Tetanus Toxoid (Adsorbed)

Pharmacology

Mechanism of Action

Tetanus toxoid preparations contain the toxin produced by virulent tetanus bacilli (detoxified growth products of Clostridium tetani). The toxin has been modified by treatment with formaldehyde so that it has lost toxicity but still retains ability to act as antigen and produce active immunity; the aluminum salt, a mineral adjuvant, delays the rate of absorption and prolongs and enhances its properties; duration ~10 years.

Pharmacokinetics/Pharmacodynamics

Duration of Action

Primary immunization: ~10 years

Use: Labeled Indications

Active immunization against tetanus when combination antigen preparations are not indicated; tetanus prophylaxis in wound management. Note: Tetanus and diphtheria toxoids for adult use (Td) is the preferred immunizing agent for most adults and for children after their seventh birthday. Young children should receive trivalent DTaP (diphtheria/tetanus/acellular pertussis) as part of their childhood immunization program, unless pertussis is contraindicated, then DT is warranted.

Contraindications

Hypersensitivity to tetanus toxoid or any component of the formulation

Dosage and Administration

Dosing: Adult

Note: Tetanus Toxoid (adsorbed) has been discontinued in the US for more than 1 year.

Note: In most patients, Td is the recommended product for primary immunization, booster doses, and tetanus immunization in wound management (refer to Diphtheria and Tetanus Toxoid monograph).

Primary immunization: IM: 0.5 mL; repeat 0.5 mL at 4-8 weeks after first dose and at 6-12 months after second dose

Routine booster dose: Recommended every 10 years

Tetanus prophylaxis in wound management: Tetanus prophylaxis in patients with wounds should consider if the wound is clean or contaminated, the immunization status of the patient, 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.

Tetanus Prophylaxis in Wound Management

History of tetanus immunization: Uncertain or <3 doses

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

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

Children ≥7 years of age and Adults: 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.

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

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

History of tetanus immunization: Three or more doses

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

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

Children ≥7 years of age and Adults: 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.

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

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

Adapted from CDC "Yellow Book" (Health Information for International Travel 2010), "Routine Vaccine-Preventable Diseases, Tetanus" (available at http://www.cdc.gov/yellowbook) and MMWR 2006, 55(RR-17).

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Tetanus Toxoid (adsorbed) has been discontinued in the US for more than 1 year.

Children ≥7 years, Adolescents, and Adults:

Primary immunization: Not indicated for this use; combined antigen vaccines are recommended. Note: In most patients, Td is the recommended product for primary immunization, booster doses, and tetanus immunization in wound management (refer to diphtheria and tetanus toxoid monograph):

Booster doses: I.M: 0.5 mL every 10 years

Tetanus prophylaxis in wound management: Tetanus prophylaxis in patients with wounds should consider if the wound is clean or contaminated, the immunization status of the patient, 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.

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 Adults, 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 Adults, 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 Adults, 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 Adults, 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

Adapted from the Yellow Book 2010, Chapter 2, Routine Vaccine-Preventable Diseases, Tetanus; Available at www.cdc.gov/yellowbook and MMWR, 2006, 55:RR-17.

Administration

IM: Inject intramuscularly in the area of the vastus lateralis (midthigh laterally) or deltoid. Do not inject into gluteal area. Shake well prior to withdrawing dose; do not use if product does not form a suspension.

For patients at risk of hemorrhage following intramuscular injection, the ACIP recommends “it should be administered intramuscularly if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, intramuscular vaccination can be scheduled shortly after such therapy is administered. A fine needle (23 gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection.” Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (CDC, 2011).

Simultaneous administration of vaccines helps ensure the patients will be fully vaccinated by the appropriate age. Simultaneous administration of vaccines is defined as administering >1 vaccine on the same day at different anatomic sites. The use of licensed combination vaccines is generally preferred over separate injections of the equivalent components. Separate vaccines should not be combined in the same syringe unless indicated by product specific labeling. Separate needles and syringes should be used for each injection. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible. Patients should be vaccinated while seated or lying down.

