HyperTET S / D

• Bayer Corp., Biological Div.

• Grifols Therapeutics, Inc.

Specific immune globulin (hyperimmune globulin).104 106 Tetanus immune globulin (TIG) contains tetanus antitoxin and is used to provide temporary passive immunity to tetanus.104 106 110 111 TIG commercially available in the US is prepared from plasma of donors immunized with tetanus toxoid.104 Other tetanus antitoxin preparations (e.g., equine tetanus antitoxin) may be available in other countries.101

Elimination

Half-life

Approximately 28 days.a

• Advise patient and/or patient's parent or guardian of the risks and benefits of TIG.104

• Advise patient and/or patient's parent or guardian that TIG is only one component of a postexposure regimen used to prevent tetanus in unvaccinated or incompletely vaccinated individuals with a tetanus-prone wound.104 Importance of completing active immunization with a preparation containing tetanus toxoid adsorbed as soon as possible.101 104 110

• Importance of informing clinicians if any adverse reactions (e.g., hypersensitivity reactions) occur.104

• Advise patient and/or patient's parent or guardian that HyperTET S/D is prepared from pooled human plasma.104 Although improved donor screening and viral-inactivating and purification procedures used in manufacture of plasma-derived preparations have reduced the risk of pathogen transmission, TIG is a potential vehicle for transmission of human viruses, including the causative agents of viral hepatitis and HIV infection, and theoretically may carry a risk of transmitting the causative agent of CJD or vCJD.104

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.104

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breastfeed.104

• Importance of informing patients of other important precautionary information. (See Cautions.) 104

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

This section provides information on the proper use of a number of products that contain tetanus immune globulin. It may not be specific to HyperTET S/D. Please read with care.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For preventing tetanus infection:
    • Adults and children—250 units injected into a muscle.

General

Hypertet S/D should not be given intravenously. Intravenous injection of immunoglobulin intended for intramuscular use can, on occasion, cause a precipitous fall in blood pressure, and a picture not unlike anaphylaxis. Injections should only be made intramuscularly and care should be taken to draw back on the plunger of the syringe before injection in order to be certain that the needle is not in a blood vessel. Intramuscular injections are preferably administered in the deltoid muscle of the upper arm or lateral thigh muscle. The gluteal region should not be used as an injection site because of the risk of injury to the sciatic nerve.(16)

Chemoprophylaxis against tetanus is neither practical nor useful in managing wounds. Wound cleaning, debridement when indicated, and proper immunization are important. The need for tetanus toxoid (active immunization), with or without TIG (passive immunization), depends on both the condition of the wound and the patient's vaccination history. Rarely has tetanus occurred among persons with documentation of having received a primary series of toxoid injections.(2) See table under INDICATIONS AND USAGE.

Skin tests should not be done. The intradermal injection of concentrated IgG solutions often causes a localized area of inflammation which can be misinterpreted as a positive allergic reaction. In actuality, this does not represent an allergy; rather, it is localized tissue irritation. Misinterpretation of the results of such tests can lead the physician to withhold needed human antitoxin from a patient who is not actually allergic to this material. True allergic responses to human IgG given in the prescribed intramuscular manner are rare.

Although systemic reactions to human immunoglobulin preparations are rare, epinephrine should be available for treatment of acute anaphylactic reactions.

Drug Interactions

Antibodies in immunoglobulin preparations may interfere with the response to live viral vaccines such as measles, mumps, polio, and rubella. Therefore, use of such vaccines should be deferred until approximately 3 months after Tetanus Immune Globulin (Human) HyperTETTM S/D administration.

No interactions with other products are known.

Pregnancy Category C

Animal reproduction studies have not been conducted with HyperTET S/D. It is also not known whether HyperTET S/D can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HyperTET S/D should be given to a pregnant woman only if clearly needed.

Pediatric Use

Safety and effectiveness in the pediatric population have not been established.

Although no data are available, clinical experience with other immunoglobulin preparations suggests that the only manifestations would be pain and tenderness at the injection site.

Store at 2–8°C (36–46°F). Solution that has been frozen should not be used.