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Hepatitis B Immune Globulin (Human)

Pronunciation

(hep a TYE tis bee i MYUN GLOB yoo lin YU man)

Index Terms

  • HBIG

Dosage Forms

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

Solution, Injection [preservative free]:

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

Solution, Intramuscular:

HyperHEP B S/D: (0.5 mL, 1 mL, 5 mL)

Nabi-HB: (1 mL, 5 mL) [thimerosal free]

Brand Names: U.S.

  • HepaGam B
  • HyperHEP B S/D
  • Nabi-HB

Pharmacologic Category

  • Blood Product Derivative
  • Immune Globulin

Pharmacology

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 U.S., HBIG has an anti-HBs high titer >1:100,000 by IRA.

Absorption

IM: Slow

Distribution

Vd: 7-15 L

Time to Peak

Serum: IM: 2-10 days

Duration of Action

Postexposure prophylaxis: 3-6 months

Half-Life Elimination

17-25 days

Use: Labeled Indications

Passive prophylactic immunity to hepatitis B following: Acute exposure to blood containing hepatitis B surface antigen (HBsAg); perinatal exposure of infants born to HBsAg-positive mothers; sexual exposure to HBsAg-positive persons; household exposure to persons with acute HBV infection

Prevention of hepatitis B virus recurrence after liver transplantation in HBsAg-positive transplant patients

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.

Contraindications

HepaGam B: Anaphylactic or severe systemic reaction to human globulin preparations; 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 S/D: No contraindications listed in manufacturer's labeling

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

Dosing: Adult

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 28-30 days after exposure in nonresponders to hepatitis B vaccine or in patients who refuse vaccination

Postexposure management of health care personnel (HCP) (CDC 62 [10], 2013): IM: 0.06 mL/kg

If the HCP has prior documentation of ≥3 doses of a hepatitis B vaccine and a postvaccination 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 postvaccination 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 nonresponder 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.

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 given with the liver transplant

Week 1 postop: One dose daily for 7 days (days 1-7)

Weeks 2-12 postop: One dose every 2 weeks starting day 14

Month 4 onward: One dose 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: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Infants born to HBsAg-positive mothers: IM: 0.5 mL as soon after birth as possible (within 12 hours); active vaccination with hepatitis B vaccine may begin at the same time in a different site (if not contraindicated). If first dose of hepatitis B vaccine is delayed for as long as 3 months, dose may be repeated. If hepatitis B vaccine is refused, dose may be repeated at 3 and 6 months.

Infants born to mothers with unknown HBsAg status at birth (CDC, 2005): IM:

Birth weight <2 kg: 0.5 mL within 12 hours of birth (along with hepatitis B vaccine) if unable to determine maternal HBsAg status within that time

Birth weight ≥2 kg: If the mother is determined to be HBsAg positive, administer 0.5 mL as soon as possible, but within 7 days of birth

Household exposure prophylaxis in infants <12 months: IM: 0.5 mL (to be administered if mother or primary caregiver has acute HBV infection).

Postexposure prophylaxis: IM: Children ≥12 months: Refer to adult dosing.

Note: 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

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Reconstitution

HepaGamB®: May dilute with NS prior to IV administration if preferred; do not dilute with D5W.

Administration

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: Postexposure 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 patients (Dickson, 2006)

Storage

Refrigerate at 2°C to 8°C (36°F to 46°F); do not freeze. Do not shake vial; avoid foaming.

HepaGamB®; Nabi-HB®: Use within 6 hours of entering vial.

HyperHEP B™ S/D: May be exposed to room temperature for a cumulative 7 days (Cohen, 2007).

Drug Interactions

Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Consult full interaction monograph for dose interval recommendations. This interaction does not apply to oral Ty21a typhoid vaccine or others listed as exceptions. Exceptions: Influenza Virus Vaccine (Live/Attenuated); Rotavirus Vaccine; Yellow Fever Vaccine; Zoster Vaccine. Consider therapy modification

Test Interactions

Glucose testing: HepaGam B™ contains maltose. Falsely-elevated blood glucose levels may occur when glucose monitoring devices and test strips utilizing the glucose dehydrogenase pyrroloquinolinequinone (GDH-PQQ) based methods are used.

Serological testing: Antibodies transferred following administration of immune globulins may provide misleading positive test results (eg, Coombs’ test)

Adverse Reactions

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% (Limited to important or life-threatening): Anaphylactic reaction (rare), angioedema, hypersensitivity, increased serum lipase, increased serum transaminases, sinus tachycardia

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.

Monitoring Parameters

Liver transplant: Serum HBsAg; infusion-related adverse events

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Use of HBIG is not contraindicated in pregnant women and may be used for postexposure prophylaxis when indicated (CDC, 2001). In addition, use of HBIG has been evaluated to reduce maternal to fetal transmission of hepatis B virus during pregnancy (ACOG, 2007)

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber signs of severe cerebrovascular disease (change in strength on one side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), angina, tachycardia, coughing up blood, or shortness of breath (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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