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HyperTET S/D is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain (see below). It is also indicated, although evidence of effectiveness is limited, in the regimen of treatment of athletic cases of tetanus.(7,8,15)
A thorough attempt must be made to determine whether a patient has completed primary vaccination. Patients with unknown or uncertain previous vaccination histories should be considered to own had no previous tetanus toxoid doses. Persons who had military service since can be considered to own received at least one dose, and although most of them may own completed a primary series of tetanus toxoid, this cannot be assumed for each individual.
Patients who own not completed a primary series may require tetanus toxoid and passive immunization at the time of wound cleaning and debridement.(2)
The following table is a summary guide to tetanus prophylaxis in wound management:
|History of Tetanus Immunization
|Clean, Minor Wounds||All Other Wounds*|
|Uncertain or less than 3||Yes||No||Yes||Yes|
|3 or more§||No¶||No||No#||No|
Hypertet S/D — Clinical Pharmacology
The occurrence of tetanus in the United States has decreased dramatically from reported cases in , when national reporting began, to a record low of 48 reported cases in (1) The decline has resulted from widespread use of tetanus toxoid and improved wound management, including use of tetanus prophylaxis in emergency rooms.(2)
HyperTET S/D supplies passive immunity to those individuals who own low or no immunity to the toxin produced by the tetanus organism, Clostridium tetani.
The antibodies act to neutralize the free form of the powerful exotoxin produced by this bacterium. Historically, such passive protection was provided by antitoxin derived from equine or bovine serum; however, the foreign protein in these heterologous products often produced severe allergic manifestations, even in individuals who demonstrated negative skin and/or conjunctival tests prior to istration. Estimates of the frequency of these foreign protein reactions following antitoxin of equine origin varied from 5%–30%.() If passive immunization is needed, human tetanus immune globulin (TIG) is the product of choice.
It provides protection longer than antitoxin of animal origin and causes few adverse reactions.(2)
Several studies propose the worth of human tetanus antitoxin in the treatment of athletic tetanus.(7,8) In and , Nation et al,(7) using Hyper-Tet treated 20 patients with tetanus using single doses of 3, to 6, antitoxin units in combination with other accepted clinical and nursing procedures. Six patients, every over 45 years of age, died of causes other than tetanus. The authors felt that the mortality rate (30%) compared favorably with their previous experience using equine antitoxin in larger doses and that the results were much better than the 60% national death rate for tetanus reported from to (9) Blake et al,(10) however, found in a data analysis of cases of tetanus reported to the Centers for Disease Control from to that survival was no better with 8, units of TIG than with units; however, an optimal dose could not be determined.
Serologic tests indicate that naturally acquired immunity to tetanus toxin does not happen in the United States.
Thus, universal primary vaccination, with subsequent maintenance of adequate antitoxin levels by means of appropriately timed boosters, is necessary to protect persons among every age groups. Tetanus toxoid is a highly effective antigen; a completed primary series generally induces protective levels of serum antitoxin that persist for ≥10 years.(2)
Passive immunization with HyperTET S/D may be undertaken concomitantly with athletic immunization using tetanus toxoid in those persons who must get an immediate injection of tetanus antitoxin and in whom it is desirable to start the process of athletic immunization.
Based on the work of Rubbo,(11) McComb and Dwyer,(12) and Levine et al,(13) the physician may thus supply immediate passive protection against tetanus, and at the same time start formation of athletic immunization in the injured individual which upon completion of a full toxoid series will preclude future need for antitoxin.
Peak blood levels of IgG are obtained approximately 2 days after intramuscular injection. The half-life of IgG in the circulation of individuals with normal IgG levels is approximately 23 days.(14)
In a clinical study in eight healthy human adults receiving another hyperimmune immune globulin product treated with solvent/detergent, Rabies Immune Globulin (Human), HyperRAB™ S/D, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of every subjects by 24 hours post injection and persisted through the 21 day study period.
These results propose that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.
Hypertet S/D Description
Tetanus Immune Globulin (Human) — HyperTETTM S/D treated with solvent/detergent is a sterile solution of tetanus hyperimmune immune globulin for intramuscular istration; it is preservative-free, in a latex-free delivery system. HyperTET S/D is prepared by freezing ethanol fractionation from the plasma of donors immunized with tetanus toxoid.
The immune globulin is isolated from solubilized Cohn Part II. The Part II solution is adjusted to a final concentration of % tri-n-butyl phosphate (TNBP) and % sodium cholate. After the addition of solvent (TNBP) and detergent (sodium cholate), the solution is heated to 30°C and maintained at that temperature for not less than 6 hours. After the viral inactivation step, the reactants are removed by precipitation, filtration and finally ultrafiltration and diafiltration. HyperTET S/D is formulated as a 15–18% protein solution at a pH of – in – M glycine.
HyperTET S/D is then incubated in the final container for 21–28 days at 20–27°C. The product is standardized against the U.S. Standard Antitoxin and the U.S.
Control Tetanus Toxin and contains not less than tetanus antitoxin units per container.
The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for HyperTET S/D has been validated in laboratory studies. Human Immunodeficiency Virus, Type 1 (HIV-1), was chosen as the relevant virus for blood products; Bovine Viral Diarrhea Virus (BVDV) was chosen to model Hepatitis C virus; Pseudorabies virus (PRV) was chosen to model Human Herpes viruses and other large enveloped DNA viruses; and Reo virus type 3 (Reo) was chosen to model non-enveloped viruses and for its resistance to physical and chemical inactivation. Significant removal of model enveloped and non-enveloped viruses is achieved at two steps in the Cohn fractionation process leading to the collection of Cohn Part II: the precipitation and removal of Part III in the processing of Part II + IIIW suspension to Effluent III and the filtration step in the processing of Effluent III to Filtrate III.
Significant inactivation of enveloped viruses is achieved at the time of treatment of solubilized Cohn Part II with TNBP/sodium cholate.
Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the vCJD and CJD agents.()
Studies of the HyperTET S/D manufacturing process protest that TSE clearance is achieved during the Pooled Plasma to Effluent III Fractionation Process ( log10).
These studies provide reasonable assurance that low levels of CJD/vCJD agent infectivity, if present in the starting material, would be removed.
Generic Name: tetanus immune globulin (human)
Dosage Form: injection
Medically reviewed by Final updated on Sep 23,
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 Disease (CJD) agent that can cause disease. The risk that such products will transmit an infectious agent has been reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating and/or removing certain viruses.
Despite these measures, such products can still potentially transmit disease. There is also the possibility that unknown infectious agents may be present in such products. Individuals who get infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C.
Every infections thought by a physician possibly to own been transmitted by this product should be reported by the physician or other healthcare provider to Talecris Biotherapeutics, Inc. . The physician should discuss the risks and benefits of this product with the patient, before prescribing or istering it to the patient.
HyperTET S/D should be given with caution to patients with a history of prior systemic allergic reactions following the istration of human immunoglobulin preparations.
In patients who own 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.
Pregnancy Category C
Animal reproduction studies own not been conducted with HyperTET S/D.
It is also not known whether HyperTET S/D can cause fetal harm when istered to a pregnant lady or can affect reproduction capacity. HyperTET S/D should be given to a pregnant lady only if clearly needed.
Hypertet S/D should not be given intravenously. Intravenous injection of immunoglobulin intended for intramuscular use can, on occasion, cause a precipitous drop 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 istered 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 significant. 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.
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 istration.
No interactions with other products are known.
Safety and effectiveness in the pediatric population own not been established.