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Hepatitis B immune globulin: Drug information

Hepatitis B immune globulin: Drug information
2024© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Hepatitis B immune globulin: Patient drug information" and "Hepatitis B immune globulin: Pediatric drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • HepaGam B;
  • HyperHEP B;
  • Nabi-HB
Brand Names: Canada
  • HepaGam B;
  • HyperHEP B;
  • HyperHep B S/D;
  • HyperHEP B S/D
Pharmacologic Category
  • Blood Product Derivative;
  • Immune Globulin
Dosing: Adult
Postexposure prophylaxis

Postexposure prophylaxis: IM: 0.06 mL/kg as soon as possible after exposure (ie, within 24 hours of needlestick, ocular, or mucosal exposure or within 14 days of sexual exposure); repeat at 28 to 30 days after exposure in non-responders to hepatitis B vaccine or in patients who refuse vaccination

Postexposure management of health care personnel (HCP) (Ref):

If the HCP has prior documentation of ≥3 doses of a hepatitis B vaccine and a post-vaccination anti-HBs ≥10 milliunits/mL, then HBIG is not needed, regardless of the patients HBsAg status.

If the HCP is unvaccinated or incompletely vaccinated, and if the source patient is HBsAg positive or their status is unknown, one dose HBIG should be administered. If the source patient is HBsAg negative, then HBIG is not needed.

If the HCP is vaccinated with 3 doses of hepatitis B vaccine but post-vaccination anti-HBs status is unknown, test HCP for anti-HBs. If anti-HBs ≥10 milliunits/mL then HBIG is not needed. If anti-HBs <10 milliunits/mL, and if the source patient is HBsAg positive or their status is unknown, 1 dose of HBIG should be administered. If anti-HBs <10 milliunits/mL, and if the source patient is HBsAg negative, then HBIG is not needed.

If the HCP is vaccinated with 6 doses of hepatitis B vaccine but documented as a non-responder to the vaccine, and if the source patient is HBsAg negative, then HBIG is not needed. If the source patient is HBsAg positive or unknown, administer 2 doses of HBIG separated by 1 month.

Postexposure management in nonoccupational settings (Ref): IM:

If the exposed person is in the process of completing the hepatitis B vaccination series and the exposure was to an HBsAg-positive source, administer one dose of HBIG and complete the vaccination series. If exposure was to an HBsAg-unknown source, HBIG treatment is not required but the hepatitis B vaccine series should be completed.

If the exposed person is unvaccinated and the exposure was to an HBsAg-positive source, administer one dose of HBIG and hepatitis B vaccine as soon as possible (preferably within 24 hours after exposure [<7 days for percutaneous exposure or <14 days for sexual exposure]); complete the vaccination series. If exposure was to an HBsAg-unknown source, HBIG treatment is not required but the hepatitis B vaccine series should be completed.

If the exposed person has prior documentation of ≥3 doses of a hepatitis B vaccine then HBIG treatment is not required.

Prevention of hepatitis B virus recurrence after liver transplantation

Prevention of hepatitis B virus recurrence after liver transplantation (HepaGam B): IV: 20,000 units/dose according to the following schedule:

Anhepatic phase (Initial dose): One dose (20,000 units) given with the liver transplant

Week 1 postop: One dose (20,000 units) daily for 7 days (days 1 to 7)

Weeks 2 to 12 postop: One dose (20,000 units) every 2 weeks starting day 14

Month 4 onward: One dose (20,000 units) monthly starting on month 4

Dose adjustment: Adjust dose to reach anti-HBs levels of 500 units/L within the first week after transplantation. In patients with surgical bleeding, abdominal fluid drainage >500 mL or those undergoing plasmapheresis, administer 10,000 units/dose every 6 hours until target anti-HBs levels are reached.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Hepatitis B immune globulin: Pediatric drug information")

Note: For exposure prophylaxis, HBIG 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.

Perinatal exposure, prophylaxis

Perinatal exposure, prophylaxis (Ref): Infants born to HBsAg-positive mothers: IM: 0.5 mL as a repeat of birth dose if the hepatitis B vaccination series is delayed for as long as 3 months (hepatitis B vaccine should also be administered at the same time/different site)

Postexposure prophylaxis

Postexposure prophylaxis:

Infants <12 months: IM: 0.5 mL as soon as possible after exposure (eg, mother or primary caregiver with acute HBV infection); initiate hepatitis B vaccine series

Children ≥12 months and Adolescents: IM: 0.06 mL/kg as soon as possible after exposure (ie, within 24 hours of needlestick, ocular, or mucosal exposure or within 14 days of sexual exposure); repeat at 28 to 30 days after exposure

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosing adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported with postexposure prophylaxis. Adverse events reported in liver transplant patients included tremor and hypotension, were associated with a single infusion during the first week of treatment, and did not recur with additional infusions.

