Tetanus Immune Globulin

250 units/mL (1ml), pre-filled syringes (IM)

Emergency Medicine Executive Summary

(Extended Version, Updated June 2021)


Tetanus Immune Globulin (TIG) is indicated for tetanus disease treatment and prophylaxis (the latter in individuals without updated or an unknown tetanus immunization who have suffered a contaminated or a tetanus-prone wound).

Adult dose:

  • Tetanus treatment:
    500 units IM with part of the dose infiltrated close to the source wound. Up to 6000 units can be used.

  • Tetanus prophylaxis:
    250 units IM (single dose).

Mechanism of Action and Dosage

TIG consists of human antibodies derived from healthy donors used for the treatment of tetanus disease and tetanus prophylaxis. It provides passive immunity towards tetanus by neutralizing unbound toxins produced by Clostridium tetani (tetanus toxin or tetanospasmin). It improves survival and is considered to be standard treatment.

Tetanus Prophylaxis Scheme (1):

  • Unknown or <3 previous doses

    • Dirty, tetanus-prone wound*:

      • Give Tetanus and diphtheria (Td) toxoids adsorbed

      • Give Tetanus immune globulin

    • Clean, not tetanus-prone wound:

      • Give Tetanus and diphtheria (Td) toxoids adsorbed, no TIG.

  • 3 or more previous doses

    • Dirty, tetanus-prone wound*:

      • Give Td only if >5 years since last booster, no TIG

    • Clean, not tetanus-prone wound:

      • Give Td only if >10 years since last booster, no TIG

*Tetanus-prone wounds: >6 hours, >1cm depth, high risk of contamination due to the mechanism of injury (missile, crush, burn, frostbite, agriculture-related injuries), presence of devitalized tissue, presence of contaminants (dirt, saliva, etc).

Adult dose

  • Tetanus treatment: 500 units IM.

The actual recommended dose is 500 units IM with part of the dose infiltrated around the source wound (1; CDC 2020). Classically the suggested dose of 3000-6000 units IM, with part of the dose infiltrated around the wound, derived from limited data from 1960-1980s studies (3; Nation 1965). HyperTET® 2020 label for active tetanus refers that the “dosage should be adjusted according to the severity of the infection” (4).

  • Tetanus prophylaxis: 250 units IM*.

*FDA Approval in 1957 (7).

Pediatric dose

  • Tetanus Prophylaxis:

<7 years: 4 units/kg IM.

>7 years: 250 units IM.

  • Tetanus Treatment: 500 units IM recommended (1; CDC 2020). Very limited data.

Renal, hepatic, geriatric or other adjustments

No adjustments needed.

Dosage Forms

  • US - HyperTET®: 250 units/mL (1ml), injectable, only intramuscular administration.

  • Chile - Ingantet®: 250 units/mL (1ml), injectable, only intramuscular administration.

Contraindications, Adverse effects, Warnings and Major Drug Interactions

  • Contraindications
    Use with caution in individuals who have experienced allergic or other adverse effects secondary to other immunoglobulin-containing products.

  • Adverse Effects

Frequency not defined:

  • Increased body temperature.

  • Local soreness at injection site, pain at injection site, tenderness at injection site

<1%, postmarketing, and/or case reports: Anaphylactic shock, angioedema, nephrotic syndrome.

  • Warnings

Product of human plasma, may potentially contain infectious agents which could transmit disease. Screening of donors, as well as testing and/or inactivation or removal of certain viruses, reduces the risk.

  • Major drug interactions:

Monitor closely the administration of live vaccines: adenovirus type 4 and 7, BCG, measles (rubeola), measles-mumps-rubella, measles-mumps-rubella-varicella, varicella virus, rubella, smallpox. As tetanus immune globulin decreases their effect. Separate any by 3 months (4).

Pregnancy and Lactation

  • Pregnancy Risk Factor Category C.
    Animal reproduction and human pregnancy studies have not been conducted. The CDC recommends Tetanus Immune Globulin and tetanus toxoid-containing vaccine as part of the standard wound management to prevent tetanus in pregnant women.

  • Lactation: very low risk, safe. Minimal risk for breastfeeding and infant. The secretion of immunoglobulin into breast milk may help to transfer passive immunization to the child.

Pharmacology

  • Half-life elimination: individuals with normal IgG concentration: ~23 days

  • Time to peak, plasma: IgG concentration: IM: ~2 days

References

  1. Centers for Disease Control and Prevention (CDC), Epidemiology and Prevention of Vaccine-Preventable Diseases. Tejpratap S.P. Tiwari, MD; Pedro L. Moro, MD, MPH; and Anna M. Acosta, MD. Chapter 21: Tetanus. Updated December 2020.
    CDC

  2. Yen LM, Thwaites CL. Tetanus. Lancet. 2019;393(10181):1657-1668. doi:10.1016/S0140-6736(18)33131-3.
    Pubmed

  3. Nation NS, Pierce NF, Adler SJ, Chinnock RF, Wehrle PF. Tetanus; The Use Of Human Hyperimmune Globulin In Treatment. Calif Med. 1963;98(6):305-307.
    Pubmed

  1. NIH - NLM (National Institutes of Health National Library of Medicine). DailyMed. Label: HyperTET® (Tetanus Immune Globuline - human injection), updated December 2020.
    DailyMed

  2. WHO/UNICEF. Breastfeeding and Maternal Medication Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development, 2002.
    WHO

  3. ACEP (American College of Emergency Physicians), ED Vaccinations, Tetanus. Visited in August 2021.
    ACEP

  4. US-FDA (United States Food and Drug Administration). Purple Book Database of Licenced Biological Products. Baytet, Hypertet. Visited in September 2021.
    US-FDA

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