Hepatitis B Immune Globulin Dosage

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Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for Exposure to Hepatitis B Virus

Prevention of recurrence following liver transplantation:
HBIG 20,000 intl units IV once with the grafting of the transplanted liver (the anhepatic phase)
Week 1 postoperative: 20,000 intl units IV daily from day 1 to 7
Week 2 to 12 postoperative: 20,000 intl units IV every two weeks from day 14
Month 4 onwards: 20,000 intl units IV monthly

If patients fail to reach anti-HBs levels of 500 intl units/L within the first week post-liver transplantation, dosage adjustments may be required.

Dosage regimen should be increased to 10,000 intl units IV every 6 hours until the target anti-HBs are reached in patients who are especially susceptible to extensive loss of circulated anti-HBs, such as those who have surgical bleeding or abdominal fluid drainage (greater than 500 mL) or patients who undergo plasmapheresis.

Percutaneous or permucosal blood exposure:
Source is HBsAg-positive and exposed person has been vaccinated:
If exposed person's anti-HBs level is less than 10 sample ratio units (10 million intl units) by RIA or negative by EIA:
Hepatitis B immune globulin (HBIG) 0.06 mL/kg IM once plus
hepatitis B vaccine booster dose or second dose of hepatitis B immune globulin 1 month later.

Source is HBsAg-positive and exposed person is unvaccinated:
HBIG 0.06 mL/kg IM once plus start hepatitis B vaccine series.

Source is high risk for HBsAg-positive and exposed person has been vaccinated:
Previously vaccinated exposed person:
If vaccine nonresponder and source is HBsAg-positive, give HBIG 0.06 mL/kg IM once plus hepatitis B vaccine booster dose or second dose of hepatitis B immune globulin 1 month later.
If exposed person does not respond to at least 4 doses of vaccine, give 2 doses of HBIG.

Source is high risk for HBsAg-positive and exposed person is unvaccinated:
Start hepatitis B vaccine series within 7 days of exposure
plus HBIG 0.06 mL/kg IM once if source tests positive for HBsAg.

Source unknown or low risk for HBsAg-positive and exposed person is vaccinated:
No treatment required.

Source unknown or low risk for HBsAg-positive and exposed person is unvaccinated:
Start hepatitis B vaccine series within 7 days of exposure.

Sexual exposure to HBsAg-positive source:
HBIG 0.06 mL/kg IM once
plus start hepatitis B vaccine series within 14 days of last contact or if contact will continue.

Usual Pediatric Dose for Exposure to Hepatitis B Virus

Infants born to HBsAg-positive mothers:
HBIG 0.5 mL IM at birth (preferably within 12 hours) plus start hepatitis B vaccine series.
Test infant for HBsAg and anti-HBs at 12 to 15 months.

Household exposure:
Less than 12 months: HBIG 0.5 mL plus hepatitis B vaccine if the mother or primary caregiver has an acute HBV infection.

Other exposures:
See adult recommendations

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Precautions

Use is contraindicated or should be approached with caution in patients with a history of anaphylactic or severe systemic reactions to other human immune globulin products. Epinephrine should be available for the treatment of anaphylactic reactions.

HBIG is made from human plasma and carries the possibility for transmission of blood-borne viral agents and theoretically, the variant Creutzfeldt-Jakob disease (vCJD) agent. The risk of transmission of known blood-borne viruses is considered to be low because of the purification procedure used for immune globulin products; however, no method has been totally effective in removing all risk and the potential exists for the presence of unknown infectious agents. Physicians should report to the manufacturer all infections thought to be transmitted by this product and discuss the risks and benefits of this product with patients.

Although allergic reactions have been reported following HBIG use actions, the product should be administered only in the setting where appropriate equipment and personnel trained in the management of acute anaphylaxis are available. If hypotension or anaphylaxis occurs, the use of HBIG should be discontinued immediately and supportive care given as needed.

The maltose contained in HBIG can interfere with some types of blood glucose monitoring systems, i.e., those based on the glucose dehydrogenase pyrroloquinequinone (GDH-PQQ) method. This can result in falsely elevated glucose readings and, consequently, in the inappropriate use of insulin, resulting in life-threatening hypoglycemia. True hypoglycemia may go untreated if the hypoglycemic state is masked by falsely elevated results.

Liver transplant patients should be monitored regularly for serum anti-HBs antibody levels using a quantitative assay.

Some adverse drug reactions may be related to the rate of infusion. The recommended infusion rate must be closely monitored. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period and immediately following an infusion.

The safety and effectiveness of some hepatitis B immune globulin formulations in the pediatric population have not been established.

Patients with selective immunoglobulin A deficiency may develop antibodies to immunoglobulin A and could have anaphylactic or anaphylactoid reactions to subsequent administration of blood products containing immunoglobulin A, including hepatitis B immune globulin.

Routine intramuscular injection into the gluteal region is not recommended due to the risk of sciatic nerve injury. The anterolateral aspect of the upper thigh or deltoid muscle of the upper arm are preferred.

For postexposure prophylaxis indications, HBIG must be administered intramuscularly only. Intramuscular administration of medications has been associated with bleeding complications in patients with thrombocytopenia or other bleeding disorders. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HBIG should be administered only if the expected benefits outweigh the potential risks.

Antibodies present in immune globulin preparations may interfere with the immune response to live virus vaccines; therefore, live virus vaccination should be deferred until approximately three months after administration of hepatitis B immune globulin.

Dialysis

No adjustment recommended

Other Comments

Hepatitis B immune globulin should stored under refrigeration. Do not freeze and do not use solution that has been frozen. Use within 6 hours of entering the vial; discard partially used vials.

Administer HBIG as soon as possible after exposure, preferably within 24 hours. Its efficacy is unknown when given beyond 7 days.

If hepatitis B vaccine is given concomitantly, it should be administered into a different site.

HBIG should be administered through a separate intravenous line using an intravenous administration set via infusion pump.

The rate of administration should be set at 2 mL per minute. It should be decreased to 1 mL per minute or slower if the patient develops discomfort, infusion-related adverse events or there is concern about the speed of infusion.

Regular monitoring of serum HBsAg and levels of anti-HBs antibody should be performed pre-infusion to track treatment responses and allow for treatment adjustment.

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