Kinrix

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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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

    • Kinrix Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Diphtheria and tetanus toxoids, acellular pertussis vaccine, aluminum hydroxide adsorbed; inactivated polio vaccine; susp for IM inj; preservative-free; contains traces of formaldehyde, polysorbate 80, neomycin, polymixin B.

    Pharmacological Class

    DTaP + IPV.

    How Supplied

    Single-dose vials—10; Single-dose prefilled Tip-Lok syringes—5 (without needles)

    Storage

    • Store refrigerated between 2° and 8°C (36° and 46°F). Do not freeze. Discard if the vaccine has been frozen.

    Manufacturer

    GlaxoSmithKline

    Mechanism of Action

    Protection against diphtheria is due to the development of neutralizing antibodies to the diphtheria toxin. Protection against tetanus is due to the development of neutralizing antibodies to the tetanus toxin. The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood. There is no well-established serological correlate of protection for pertussis. Neutralizing antibodies against the 3 poliovirus serotypes are recognized as conferring protection against poliomyelitis disease.

    Kinrix Indications

    Indications

    Immunization against diphtheria, tetanus, pertussis, and polio: As the 5th dose in the DTaP immunization series and the 4th dose in the inactivated poliovirus vaccine (IPV) series in children 4–6 years of age (before 7th birthday) who previously received Infanrix (DTaP) and/or Pediarix (DTaP, HB, IPV) for the first 3 doses and Infanrix for the 4th dose.

    Kinrix Dosage and Administration

    Adult

    Not applicable.

    Children

    <4yrs or ≥7yrs: not recommended. 4–6yrs: One dose of 0.5mL IM in deltoid muscle.

    Kinrix Contraindications

    Contraindications

    Anaphylaxis associated with previous diphtheria, tetanus, pertussis, or polio vaccine. Encephalopathy within 7 days of previous pertussis vaccine. Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

    Contraindications

    Hypersensitivity

    • Severe allergic reaction (eg, anaphylaxis) associated with previous diphtheria, tetanus, pertussis, or polio vaccine, or to any component of Kinrix, including neomycin and polymyxin B.

    • Do not vaccinate further with any of these components due to the uncertainty as to which component of the vaccine might be responsible.

    • Refer individuals to an allergist for evaluation if immunization with any of these components is considered.

    Encephalopathy

    • Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of previous pertussis vaccine that is not attributable to another identifiable cause.

    Progressive Neurologic Disorder

    • Progressive neurological disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy).

    • Do not administer pertussis vaccine to individuals with these conditions until a treatment regimen has been established and the condition has stabilized.

    Kinrix Boxed Warnings

    Not Applicable

    Kinrix Warnings/Precautions

    Warnings/Precautions

    Guillain-Barre syndrome within 6 weeks of previous tetanus vaccination. Fever (≥105°F within 48hrs), persistent inconsolable crying (≥3hrs within 48hrs), shock (within 48hrs), or seizures (within 3 days) after previous pertussis vaccine: see literature. Seizure risk: may give antipyretics. Latex allergy (prefilled syringes). Have epinephrine available. Pregnancy (Cat.C): not applicable.

    Warnings/Precautions

    Guillain-Barré Syndrome

    • If Guillain-Barré Syndrome (GBS) occurred within 6 weeks of a previous vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including Kinrix, should be based on careful consideration of the potential benefits and possible risks. 

    • Other available vaccines should be given as indicated if administration of tetanus toxoid is withheld.

    Latex

    • The tip caps of the prefilled syringes contain natural rubber latex and may cause allergic reactions.

    Syncope

    • Syncope may occur. Procedures should be in place to avoid injury from fainting and to restore cerebral perfusion after syncope.

    Adverse Reactions following Prior Pertussis Vaccination

    • Carefully consider the potential benefits and possible risks of administering Kinrix if any of the following events occur after administration of a pertussis-containing vaccine:

      • Temperature of 40.5°C (105°F) within 48 hours, not attributable to another identifiable cause. 

      • Collapse or shock-like state (hypotonic-hyporesponsive episode [HHE]) within 48 hours. 

      • Persistent, inconsolable crying lasting at least 3 hours within 48 hours. 

      • Seizures with or without fever within 3 days.

    Children at Risk for Seizures

    • Increased risk of seizure in children at the time of vaccination with a pertussis-containing vaccine (including Kinrix) and for the following 24 hours after; may administer appropriate antipyretic to reduce the possibility of post-vaccination fever. 

    Preventing and Managing Allergic Vaccine Reactions

    • Have epinephrine and other appropriate agents immediately available in case an acute anaphylactic reaction occurs.

    • Review the patient’s immunization history for hypersensitivity prior to administration.

    Pediatric Considerations

    • Safety and effectiveness of Kinrix in children younger than 4 years and children aged 7 to 16 years have not been evaluated. 

    • Kinrix is not approved for use in persons in these age groups.

    Kinrix Pharmacokinetics

    See Literature

    Kinrix Interactions

    Interactions

    May give with concomitant vaccines (eg, MMR). Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.

    Kinrix Adverse Reactions

    Adverse Reactions

    Inj site pain, redness, local swelling, increase in arm circumference, drowsiness, fever, loss of appetite.

    Kinrix Clinical Trials

    Clinical Trials

    Immunological Evaluation

    • The immunogenicity of Kinrix was evaluated in a US multicenter study (Study 048) which included 4209 children 4 through 6 years of age who previously received 4 doses of Infanrix, 3 doses of IPV, and 1 dose of MMR vaccine.

    • Patients were randomly assigned 3:1 to receive either Kinrix or Infanrix and IPV (Sanofi Pasteur SA) administered concomitantly at separate sites. Patients also received MMR vaccine (Merck & Co., Inc.) administered concomitantly at a separate site.

    • Levels of antibodies to the diphtheria, tetanus, pertussis (PT, FHA, and pertactin), and poliovirus antigens were measured in sera obtained immediately prior to vaccination and 1 month (range: 31 to 48 days) after vaccination. 

    • The co-primary immunogenicity endpoints were anti-diphtheria toxoid, anti-tetanus toxoid, anti-PT, anti-FHA, and anti-pertactin booster responses, and anti-poliovirus Type 1, Type 2, and Type 3 geometric mean antibody titers (GMTs) 1 month after vaccination.

    • Kinrix achieved noninferiority to Infanrix and IPV with regards to booster responses to DTaP antigens and post-vaccination GMTs for anti-poliovirus antibodies.

    Concomitant Vaccine Administration 

    • The immune responses to the antigens contained in Kinrix was evaluated in a US study (Study 055) that enrolled children aged 4 to 6 years. Patients received Kinrix concomitantly at separate sites with MMR vaccine (Merck & Co., Inc.) (n=237) or with MMR vaccine and varicella vaccine (Merck & Co., Inc.) (n = 239).

    • Immune responses to the antigens contained in Kinrix were measured approximately 1 month (28 to 48 days) after vaccination.

    • Booster responses to diphtheria, tetanus, and pertussis antigens and GMTs for poliovirus (Type 1, 2, and 3) after the receipt of Kinrix administered concomitantly with MMR vaccine and varicella vaccine were non-inferior to immune responses following concomitant administration of Kinrix administered with MMR vaccine.

    Kinrix Note

    Notes

    Report adverse events to VAERS at (800) 822-7967 and to GlaxoSmithKline at (888) 825-5249.

    Kinrix Patient Counseling

    Patient Counseling

    • Inform of the potential benefits and risks of immunization with Kinrix. 

    • Inform about the potential for adverse reactions that have been temporally associated with administration of KINRIX or other vaccines containing similar components. 

    • Give the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).

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