Tetanus Immune Globulin (Human)

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)

Pharmacology

Mechanism of Action

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

Pharmacokinetics/Pharmacodynamics

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.

Dosage and Administration

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.

Table has been converted to the following text.

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

History of tetanus immunization: Uncertain or <3 doses

Clean, minor wounds: Administer a tetanus toxoid-containing vaccine.

Infants and Children <7 years of age: DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone.

Children ≥7 years of age, Adolescents, and Adults: Td is preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap and in pregnant women.

Other wounds (such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite): Administer a tetanus toxoid-containing vaccine and TIG.

Infants and Children <7 years of age: DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone.

Children ≥7 years of age, Adolescents, and Adults: Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap and in pregnant women.

History of tetanus immunization: ≥3 doses

Clean, minor wounds: Administer a tetanus toxoid-containing vaccine if ≥10 years since last dose.

Infants and Children <7 years of age: DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone.

Children ≥7 years of age, Adolescents, and Adults: Td is preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap and in pregnant women.

Other wounds (such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite): Administer a tetanus toxoid-containing vaccine if ≥5 years since last dose.

Infants and Children <7 years of age: DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone.

Children ≥7 years of age, Adolescents, and Adults: Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap or in pregnant women.

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.

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.

Table has been converted to the following text.

History of Tetanus Immunization (Doses): Uncertain or <3 doses

Clean, Minor Wounds: Administer 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.

Other Wounds (such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite): Administer a tetanus toxoid containing vaccine and TIG. 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.

History of Tetanus Immunization (Doses): 3 or more doses

Clean, Minor Wounds: Administer a tetanus toxoid containing vaccine if ≥10 years since last dose. 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.

Other Wounds (such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; wounds from crushing, tears, burns, and frostbite): Administer a tetanus toxoid containing vaccine if ≥5 years since last dose. For children <7 years old DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≥7 years of age and Adolesscents, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

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®, Tripedia®); 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

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. Exceptions: Adenovirus (Types 4, 7) Vaccine; Cholera Vaccine; Influenza Virus Vaccine (Live/Attenuated); Poliovirus Vaccine (Live/Bivalent/Oral); Poliovirus Vaccine (Live/Trivalent/Oral); Rotavirus Vaccine; Yellow Fever Vaccine; Zoster Vaccine (Live/Attenuated). Consider therapy modification

Adverse Reactions

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

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

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience short-term pain (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.