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Adacel

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Adacel

Adacel

WARNINGS

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-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give Adacel (tetanus toxoid, reduced diphtheria toxoid 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. (5) (10) (11)

In the following situations, Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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)

PRECAUTIONS

General

Before administration of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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 (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.

Information for Vaccine Recipients and/or Parent or Guardian

Before administration of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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 (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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 (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine during pregnancy. If they are pregnant or become aware they were pregnant at the time of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been performed with Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine to evaluate carcinogenicity, mutagenic potential, or impairment of fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine. It is also not known whether Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine should be given to a pregnant woman only if clearly needed. Animal fertility studies have not been conducted with Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine. The effect of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine on embryo-fetal and pre-weaning development was evaluated in two developmental toxicity studies using pregnant rabbits. Animals were administered Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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 (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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)

Nursing Mothers

It is not known whether Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) 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 refer to manufacturers' package inserts for DTaP vaccines.

Geriatric Use

Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine is not indicated for individuals 65 years of age and older. No data are available regarding the safety and effectiveness of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine in individuals 65 years of age and older as clinical studies of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) vaccine did not include participants in the geriatric population.

REFERENCES

4 CDC. Diphtheria, tetanus and pertussis: recommendations for vaccine use and other preventive measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-10):1-28.

5 CDC. General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.

9 Data on file at Sanofi Pasteur Limited.

10 CDC. Preventing tetanus, diphtheria and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine. MMWR 2006;55(RR-17):1-36.

11 CDC. Preventing tetanus, diphtheria and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines. MMWR 2006;55(RR-3):1-35.

12 CDC. Update: vaccine side effects, adverse reactions, contraindications and precautions. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(RR-12):1-35.

13 CDC. Update on adult immunization. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(RR-12):1-52.

Last reviewed on RxList: 1/6/2009
This monograph has been modified to include the generic and brand name in many instances.

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