pharmacopeia
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/api/v1/drug/hepatitis-b-immune-globulin

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Virus Neutralization.

Indications

Sourced from openFDA
  • 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 .ICD-10: B18.1

Contraindications

Sourced from openFDA
  • 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. Nabi-HB contains not more than 40 micrograms per mL IgA.contraindicated

Dosage & administration

Sourced from openFDA

This product is for intramuscular use only. The use of this product by the intravenous route is not indicated. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. It is important to use a separate vial, sterile syringe, and needle for each individual patient, in order to prevent transmission of infectious agents from one person to another. Any vial of Nabi-HB, Hepatitis B Immune Globulin (Human) that has been entered should be used promptly. Do not reuse or save for future use. This product contains no preservative; therefore, partially used vials should be discarded immediately. Hepatitis B Immune Globulin (Human) may be administered at the same time (but at a different site), or up to one month preceding hepatitis B vaccination without impairing the active immune response to hepatitis B vaccine 11 . Acute Exposure to Blood Containing HBsAg Table 2 summarizes prophylaxis for percutaneous (needlestick, bite, sharps), ocular, or mucous membrane exposure to blood according to the source of exposure and vaccination status of the exposed person. For greatest effectiveness, passive prophylaxis with Hepatitis B Immune Globulin (Human) should be given as soon as possible after exposure, as its value after seven days following exposure is unclear 12 . An injection of 0.06 mL/kg of body weight should be administered intramuscularly as soon as possible after exposure and within 24 hours, if possible. Consult the hepatitis B vaccine package insert for dosage information regarding the vaccine.

Warnings & precautions

Sourced from openFDA

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

Sourced from openFDA

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 .

Use in specific populations

Sourced from openFDA

Pregnancy Category C Animal reproduction studies have not been conducted with Nabi-HB. It is also not known whether Nabi-HB can cause fetal harm when administered to a pregnant woman or can affect a woman’s ability to conceive. Nabi-HB should be given to a pregnant woman only if clearly indicated.

Pharmacokinetics

Sourced from openFDA
Metabolism
Pharmacokinetics trials 20 of Nabi-HB, Hepatitis B Immune Globulin (Human), given intramuscularly to 50 healthy volunteers demonstrated pharmacokinetic parameters similar to those reported by Scheiermann and Kuwert 21 . The half-life for Nabi-HB was 23.1 ± 5.5 days.

Overdosage

Sourced from openFDA

Although no data are available, clinical experience reported with other human immune globulins suggests that the only manifestations of overdose with Nabi-HB, Hepatitis B Immune Globulin (Human), would be pain and tenderness at the injection site.

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
51 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Expired Product Administered59.8%
  2. 2Renal Failure47.8%
  3. 3Drug Ineffective35.9%
  4. 4Liver Function Test Abnormal35.9%
  5. 5Multi-organ Failure35.9%
  6. 6Off Label Use35.9%
  7. 7Sepsis35.9%
  8. 8Acute Respiratory Distress Syndrome23.9%
  9. 9Acute Respiratory Failure23.9%
  10. 10Anti-hbs Antibody Positive23.9%
  11. 11Blood Alkaline Phosphatase Increased23.9%
  12. 12Cytomegalovirus Hepatitis23.9%
  13. 13Drug Resistance23.9%
  14. 14Gamma-glutamyltransferase Increased23.9%
  15. 15Hepatic Necrosis23.9%

Literature

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Recent PubMed references pinned to Hepatitis B Immune Globulin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 157 ClinicalTrials.gov registrations naming Hepatitis B Immune Globulin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Hepatitis B Immune Globulin work?
Mechanism-of-action class: Virus Neutralization.
What is Hepatitis B Immune Globulin used for?
According to FDA labeling, Hepatitis B Immune Globulin carries indications including: 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 .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Hepatitis B Immune Globulin?
Hepatitis B Immune Globulin is classified as Specific immunoglobulins, Human Immunoglobulin, Virus Neutralization, Passively Acquired Immunity.
What are the brand names for Hepatitis B Immune Globulin?
Hepatitis B Immune Globulin is marketed under brand names including HepaGam B, Hyperhep B, Nabi-HB.
What are the contraindications for Hepatitis B Immune Globulin?
Hepatitis B Immune Globulin labeling lists contraindications including: 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. Nabi-HB contains not more than 40 micrograms per mL IgA.. Always consult the full prescribing information and a clinician.
Note. Data for hepatitis-b-immune-globulin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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