Hepatitis B Immune Globulin

( HBIG )

Pronunciation: hep-ah-TYE-tiss B ih-MYOON GLAH-bu-lin
Class: Immune globulin

Trade Names

HepaGam B
- Injection > 312 units/mL

HyperHEP B S/D
- Injection 220 units/mL

Nabi-HB
- Injection > 312 units/mL

HYPERHEP B S/D (Canada)

Pharmacology

Directly neutralizes hepatitis B virus (HBV).

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Pharmacokinetics

Absorption

T max is 6.5 ± 4.3 days ( Nabi-HB ); T max is 4 to 5 days ( HepaGam B ).

Distribution

Vd is 11.2 ± 3.4 L ( Nabi-HB ); Vd is 7.5 L ( HepaGam B ).

Elimination

Half-life is 23.1 ± 5.5 days ( Nabi-HB ); half-life is 22 to 25 days ( HepaGam B ); half-life is 17.5 to 25 days ( HyperHEP B S/D ).

Cl is 0.3 ± 0.12 L/d ( Nabi-HB ); Cl is 0.21 to 0.24 L/d ( HepaGam B ).

Indications and Usage

Prevention of hepatitis B infection following parenteral exposure (eg, needle stick), direct mucous membrane contact, or oral ingestion (eg, pipetting accident); prevention of hepatitis B in infants born to hepatitis B surface antigen (HBsAg)–positive mothers; prevention of hepatitis B after sexual exposure to an HBsAg-positive person; prevention of hepatitis B following household exposure to persons with acute HBV infections (eg, infants exposed to HBsAg-positive mother or caregiver); prevention of hepatitis B recurrence following liver transplantation in HBsAg-positive patients ( HepaGam B only).

Contraindications

Anaphylactic or severe systemic reaction to human globulin; thrombocytopenia or a coagulation disorder that would contraindicate IM injection.

Dosage and Administration

Newborns of HBsAg-Positive Mothers

IM 0.5 mL. Administer first HBIG dose as soon as possible, preferably less than 12 h after birth. Also give hepatitis B vaccine. Test patient for HBsAg and antibody to hepatitis B surface antigen (anti-HBs) at 12 to 15 months of age.

Acute Exposure to Blood Containing HBsAg

IM 0.06 mL/kg as soon as possible after exposure and within 24 h plus hepatitis B vaccine series, if possible. For persons who refuse hepatitis vaccine or who are known nonresponders to vaccine, a second dose of HBIG should be given 1 month after the first dose.

Sexual Exposure to an HBsAg-Positive Person
Adults

IM 0.06 mL/kg within 14 days of last sexual contact. Also give hepatitis B vaccine.

Household Exposure to Persons With Acute HBV Infection
Infants younger than 12 months of age.

IM 0.5 mL. HBIG may be administered at the same time as, or up to 1 month preceding, hepatitis B vaccination.

Liver Transplantation ( HepaGam B only)
Adults

IV 20,000 units/dose. Coadminister the first dose with the grafting of the transplanted liver, then administer daily from day 1 to 7, then every 2 wk from day 14 to week 12 postoperative, and monthly from month 4 onwards. Administer at a rate of 2 mL/min. Decrease the rate to 1 mL/min or slower if patient develops discomfort or infusion-related adverse reactions, or if there is concern about the speed of the infusion.

General Advice

  • Inspect solution for particulate matter and discoloration before administration.
  • Administer IM, preferably in anterolateral aspects of upper thigh or deltoid muscle. In newborns, administer IM in anterolateral thigh.
  • If gluteal region is used, use only upper outer quadrant. Avoid central region to reduce risk of injury to sciatic nerve.
  • HBIG and hepatitis B vaccine may be given at the same time but at different sites.
  • Do not mix HBIG with other drugs.

Storage/Stability

Store vials in refrigerator (36° to 46°F). Do not freeze. Administer within 6 h after vial has been entered.

Drug Interactions

Vaccines

To avoid inactivating vaccines containing live viruses, give live vaccines 3 mo after HBIG.

Laboratory Test Interactions

HepaGam B : Product contains maltose, which can interfere with some types of blood glucose monitoring systems (ie, those based on glucose dehydrogenase pyrroloquinequinone method). Antibodies present in HepaGam B may interfere with some serologic tests.

Adverse Reactions

Cardiovascular

Hypertension; hypotension.

CNS

Headache (14%); malaise (6%); agitation; amnesia; essential tremor; fatigue; light-headedness/fainting (3%); pyrexia.

Dermatologic

Angioedema; pruritus; rash; urticaria.

EENT

Presbyopia.

GI

Nausea (4%); vomiting (2%). Aphthous stomatitis; diarrhea; dyspepsia; gingival hyperplasia; infectious diarrhea.

Genitourinary

Nocturia.

Hematologic-Lymphatic

Decreased WBC, ecchymosis (2%). Splenomegaly.

Hepatic

Hepatobiliary disease.

Lab Tests

Elevated alkaline phosphatase (4%); elevated AST, elevated creatinine (2%).

Local

Erythema (12%); aching (4%); pain, tenderness at the injection site.

Metabolic-Nutritional

Hyperglycemia.

Musculoskeletal

Myalgia (10%); joint stiffness (2%). Back pain.

Respiratory

Pleural effusion; pneumonia.

Miscellaneous

Cold symptoms or flu (10%); anaphylactic reactions; liver transplant rejection; peripheral edema; sepsis.

Precautions

Monitor

Monitor liver transplant patients for serum anti-HBs antibody levels using a quantitative assay.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in children not established ( HyperHEP B S/D , Nabi-HB ).

Allergy

Use with caution in patients with a history of systemic allergic reactions following administration of human immune globulin products.

Infection

Because HBIG is made from human plasma, there is a risk of transmitting infectious agents (eg, viruses), including Creutzfeldt-Jakob disease.

Overdosage

Symptoms

Pain, tenderness at the injection site.

Patient Information

  • Instruct parent to vaccinate all at-risk infants as soon after birth as possible and again at 3 mo.
  • Instruct patient that therapy is useful as postexposure prophylaxis as soon after exposure as possible (preferably within 7 days).
  • Provide patient or parent with immunization history record and record this injection in patient's medical records.
  • Instruct patient to give analgesic for local pain. Avoid giving aspirin to children.
  • Inform parent or patient of schedule for vaccination program if necessary.

Copyright © 2009 Wolters Kluwer Health.

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