Because intramuscular injection can cause injection site hematoma, ADACEL vaccine should not be given to persons with any bleeding disorder, such as hemophilia or thrombocytopenia, or to persons on anticoagulant therapy unless the potential benefits clearly outweigh the risk of administration. If the decision is made to administer ADACEL vaccine in such persons, it should be given with caution, with steps taken to avoid the risk of hematoma formation following injection. ⁽¹⁰⁾

If any of the following events occurred in temporal relation to previous receipt of a vaccine containing a whole-cell pertussis (eg. DTP) or an acellular pertussis component, the decision to give ADACEL vaccine should be based on careful consideration of the potential benefits and possible risks: ^{(4) (13)}

† 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 vaccine, Td vaccine should be given.

Persons who experienced Arthus-type hypersensitivity reactions (eg., severe local reactions associated with systemic symptoms) ⁽¹⁴⁾ following a prior dose of tetanus toxoid usually have high serum tetanus antitoxin levels and should not be given emergency doses of tetanus toxoid-containing vaccines more frequently than every 10 years, even if the wound is neither clean nor minor. ^{(5) (14)}

If Guillain-Barré Syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give subsequent doses of ADACEL vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. ⁽¹⁰⁾

The decision to administer a pertussis-containing vaccine to individuals with stable central nervous system (CNS) disorders must be made by the health-care provider on an individual basis, with consideration of all relevant factors and assessment of potential risks and benefits for that individual. The ACIP has issued guidelines for immunizing such individuals. ⁽⁴⁾

A family history of seizures or other CNS disorders is not a contraindication to pertussis vaccine. ⁽⁴⁾

The ACIP has published guidelines for vaccination of persons with recent or acute illness. ⁽¹⁰⁾

General

Do not administer by intravascular injection: ensure that the needle does not penetrate a blood vessel.

ADACEL vaccine should not be administered into the buttocks nor by the intradermal route, since these methods of administration have not been studied; a weaker immune response has been observed when these routes of administration have been used with other vaccines. ⁽¹⁰⁾

The possibility of allergic reactions in persons sensitive to components of the vaccine should be evaluated. Epinephrine Hydrochloride Solution (1:1,000) and other appropriate agents and equipment should be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

Prior to administration of any dose of ADACEL vaccine, the vaccine recipient and/or the parent or guardian must be asked about personal health history, including immunization history, current health status and any adverse event after previous immunizations. In persons who have a history of serious or severe reaction within 48 hours of a previous injection with a vaccine containing similar components, administration of ADACEL vaccine must be carefully considered.

The ACIP has published guidelines for the immunization of immunocompromised individuals.^{(15 )} Immune responses to inactivated vaccines and toxoids when given to immunocompromised persons may be suboptimal. ⁽¹⁰⁾ The immune response to ADACEL vaccine administered to immunocompromised persons (whether from disease or treatment) has not been studied.

A separate, sterile syringe and needle, or a sterile disposable unit, must be used for each person to prevent transmission of blood borne infectious agents. Needles should not be recapped but should be disposed of according to biohazard waste guidelines.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been performed with ADACEL vaccine to evaluate carcinogenicity, mutagenic potential, or impairment of fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with ADACEL vaccine. It is also not known whether ADACEL vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ADACEL vaccine should be given to a pregnant woman only if clearly needed. Animal fertility studies have not been conducted with ADACEL vaccine. The effect of ADACEL vaccine on embryo-fetal and pre-weaning development was evaluated in two developmental toxicity studies using pregnant rabbits. Animals were administered ADACEL vaccine twice prior to gestation, during the period of organogenesis (gestation day 6) and later during pregnancy on gestation day 29, 0.5 mL/rabbit/occasion (a 17-fold increase compared to the human dose of ADACEL vaccine on a body weight basis), by intramuscular injection. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no vaccine related fetal malformations or other evidence of teratogenesis noted in this study. ⁽¹²⁾

Pregnancy Registry

Health-care providers are encouraged to register pregnant women who receive ADACEL vaccine in Aventis Pasteur Inc.†s vaccination pregnancy registry by calling 1-800-822-2463 (1-800-VACCINE).

Nursing Mothers

It is not known whether ADACEL vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ADACEL vaccine is given to a nursing woman.

Pediatric Use

ADACEL vaccine is not indicated for individuals less than 11 years of age. (See INDICATIONS AND USAGE.) For immunization of persons 6 weeks through 6 years of age against diphtheria, tetanus and pertussis, a Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP) may be used, unless otherwise contraindicated.

Geriatric Use

ADACEL vaccine is not indicated for individuals 65 years of age and older. No data are available regarding the safety and effectiveness of ADACEL vaccine in individuals 65 years of age and older as clinical studies of ADACEL vaccine did not include subjects in the geriatric population.

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