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Adacel

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Adacel

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

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.

Latex

The tip caps of the Adacel prefilled syringe may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals. The vial stopper is not made with natural rubber latex. [ See HOW SUPPLIED/Storage And Handling]

Guillain-Barre Syndrome And Brachial Neuritis

A review by the Institute of Medicine found evidence for acceptance of a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome.1 If Guillain-Barre syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the risk for Guillain-Barre syndrome may be increased following a dose of Adacel vaccine.

Progressive Or Unstable Neurologic Disorders

Progressive or unstable neurologic conditions are reasons to defer Adacel. It is not known whether administration of Adacel to persons with an unstable or progressive neurologic disorder might hasten manifestations of the disorder or affect the prognosis. Administration of Adacel to persons with an unstable or progressive neurologic disorder may result in diagnostic confusion between manifestations of the underlying illness and possible adverse effects of vaccination.

Arthus-Type Hypersensitivity

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive Adacel unless at least 10 years have elapsed since the last dose of a tetanus toxoid containing vaccine.

Altered Immunocompetence

If Adacel vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See DRUG INTERACTIONS.]

Syncope

Syncope (fainting) can occur in association with administration of injectable vaccines, including Adacel. Procedures should be in place to prevent falling injury and manage syncopal reactions.

REFERENCES

1 Stratton KR, et al, editors. Adverse events associated with childhood vaccines; evidence bearing on causality. Washington: National Academy Press; 1994. p. 67-117.

Use In Specific Populations

Pregnancy

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.

Registry of Receipt of Adacel Vaccine During Pregnancy

Sanofi Pasteur Inc. maintains a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with Adacel vaccine during pregnancy. Women who receive Adacel vaccine during pregnancy are encouraged to contact directly or have their health-care professional contact Sanofi Pasteur Inc. at 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 approved for individuals less than 10 years of age. Safety and effectiveness of Adacel vaccine in persons less than 10 years of age have not been established.

Geriatric Use

Adacel vaccine is not approved for use in individuals 65 years of age and older. In a clinical study, individuals 65 years of age and older received a single dose of Adacel vaccine. Based on pre-specified criteria, persons 65 years of age and older who received a dose of Adacel vaccine had lower geometric mean concentrations of antibodies to PT, PRN and FIM when compared to infants who had received a primary series of DAPTACEL® , Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP).

Last reviewed on RxList: 10/6/2014
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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