ASKING THE RIGHT QUESTIONS CAN TELL YOU WHICH TETANUS VACCINE YOUR PATIENT NEEDS

Td MAY BE ALL THEY NEED

IMPORTANT SAFETY INFORMATION

Tetanus Diphtheria Toxoids Adsorbed (Td)

MassBiologics' Tetanus and Diphtheria Toxoids Adsorbed (Td) 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.

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 this Td vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.

Vaccination with MassBiologics' Td 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 MassBiologics' Td, the vaccine recipient's current health status and health history should be reviewed. This includes a review of the immunization history of the patient, the presence of any contraindications to immunization, and any adverse events after previous immunizations to allow an assessment of the benefits and risks of vaccination.

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

Prior to administration of MassBiologics' Td, patients, parents, or guardians should be informed by the health care provider of the benefits and risks of immunization with Td and of the importance of completing the primary immunization series or receiving recommended booster doses.

The health care provider should inform the patient, parent, or guardian of the potential for adverse reactions that have been temporally associated with MassBiologics' Td or other vaccines containing similar ingredients. Patients, parents, or guardians should be instructed to report any suspected adverse reactions to their health care 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 MassBiologics' Td vaccine with other U.S. licensed vaccines.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. However, the adverse reaction information from clinical trials provides a basis for identifying adverse events that appear to be related to vaccine use and for approximating rates. Data on adverse reactions following fluid and adsorbed preparations of MassBiologics' Td 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 MassBiologics' Td. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to vaccination. The following adverse events were included because of seriousness or frequency of reporting:

General Disorders and Administration Site Conditions: Injection site reactions, including pain, tenderness, erythema, induration, pruritis, swelling and warmth; peripheral oedema, pyrexia, malaise

Nervous System Disorders: Dizziness, headache, convulsions

Musculoskeletal and Connective Tissue Disorders: Myalgia, musculoskeletal stiffness or pain, arthralgia

Skin and Subcutaneous Tissue Disorders: Rash

Gastrointestinal Disorders: Nausea

Infections and Infestations: 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 accompanying Tetanus and Diphtheria Toxoids Adsorbed (Td) full Prescribing Information for complete prescribing details.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

HyperTET® S/D (tetanus immune globulin [human])

HyperTET S/D is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain.

HyperTET S/D should be given with caution to patients with a history of prior systemic allergic reactions following the administration of human immunoglobulin preparations.

In patients who have severe thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injections, HyperTET S/D should be given only if the expected benefits outweigh the risks.

Slight soreness at the site of injection and slight temperature elevation may be noted at times. Sensitization to repeated injections of human immunoglobulin is extremely rare. In the course of routine injections of large numbers of persons with immunoglobulin, there have been a few isolated occurrences of angioneurotic edema, nephrotic syndrome, and anaphylactic shock after injection. Administration of live virus vaccines (e.g., MMR) should be deferred for approximately 3 months after Tetanus Immune Globulin (Human) administration.

HyperTET S/D is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses and theoretically, the Creutzfeldt-Jakob (CJD) agent that can cause disease. There is also the possibility that unknown infectious agents may be present in such products.

Please see accompanying full Prescribing Information for HyperTET S/D for complete prescribing details.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch, or call 1-800-FDA-1088.