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 ?
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 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.
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.
for Nabi-HB Intravenous and is currently under review by the FDA.
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.
Immune Globulin Intravenous (Human), 10% Liquid] for the treatment of primary humoral immunodeficiency (PI) and Nabi-HB hyperimmune globulin for the treatment of acute exposure to blood containing hepatitis B surface antigen (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.
Nabi-HB has been the industry gold standard for the prevention of hepatitis B infection following accidental exposure to hepatitis B virus and many hospitals, physicians and patients have come to rely on Nabi-HB's long, safe and effective history since its approval in the late 1990s.
Until the licenses have been transferred to Biotest Pharmaceuticals, Nabi will continue to have regulatory oversight and operational authority for the manufacture, marketing, sale and distribution of Nabi-HB.
Nabi Biologics has responsibility for the company's protein and immunological products and development pipeline, including Nabi-HB.
or other markets, including approval of Nabi-HB Intravenous; realize sales from Nabi-HB due to patient treatment protocols, the number of liver transplants performed in HBV-positive patients and competitive products; achieve market acceptance of our products; expand our sales and marketing capabilities or enter into and maintain arrangements with third parties to market and sell our products; effectively and/or profitability use, or utilize the full capacity of, our vaccine manufacturing facility; manufacture NicVAX or other products in our own vaccine manufacturing facility; comply with reporting and payment obligations under government rebate and pricing programs; raise additional capital on acceptable terms, or at all; and re-pay our outstanding convertible senior notes when due.
Nabi also provided today updates regarding the company's ongoing operations, its strategic alternatives process and the Nabi-HB regulatory efforts: