Included as part of the PRECAUTIONS section.

Latex Allergy

The stopper of the vial contains dry natural latex rubber that may cause allergic reactions in latex-sensitive individuals.

Management of Acute Allergic Reactions

Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

Adverse Reactions Following Prior Pertussis Vaccination

If any of the following events occur within the specified period after administration of a whole-cell pertussis vaccine or a vaccine containing an acellular pertussis component, the decision to administer DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine should be based on careful consideration of potential benefits and possible risks. (1) [See DOSAGE AND ADMINISTRATION.]

• 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 ≥ 3 hours within 48 hours.
• Seizures with or without fever within 3 days.

Guillain-Barré Syndrome and Brachial Neuritis

A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. (2) If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. (1)

Infants and Children with a History of Previous Seizures

For infants or children with a history of previous seizures, an appropriate antipyretic may be administered (in the dosage recommended in its prescribing information) at the time of vaccination with a vaccine containing an acellular pertussis component (including DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine) and for the following 24 hours, to reduce the possibility of post-vaccination fever. (1)

Limitations of Vaccine Effectiveness

Vaccination with DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine may not protect all individuals.

Altered Immunocompetence

If DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Immunosuppressive Treatments.]

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C

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

Pediatric Use

DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine is not indicated for infants below 6 weeks of age or children 7 years of age or older. Safety and effectiveness of DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) vaccine in these age groups have not been established.

Last reviewed on RxList: 10/30/2009
This monograph has been modified to include the generic and brand name in many instances.