Tetanus immune globulin (human): Drug information

(For additional information see "Tetanus immune globulin (human): Patient drug information" and see "Tetanus immune globulin (human): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)

Brand Names: US

HyperTET

Brand Names: Canada

HyperTET;
HyperTET S/D

Pharmacologic Category

Blood Product Derivative;
Immune Globulin

Dosing: Adult

Tetanus, prophylaxis

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 wounds^a
History of tetanus immunization doses	Tetanus toxoid^b	TIG	Tetanus toxoid^b	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	No^c

Tetanus, treatment

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: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Tetanus immune globulin (human): Pediatric drug information")

Tetanus, prophylaxis

Tetanus, prophylaxis:

Infants and Children <7 years: IM: 250 units as a single dose. May also calculate 4 units/kg; however, full dose of 250 units is recommended (Red Book [AAP 2018]; manufacturer's labeling).

Children ≥7 years and Adolescents: IM: 250 units as a single dose (Red Book [AAP 2018]; manufacturer's labeling).

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 [Havers 2020]; CDC/ACIP [Liang 2018]). See table.

**Tetanus Prophylaxis Wound Management**
History of tetanus immunization doses	Clean, minor wounds		All other wounds^a
^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 ≤6 years of age, DTaP (DT, if pertussis vaccine contraindicated) is recommended. For children 7 to 10 years who are not fully immunized against pertussis, diphtheria, or tetanus, Tdap should be used (followed by completion of catch-up series). Tdap is preferred in patients ≥11 years of age if the patient has not previously been vaccinated with Tdap, if Tdap history is unknown, or if the patient is pregnant. In patients who have previously been vaccinated with Tdap, either Td or Tdap may be used.
^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
	Tetanus toxoid^b	TIG	Tetanus toxoid^b	TIG
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	No^c

Tetanus, treatment

Tetanus, treatment: Limited data available; dosing regimens variable: Infants, Children, and Adolescents: IM: 3,000 to 6,000 units as a single dose. 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 2021; Red Book [AAP 2018]; WHO 2010).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

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

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling:

HyperTET: Hypersensitivity (eg, anaphylaxis, severe systemic reaction) to tetanus immune globulin (human) or any component of the formulation; severe thrombocytopenia or any coagulation disorder that would contraindicate IM injections; IgA-deficient patients with antibodies against IgA and a history of hypersensitivity.

HyperTET S/D: There are no contraindications listed in the manufacturer's labeling.

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.

Dosage Forms: US

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

Injectable, Intramuscular:

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

Generic Equivalent Available: US

Pricing: US

Solution Prefilled Syringe (HyperTET Intramuscular)

250 units/mL (per mL): $779.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Solution Prefilled Syringe, Intramuscular:

HyperTET: 250 units/mL (1 ea)

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

Administration: Adult

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).

Administration: Pediatric

Parenteral: IM: For IM use only; do not administer IV. Administer into lateral aspect of thigh or deltoid muscle of upper arm. Avoid gluteal region due to risk of injury to sciatic nerve. Do not administer tetanus toxoid and tetanus immune globulin in same syringe (toxoid will be neutralized); tetanus toxoid may be administered at the same time in separate limbs. When administered for treatment of tetanus, part of dose may be infiltrated locally around the wound site (CDC 2020; Red Book [AAP 2018]).

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/ACIP/HICPAC [Kretsinger 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).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Vaccines (Live): Immune Globulins may diminish the therapeutic effect of Vaccines (Live). Management: Live organism vaccination should be withheld for as long as 6 to 11 months following immune globulin administration. Recommendations vary by product and immune globulin dose, see full monograph for details. Risk D: Consider therapy modification

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).

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

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

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

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(BD) Bangladesh: Protet ig;
(BR) Brazil: Gama anti tetano grifols;
(CO) Colombia: Hypertet | Tetanus gamma;
(EE) Estonia: Tetanus gamma;
(HU) Hungary: Tetanus gamma;
(IT) Italy: Tetanus gamma;
(KR) Korea, Republic of: Hyper tet | Tetabulin sn;
(LB) Lebanon: Tetanus gamma;
(PE) Peru: Clostet;
(PH) Philippines: Baxter Human Tetanus Immunoglobulin;
(PL) Poland: Tetanus gamma;
(SA) Saudi Arabia: Tetanus gamma;
(SE) Sweden: Immunglobulin mot tetanus;
(TN) Tunisia: Gammatetanos | Tetanus gamma

