|
| U.S. Brand
Names |
|
| H-BIG®; HyperHep® |

|
|
| Generic
Available |
|
|
No |

|
|
| Synonyms |
|
|
HBIG |

|
|
| Pharmacological Index |
|
|
Immune Globulin |

|
|
| Use |
|
|
Provide prophylactic passive immunity to hepatitis B infection to those
individuals exposed; newborns of mothers known to be hepatitis B surface antigen
positive; hepatitis B immune globulin is not indicated for treatment of active
hepatitis B infections and is ineffective in the treatment of chronic active
hepatitis B infection |

|
|
| Pregnancy Risk
Factor |
|
|
C |

|
|
| Contraindications |
|
|
Hypersensitivity to hepatitis B immune globulin or any component; allergies
to gamma globulin or anti-immunoglobulin antibodies; allergies to thimerosal;
IgA deficiency; I.M. injections in patients with thrombocytopenia or coagulation
disorders |

|
|
| Adverse
Reactions |
|
|
1% to 10%:
Central nervous system: Dizziness, malaise
Dermatologic: Urticaria, angioedema, rash, erythema
Local: Pain and tenderness at injection site
Neuromuscular & skeletal: Arthralgia
<1%: Anaphylaxis |

|
|
| Drug
Interactions |
|
|
Interferes with immune response of live virus vaccines |

|
|
| Stability |
|
|
Refrigerate at 2°C to 8°C
(36°F to 46°F); do not
freeze |

|
|
| Mechanism of
Action |
|
|
Hepatitis B immune globulin (HBIG) is a nonpyrogenic sterile solution
containing 10% to 18% protein of which at least 80% is monomeric immunoglobulin
G (IgG). 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. There is no evidence that the causative agent of
AIDS (HTLV-III/LAV) is transmitted by HBIG. |

|
|
| Pharmacodynamics/Kinetics |
|
|
Absorption: Slow
Time to peak serum concentration: 1-6 days |

|
|
| Usual Dosage |
|
|
I.M.:
Adults: Postexposure prophylaxis: 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); usual dose: 3-5 mL; repeat at 28-30 days
after exposure
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 |

|
|
| Administration |
|
|
Administration of HBIG preceding or concomitantly with hepatitis B vaccine
does not interfere with the immune response to vaccine; the two together provide
more rapid protective antibodies to hepatitis B than when vaccine is used alone;
rapid levels may be necessary in certain settings |

|
|
| Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
|
|
No information available to require special precautions |

|
|
| Dental Health:
Effects on Dental Treatment |
|
|
No effects or complications reported |

|
|
| Patient
Information |
|
|
Be aware of adverse effects |

|
|
| Nursing
Implications |
|
|
I.M. injection only; to prevent injury from injection care should be taken
when administering to patients with thrombocytopenia or bleeding disorders; do
not administer I.V. |

|
|
| Dosage Forms |
|
|
Injection:
HyperHep®: 0.5 mL, 1 mL, 5 mL
|

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