Hiberix

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  • Vaccines
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Hiberix Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Haemophilus b conjugate vaccine (tetanus toxoid conjugate); lyophilized pwd for IM inj after reconstitution; preservative-free; contains lactose, residual formaldehyde.

    Pharmacological Class

    Hib (PRP-T).

    How Supplied

    Single-dose vials—10 (w. diluent)

    Storage

    Storage Before Reconstitution

    • Hiberix: Store refrigerated between 2° and 8°C (36° and 46°F). Protect vials from light.

    • Diluent: Store refrigerated or at controlled room temperature between 2° and 25°C (36° and 77°F). Do not freeze.

    Storage After Reconstitution

    • Administer within 24 hours of reconstitution.

    • After reconstitution, store refrigerated between 2° and 8°C (36° and 46°F).

    Manufacturer

    GlaxoSmithKline

    Mechanism of Action

    H. influenzae type b can cause invasive disease such as meningitis and sepsis. Anti-PRP antibody has been shown to correlate with protection against invasive disease due to H. influenzae type b.

     

    Hiberix Indications

    Indications

    Active immunization against invasive disease caused by Haemophilus influenzae type b in children 6 weeks through 4 years of age (prior to 5th birthday).

    Hiberix Dosage and Administration

    Adult

    Not recommended.

    Children

    Children: (<6wks) or (5yrs–15yrs): not established. Inject IM into the anterolateral aspect of the thigh or deltoid. Give as a 4 dose series: 0.5mL at 2 months, 4 months, and 6 months of age, followed by a booster dose of (0.5mL) at 15–18 months of age. May give 1st dose as early as 6 weeks of age.

    Hiberix Contraindications

    Not Applicable

    Hiberix Boxed Warnings

    Not Applicable

    Hiberix Warnings/Precautions

    Warnings/Precautions

    Not a substitute for routine tetanus immunization. Have epinephrine inj (1:1000) available. Guillain-Barre syndrome (within 6 weeks) of previous tetanus toxoid vaccine. Syncope. Risk of apnea in premature infants. Immunocompromised. 

    Pregnancy Considerations

    • Not approved for use in individuals aged 5 years and older.

    Nursing Mother Considerations

    • Not approved for use in individuals aged 5 years and older.

    Pediatric Considerations

    • Safety and effectiveness of Hiberix in children younger than 6 weeks and in children aged 5 to 16 years have not been established.

    Hiberix Pharmacokinetics

    See Literature

    Hiberix Interactions

    Interactions

    Concomitant vaccines: see full labeling. Urine antigen detection may not have a diagnostic value in suspected disease due to H. influenzae type b within 1 to 2 weeks after receiving Hiberix. Immunosuppressants (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [high-dose]): may get suboptimal response.

    Hiberix Adverse Reactions

    Adverse Reactions

    Inj site reactions (eg, pain, redness), irritability, drowsiness, fever, loss of appetite, fussiness, restlessness.

    Hiberix Clinical Trials

    Clinical Trials

    Immunological Evaluation

    • Primary Series Vaccination (Doses 1, 2, and 3)

      • Hiberix was approved based on immunogenicity data from a randomized, controlled trial (Study 1). Patients received either Hiberix or control vaccines, in addition to US-licensed vaccines.

      • Hiberix achieved noninferiority to Control PRP-T with anti-PRP ≥0.15mcg/mL.

    • Booster Vaccination (Dose 4)

      • The immunogenicity of Hiberix administered as a booster dose at 15 to 18 months of age was evaluated in a subset of children from Study 1 (n = 336) in comparison with US-licensed vaccines following primary vaccination at 2, 4, and 6 months of age.

      • The booster dose of Hiberix and Control PRP-T was administered concomitantly with Infanrix.

      • Hiberix achieved noninferiority to Control PRP-T with anti-PRP ≥1.0mcg/mL at 1 month after the booster dose.

    Concomitant Vaccine Administration

    • Primary Series Vaccination (Doses 1, 2, and 3)

      • In Study 1, patients who received Hiberix were also given Pediarix and PCV 13 at 2, 4, and 6 months of age. These patients had no evidence for reduced antibody responses relative to the response in control subjects administered Control PRP-T (Sanofi Pasteur SA) concomitantly with Pediarix (DTaP-HBV-IPV) and PCV13, to pertussis antigens (GMC to pertussis toxin, filamentous hemagglutinin, and pertactin), diphtheria toxoid (antibody levels ≥0.1 IU/mL), tetanus toxoid (antibody levels ≥0.1 IU/mL), poliovirus types 1, 2, and 3 (antibody levels ≥1:8 to each virus), PCV13 (antibody levels ≥0.2 mcg/mL and GMC to each serotype), or hepatitis B (anti-hepatitis B surface antigen ≥10 mIU/mL). 

    • Booster Vaccination (Dose 4)

      • In Study 1, patients who received a booster dose of Hiberix were also given Infanrix at 15 to 18 months of age. These patients had not evidence for reduced antibody responses to pertussis antigens (GMC to pertussis toxin, filamentous hemagglutinin, and pertactin), diphtheria toxoid (antibody levels ≥0.1 IU/mL), and tetanus toxoid (antibody levels ≥0.1 IU/mL), relative to the responses in control subjects administered Control PRP-T (Sanofi Pasteur SA) concomitantly with Infanrix.

    Hiberix Note

    Not Applicable

    Hiberix Patient Counseling

    See Literature

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