Indication 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 infection 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.
- 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.
Nabi-HB can be administered in a hospital setting or in a physician's office.
- Sterile solution of immunoglobin containing antibodies to hepatitis B surface antigen
- Provides passive immunization for those exposed to the hepatitis B virus
- Formulated in 0.042-0.108 M sodium chloride, 0.10-0.20 M glycine, and 0.005-0.050% polysorbate 80 at pH 5.8-6.5
- Half-life of 23.1 + 5.5 days
- May be stored in unopened vial for up to 39 months (until expiration date on vial packaging) at 2°C to 8°C (36°F to 46°F)1,2
Supply, Storage and Handling
Available Vial Sizes
- 1 mL dose in a single-use vial (>312 IU)
- 5 mL dose in a single-use vial (>1560 IU)
Handling and Storage
- Prior to use, Nabi-HB is stable for up to 39 months when stored unopened between 2 to 8°C (36 to 46°F)1,2
- Do not freeze
- Do not use after expiration date
- Use within 6 hours after the vial has been entered
- Protect from physical damage
Manufacturing of Nabi-HB
- Manufactured solely from US plasma from Food and Drug Administration (FDA)-licensed plasma collection centers
- Produced using a manufacturing process based on cold ethanol fractionation followed by ion exchange chromatography
- Three virus inactivation/removal steps – precipitation and removal of fraction III of the cold ethanol fractionation process, solvent/detergent, and virus filtration
STEP 1: Precipitation and removal of fraction III of the cold ethanol process removes some nonenveloped viruses
STEP 2: Solvent/detergent treatment designed to inactivate enveloped viruses
STEP 3: Nanofiltration with 35 nm filters to remove nonenveloped and enveloped viruses
VIRAL SAFETY BUILT INTO THE MANUFACTURING
The Nabi-HB manufacturing process employs a multistep viral removal/inactivation system, which increases the safety of all our plasma protein-based products. Manufacturing processes have been validated for their capability to eliminate or inactivate viruses. Incorporation of these processes into manufacturing ensures that our products fully comply with the requirements of the FDA and are safe.
The manufacturing process used in our facility employs 3 effective steps to remove/inactivate adventitious viruses to minimize the risk of virus transmission. The steps are "precipitation" during cold ethanol fractionation, classical "solvent/detergent treatment," and "nanofiltration with 35 nm filters." In compliance with current guidelines, all 3 steps have been individually validated in a series of in vitro experiments for their capacity to inactivate or remove both enveloped and nonenveloped viruses.
Precipitation removes both enveloped and nonenveloped viruses. Solvent/detergent treatment represents a virus inactivation step for enveloped viruses, and 35 nm virus nanofiltration removes both enveloped and nonenveloped viruses by size exclusion. In addition to the steps above, maintaining a low pH level during several steps of the production process contributes to virus inactivation.
Because this product is made from human blood, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
While precautions have been taken to eliminate adventitious agents, transmission of such agents (known and unknown) is still possible. No cases of transmission of viral diseases, vCJD or CJD have been associated with the use of Nabi-HB.
- Nabi-HB [Prescribing Information]. Boca Raton, FL: Biotest Pharmaceuticals Corporation; 2008.
- Data on file, ADMA Biologics.
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.