Indicated for active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use as a single dose in persons 10 through 64 years of age.

There are no data to support repeat administration of Adacel vaccine.

Five years should have elapsed since the recipient’s last dose of tetanus toxoid, diphtheria toxoid and/or pertussis containing vaccine and the administration of Adacel vaccine.

The safety and effectiveness of Adacel vaccine used as a primary series or to complete the primary series, for diphtheria, tetanus, or pertussis has not been demonstrated.

If tetanus prophylaxis is needed for wound management, Adacel may be given if no previous dose of any Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) has been administered.

Encephalopathy (eg, coma, prolonged seizures, or decreased level of consciousness) within 7 days of a previous dose of a pertussis containing vaccine not attributable to another identifiable cause is a contraindication to administration of any pertussis containing vaccine, including Adacel vaccine.

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

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.

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.

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

When Adacel vaccine was administered concomitantly with trivalent inactivated influenza vaccine (TIV) to adults 19-64 years of age, a lower antibody response was observed for pertactin antigen as compared to Adacel vaccine administered alone.

Immunosuppressive therapies may reduce the immune response to Adacel.

Safety and effectiveness of Adacel vaccine have not been established in pregnant women.

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.

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• Use in patients under the age of 10 and over the age of 64. GoToSource

Syncope (sudden loss of consciousness). GoToSource  

Anaphylaxis, encephalopathy (brain disease), arthralgia (joint pain), fever, guillain-barré syndrome (immune system attacks nerves) and arthus reaction (severe pain, swelling, induration, edema, hemorrhage and local necrosis). GoToSource

Claims filed for transverse myelitis and guillain-barré syndrome.