Persons who experienced Arthus-type hypersensitivity reactions (e.g., severe local reactions associated with systemic symptoms) (12) 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. (4) (10) (11) (13)
If Guillain-Barrę syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give Adacel vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks. (5) (10) (11)
In the following situations, Adacel vaccine should generally be deferred:
- Moderate or severe acute illness with or without fever, until the acute illness resolves. (10) (11)
- In adolescents, progressive neurologic disorder, including progressive encephalopathy, or uncontrolled epilepsy, until the condition has stabilized. (11)
- In adults, unstable neurologic condition (e.g., cerebrovascular events and acute encephalopathic conditions), until the condition has resolved or is stabilized. (10)
Before administration of Adacel vaccine, the patient's current health status and medical history should be reviewed in order to determine whether any contraindications exist and to assess the benefits and risks of vaccination. (See CONTRAINDICATIONS and WARNINGS.)
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.
If Adacel vaccine is administered to immunocompromised persons, including persons receiving immunosupressive therapy, the expected immune response may not be obtained.
Information for Vaccine Recipients and/or Parent or Guardian
Before administration of Adacel vaccine, health-care providers should inform the vaccine recipient and/or parent or guardian of the benefits and risks.
The health-care provider should inform the vaccine recipient and/or parent or guardian about the potential for adverse reactions that have been temporally associated with Adacel vaccine or other vaccines containing similar components. The health-care provider should provide the Vaccine Information Statements (VISs) that are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization.
The vaccine recipient and/or parent or guardian should be instructed to report any serious adverse reactions to their health-care provider. Females of child-bearing potential should be informed that Sanofi Pasteur Inc. maintains a pregnancy surveillance system to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with Adacel vaccine during pregnancy. If they are pregnant or become aware they were pregnant at the time of Adacel vaccine immunization, they are encouraged to contact directly or have their health-care professional contact Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE).
Reporting adverse events after vaccination to VAERS (Vaccine Adverse Event Reporting System) by recipients and/or parents/or guardian should be encouraged. The toll-free number for VAERS forms and information is 1-800-822-7967. Reporting forms may also be obtained at the VAERS website at www.vaers.hhs.gov
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines. (See PRECAUTIONS, General.)
For information regarding simultaneous administration with other vaccines refer to the CLINICAL PHARMACOLOGY, CONCURRENTLY ADMINISTERED VACCINES, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION sections.
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. (9)
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.
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 refer to manufacturers' package inserts for DTaP vaccines.
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 participants in the geriatric population.