>10%:

Central nervous system: Headache (14%)

Dermatologic: Erythema (12%)

1% to 10%:

Cardiovascular: Hypotension (2%)

Central nervous system: Malaise (6%)

Dermatologic: Ecchymoses (2%)

Gastrointestinal: Nausea (2% to 4%), vomiting (2%)

Hematologic & oncologic: Change in WBC count (2%)

Hepatic: Increased serum alkaline phosphatase (4%), increased liver enzymes (2%)

Local: Pain at injection site (4%)

Neuromuscular & skeletal: Myalgia (10%), joint stiffness (2%)

Renal: Increased serum creatinine (2%)

<1%, postmarketing, and/or case reports: Abdominal pain, anaphylactic reaction (rare), angioedema, back pain, chills, diaphoresis, dizziness, dyspnea, fever, flu-like symptoms, hypersensitivity, increased serum lipase, increased serum transaminases, sinus tachycardia, tenderness at injection site, urticaria

Contraindications

HepaGam B: Anaphylactic or severe systemic reaction to human globulin preparations; IgA deficiency; postexposure prophylaxis in patients with severe thrombocytopenia or other coagulation disorders which would contraindicate IM injections (administer only if benefit outweighs the risk).

HyperHEP B:

US labeling: There are no contraindications listed in the US manufacturer's labeling.

Canadian labeling:

HyperHEP B: Hypersensitivity to hepatitis B immune globulin or any component of the formulation; severe thrombocytopenia or other coagulation disorders that would contraindicate IM injections; IgA deficient patients with antibodies against IgA and a history of sensitivity.

HyperHEP B S/D: Hypersensitivity to hepatitis B immune globulin or any component of the formulation; severe thrombocytopenia or other coagulation disorders that would contraindicate IM injections (administer only if benefit outweighs the risk).

Nabi-HB: Anaphylactic or severe systemic reaction to human globulin preparations.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; immediate treatment (including epinephrine 1 mg/mL) should be available. Use with caution in patients with isolated immunoglobulin A deficiency or a history of systemic hypersensitivity to human immunoglobulins.

• Infusion reactions: When administered IV, do not exceed recommended infusion rates; may increase risk of adverse events. Patients should be monitored for adverse events during and after the infusion.

• Thrombotic events: Thrombotic events have been reported with administration of intravenous immune globulin; use with caution in patients of advanced age, with a history of atherosclerosis or cardiovascular and/or thrombotic risk factors, patients with impaired cardiac output, coagulation disorders, prolonged immobilization, or patients with known/suspected hyperviscosity. Consider a baseline assessment of blood viscosity in patients at risk for hyperviscosity.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with thrombocytopenia or coagulation disorders; IM injections may be contraindicated.

Dosage form specific issues:

• Human plasma: Product of human plasma; may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk. Infections thought to be transmitted by this product should be reported to the manufacturer.

• Maltose: Some products may contain maltose, which may result in falsely-elevated blood glucose readings.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Injection:

HepaGam B: 312 units/mL (1 mL) [contains polysorbate 80]

Solution, Injection [preservative free]:

HepaGam B: 312 units/mL (1 mL [DSC], 5 mL) [contains polysorbate 80]

Solution, Intramuscular:

HyperHEP B: (0.5 mL, 5 mL)

Nabi-HB: (1 mL, 5 mL) [thimerosal free; contains polysorbate 80]

Solution, Intramuscular [preservative free]:

Nabi-HB: (1 mL, 5 mL) [contains polysorbate 80]

Solution Prefilled Syringe, Intramuscular:

HyperHEP B: 220 units/mL (1 mL [DSC])

Generic Equivalent Available: US

No

Pricing: US

Solution (HepaGam B Injection)

312 units/mL (per mL): $244.02

Solution (HyperHEP B Intramuscular)

220 units/mL (per mL): $192.06

Solution (Nabi-HB Intramuscular)

312 units/mL (per mL): $200.26

Solution Prefilled Syringe (HyperHEP B Intramuscular)

110 units/0.5 mL (per 0.5 mL): $106.14

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Injection:

HepaGam B: 312 units/mL (1 mL, 5 mL) [contains polysorbate 80]

Solution, Intramuscular:

HyperHEP B: 220 units/mL (1 mL, 5 mL)

HyperHep B S/D: 217 units/mL (0.5 mL, 1 mL, 5 mL)

Solution Prefilled Syringe, Intramuscular:

HyperHEP B: 110 units/0.5 mL (0.5 mL)

HyperHEP B S/D: 110 units/0.5 mL (0.5 mL)

Administration: Adult

HBIG 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.

