Status: approvals withdrawn

Organizations involved:

Abbott Laboratories – Manuf.; R&D; Tech.; Former

Nabi – USA mark.; Former

Cross ref: See the entry for Hepatitis B Immune Globulin, i.v. (Nabi-HB) (#756), an intravenously administered product which has replaced this intramuscularly administered product. See the entries for Hepatitis B Immune Globulin Products (#751) and Immune Globulin Products (#743). See also the other hepatitis B virus immune globulin products. See the Hepatitis B Vaccine Products entry (#468) for background about hepatitis B virus and chronic hepatitis B.

Description: Hepatitis B Immune Globulin (Human) or H-BIG was a sterile 16.5% solution of protein (over 90% immune globulin) prepared from Cohn-Oncley cold alcohol fractionated pooled Plasma obtained from donors with high titers of hepatitis B virus surface antigen (HBsAg; donors having received vaccination with one of the two approved hepatitis B virus vaccines). Each vial of H-BIG contained HBsAg antibodies equivalent to or exceeding the potency of HBsAg antibodies in a U.S. Reference hepatitis immune globulin (maintained by CBER, FDA). H-BIG contained 1:10,000 thimerosal (sodium ethyl-mer-cur-i-thiosalicylate; mercury derivative; see entry #737) as an antimicrobial preservative. H-BIG contained 16.5% protein, at least 80% monomeric (non-polymerized) IgG. Trace amounts of IgA may be present. Excipients included hydrochloric acid or sodium hydroxide used for pH adjustment.

H-BIG was packaged in 0.5 mL single-dose syringes for use in newborn infants; a 1.0 mL multi-dose vial; and a 5 mL multi-dose vial. H-BIG was stored at 2-8˚C (refrigerated). The dating period was two years. The date of manufacture was the date of filling of the final containers.

Nomenclature: Hepatitis B Immune Globulin, i.v./Nabi [BIO]; H-BIG [TR]; Hepatitis B Immune Globulin (Human) [FDA]; H-BIG 16.5% Intravenous (IV) [SY]; NDC 05973-0399-01; NDC 05973-0399-05; NDC 05973-0399-11 [NDC]

Companies.: H-BIG was manufactured by Abbott Labs., FDA CBER est. no. 0043, at Rocky Mount, NC, facilities; and warehoused at its N. Chicago, IL, facilities. Source high HBsAg antibody titer Plasma may also have been obtained from Armour/Centeon, later Aventis Behring (now CSL Bioplasma). The plasma used to make Fraction II powder for potency adjustment was fractionated by Armour/Centeon, now CSL Bioplasma; and/or Michigan Biologics Products Institute, now BioPort Corp., a subsidiary of Emergent Biosolutions Inc.

H-BIG was exclusively marketed in the U.S. by Nabi, (formed from the merger of North American Biologicals, Inc. and Univax, Inc.). See entry #649 for Nabi’s replacement product.

Manufacture: Plasma used for manufacture of H-BIG was hyperimmune plasma from donors with high titers of HBsAg antibodies – paid plasmapheresis donors having received hepatitis B virus vaccine. Raw materials included Immune Globulin (Human) Fraction II Bulk Powder [originally manufactured by Armour Pharmaceutical (est. 0149); later Aventis Behring, now CSL Bioplasma, Inc.] from donors with high titers of HBsAg antibodies, and normal Plasma. The powdered immune globulins were received by Abbott and tested for protein, glycine, moisture, identity, purity, pyrogen, pH, chromatographic purity, heat stability, and visual inspection. High-titer fraction II powder was blended with normal fraction II powder to give the proper potency. The blended powder was dissolved in cold water containing glycine, sodium chloride, and thimerosal. The solution was sterile filtered and the sterile bulk filled into vials and stored under refrigeration.

Final bulk and final container H-BIG were tested for protein, glycine, pH, heat stability, thimerosal, chromatographic purity, pyrogen, sterility, potency, and electrophoretic purity. Final containers are also tested for safety, identity, and visually (with final lot release by CBER).

FDA class: Biologic PLA

CBER class: Blood And Blood Derivatives

Approvals: Date = 19770615; first approval, PLA ref. no. 85-0324; ELA ref. no. 85-0340; granted to Abbott Labs.; Indication = for post-exposure prophylaxis following either parenteral exposure (e.g., accidental needlestick), direct mucous membrane contact (e.g., incidental splash), sexual exposure, or oral ingestion (e.g., pipetting accident) involving HBsAg positive materials such as blood, plasma and serum

Date = not available; Indication = for post-exposure prophylaxis in infants born to hepatitis B virus surface antigen-positive mothers (preventing the hepatitis B infection carrier state in 75% of cases if given immediately after birth and in the early months of life; and prophylactic efficacy increases to about 94% if given concurrently with hepatitis B virus vaccine)

Status: This product is no longer approved, manufactured or marketed. It has been replaced by a more highly purified intravenous product, Nabi-HB.

Medical: The recommended dosage was 0.06 mL/kg body mass (usually 3-5 mL) administered by intravenous injection as soon as possible after exposure, generally along with hepatitis B virus vaccine.

Competition: Nabi has developed and currently markets a new formulation, Nabi-HB (see entry below), for intravenous administration, with manufacture including solvent detergent viral inactivation and nanofiltration for virus removal. Also, the new product contains no thimerosal preservative.