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Intended for U.S. audiences only

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Clinical Pharmacology

Nabi-HB® [Hepatitis B Immune Globulin (Human)] (HBIG) provides passive immunization for individuals exposed to the hepatitis B virus (HBV) as evidenced by a reduction in the attack rate of hepatitis B virus following use.1

Clinical studies conducted prior to 1983 with HBIG similar to Nabi-HB® indicate the advantage of simultaneous administration of the hepatitis B vaccine and HBIG. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) advises that the combination prophylaxis be provided in certain instances of exposure based upon the increased efficacy found with that regimen in neonates.1

Cases of hepatitis B are rarely seen following exposure to HBV in persons with preexisting anti-HBs. However, no prospective studies have been performed on the efficacy of concurrent hepatitis B vaccine and HBIG administration following parenteral exposure, mucous membrane contact, or oral ingestion in adults. Infants born to HBsAg-positive mothers are at risk of being infected with HBV and becoming chronic carriers. The risk is especially great if the mother is also HBeAg-positive. Studies conducted with HBIG similar to Nabi-HB indicated that for an infant with perinatal exposure to an HBsAg-positive and HBeAg-positive mother, a regimen combining 1 dose of HBIG at birth with the hepatitis B vaccine series started soon after birth is 85% to 98% effective in preventing development of the HBV carrier state.1

Regimens involving either multiple doses of HBIG alone or the vaccine series alone have a 70% to 90% percent efficacy, while a single dose of HBIG alone has 50% efficacy.1

Since infants have close contact with primary caregivers and they have a higher risk of becoming HBV carriers after acute HBV infection, prophylaxis of an infant <12 months of age with HBIG and hepatitis B vaccine is indicated if the mother or primary caregiver has acute HBV infection.1

Sexual partners of HBsAg-positive persons are at increased risk of acquiring HBV infection. A single dose of HBIG is 75% effective if administered within 2 weeks of the last sexual exposure to a person with acute hepatitis B.1

Pharmacokinetics

Pharmacokinetics trials of Nabi-HB® given intramuscularly to 50 healthy volunteers demonstrated pharmacokinetic parameters similar to those reported by Scheiermann and Kuwert.1 The half-life for Nabi-HB® was 23.1 ± 5.5 days. The clearance rate was 0.35 ± 0.12 L/day and the volume of distribution was 11.2 ± 3.4 L. Maximum concentration of Nabi-HB® was reached in 6.5 ± 4.3 days. The maximum concentration of anti-HBs and the area under the time-concentration curve achieved by Nabi-HB® were bioequivalent to that of another licensed HBIG when compared in the same pharmacokinetics trial. Comparability of pharmacokinetics between Nabi-HB® and a commercially available HBIG indicate that similar efficacy of Nabi-HB® should be inferred.1

Safety Data

Fifty male and female volunteers received Nabi-HB, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials. The number of patients with reactions related to the administration of Nabi-HB included local reactions such as erythema (12%) and ache (4%) at the injection site, as well as systemic reactions such as headache (14%), myalgia (10%), malaise (6%), nausea (4%), and vomiting (2%). The majority (92%) of reactions were reported as mild.1

The following adverse events were reported in the pharmacokinetics trials and were considered probably related to Nabi-HB: elevated alkaline phosphatase (4%), ecchymosis (2%), joint stiffness (2%), elevated AST (2%), decreased WBC (2%), and elevated creatinine (2%). All adverse events were mild in intensity. There were no serious adverse events.1

No anaphylactic reactions with Nabi-HB have been reported. However, these reactions, although rare, have been reported following the injection of human immune globulins.1

View the NABI-HB material safety data sheet

Reference:

  1. Nabi-HB® Prescribing Information, Biotest Pharmaceutical Corporation, 2008.

Important Safety Information for Nabi-HB®

Individuals known to have had an anaphylactic or severe systemic reaction to human globulin should not receive Nabi-HB® [Hepatitis B Immune Globulin (Human)] or any other human immune globulin. Individuals who are deficient in IgA have the potential to develop antibodies against IgA and anaphylactic reactions.

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB should be given only if the expected benefits outweigh the potential risks.

Nabi-HB is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents (e.g., viruses) and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Nabi-HB [Hepatitis B Immune Globulin (Human)], must be administered only intramuscularly for post-exposure prophylaxis.

Vaccination with live virus vaccines (e.g., MMR) should be deferred until approximately three months after administration of Nabi-HB.

The most common adverse reactions associated with Nabi-HB in clinical trials were erythema and ache at the injection site as well as systemic reactions such as headache, myalgia, malaise, nausea and vomiting. No anaphylactic reactions with Nabi-HB have been reported.

Please see the full Prescribing Information for Nabi-HB [Hepatitis B Immune Globulin (Human)].

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/MedWatch or call 1-800-FDA-1088.