American Academy of Pediatrics (AAP). In: Kimberlin DW, Brady MT, Jackson MA, Long SA, eds. Red Book: 2018 Report of the Committee on Infectious Diseases. 31st ed. Itasca, IL: American Academy of Pediatrics; 2018.
Bradley JS, Nelson JD, Barnett ED, et al, eds. Nelson's Pediatric Microbial Therapy. 27th ed. American Academy of Pediatrics; 2021.
Centers for Disease Control and Prevention (CDC). Epidemiology and prevention of vaccine-preventable diseases. Hamborsky J, Kroger A, Wolfe S, eds. 13th ed. Washington DC: Public Health Foundation; 2015a. https://www.cdc.gov/vaccines/pubs/pinkbook/index.html.
Centers for Disease Control and Prevention (CDC). Epidemiology and prevention of vaccine-preventable diseases: tetanus. Tiwari TS, Moro PL, Acosta AM, eds. Updated December 2020. Available at https://www.cdc.gov/vaccines/pubs/pinkbook/tetanus.html
Centers for Disease Control, “Diphtheria, Tetanus, and Pertussis: Recommendations for Vaccine Use and Other Preventive Measures,” MMWR Recomm Rep, 1991, 40(RR-10):1-28. [PubMed 1865873]
Centers for Disease Control, “Recommendations for Postexposure Interventions to Prevent Infection With Hepatitis B Virus, Hepatitis C Virus, or Human Immunodeficiency Virus, and Tetanus in Persons Wounded During Bombings and Other Mass-Casualty Events -- United States, 2008: Recommendations of the Centers For Disease Control And Prevention (CDC),” MMWR Recomm Rep, 2008, 57(RR-6):1-21. [PubMed 18668022]
Centers for Disease Control, “Prevention of Pertussis, Tetanus, and Diphtheria Among Pregnant and Postpartum Women and Their Infants, Recommendations of the Advisory Committee on Immunization Practices (ACIP),” MMWR Recomm Rep, 2008, 57(early release):1-47. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/rr57e0514a1.htm?s_cid=rr57e0514a1_e
Centers for Disease Control. Preventing Tetanus, Diphtheria, and Pertussis Among Adolescents: Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2006; 55(RR-3).
Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W, Wolfe S, Hamborsky J, eds. 12th ed., second printing. Washington DC: Public Health Foundation; 2012.
Centers for Disease Control and Prevention (CDC). Missed opportunities for tetanus postexposure prophylaxis – California, January 2008 – March 2014. MMWR Morb Mortal Wkly Rep. 2015b; 64(9)243-246. [PubMed 25763876]
Centers for Disease Control and Prevention (CDC). Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women--Advisory Committee on Immunization Practices (ACIP), 2012. MMWR Morb Mortal Wkly Rep. 2013;62(7):131-135. [PubMed 23425962]
Cohen V, Jellinek SP, Teperikidis L, et al, “Room-Temperature Storage of Medications Labeled for Refrigeration,” Am J Health-Syst Pharm, 2007, 64(16):1711-15. [PubMed 17687059]
Havers FP, Moro PL, Hunter P, Hariri S, Bernstein H. Use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines: updated recommendations of the Advisory Committee on Immunization Practices - United States, 2019. MMWR Morb Mortal Wkly Rep. 2020;69(3):77-83. [PubMed 31971933]
HyperTET (tetanus immune globulin [human]) [prescribing information]. Research Triangle Park, NC: Grifols Therapeutics LLC; August 2022.
HyperTET (tetanus immune globulin [human]) [product monograph]. Mississauga, Ontario, Canada: Grifols Therapeutics; September 2021.
HyperTET S/D (tetanus immune globulin [human]) [product monograph]. Mississauga, Ontario, Canada: Grifols Therapeutics; February 2012.
Kretsinger K, Broder KR, Cortese MM, et al; Centers for Disease Control and Prevention; Advisory Committee on Immunization Practices; Healthcare Infection Control Practices Advisory Committee. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel. MMWR Recomm Rep. 2006;55(RR-17):1-37. [PubMed 17167397 ]
Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67(2):1-44. doi: 10.15585/mmwr.rr6702a1. [PubMed 29702631]
World Health Organization, WHO Technical Note. Current recommendations for the treatment of tetanus during humanitarian emergencies. January 2010. Available at: http://www.who.int/diseasecontrol_emergencies/who_hse_gar_dce_2010_en.pdf.

Topic 9983 Version 155.0

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Tetanus immune globulin (human): Drug information