Tetanus immune globulin (TIG), human, is a parenteral preparation of immunoglobulins prepared from plasma of adults hyperimmunized with tetanus toxoid. TIG contains tetanus antibodies that neutralize the exotoxin produced by Clostridium tetani, thereby providing passive immunity to tetanus toxin. Tetanus immune globulin (TIG) is used primarily for prophylaxis of tetanus infection in patients with traumatic injuries. Patients who have not completed a primary vaccination series with tetanus toxoid may require both tetanus toxoid and passive immunization with TIG at the time of wound cleansing and debridement. Previously, tetanus antitoxin derived from either horse or bovine was used to provide passive immunity against tetanus. Human TIG is now the agent of choice when passive immunization against tetanus is required. Human TIG provides longer protection and induces fewer severe allergic reactions than the animal-derived tetanus antitoxins. TIG undergoes solvent and detergent treatment to inactivate blood borne virus such as HIV, hepatitis B, and hepatitis C. TIG is indicated for prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain. Passive immunization with TIG may be given concurrently with tetanus toxoid in patients who must receive immediate protection against tetanus and in whom concomitant active immunization is desired. TIG is also indicated for the active treatment of tetanus infection, although efficacy data supporting this indication are limited. The FDA originally approved tetanus immune globulin in October 1957.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Intramuscular Administration:
-Tetanus immune globulin is administered intramuscularly only. Do not administer intravenously.
-Tetanus immune globulin should not be given in the same syringe or injected at the same site as tetanus toxoid.
-Tetanus immune globulin does not contain preservatives.
Intramuscular injection:
-Draw back on the syringe prior to injection to ensure the needle is not in a blood vessel. If a vessel is penetrated, withdraw the needle and use a new syringe and needle at a different injection site.
-The gluteal region should not be routinely used as on injection site due to the risk of damage to the sciatic nerve. If the gluteal region is used, only the upper outer quadrant should be used; avoid the central region.
-In adults and children: Intramuscular injections should be made into the deltoid muscle or into the anterolateral muscles of the thigh. The upper outer quadrant of the gluteus maximus should be used only if large volumes are administered or when large doses must be divided into multiple IM injections.
-In neonates, infants, and small children: Intramuscular injections should be made into the anterolateral muscles of the thigh.
An injection site reaction consisting of soreness at the injection site may be noted after administration of tetanus immune globulin, human, TIG. A slight fever may also be noted. Hypersensitivity reactions to repeated administration of immune globulin products is rare. A few isolated occurrences of angioneurotic edema (angioedema), nephrotic syndrome, and anaphylactic shock have been noted after immunoglobulin administration to large numbers of patients. Although systemic reactions to human immunoglobulin preparations are rare, have epinephrine available for the treatment of acute anaphylactic reactions.
Tetanus immune globulin, human, TIG is made from human plasma and, thus, could be a source of viral transmission. For example, theoretically, Creutzfeld-Jakob disease (CJD) could be transmitted. The risk of infectious agent transmission is reduced by screening plasma donors for prior exposure to certain viruses, by testing for the presence of certain current virus infections, and by inactivating or removing certain viruses. Despite these measures, unknown viruses may be present. Report any infection thought to be transmitted by this product by calling 1-800-520-2807.
Tetanus immune globulin (TIG) should be used cautiously in patients with a history of human immune globulin hypersensitivity.
Intravenous administration of tetanus immune globulin (TIG) is not recommended. Intravenous administration of TIG significantly increases the risk of developing an anaphylactic reaction. TIG should only be administered intramuscularly.
Patients with IgA deficiency often develop antibodies against IgA and are more likely to have anaphylactic or immune-mediated adverse reactions to pooled immunoglobulin products such as tetanus immune globulin (TIG).
As with other products derived from or purified with human blood components, the possibility of transmission of viral or bacterial infections exists in patients receiving tetanus immune globulin (TIG). Screening plasma donors for prior exposure to certain viruses, testing for the presence of viruses, and inactivating and/or reducing viruses has reduced the risk of transmission of an infectious agent. The manufacturing processes are designed to reduce the risk of transmitting viral infection; however, none of the processes are completely effective. There is also the possibility that unknown infectious agents may be present in this product.
IM injections of tetanus immune globulin (TIG) can cause injury at the injection site and should be used cautiously in patients with thrombocytopenia or coagulopathy (e.g., hemophilia).
Tetanus immune globulin (TIG) is an FDA pregnancy risk category C drug. No well-controlled studies have been conducted in pregnant women and it is unknown if TIG can cause fetal harm or affect the reproductive system. According to the Advisory Committee on Immunization Practices, administration of immune globulin preparations to pregnant women results in no known risk to the fetus.
No data are available from the manufacturer regarding use of tetanus immune globulin (TIG) during breast-feeding and it is not known if TIG is excreted in breast milk. Case reports of two nursing mothers receiving intravenous immune globulin therapy suggest transfer of IgG and IgM into the colostrum and breast milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.
The immune globulins present in tetanus immune globulin (TIG) may interfere with live virus vaccination, such as measles. Vaccinations should be delayed until 3 months after TIG administration and it may be necessary to revaccinate persons who received TIG shortly after live virus vaccination. If necessary due to imminent exposure to disease, the measles, mumps, and rubella virus vaccine live can be administered simultaneously with immune globulin preparations, however the vaccine-induced immunity may be reduced. Tetanus toxoid may be given at the same time, but at a different site.
