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HepaGam B® is a Hepatitis B Immune Globulin Intravenous (Human) 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 Safety Information:
Individuals known to have anaphylactic or severe systemic reactions to the parenteral administration of human globulin preparations should not receive HepaGam B®. 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.
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, e.g., viruses and, theoretically, the Creutzfeldt-Jacob disease (CJD) agent.
Severe hypersensitivity reactions may occur with HepaGam B®. Certain adverse drug reactions may be related to the rate of infusion. The recommended infusion rate given under Dosage and Administration in the prescribing information must be closely followed.
Thrombotic events may occur during or following treatment with IVIG products. 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.
For postexposure 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.
The maltose contained in HepaGam B® can interfere with some types of blood glucose monitoring systems. This can result in falsely elevated glucose readings that can lead to untreated hypoglycemia or to inappropriate insulin administration, resulting in life-threatening hypoglycemia.
The only adverse reactions observed in clinical trial subjects were hypotension and nausea (2% of clinical trial subjects).
Please see full Prescribing Information for full prescribing details.