Drug information of Hepatitis B Immune Globulin
Hepatitis B Immune Globulin
Hepatitis B immunoglobulin (HBIG) is a human immunoglobulin that is used to prevent the development of hepatitis B. Long-term hepatitis B immune globulin (HBIG) has been shown to reduce hepatitis B virus (HBV) reinfection in patients transplanted for hepatitis B. Infection with hepatitis B may lead to hepatocellular carcinoma, a type of liver cancer.
Therefore, the hepatitis-B vaccines are cancer-preventing vaccines. According to the Centers for Disease Control and Prevention (CDC), the hepatitis B vaccine was the first anti-cancer vaccine.
HBIG is prepared from the plasma of donors who have high antibody levels of the hepatitis B surface antigen. It is extracted from the Cohn fraction II.During the process, viruses are deactivated, and in the final steps, solvents used in the preparation are removed. The preparation is tested for absence of HIV, HCV, herpes virus, and reovirus.
Mechanism of effect
In countries with high rates of hepatitis B infection, vaccination of newborns has not only reduced the risk of infection, but has also led to marked reduction in liver cancer.
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
- Half-Life: 17-25 days
- Peak Plasma Time: 2-10 days (IM)
- Duration of action: 3-6 months (postexposure prophylaxis)
- Vd: 7-15 L
- Clearance: 0.35 L/day
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) 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.
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
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.
Side effectsHeadache , Nephrotic syndrome , nausea , vomiting , asthenia , fever , myalgia , lethargy , tightness in the chest
- IgA deficiency, thrombocytopenia, coagulopathies:
May elevate alkaline phosphatase, AST, creatinine-
May decrease WBC-
- Use caution in patients with bleeding disorders
- Thrombotic events reported
- Do NOT give IV
- Separate live vaccines by 3 months
Points of recommendation
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
This medication is made from human blood.
Even though the blood is carefully tested, and this medication goes through a special manufacturing process, there is an extremely small chance that you may get infections (such as hepatitis A) from the medication. Consult your doctor or pharmacist for more information.
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