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Tetanus Immune Globulin (Human) — BayTet® (tetanus immune globulin human solvent/detergent treated 250 units) treated with solvent/detergent is a sterile solution of tetanus hyperimmune immune globulin for intramuscular administration; it contains no preservative. BayTet (tetanus immune globulin human solvent/detergent treated 250 units) is prepared by cold ethanol fractionation from the plasma of donors immunized with tetanus toxoid. The immune globulin is isolated from solubilized Cohn Fraction II. The Fraction II solution is adjusted to a final concentration of 0.3% tri-n-butyl phosphate (TNBP) and 0.2% 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. BayTet (tetanus immune globulin human solvent/detergent treated 250 units) is formulated as a 15–18% protein solution at a pH of 6.4–7.2 in 0.21–0.32 M glycine. BayTet (tetanus immune globulin human solvent/detergent treated 250 units) 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 250 tetanus antitoxin units per container.
The removal and inactivation of spiked model enveloped and non-enveloped viruses during the manufacturing process for BayTet 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 Hepatitis B virus and the Herpes 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 Fraction II: the precipitation and removal of Fraction III in the processing of Fraction 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 Fraction II with TNBP/sodium cholate.
BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) 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 active 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 have had no previous tetanus toxoid doses. Persons who had military service since 1941 can be considered to have received at least one dose, and although most of them may have completed a primary series of tetanus toxoid, this cannot be assumed for each individual. Patients who have 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:
Guide to Tetanus Prophylaxis in Wound Management2
|History of Tetanus Immunization (Doses)||Clean, Minor||Wounds||All Other||Wounds*|
|Uncertain or less than 3||Yes||No||Yes||Yes|
|3 or more§||No||||No||No¶||No|
|* Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns and frostbite. |
† Adult type tetanus and diphtheria toxoids. If the patient is less than 7 years old, DT or DTP is preferred to tetanus toxoid alone. For persons ≥ 7 years of age, Td is preferred to tetanus toxoid alone. (see DOSAGE AND ADMINISTRATION)
‡ Tetanus Immune Globulin (Human). §If only three doses of fluid tetanus toxoid have been received, a fourth dose of toxoid, preferably an adsorbed toxoid, should be given.
|| Yes if more than 10 years since the last dose.
¶ Yes if more than 5 years since the last dose. (More frequent boosters are not needed and can accentuate side effects).
BayTet is made from human plasma. Products made from human plasma may contain infectious agents, such as viruses, 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 receive infusions of blood or plasma products may develop signs and/or symptoms of some viral infections, particularly hepatitis C. ALL infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Bayer Corporation [1-800-288-8371].
The physician should discuss the risks and benefits of this product with the patient, before prescribing or administering it to the patient.
BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) 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, BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) should be given only if the expected benefits outweigh the risks.
The occurrence of tetanus in the United States has decreased dramatically from 560 reported cases in 1947, when national reporting began, to a record low of 48 reported cases in 1987.1 The decline has resulted from widespread use of tetanus toxoid and improved wound management, including use of tetanus prophylaxis in emergency rooms.2
BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) supplies passive immunity to those individuals who have 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 administration. Estimates of the frequency of these foreign protein reactions following antitoxin of equine origin varied from 5%–30%.3-6 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 suggest the value of human tetanus antitoxin in the treatment of active tetanus.7,8 In 1961 and 1962, Nation et al,7 using Hyper-Tet treated 20 patients with tetanus using single doses of 3,000 to 6,000 antitoxin units in combination with other accepted clinical and nursing procedures. Six patients, all 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 1951 to 1954.9 Blake et al,10 however, found in a data analysis of 545 cases of tetanus reported to the Centers for Disease Control from 1965 to 1971 that survival was no better with 8,000 units of TIG than with 500 units; however, an optimal dose could not be determined.
Serologic tests indicate that naturally acquired immunity to tetanus toxin does not occur 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 all 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 BayTet (tetanus immune globulin (human) solvent/detergent treated 250 units) may be undertaken concomitantly with active immunization using tetanus toxoid in those persons who must receive an immediate injection of tetanus antitoxin and in whom it is desirable to begin the process of active 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 begin formation of active 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), BayRab®, prepared by the same manufacturing process, detectable passive antibody titers were observed in the serum of all subjects by 24 hours post injection and persisted through the 21 day study period. These results suggest that passive immunization with immune globulin products is not affected by the solvent/detergent treatment.
1. Tetanus — United States, 1987 and 1988, MMWR 39(3): 37-41, 1990.
2. Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures. Recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 40 (RR-10): 1-28, 1991.
3. Moynihan NH: Tetanus prophylaxis and serum sensitivity tests. Br Med J 1:260-4, 1956.
4. Scheibel I: The uses and results of active tetanus immunization. Bull WHO 13:381-94, 1955.
5. Edsall G: Specific prophylaxis of tetanus. JAMA 171(4):417-27, 1959.
6. Bardenwerper HW: Serum neuritis from tetanus antitoxin. JAMA 179(10):763-6, 1962.
7. Nation NS, Pierce NF, Adler SJ, et al: Tetanus: the use of human hyperimmune globulin in treatment. Calif Med 98(6):305-6, 1963.
8. Ellis M: Human antitetanus serum in the treatment of tetanus. Br Med J 1(5338):1123-6, 1963.
9. Axnick NW, Alexander ER: Tetanus in the United States: A review of the problem. Am J Public Health 47(12):1493-1501, 1957.
10. Blake PA, Feldman RA, Buchanan TM, et al: Serologic therapy of tetanus in the United States, 1965-1971. JAMA 235(1):42-4, 1976.
11. Rubbo SD: New approaches to tetanus prophylaxis. Lancet 2(7461):449-53, 1966.
12. McComb JA, Dwyer RC: Passive-active immunization with tetanus immune globulin (human). N Engl J Med 268(16):857-62, 1963.
13. Levine L, McComb JA, Dwyer RC, et al: Active-passive tetanus immunization; choice of toxoid, dose of tetanus immune globulin and timing of injections. N Engl J Med 274(4):186-90, 1966.
14. Waldmann TA, Strober W, Blaese RM: Variations in the metabolism of immunoglobulins measured by turnover rates. In Merler E (ed.): Immunoglobulins: biologic aspects and clinical uses. Washington, DC, Nat Acad Sci, 1970, p. 33-51.
Commonly used brand name(s)
In the U.S.
- HyperTET S/D
Available Dosage Forms:
Therapeutic Class: Immune Serum
For Healthcare Professionals
Applies to tetanus immune globulin: intramuscular solution
Local side effects have included soreness, pain, and tenderness at the injection site.[Ref]
Renal side effects have included rare cases of nephrotic syndrome.[Ref]
Hypersensitivity reactions have included rare cases of angioneurotic edema and anaphylactic shock.[Ref]
Other side effects have included slight temperature elevation.[Ref]
Some side effects of BayTet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Tetanus immune globulin Pregnancy Warnings
Tetanus immune globulin (TIG) has been assigned to pregnancy category C by the FDA. Animal studies have not been reported. There are no controlled data in human pregnancy. TIG should only be given during pregnancy if clearly needed. TIG is recommended for postexposure prophylaxis during pregnancy by the American College of Obstetricians and Gynecologists.
Tetanus immune globulin Breastfeeding Warnings
There are no data on the excretion of tetanus immune globulin into human milk.