IM: Post-exposure prophylaxis: IM injection only in anterolateral aspect of upper thigh and deltoid muscle of upper arm; to prevent injury from injection, care should be taken when giving to patients with thrombocytopenia or bleeding disorders.

IV:

HepaGam B: Liver transplant: Administer at 2 mL/minute. Decrease infusion to ≤1 mL/minute for patient discomfort or infusion-related adverse events. Actual volume of infusion is dependent upon potency labeled on each individual vial.

Nabi-HB: Although not FDA-approved for this purpose, Nabi-HB has been administered intravenously in hepatitis B-positive liver transplant recipients (Dickson 2006).

Administration: Pediatric

IM: Inject only in the anterolateral aspects of the upper thigh or the deltoid muscle; multiple injections may be necessary when the dosage is a large volume (postexposure prophylaxis). Do not administer hepatitis vaccine and HBIG in same syringe (vaccine will be neutralized); hepatitis vaccine may be administered at the same time at a separate site

Use: Labeled Indications

Postexposure prophylaxis following acute exposure to hepatitis B surface antigen (HBsAg) blood, plasma, or serum (eg, parenteral exposure, direct mucus membrane contact, oral ingestion); perinatal exposure of infants born to HBsAg-positive mothers; sexual exposure to HBsAg-positive persons; and household exposure to persons with acute HBV infection

In addition, the Advisory Committee on Immunization Practices (ACIP) also recommends administration to neonates born to mothers in which HBsAg test results are not available and other evidence suggests possible maternal HBV infection; postexposure prophylaxis to a health care provider (HCP) in which the source has an unknown HBsAg status; in a nonoccupational setting, postexposure prophylaxis to a person who has not been completely vaccinated (CDC/ACIP [Schillie 2018]).

Prevention of hepatitis B virus recurrence after liver transplantation in HBsAg-positive transplant recipients (HepaGam B only)

Note: Hepatitis B immune globulin is not indicated for treatment of active hepatitis B infection and is ineffective in the treatment of chronic active hepatitis B infection.

Medication Safety Issues
Sound-alike/look-alike issues:

HBIG may be confused with BabyBIG

International issues:

Bayhep-B [Philippines, Turkey] may be confused with Bayrab which is a brand name for rabies immune globulin [Philippines, Turkey]; Bayrho-D which is brand name for RhoD immune globulin [Israel, Turkey]

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Dinutuximab Beta: Immune Globulins may diminish the therapeutic effect of Dinutuximab Beta. Risk X: Avoid combination

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification

Pregnancy Considerations

Use of hepatitis immune globulin (HBIG) in pregnant patients following accidental or occupational exposure to hepatitis B virus should be the same as in nonpregnant persons. HBIG should not be administered to pregnant patients with hepatitis B infection to reduce the risk of neonatal infection (ACOG 2023).

Breastfeeding Considerations

It is not known if hepatitis B immune globulin is present in breast milk; however, endogenous immune globulins are present in breast milk (Agarwal 2011).

The manufacturer recommends that caution be used if administered to patients who are breastfeeding. Infants born to hepatitis B surface antigen (HBsAg)-positive mothers or to mothers with unknown HBsAg status will receive hepatitis immune globulin postexposure prophylaxis and may breastfeed (CDC/ACIP [Schillie 2018]).

Monitoring Parameters

Liver transplant: Serum HBsAg; LFTs; infusion-related adverse events

Mechanism of Action

Hepatitis B immune globulin (HBIG) is a nonpyrogenic sterile solution containing immunoglobulin G (IgG) specific to hepatitis B surface antigen (HBsAg). HBIG differs from immune globulin in the amount of anti-HBs. Immune globulin is prepared from plasma that is not preselected for anti-HBs content. HBIG is prepared from plasma preselected for high titer anti-HBs. In the US, HBIG has an anti-HBs high titer >1:100,000 by IRA.

