Nabi-HB

hepatitis B immune globulin

(hep-a-tite-iss B i-myoon glo-byoo-lin) ,

BayHep B

(trade name),

Nabi-HB

(trade name)

Classification

Therapeutic: vaccines immunizing agents
Pharmacologic: immune globulins
Pregnancy Category: C

Indications

Prevents hepatitis B infection in patients who are known to have been exposed, including neonates born to HBsAg-positive women, by providing passive immunity.

Action

An immune gamma-globulin fraction containing high titers of antibodies to the hepatitis B surface antigen. Confers passive immunity to hepatitis B infection.

Therapeutic effects

Prevention of hepatitis B infection.

Pharmacokinetics

Absorption: Slowly absorbed after IM administration.
Distribution: Unknown. Probably crosses the placenta.
Metabolism and Excretion: Unknown.
Half-life: 21 days.

Time/action profile (development of anti-HBs antibodies)

ROUTEONSETPEAKDURATION
IM1–6 days3–11 days2–6 mo

Contraindications/Precautions

Contraindicated in: Hypersensitivity to immune globulins, glycine, or thimerosal.
Use Cautiously in: Thrombocytopenia; IgA deficiency; Lactation: Lactation; Obstetric: Has been used during pregnancy.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • faintness
  • malaise
  • weakness

Dermatologic

  • pruritus
  • rashes
  • urticaria

Local

  • erythema at IM site
  • pain
  • swelling
  • tenderness

Musculoskeletal

  • joint pain

Miscellaneous

  • allergic reactions including anaphylactic shock and angioedema (life-threatening)

Interactions

Drug-Drug interaction

May interfere with the immune response to live-vaccines.

Route/Dosage

Intramuscular (Adults) 0.06 mL/kg (usual dose 3–5 mL) within 7 days of exposure, repeated 28–30 days after exposure.
Intramuscular (Neonates) 0.5 mL within 12 hr of birth.

Availability

Injection: 0.5-mL prefilled syringes, 1-, 4-, 5-mL vials

Nursing implications

Nursing assessment

  • For passive immunity, determine the date of exposure to infection. Hepatitis B immune globulin should be administered preferably within 24 hr but not later than 7 days after exposure to hepatitis B.
  • Assess patient for signs of anaphylaxis (hypotension, flushing, chest tightness, wheezing, fever, dizziness, nausea, vomiting, diaphoresis) after administration. Epinephrine and antihistamines should be available for treatment of anaphylactic reactions.

Potential Nursing Diagnoses

Risk for infection (Indications)

Implementation

  • Solution for injection is clear, slightly amber, and viscous. Keep refrigerated.
    • If administered with hepatitis B virus vaccine, do not administer via same syringe or into same injection site.
  • Intramuscular: Administer hepatitis B immune globulin (HBIG) in adults and children into the deltoid muscle or anterolateral thigh. The gluteal site should be used only in adults with injections of large volumes or when large volumes are divided into multiple doses.
    • Do not administer IV.

Patient/Family Teaching

  • Explain to patient the use and purpose of hepatitis B immune globulin therapy. Discuss methods of transmission and vaccination for prophylaxis.
  • Advise patient to report symptoms of anaphylaxis immediately.
  • Inform patient that pain, tenderness, swelling, and erythema at the injection site may occur after IM injections.

Evaluation/Desired Outcomes

  • Prevention of hepatitis B infection in exposed patients by providing passive immunity.

Nabi-HB

Immunology An IM formulation of human HBV immune globulin used to manage 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 acuteHBV infection. See Hepatitis B.
References in periodicals archive ?
It will also be used in Nabi-HB hyperimmune globulin to treat acute exposure to blood containing hepatitis B surface antigen, perinatal exposure of infants born to HBsAg-positive mothers, sexual exposure to HBsAg-positive persons and household exposure to persons with acute HBV infection.
Nabi Biopharmaceuticals, Boca Raton, FL, announced the Blood Products Advisory Committee (BPAC) of the US Food and Drug Administration (FDA) voted to recommend approval of the company's Biologic License Application (BLA) for Nabi-HB Intravenous (Hepatitis B Immune Globulin (Human) Intravenous).
Nabi submitted its BLA for Nabi-HB Intravenous in Nov.
If Nabi-HB Intravenous ultimately receives FDA approval, it would be the only product available in the US indicated for the protection of the transplanted liver from HBV in HBV-positive liver transplant patients.
The company's Nabi-HB, a non-intravenous form of the product, is currently licensed in the US to provide protection from infection after accidental exposure to HBV.
Nabi Biopharmaceuticals created what today is a very favorable commercial product in Nabi-HB, the current gold standard in the United States for prevention of re-infection with hepatitis B in liver transplant patients.
The company has three products on the market today: PhosLo (calcium acetate), Nabi-HB (Hepatitis B Immune Globulin (Human)), and Aloprim (allopurinol sodium) for Injection.
We have three products on the market today: PhosLo (calcium acetate), Nabi-HB (Hepatitis B Immune Globulin (Human)), and Aloprim (Allopurinol sodium (for injection)) and a number of products in various stages of clinical and preclinical development.
Nabi Biopharmaceuticals has several products in clinical trials, as well as four marketed products, including Nabi-HB (Hepatitis B Immune Globulin (Human)), for the prevention of hepatitis B infections and WinRho SDF (Rho (D) Immune Globulin Intravenous (Human)), for the treatment of acute, chronic and HIV-related immune thrombocytopenia purpura.