INDICATIONS AND USAGE Nabi-HB, Hepatitis B Immune Globulin (Human), is indicated for treatment of acute exposure to blood containing HBsAg, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infec- tion in the following settings: Acute Exposure to Blood Containing HBsAg: Following either parenteral exposure (needlestick, bite, sharps), direct mucous membrane contact (accidental splash), or oral ingestion (pipetting accident), involving HBsAg-positive materials such as blood, plasma, or serum.

Perinatal Exposure of Infants Born to HBsAg-positive Mothers: Infants born to mothers positive for HBsAg with or without HBeAg 12 .

Sexual Exposure to HBsAg-positive Persons: Sexual partners of HBsAg-positive persons.

Household Exposure to Persons with Acute HBV Infection: Infants less than 12 months old whose mother or primary caregiver is positive for HBsAg.

Other household contacts with an identifiable blood exposure to the index patient.

Nabi-HB is indicated for intramuscular use only.

WARNINGS In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, Nabi-HB, Hepatitis B Immune Globulin (Human), 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 contain infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The risk that such products can transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current viral infections, and by inactivating and/or reducing certain viruses.

The Nabi-HB manufacturing process includes a solvent/detergent treatment step (using tri- n -butyl phosphate and Triton ® X-100) that is effective in inactivating known enveloped viruses such as HBV, HCV, and HIV.

Nabi-HB is filtered using a Planova ® 35 nm Virus Filter that is effective in reducing the levels of some enveloped and non-enveloped viruses.

These two processes are designed to increase product safety.

Despite these measures, such products can still potentially transmit disease.

There is also the possibility that unknown infectious agents may be present in such products.

ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other health care provider to ADMA Biologics at 1-800-458-4244.

The physician should discuss the risks and benefits of this product with the patient.

ADVERSE REACTIONS SECTION Fifty male and female volunteers received Nabi-HB, Hepatitis B Immune Globulin (Human), intramuscularly in pharmacokinetics trials 20 .

The number of patients with reactions related to the administration of Nabi-HB included local reactions such as erythema 6 (12%) and ache 2 (4%) at the injection site, as well as systemic reactions such as headache 7 (14%), myalgia 5 (10%), malaise 3 (6%), nausea 2 (4%), and vomiting 1 (2%).

The majority (92%) of reactions were reported as mild.

The following adverse events were reported in the pharmacokinetics trials and were considered probably related to Nabi-HB: elevated alkaline phosphatase 2 (4%), ecchymosis 1 (2%), joint stiffness 1 (2%), elevated AST 1 (2%), decreased WBC 1 (2%), and elevated creatinine 1 (2%).

All adverse events were mild in intensity.

There were no serious adverse events.

No anaphylactic reactions with Nabi-HB have been reported.

However, these reactions, although rare, have been reported following the injection of human immune globulins 23 .