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TDVAXTM (tetanus and diphtheria toxoids adsorbed) is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria. This vaccine is approved for use in persons 7 years of age and older.

A severe allergic reaction (eg, anaphylaxis) occurring after a previous dose of this vaccine, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine is a contraindication to administration. Because of the uncertainty as to which component of the vaccine might be responsible, no further vaccination with diphtheria or tetanus components should be carried out. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.

More frequent administration than described in the product insert may be associated with an 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 Td more frequently than every 10 years, even for tetanus prophylaxis as part of wound management.

A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and Guillain-Barré syndrome. If Guillain-Barré syndrome occurred within 6 weeks after receipt of a previous dose of tetanus toxoid-containing vaccine, the decision to give subsequent doses of TDVAX or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

Vaccination with TDVAX may not protect all individuals.

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

Prior to the administration of TDVAX, the vaccine recipient's current health status and health history should be reviewed, including immunization history, presence of any contraindications to immunization, and any adverse events after previous immunizations.

If TDVAX is administered to immunocompromised persons (whether from disease or treatment) the expected immune response may not be obtained.

Prior to administration of TDVAX, healthcare providers should inform patients, parents, or guardians of the benefits and risks of immunization with Td; the importance of completing the primary immunization series or receiving recommended booster doses; the potential for adverse reactions associated with TDVAX or other vaccines containing similar ingredients; and to report any suspected adverse reactions to the healthcare provider.

Patients who are on immunosuppressive therapy, including alkylating agents, antimetabolites, cytotoxic drugs, irradiation, or corticosteroids (used in greater than physiologic doses), may have a reduced immune response to vaccines.

No safety and immunogenicity data are available on the concomitant administration of TDVAX vaccine with other US licensed vaccines.

Data on adverse reactions following fluid and adsorbed preparations of TDVAX with various doses of the diphtheria and tetanus components have been reported in a series of studies.

The following adverse events have been identified during post-approval use of TDVAX and are included because of seriousness or frequency of reporting: Injection-site reactions, including pain, tenderness, erythema, induration, pruritus, swelling, and warmth; peripheral oedema; pyrexia; malaise; dizziness; headache; convulsions; myalgia; musculoskeletal stiffness or pain; arthralgia; rash; nausea; and cellulitis.

To report SUSPECTED ADVERSE REACTIONS, contact MassBiologics at 1-800-457-4626 or Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967 or www.vaers.hhs.gov.

Please see full Prescribing Information for TDVAX (tetanus and diphtheria toxoids adsorbed).