For the treatment of tetanus:
Intramuscular dosage:
Adults: The optimal dosage has not been established. 500 units IM once appears as effective as 3,000 to 6,000 units. May adjust the dose based on the infection severity.
Infants, Children, and Adolescents 6 months to 17 years: The optimal dosage has not been established. 500 units IM once appears as effective as 3,000 to 6,000 units. May adjust the dose based on the infection severity.
Infants 1 to 5 months: The optimal dosage has not been established. 500 units IM once appears as effective as 3,000 to 6,000 units. Consider maternal tetanus toxoid immunization history at the time of delivery in determining the need for therapy. May adjust the dose based on the infection severity.
Neonates: The optimal dosage has not been established. 500 units IM once appears as effective as 3,000 to 6,000 units. Consider maternal tetanus toxoid immunization history at the time of delivery in determining the need for therapy. May adjust the dose based on the infection severity.
For postexposure tetanus prophylaxis in patients whose immunization is incomplete or uncertain:
NOTE: Tetanus immune globulin is recommended for patients with contaminated, dirty wounds when immune status is incomplete or uncertain and for persons living with HIV or severe immunodeficiency who have contaminated wounds, including minor wounds, regardless of tetanus immunization history.
Intramuscular dosage:
Adults: 250 units IM once.
Children and Adolescents 7 to 17 years: 250 units IM once.
Infants and Children 6 months to 6 years: 250 units IM once. Alternatively, 4 units/kg IM once.
Infants 1 to 5 months: 250 units IM once. Alternatively, 4 units/kg IM once.
Neonates: 250 units IM once. Alternatively, 4 units/kg IM once. Consider maternal tetanus toxoid immunization history at the time of delivery in determining the need for therapy.
Maximum Dosage Limits:
-Adults
250 units IM for prophylaxis; up to 6000 units IM has been suggested for treatment.
-Elderly
250 units IM for prophylaxis; up to 6000 units IM has been suggested for treatment.
-Adolescents
250 units IM for prophylaxis; up to 6000 units IM has been suggested for treatment.
-Children
>= 7 years: 250 units IM for prophylaxis; up to 6000 units IM has been suggested for treatment.
< 7 years: 4 units/kg IM or 250 units IM for prophylaxis; up to 6000 units IM has been suggested for treatment.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: (Major) Do not give immune globulin including varicella zoster immune globulin concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations. (Major) Do not vaccinate patients with live virus vaccines for 3 months following administration of tetanus immune globulin. TIG contains antibodies that can interact with live virus vaccines. If is necessary to administer TIG simultaneously with live vaccines, administer at different sites and revaccinate or test for sero-conversion after 3 months.
Measles/Mumps/Rubella Vaccines, MMR: (Major) Do not vaccinate patients with live virus vaccines for 3 months following administration of tetanus immune globulin. TIG contains antibodies that can interact with live virus vaccines. If is necessary to administer TIG simultaneously with live vaccines, administer at different sites and revaccinate or test for sero-conversion after 3 months.
Rotavirus Vaccine: (Major) Defer vaccination with live virus vaccines such as Rotavirus Vaccine until approximately 3 months after Tetanus immune globulin administration. Inform the immunizing physician of recent therapy with the immune globulin so that appropriate measures can be taken. The efficacy of live attenuated virus vaccines such as Rotavirus Vaccine may be impaired by Tetanus immune globulin administration; revaccination may be necessary. The passive transfer of antibodies from the immune globulin may impair the efficacy of live attenuated virus vaccines.
Varicella-Zoster Virus Vaccine, Live: (Major) Do not give immune globulin including varicella zoster immune globulin concurrently with the varicella-zoster virus vaccine, live. Because of the potential inhibition of the immune response to vaccination by passively transferred antibodies, it is advisable not to give varicella-zoster virus vaccine, live to any patient who has received blood (except washed red blood cells), plasma transfusions, or immunoglobulins within the previous 5 months. After varicella vaccination, the CDC recommends that immune globulin products should not be given for 3 weeks, unless the benefit outweighs the risk; the manufacturer recommends waiting 2 months before administering immunoglobulins. In the case that IgG products are administered within 3 weeks of vaccination, the vaccinee should be either revaccinated at 5 months or tested for immunity and revaccinated if seronegative. Consult current CDC guidelines for recommendations.
Tetanus immune globulin is a sterile solution of primarily immunoglobulin G (IgG) containing 15-18% protein. TIG is standardized against the US Standard Antitoxin and US Control Tetanus Toxin and contains not less than 250 tetanus antitoxin units per vial. The pooled monomeric IgG present in TIG provides a variety of antibodies capable of neutralizing the Clostridium tetani exotoxin by opsonization, resulting in complement activation and stimulation of cell-mediated immunity. The passive immunity imparted by TIG is capable of attenuating or preventing tetanus infection by binding free exotoxin. TIG will not reverse the effects of exotoxin already bound to nerve tissue. Passive immunization is not affected by solvent/detergent treatment.
Pharmacokinetics:
Tetanus immune globulin is administered intramuscularly. Peak IgG levels are obtained approximately 2 days after administration. The half-life of IgG in the circulation is approximately 23 days.
-Route-Specific Pharmacokinetics
Intramuscular Route
Peak IgG levels are obtained approximately 2 days after administration of tetanus immune globulin (TIG).