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Decavac

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Decavac

WARNINGS

More frequent administration of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine than described in DOSAGE AND ADMINISTRATION may be associated with increased incidence and severity of adverse reactions.

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus-toxoid containing vaccine usually have high serum tetanus antitoxin levels and should not receive DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine more frequently than every 10 years, even for tetanus prophylaxis as part of wound management (see DOSAGE AND ADMINISTRATION).

A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.6 If Guillain-Barré syndrome occurred within 6 weeks after receipt of a prior vaccine containing tetanus toxoid, the decision to give DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.7

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

PRECAUTIONS

General

Prior to administration of any dose of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine, the vaccine recipient's current health status and personal health history should be reviewed. This should include a review of the patient's immunization history, any adverse events after previous immunizations and history concerning possible sensitivity to the vaccine, in order to determine the existence of any contraindications to administration of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine, and to allow an assessment of the benefits and risks of vaccination.

Epinephrine injection (1:1000) and other appropriate agents and equipment must be immediately available should an acute anaphylactic reaction occur.

Immune responses to inactivated vaccines and toxoids when given to immunocompromised persons may be suboptimal.7 The immune response to DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine administered to immunocompromised individuals (whether from disease or treatment) has not been studied.

REFERENCES

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

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been performed with DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine to evaluate carcinogenicity, mutagenic potential, or impact on fertility.

Pregnancy Category C

Animal reproduction studies have not been conducted with DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine. It is also not known whether DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine is administered to a nursing woman.

Pediatric Use

DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine is not approved for use in infants and children younger than 7 years of age. Safety and effectiveness of DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine in this age group have not been established.

Geriatric Use

The clinical study that evaluated the immunogenicity and safety of the tetanus and diphtheria toxoids contained in DECAVAC (tetanus and diphtheria toxoids adsorbed) vaccine did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently than younger subjects.

REFERENCES

6. Institute of Medicine (US). Stratton KR, et al, eds. Adverse events associated with childhood vaccines: evidence bearing on causality. Washington (DC): National Academy Press. 1994:67-117.

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

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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