Kinrix

What is Kinrix?

• Kinrix (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine) is used for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series.

What are the uses of this medicine?

• Kinrix is used for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children aged 4 through 6 years (prior to the 7th birthday) whose previous DTaP vaccine doses have been with INFANRIX (Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed) and/or PEDIARIX [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine] for the first 3 doses and INFANRIX for the fourth dose.

How does this medicine work?

• Diphtheria is an acute toxin-mediated infectious disease caused by toxigenic strains of C. diphtheriae. Protection against disease is due to the development of neutralizing antibodies to the diphtheria toxin.
• Tetanus is an acute toxin-mediated disease caused by a potent exotoxin released by C. tetani. Protection against disease is due to the development of neutralizing antibodies to the tetanus toxin.
• Pertussis (whooping cough) is a disease of the respiratory tract caused by B. pertussis. The role of the different components produced by B. pertussis in either the pathogenesis of, or the immunity to, pertussis is not well understood.
• Poliovirus is an enterovirus that belongs to the picornavirus family. Three serotypes of poliovirus have been identified (Types 1, 2, and 3). Neutralizing antibodies against the 3 poliovirus serotypes are recognized as conferring protection against poliomyelitis disease.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who have:

• Severe allergic reaction (e.g., anaphylaxis) after a previous dose of any diphtheria toxoid-, tetanus toxoid-, pertussis- or poliovirus-containing vaccine, or to any component of KINRIX, including neomycin and polymyxin B.
• Encephalopathy within 7 days of administration of a previous pertussis-containing vaccine.
• Progressive neurologic disorders.

What drug interactions can this medicine cause?

• When KINRIX is administered concomitantly with other injectable vaccines, they should be given with separate syringes. KINRIX should not be mixed with any other vaccine in the same syringe or vial.
• Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to KINRIX.

Is this medicine FDA approved?

• It was approved for medical use in the United States in 2008.

How should this medicine be used?

Recommended dosage:

• KINRIX is to be administered as a 0.5-mL dose by intramuscular injection.
• The preferred site of administration is the deltoid muscle of the upper arm.
• KINRIX may be used for the fifth dose in the DTaP immunization series and the fourth dose in the IPV immunization series in children aged 4 through 6 years (prior to the 7th birthday) whose previous DTaP vaccine doses have been with INFANRIX and/or PEDIARIX for the first 3 doses and INFANRIX for the fourth dose.

Administration:

• Shake vigorously to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur with vigorous shaking.
• For the prefilled syringes, attach a sterile needle and administer intramuscularly.
• For the vials, use a sterile needle and sterile syringe to withdraw the 0.5-mL dose and administer intramuscularly.
• Changing needles between drawing vaccine from a vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated.
• Use a separate sterile needle and syringe for each individual.
• Do not administer this product intravenously, intradermally, or subcutaneously.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Single-dose vials and single-dose, prefilled syringes containing a 0.5‑mL suspension for injection.

This medicine is available in fallowing brand namesː

• KINRIX

What side effects can this medication cause?

The most common side effects of this medicine include:

• injection site pain
• redness
• increase in arm circumference
• swelling
• drowsiness
• fever (≥99.5°F)
• loss of appetite

What special precautions should I follow?

• If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give KINRIX should be based on potential benefits and risks.
• The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions.
• Syncope (fainting) can occur in association with administration of injectable vaccines, including KINRIX. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope.
• If temperature ≥105°F, collapse or shock-like state, or persistent, inconsolable crying lasting ≥3 hours have occurred within 48 hours after receipt of a pertussis-containing vaccine, or if seizures have occurred within 3 days after receipt of a pertussis-containing vaccine, the decision to give KINRIX should be based on potential benefits and risks.
• For children at higher risk for seizures, an antipyretic may be administered at the time of vaccination with KINRIX.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• KINRIX cannot be used during pregnancy.

Can this medicine be used in children?

• 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.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
• CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED)
• BORDETELLA PERTUSSIS FILAMENTOUS HEMAGGLUTININ ANTIGEN (FORMALDEHYDE INACTIVATED)
• BORDETELLA PERTUSSIS PERTACTIN ANTIGEN (FORMALDEHYDE INACTIVATED)
• BORDETELLA PERTUSSIS TOXOID ANTIGEN (FORMALDEHYDE, GLUTARALDEHYDE INACTIVATED
• POLIOVIRUS TYPE 1 ANTIGEN (FORMALDEHYDE INACTIVATED)
• POLIOVIRUS TYPE 2 ANTIGEN (FORMALDEHYDE INACTIVATED)
• POLIOVIRUS TYPE 3 ANTIGEN (FORMALDEHYDE INACTIVATED)

Inactive ingredients:

• ALUMINUM HYDROXIDE
• FORMALDEHYDE
• NEOMYCIN SULFATE
• POLYMYXIN B
• POLYSORBATE 80
• SODIUM CHLORIDE

Who manufactures and distributes this medicine?

• Manufactured by GlaxoSmithKline Biologicals
• Rixensart, Belgium, , and
• GSK Vaccines GmbH
• Marburg, Germany

Distributed by GlaxoSmithKline

• Research Triangle Park, NC

What should I know about storage and disposal of this medication?

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

• Dailymed label info on Kinrix
• FDA Kinrix

Kinrix Resources
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