (GDH-PQQ). (See Specific Drugs and Laboratory Tests under Interactions.)

Sensitivity Reactions

Hypersensitivity Reactions

Although not reported to date with HBIG, anaphylaxis has been reported rarely following administration of human immune globulins.

Use caution in individuals with history of systemic allergic reactions to immune globulins.

Epinephrine should be readily available in case anaphylaxis occurs. If hypotension or a hypersensitivity reaction (e.g., anaphylaxis) occurs, immediately discontinue HBIG and institute appropriate therapy as indicated.

Selective IgA Deficiency

Use caution in individuals with specific IgA deficiency; these individuals may have antibodies to IgA or may develop such antibodies following administration of HBIG preparations containing IgA. Anaphylaxis could occur.

HepaGam B contains <40 mcg/mL and Nabi-HB contains <100 mcg/mL of IgA. Weigh potential benefits against potential for hypersensitivity reaction.

General Precautions

Individuals with Altered Immunocompetence

May be administered to individuals immunosuppressed as the result of disease or immunosuppressive therapy.

Recommendations regarding use in HIV-infected individuals or use in neonates born to HIV-infected women are the same as those for individuals who are not infected with HIV.

Infusion Reactions

HyperHEP B administered by IV infusion may be associated with certain adverse effects related to the rate of infusion. Do not exceed recommended infusion rate (2 mL/minute). Monitor closely during and immediately following infusion.

Serologic Testing

All infants born to HBsAg-positive women should undergo serologic testing at 9–18 months of age (usually at next well-child visit) to document whether the combined regimen of active immunization with HepB vaccine and passive immunization with HBIG prevented perinatal HBV infection. Do not test before 9 months of age to avoid detecting anti-HBs passively acquired from the HBIG dose administered at birth and to maximize the likelihood of detecting late HBV infections. This follow-up serologic testing not necessary in infants born to HBsAg-negative women.

Prior to initiation of HBV postexposure prophylaxis, serologic testing usually is indicated to determine immune status of individuals exposed to HBV or HBsAg-positive materials (e.g., health-care personnel, sexual or intimate contacts of individuals with acute HBV infection). In those who have had sexual or intimate exposure to individuals with acute HBV infection, such testing should be done only if it will not delay administration of HBIG beyond 14 days.

If a combined regimen of HBIG and HepB vaccine is used for postexposure prophylaxis following exposure to HBV or HBsAg-positive materials, postvaccination testing for anti-HBs should not be performed until 3–4 months after the HBIG dose. (See Specific Drugs and Laboratory Tests under Interactions.)

Specific Populations

Pregnancy

Category C.

Because of potential risks to the neonate from exposure to HBV infection, pregnancy is not considered a contraindication to use of HBIG when indicated.

ACIP states there are no known risks associated with use of immune globulins for passive immunization in pregnant women.

Lactation

Not known whether HBIG is distributed into milk; use caution.

Pediatric Use

HepaGam B: Labeled by the FDA for use in neonates and children.

HyperHEP B and Nabi-HB: Although safety and efficacy not established in infants and children, safety and efficacy of similar HBIG preparations have been demonstrated in infants and children.

HBIG is used in conjunction with HepB vaccine for postexposure prophylaxis in neonates born to HBsAg-positive mothers and for postexposure prophylaxis in unvaccinated children <12 months of age whose mother or primary care-giver has acute HBV infection. (See Uses.)

Geriatric Use

Nabi-HB: Clinical studies did not include sufficient numbers of adults ≥65 years of age to determine whether geriatric adults respond differently than younger individuals. Other reported clinical experience has not identified differences in responses between geriatric and younger individuals.

Common Adverse Effects

IM injection: Injection site reactions (pain, tenderness, swelling, erythema), headache, myalgia, malaise, GI effects (nausea, vomiting), flu or cold symptoms, lightheadedness/fainting.

IV infusion: Tremor and hypotension reported with HepaGam B given by IV infusion. Chills, fever, headache, vomiting, allergic reactions, nausea, arthralgia, moderate low back pain have been reported with other IV immune globulins.

Drug Interactions

Inactivated Vaccines and Toxoids

Immune globulins, including HBIG, are not expected to have a clinically important effect on the immune response to inactivated vaccines or toxoids; inactivated vaccines, recombinant vaccines, polysaccharide vaccines, or toxoids may be administered simultaneously with (using different syringes and different injection sites) or at any interval before or after HBIG. Neonates born to HBsAg-positive women who receive combined passive immunization with HBIG and active immunization with HepB vaccine at birth can receive other age-appropriate vaccines according to the usually recommend childhood immunization schedule.

