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Tetanus Immune Globulin (Human)

Medically reviewed by Drugs.com. Last updated on Oct 23, 2020.

Pronunciation

(TET a nus i MYUN GLOB yoo lin HYU man)

Index Terms

  • TIG

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injectable, Intramuscular:

HyperTET S/D: 250 units/mL (1 ea)

Brand Names: U.S.

  • HyperTET S/D

Pharmacologic Category

  • Blood Product Derivative
  • Immune Globulin

Pharmacology

Provides passive immunity towards tetanus by supplying antibodies to neutralize the free form of toxins produced by Clostridium tetani.

Time to Peak

Plasma: IgG concentration: IM: ~2 days

Half-Life Elimination

Individuals with normal IgG concentration: ~23 days

Use: Labeled Indications

Tetanus, prophylaxis: Prophylaxis against tetanus following injury in patients whose immunization is incomplete or uncertain

Tetanus, treatment: Treatment of active tetanus

The Advisory Committee on Immunization Practices (ACIP) recommends passive immunization with TIG for the following:

• Persons with a wound that is not clean or minor and who have received ≤2 or an unknown number of adsorbed tetanus toxoid doses (CDC 55[RR3] 2006; CDC 55[RR17] 2006).

• Persons who are wounded in bombings or similar mass casualty events if no reliable history of completed primary vaccination with tetanus exists. In case of shortage, use should be reserved for persons ≥60 years of age and immigrants from regions other than Europe or North America (CDC 57[RR6] 2008).

Contraindications

There are no contraindications listed in the manufacturer’s labeling.

Dosing: Adult

Tetanus, prophylaxis: IM: 250 units in conjunction with a tetanus toxoid-containing vaccine. Note: Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated and the immunization status of the patient. Wound management includes proper use of tetanus toxoid and/or tetanus immune globulin (TIG), wound cleaning, and (if required) surgical debridement and the proper use of antibiotics. Patients with an uncertain or incomplete tetanus immunization status should have additional follow-up to ensure a series is completed. Patients with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose even if they have a wound that is neither clean nor minor (CDC/ACIP [Liang 2018]). See table.

Tetanus Prophylaxis in Wound Management (CDC/ACIP [Liang 2018])

History of tetanus immunization doses

Clean, minor wounds

All other woundsa

Tetanus toxoidb

TIG

Tetanus toxoidb

TIG

aSuch as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite.

bTetanus toxoid in this chart refers to a tetanus toxoid-containing vaccine. For children age <7 years, DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children age ≥7 years and adults, Td is preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap or if tetanus vaccine is indicated for a pregnant woman.

cFor patients with HIV infection or severe immunodeficiency with contaminated wounds, TIG should be administered, regardless of history of tetanus immunization.

Abbreviations: DT = diphtheria and tetanus toxoids (formulation for age ≤6 years); DTaP = diphtheria and tetanus toxoids, and acellular pertussis (formulation for age ≤6 years; Daptacel, Infanrix); Td = diphtheria and tetanus toxoids (formulation for age ≥7 years; Tenivac); Tdap = diphtheria and tetanus toxoids, and acellular pertussis (Adacel or Boostrix [formulations for age ≥7 years]); TIG = tetanus immune globulin.

Uncertain or <3 doses

Yes

No

Yes

Yes

≥3 doses

Only if ≥10 years since last dose

No

Only if ≥5 years since last dose

Noc

Tetanus, treatment: IM: 3,000 to 6,000 units. Infiltration of part of the dose around the wound is recommended (CDC 2015a). Some experts recommend a lower 500 unit dose which appears to be as effective as higher doses and may cause less discomfort (CDC 2015a; WHO 2010).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Prophylaxis of tetanus:

Infants and Children <7 years: I.M.: 250 units regardless of weight or age (Red Book [AAP 2012); may also calculate 4 units/kg; however, most experts recommend using full vial dose.

