Can Tetanus Result From a Rabies Exposure?

Important Safety Information for HyperRAB^® (rabies immune globulin [human])

Indication and Usage
HYPERRAB^® (rabies immune globulin [human]) is indicated for postexposure prophylaxis, along with rabies vaccine, for all persons suspected of exposure to rabies.

Limitations of Use
Persons who have been previously immunized with rabies vaccine and have a confirmed adequate rabies antibody titer should receive only vaccine. For unvaccinated persons, the combination of HYPERRAB and vaccine is recommended for both bite and nonbite exposures regardless of the time interval between exposure and initiation of postexposure prophylaxis. Beyond 7 days (after the first vaccine dose), HYPERRAB is not indicated since an antibody response to vaccine is presumed to have occurred.

Important Safety Information

For infiltration and intramuscular use only.

Severe hypersensitivity reactions may occur with HYPERRAB. Patients with a history of prior systemic allergic reactions to human immunoglobulin preparations are at a greater risk of developing severe hypersensitivity and anaphylactic reactions. Have epinephrine available for treatment of acute allergic symptoms, should they occur.

HYPERRAB is made from human blood and may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

The most common adverse reactions in >5% of subjects during clinical trials were injection-site pain, headache, injection-site nodule, abdominal pain, diarrhea, flatulence, nasal congestion, and oropharyngeal pain.

Do not administer repeated doses of HYPERRAB once vaccine treatment has been initiated as this could prevent the full expression of active immunity expected from the rabies vaccine.

Other antibodies in the HYPERRAB preparation may interfere with the response to live vaccines such as measles, mumps, polio, or rubella. Defer immunization with live vaccines for 4 months after HYPERRAB administration.

Please see full Prescribing Information for HYPERRAB.

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

Important Safety Information for HyperTET^® (tetanus immune globulin [human])

HyperTET^® (tetanus immune globulin [human]) is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain.

HyperTET 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 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 (eg, MMR) should be deferred for approximately 3 months after tetanus immune globulin (human) administration.

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

Please see HyperTET full Prescribing Information for complete prescribing details.

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

Important Safety Information for TdVax™ (tetanus and diphtheria toxoids adsorbed)

TDVAX™ (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).