Live Vaccines

Antibodies present in immune globulins, including HBIG, may interfere with the immune response to certain live virus vaccines (e.g., measles virus vaccine live, mumps virus vaccine live, rotavirus vaccine live oral, rubella virus vaccine live, varicella virus vaccine live); these vaccines should not be administered simultaneously with or for specified intervals before or after HBIG. (See Specific Drugs and Laboratory Tests under Interactions.) There is no evidence that immune globulin preparations interfere with the immune response to yellow fever virus vaccine live, typhoid vaccine live oral, influenza virus vaccine live intranasal, or poliovirus vaccine live oral (OPV; no longer commercially available in the US).

Specific Drugs and Laboratory Tests

Hepatitis B Immune Globulin Pharmacokinetics

Absorption

Bioavailability

Absorbed slowly following IM administration.

Following an IM dose of HBIG, serum concentrations of anti-HBs usually peak within 3–7 days and persist for about 2–6 months. In a study using HepaGam B, mean peak concentrations occurred 4–5 days after an IM dose of 0.06 mL/kg.

Distribution

Extent

Although specific information not available, it is likely that HBIG crosses the placenta since other immunoglobulins cross the placenta.

Information on distribution of HBIG into milk not available; HBIG may be distributed into milk since immunoglobulins (e.g., IgA, IgM, IgG) are present in colostrum.

Elimination

Half-life

HepaGam B: 22–25 days following IM administration.

HyperHEP B: 17.5–25 days.

Nabi-HB: 23 days.

Stability

Storage

Parenteral

Injection, for IM Use

HyperHEP B and Nabi-HB: 2–8°C; do not freeze. Use single-dose vials within 6 hours after vial has been entered; discard any unused portion.

HyperHEP B and Nabi-HB do not contain thimerosal or any other preservatives.

Injection, for IV or IM Use

HepaGam B: 2–8°C; do not freeze. Use single-dose vial within 6 hours after vial has been entered; discard any unused portion.

HepaGam B does not contain thimerosal or any other preservatives.

Actions

• HBIG is a sterile solution prepared from plasma of healthy individuals with high titers of antibody to hepatitis B surface antigen (anti-HBs) and without serologic evidence of HBsAg.

• HepaGam B contains 5% protein, HyperHEP B contains 15–18% protein, and Nabi-HB contains 4–6% protein.

• Anti-HBs present in HBIG combines with HBsAg and neutralizes circulating HBV so that its infective or pathogenic properties are inhibited.

• HBIG is used to provide temporary passive immunity to HBV infection in the prophylactic treatment of individuals exposed to HBV or HBsAg-positive materials (e.g., blood, plasma, serum).

• A single HBIG dose provides passive immunity against HBV for about 3–6 months.

• Once HBV infection becomes clinically apparent and/or serologic testing indicates presence of HBsAg, the virus may not be neutralized by HBIG, although HBIG may modify or ameliorate the infection.

• Without HBV prophylaxis administered at birth, about 70–90% of neonates born to women who are HBsAg-positive and HBeAg-positive at the time of delivery become infected with HBV and 85–95% of untreated infected neonates become chronic carriers of HBsAg.

• HBIG given by IV infusion to HBsAg-positive individuals undergoing liver transplantation may protect the new liver from HBV reinfection. Reinfection in such individuals may occur immediately at the time of liver reperfusion because of circulating HBV or may occur at a later time because of HBV retained in extrahepatic sites.

• The mechanism by which HBIG protects the transplanted liver against HBV reinfection has not been fully determined. HBIG may protect naive hepatocytes against infection by blocking a HBV receptor. Alternatively, HBIG may neutralize circulating HBV through immune precipitation and immune complex formation or may trigger an antibody-dependent cell-mediated cytotoxicity response resulting in target cell lysis. There is evidence that HBIG binds to hepatocytes and interacts with HBsAg within cells.

Advice to Patients

• Advise patient and/or patient’s parent or guardian of the risks and benefits of HBIG.

• Advise patient and/or patient’s parent or guardian that HBIG is prepared from pooled human plasma. Although improved donor screening and viral-inactivating and purification procedures used in manufacture of plasma-derived preparations have reduced the risk of pathogen transmission, HBIG is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of CJD or vCJD. Importance of reporting any infection believed to have been transmitted by HBIG.

• Advise patients with IgA deficiency that HepaGam B and Nabi-HB contain trace amounts of IgA and potentially could result in life-threatening allergic reactions if used in patients who have developed IgA antibodies.

• Advise patients receiving HepaGam B that this preparation contains maltose and may cause falsely-elevated glucose readings when blood glucose monitoring systems based on GDH-PQQ are used; this could result in inappropriate administration of insulin and life-threatening hypoglycemia or may mask true hypoglycemia. Importance of using glucose-specific test methods not affected by maltose (e.g., GDH-NAD, glucose oxidase, glucose hexokinase).

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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