NABI-HB- human hepatitis b virus immune globulin injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN (UNII: XII270YC6M) (HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN - UNII:XII270YC6M)

Available from:

ADMA Biologics, Inc

INN (International Name):

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN

Composition:

HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN 312 [iU] in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 HBeAg12. 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 i

Product summary:

HOW SUPPLIED Nabi-HB, Hepatitis B Immune Globulin (Human), is supplied as: NDC Number Contents 59730-4202-1 a carton containing a 1 mL dose in a single-use vial (>312 IU) and package insert 59730-4203-1 a carton containing a 5 mL dose in a single-use vial (>1560 IU) and package insert

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

NABI-HB- HUMAN HEPATITIS B VIRUS IMMUNE GLOBULIN INJECTION
ADMA BIOLOGICS, INC
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HEPATITIS B IMMUNE GLOBULIN (HUMAN) NABI-HB SOLVENT DETERGENT TREATED
AND FILTERED
DESCRIPTION Hepatitis B Immune Globulin (Human), Nabi-HB, is a sterile
solution of
immunoglobulin (5 1 percent protein) containing antibodies to
hepatitis B surface antigen (anti-HBs). It
is prepared from plasma donated by individuals with high titers of
anti-HBs. The plasma is processed
using a modified Cohn 6 Oncley 9 cold-alcohol fractionation process1,
2 with two added viral
reduction steps described below. Nabi-HB is formulated in 0.042-0.108
M sodium chloride, 0.10-0.20
M glycine, and 0.005-0.050 percent polysorbate 80, at pH 5.8-6.5. The
product is supplied as a
nonturbid sterile liquid in single dose vials and appears as clear to
opalescent. It contains no
preservative and is intended for single use by the intramuscular route
only. Each plasma donation used
for the manufacture of Nabi-HB is tested for the presence of hepatitis
B virus (HBV) surface antigen
(HBsAg), human immunodeficiency viruses (HIV) 1/2, and hepatitis C
virus (HCV) antibodies. In
addition, pooled samples of Source Plasma used in the manufacture of
this product are tested by FDA
licensed Nucleic Acid Testing (NAT) for HIV and HCV and found to be
negative. Investigational NAT
for hepatitis A virus (HAV) and HBV is also performed on pooled
samples of all Source Plasma used,
and found to be negative; however, the significance of a negative
result has not been established.
Investigational NAT for parvovirus B19 (B19) is also performed on
pooled samples of all Source
Plasma and the limit for B19 DNA in a manufacturing pool is set not to
exceed 104 IU/mL. The
manufacturing steps for Nabi-HB are designed to reduce the risk of
transmission of viral disease. The
solvent/detergent treatment step, using tri-n-butyl phosphate and
Triton X-100, is effective in
inactivating known enveloped viruses such as hepatitis B virus (HBV),
hepatitis C virus (HCV), and
human immunodeficiency