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Kinrix

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Kinrix

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Guillain-Barre Syndrome

If Guillain-Barré syndrome occurs within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give any tetanus toxoid-containing vaccine, including KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) , should be based on careful consideration of the potential benefits and possible risks. When a decision is made to withhold tetanus toxoid, other available vaccines should be given, as indicated.

Latex

The tip cap and the rubber plunger of the needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex sensitive individuals. The vial stopper is latex-free.

Adverse Events Following Prior Pertussis Vaccination

If any of the following events occur in temporal relation to receipt of a pertussis­containing vaccine, the decision to give any pertussis-containing vaccine, including KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) ,

should be based on careful consideration of the potential benefits and possible risks:

  • Temperature of ≥ 40.5°C (105°F) within 48 hours not due to another identifiable cause;
  • Collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours;
  • Persistent, inconsolable crying lasting ≥ 3 hours, occurring within 48 hours;
  • Seizures with or without fever occurring within 3 days.

When a decision is made to withhold pertussis vaccination, other available vaccines should be given, as indicated.

Children at Risk for Seizures

For children at higher risk for seizures than the general population, an appropriate antipyretic may be administered at the time of vaccination with a pertussis-containing vaccine, including KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) , and for the ensuing 24 hours to reduce the possibility of post-vaccination fever.

Preventing and Managing Allergic Vaccine Reactions

Prior to administration, the healthcare provider should review the history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) . It is also not known whether KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.

Pediatric Use

Safety and effectiveness of KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) in children younger than 4 years of age and children 7 to 16 years of age have not been evaluated. KINRIX (diptheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) is not approved for use in persons in these age groups.

Last reviewed on RxList: 7/23/2008
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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