Pharmacokinetics (Adult Data Unless Noted)

Duration: Postexposure prophylaxis: 3 to 6 months

Absorption: IM: Slow

Half-life: 17 to 25 days

Distribution: Vd: 7 to 15 L

Time to peak, serum: IM: 2 to 10 days

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Hepatect | Hepatitis b immunoglobulin | Hepuman;
  • (AT) Austria: Hepatect | Uman big;
  • (AU) Australia: Hepatitis b immunoglobulin;
  • (BE) Belgium: Neohepatect;
  • (BG) Bulgaria: Hepatect cp;
  • (BR) Brazil: Hepatect | Niuliva;
  • (CL) Chile: Igantibe;
  • (CN) China: Hepatitis b ig. | Hepatitis b immun | Hepatitis b immuno | Human Hepatitis B Immunoglobulin;
  • (CO) Colombia: Hepatect cp | Hepuman | Hyperhep b | Immunohbs | Niuliva;
  • (CZ) Czech Republic: Hepatect | Human antihep.b | Neohepatect;
  • (DE) Germany: Aunativ | Fovepta | Hepatect | Hepatect cp | Hepatitis b immunglobulin | Umanbig;
  • (DO) Dominican Republic: Hepuman;
  • (EE) Estonia: Hepatitis b immunoglobulin behring | Hepatitis b immunoglobulin p Behring | Uman big;
  • (EG) Egypt: Hepabig;
  • (ES) Spain: Gamma anti-hepatitis B | Hepatect | Hepuman;
  • (FI) Finland: Hepatect;
  • (FR) France: Hepatect cp | Ivhebex | Zutectra;
  • (GB) United Kingdom: Hepatect cp | Hepatitis b ig | ImmunoGam;
  • (GR) Greece: Aunativ s.d. | Hepatect cp | Hepatitis b immunoglobulin;
  • (HK) Hong Kong: Hepatect | Hepuman;
  • (HR) Croatia: Imunoglobulin protiv hepatitisa B;
  • (HU) Hungary: Hepatect | Umanbig;
  • (ID) Indonesia: Bayhep | Hepatitis b immunoglobulin | Hepbquin;
  • (IN) India: Fovepta | Hepa bsv | Hepabig | Samhep;
  • (IT) Italy: Haimabig | Hepuman b | Igantibe | Immunohbs | Keyvenb | Neohepatect | Uman big;
  • (JP) Japan: H big abbott | H big mitsubishi | Hb Globulin | Hebsbulin ih | Hepatothera | Hepatothera fujisawa;
  • (KR) Korea, Republic of: Hepabig | Hepabulin sn | Iv hepabulin sn;
  • (LB) Lebanon: Hepuman;
  • (LT) Lithuania: Hepaga b | Hepatect cp | Keyvenb;
  • (LV) Latvia: Hepaga b;
  • (MA) Morocco: Immunohbs;
  • (MY) Malaysia: H-Big | Hepabig | Hepuman berna | Igantibe;
  • (NL) Netherlands: Hepatitis b | Hepbquin;
  • (NO) Norway: Aunativ | Hepatect | Hepatect cp | Hepatitis b immunoglobulin p Behring | Omri-hep-b | Umanbig;
  • (NZ) New Zealand: Hepatitis b immunoglobulin;
  • (PE) Peru: Fovepta;
  • (PH) Philippines: Hepabig | Hepuman;
  • (PK) Pakistan: Bayhep B | Hepatect | Hepatitis b immunoglobulin | Hyperhep b;
  • (PL) Poland: Gamma anty hbs | Hepatect | Hepatect cp | Niuliva | Uman big;
  • (PR) Puerto Rico: Bayhep B | Hepagam b | Nabi-hb;
  • (PT) Portugal: Gammaglobulina antihepatitis-B P Behring | Hepatect | Hepatect cp | Hepuman berna | Uman big;
  • (QA) Qatar: Hepatect CP;
  • (RO) Romania: Hepatect cp;
  • (RU) Russian Federation: Antihep | Hepatect | Neohepatect;
  • (SA) Saudi Arabia: Aunative | Fovepta | Hepagam b | Hepatect | Hepuman;
  • (SE) Sweden: Aunativ | Neohepatect | Umanbig;
  • (SG) Singapore: Bayhep B | Hyperhep B S/D;
  • (SK) Slovakia: Aunativ | Hepatect | Neohepatect | Pasteurised Human Antihepatitis B Immunogl. G;
  • (TH) Thailand: Hbig | Hepatect | Hepuman berna | Human Hepatitis B Immunoglobulin | Igantibe | Immunohbs;
  • (TN) Tunisia: Aunativ | Hepatect | Immuno hbs;
  • (TR) Turkey: Bayhep B | Hepagam b | Hepatect | Hepatitis b immune globulin | Hepatitis b immunoglobulin p | Hepuman | Hyperhep b | Ivhebex;
  • (TW) Taiwan: Bayhep B | Hepatect | Hepatitis b ig p | Hepatitis b immunoglobulin p;
  • (UY) Uruguay: Anti b cp | Hepatect cp | Igantibe;
  • (ZA) South Africa: Hebagam
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