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An established choice for HBV post-exposure prophylaxis1

An established choice for HBV post-exposure prophylaxis1

HepaGam B® [Hepatitis B® Immune Globulin Intravenous (Human)] is FDA-approved for post-exposure prophylaxis1

HepaGam B® is indicated for post-exposure
prophylaxis in the following settings1:

Acute exposure to blood containing HBsAg

Perinatal exposure of infants born to HBsAg-positive mothers

Sexual exposure to HBsAg-positive persons

Household exposure to persons with acute HBV infection

  • Household exposure of infants less than 12 months old whose mothers or primary care givers are positive for HBsAg

HepaGam B® Dosing Regimen for Post-exposure Prophylaxis (Intramuscular)

Indication

Dosing

Instructions

Acute Exposure to Blood Containing HBsAg

0.06 mL/kg

Administer HepaGam B® as soon as possible after exposure. The value after seven days following exposure is unclear.

For persons who refuse Hepatitis B vaccine or who are known non-responders to vaccine, give a second dose of HepaGam® one month after the first dose.

Perinatal Exposure of Infants Born to HBsAg-Positive Mothers

0.5 mL

Administer after physiologic stabilization of the infant and preferably within twelve hours of birth. Administer concurrently with Hepatitis B vaccine.

Sexual Exposure to HBsAg-Positive Persons

0.06 mL/kg

Administer HepaGam B® and Hepatitis B Vaccine series within 14 days of sexual contact or if sexual contact with the infected person will continue.

Household Exposure to Person with Acute HBV Infection

0.5 mL

For infants less than twelve months of age administered concurrently with Hepatitis B Vaccine. Prophylaxis of other household contacts of persons with acute HBV infection is not indicated unless there is an identifiable blood exposure to the index patient, such as by sharing toothbrushes or razors. Treat such exposures like sexual exposures.

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Indications

HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)] is an intravenous immune globulin indicated for the following:

  • Prevention of Hepatitis B recurrence following liver transplant in HBsAg-positive liver transplant patients

  • Post-exposure prophylaxis including:

    • Acute exposure to HBsAg-positive blood, plasma, or serum (parenteral exposure, direct mucus membrane contact, oral ingestion, etc.),
    • Perinatal exposure of infants born to HBsAg-positive mothers,
    • Sexual exposure to HBsAg-positive persons, and
    • Household exposure to persons with acute HBV infection.

Important Risk Information

CONTRAINDICATIONS: Individuals known to have severe, potentially life-threatening reaction to human globulin preparations should not receive HepaGam B® or any other immune globulin (human). Individuals who are deficient in IgA may have the potential to develop IgA antibodies and have severe, potentially life-threatening allergic reactions.

For post-exposure prophylaxis indications, HepaGam B® must be administered intramuscularly only. In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HepaGam B® should be given only if the expected benefits outweigh the potential risks.

WARNINGS and PRECAUTIONS: HepaGam B® [Hepatitis B Immune Globulin Intravenous (Human)] is a sterile solution of gamma globulin (IgG) made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, eg, viruses and, theoretically, the Creutzfeldt-Jacob disease (CJD) agent.

Thrombotic events have been reported in association with the use of immune globulins. Patients at risk include those with a history of atherosclerosis, multiple cardiovascular risk factors, advanced age, impaired cardiac output, coagulation disorders, prolonged periods of immobilization, and/or known/suspected hyperviscosity.

The maltose contained in HepaGam B® can interfere with some types of blood glucose monitoring systems. Only testing systems that are glucose-specific should be used in patients receiving HepaGam B®. This interference can result in falsely elevated glucose readings that can lead to untreated hypoglycemia or to inappropriate insulin administration, resulting in life-threatening hypoglycemia.

Liver transplant patients should be monitored regularly for serum anti-HBs antibody levels.

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

The most common adverse drug reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects).

For product inquiries about HepaGam B®, call (877) 437-2426.

Please see full Prescribing Information for full prescribing details.

For more information about these indications please see the full Prescribing Information.

Reference: 1. HepaGam B® [package insert]. Aptevo Therapeutics, Inc., Berwyn, PA; August 2016.