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🏅 FDA Orphan Designation

HepaGam B

hepatitis B immune globulin (human)

Manufacturer: Cangene Corporation

Indicated for:
Hepatitis B reinfection following liver transplantationOrphanFetal minoxidil syndromeHepatitis delta

FDA-Approved Indications (3)

Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients

treatment of perinatal exposure of infants born to HBsAg-positive mothers

Population: infants

treatment of household exposure to persons with acute HBV infection in infants less than 12 months old whose mother or primary caregiver is positive for HBsAg, and other household contacts with an ide

Population: infants and household contacts

Indications & Usage

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.

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.