Du Hep™ – Hepatitis B Immunoglobulin (Human- IM)

Description

Du-Hep is a sterile solution containing hepatitis B immune globulin (HBIG) which is prepared by Cold ethanol method from plasma of individuals with high titers of HIV1/2 and HCV before being used to prepare the hepatitis B immune globulin.

Indications

  • Infants born to mothers positive for HBsAg with or without HBeAg.
  • Infants less than 12 months old whose mother or primary caregiver is positive for
    HBsAg.
  • Following either parenteral exposure (needle stick, bite, sharps), direct mucous
    membrane contact (accidental splash), or oral ingestion (pipetting accident), involving
    HBsAg-positive materials such as blood, plasma or serum.
  • Sexual partners of HBsAg-positive persons.

Composition

Each 1 mL, 2 mL, and 4 mL of ampoule contains 100 IU, 200 IU and 400 IU (100 IU/mL) of hepatitis B antibodies respectively. This preparation contains no antimicrobial preservatives and is stabilized with glycine.

Clinical Efficiency

In a randomized double-blind, placebo-controlled efficacy trail of HBIG for prevention of the mother-to-infant transmitted HBsAg carrier state conducted in Taiwan, the clinical efficacy was 71% and 42% for the infants who received HBIG 0.5 mL at birth, 3 months, 6 months and in infants who received single dose of HBIG at birth respectively.

Pharmacokinetics

Administration of Du-Hep results in detectable level of circulating antiHBs which persists for 2 months or longer. The half-life is 24.8+/-5.6 days. The clearance rate is 0.433+/- 0.144 L/day and the volume of distribution 15.3+/- 6.2L.

Administration

Du-Hep is indicated for intra muscular use only.

Contraindications

Individuals known to have had an anaphylactic or severe systemic reaction to human immune
globulin.

Adverse reactions

Local reactions such as pain, ache, erythema, heat, and burning at the injection site, as well as systemic reactions such as headache, malaise, nausea, diarrhea and myalgia. Other reactions include chills, fatigue, lightheadedness, abdominal cramping, and itching.

How supplied

Supplied in 100 IU/ 1 mL, 200 IU/2 mL, and 400 IU/4 mL of hepatitis B antibodies ampoules.

Storage

Refrigerate between 2 to 8oC (36 to 46oF). Do not freeze.