Children ≥7 years and Adolescents: IM: 250 units as a single dose; may be increased to 500 units if there has been a delay in initiating prophylaxis or when the wound is considered very tetanus prone

Tetanus prophylaxis in wound management (CDC/ACIP [Broder 2006]): Infants, Children, and Adolescents: IM: Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated and the immunization status of the patient. Wound management includes proper use of tetanus toxoid and/or tetanus immune globulin (TIG), wound cleaning, and (if required) surgical debridement and the proper use of antibiotics. Patients with an uncertain or incomplete tetanus immunization status should have additional follow-up to ensure a series is completed. Patients with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose even if they have a wound that is neither clean nor minor. See table.

Tetanus Prophylaxis Wound Management

History of Tetanus Immunization (Doses)

Clean, Minor Wounds

All Other Wounds1

1Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite.

2Tetanus toxoid in this chart refers to a tetanus toxoid containing vaccine. For children <7 years old DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≥7 years of age and Adolescents, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

3Yes, if ≥10 years since last dose.

4Yes, if ≥5 years since last dose.

Abbreviations: DT = Diphtheria and Tetanus Toxoids (formulation for age ≤6 years); DTaP = Diphtheria and Tetanus Toxoids, and Acellular Pertussis (formulation for age ≤6 years; Daptacel®, Infanrix®); Td = Diphtheria and Tetanus Toxoids (formulation for age ≥7 years; Decavac®, Tenivac™); TT = Tetanus toxoid (adsorbed [formulation for age ≥7 years]); Tdap = Diphtheria and Tetanus Toxoids, and Acellular Pertussis (Adacel® or Boostrix® [formulations for age ≥7 years]); TIG = Tetanus Immune Globulin

Tetanus toxoid 2

TIG

Tetanus toxoid 2

TIG

Uncertain or <3 doses

Yes

No

Yes

Yes

3 or more doses

No3

No

No4

No

Treatment of tetanus: Infants, Children, and Adolescents: IM: 3,000 to 6,000 units. Infiltration of part of the dose around the wound is recommended. Some experts recommend a lower 500 unit dose which appears to be as effective as higher doses and may cause less discomfort (Bradley 2015; Red Book [AAP 2012]; WHO 2010).

Administration

IM: For IM use only; do not administer IV. Administer in the anterolateral aspects of the upper thigh or the deltoid muscle of the upper arm. Avoid gluteal region due to risk of injury to sciatic nerve; if gluteal region is used, administer only in the upper outer quadrant. If tetanus vaccine and tetanus immune globulin are administered simultaneously, separate syringes at different anatomical sites should be used for each injection. When used for the treatment of tetanus, infiltration of part of the dose around the wound is recommended (CDC 2015a).

Storage

Store at 2°C to 8°C (26°F to 46°F). Do not use if frozen.

Drug Interactions

Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Consult full interaction monograph for dose interval recommendations. This interaction does not apply to oral Ty21a typhoid vaccine or others listed as exceptions. Consider therapy modification

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

Frequency not defined.

Central nervous system: Increased body temperature

Local: Local soreness/soreness at injection site, pain at injection site, tenderness at injection site

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

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis/hypersensitivity reactions: Hypersensitivity and anaphylactic reactions can occur; immediate treatment (including epinephrine 1 mg/mL) should be available. Use with caution in patients with isolated immunoglobulin A deficiency or a history of systemic hypersensitivity to human immunoglobulins.

Disease-related concerns:

• Bleeding disorders: Use with caution in patients with thrombocytopenia or coagulation disorders; IM injections may be contraindicated.

Dosage form specific issues:

• Human plasma: 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. Infections thought to be transmitted by this product should be reported to the manufacturer.

Other warnings/precautions:

• Administration: Not for intravenous administration.

• Appropriate use: When used for the treatment of tetanus infection, TIG removes circulating toxin, but does not remove toxin bound to nerve endings (CDC 2012). Larger doses of TIG are needed for treatment than prophylaxis (see Dosage) (MMWR 2015).

• Skin testing: Skin testing should not be performed as local irritation can occur and be misinterpreted as a positive allergic reaction.

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Tetanus immune globulin and a tetanus toxoid containing vaccine are recommended by the ACIP as part of the standard wound management to prevent tetanus in pregnant women (CDC 57[RR6], 2008; CDC 62[7], 2013).

Patient Education

What is this drug used for?

• It is used to treat or prevent tetanus.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Short-term pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.