Antipyretics have not been shown to prevent febrile seizures. Antipyretics may be used to treat fever or discomfort following vaccination (CDC, 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; the clinical significance of this reduction in immune response has not been established (Prymula, 2009).

Storage

Store at 2°C to 8°C (26°F to 46°F); do not freeze.

Drug Interactions

Fingolimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting fingolimod. If vaccinated during fingolimod therapy, revaccinate 2 to 3 months after fingolimod discontinuation. Consider therapy modification

Immunosuppressants: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Exceptions: Cytarabine (Liposomal). Consider therapy modification

Meningococcal Polysaccharide (Groups A / C / Y and W-135) Tetanus Toxoid Conjugate Vaccine: May diminish the therapeutic effect of Tetanus Toxoids Vaccines. Management: When possible, administer the meningococcal polysaccharide (groups A / C / Y and W-135) tetanus toxoid conjugate vaccine either together with or at least one month before a tetanus toxoids-containing vaccine. Consider therapy modification

Siponimod: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Avoid administration of vaccines (inactivated) during treatment with siponimod and for 1 month after discontinuation due to potential decreased vaccine efficacy. Consider therapy modification

Venetoclax: May diminish the therapeutic effect of Vaccines (Inactivated). Monitor therapy

Adverse Reactions

Frequency not defined.

Cardiovascular: Hypotension

Central nervous system: Guillain-Barré syndrome, malaise, neuritis (brachial), pain

Dermatologic: Rash at injection site, skin sclerosis (with or without tenderness), urticaria at injection site

Gastrointestinal: Nausea

Hypersensitivity: Anaphylaxis, Arthus phenomenon

Local: Erythema at injection site, swelling at injection site, warm sensation at injection site

Neuromuscular & skeletal: Arthralgia

Miscellaneous: Fever

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactoid/hypersensitivity reactions: Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during use.
• Arthus-type hypersensitivity: Tetanus containing vaccines and emergency doses of tetanus vaccine should not be given more frequently than every 10 years in patients who have experienced a serious Arthus-type hypersensitivity reaction following a prior use of tetanus toxoid.
• Syncope: Syncope has been reported with use of injectable vaccines and may be accompanied by transient visual disturbances, weakness, or tonic-clonic movements. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs.

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. Immunization should be delayed during the course of an acute febrile illness.
• Bleeding disorders: Use with caution in patients with a history of bleeding disorders (including thrombocytopenia) and/or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration.
• Guillain-Barré syndrome: Use with caution if Guillain-Barré syndrome occurred within 6 weeks of prior tetanus toxoid.

Concurrent drug therapy issues:

• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration of all age-appropriate vaccines (live or inactivated) for which a person is eligible at a single clinic visit, unless contraindications exist. The use of combination vaccines is generally preferred over separate injections, taking into consideration provider assessment, patient preference, and adverse events. When using combination vaccines, the minimum age for administration is the oldest minimum age for any individual component; the minimum interval between dosing is the greatest minimum interval between any individual component.

Special populations:

• Immunocompromised patients: Patients who are immunocompromised may have reduced response; may be used in patients with HIV infection. In general, household and close contacts of persons with altered immunocompetence may receive all age appropriate vaccines (CDC, 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (Rubin, 2014).

Dosage form specific issues:

• Thimerosal: Product may contain thimerosal.

Other warnings/precautions:

• Administration: Avoid injection into a blood vessel.
• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) and may be improved by administering the vaccine at the recommended dose, route, and interval. Vaccines may not be effective if administered during periods of altered immune competence (CDC, 2011).

Monitoring Parameters

Monitor for syncope for 15 minutes following administration. If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal studies have not been conducted. Inactivated bacterial vaccines have not been shown to cause increased risks to the fetus (CDC, 2011). The ACIP recommends vaccination in previously unvaccinated women or in women with an incomplete vaccination series, whose child may be born in unhygienic conditions. 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. Vaccination using Td is preferred.

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 injection site irritation, fever (mild), joint pain, or nausea. Have patient report immediately to prescriber dizziness, passing out, burning or numbness feeling, severe loss of strength or energy, or abnormal gait (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.