Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine

Dosage Forms

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

Injection, suspension [Tdap, booster formulation]:

Adacel: Diphtheria 2 Lf units, tetanus 5 Lf units, and acellular pertussis antigens [detoxified pertussis toxin 2.5 mcg, filamentous hemagglutinin 5 mcg, pertactin 3 mcg, fimbriae (types 2 and 3) 5 mcg] per 0.5 mL (0.5 mL) [contains aluminum, formaldehyde; may contain natural rubber/natural latex in prefilled syringe]

Boostrix: Diphtheria 2.5 Lf units, tetanus 5 Lf units, and acellular pertussis antigens [inactivated pertussis toxin 8 mcg, filamentous hemagglutinin 8 mcg, pertactin 2.5 mcg] per 0.5 mL (0.5 mL) [contains aluminum and polysorbate 80; may contain natural rubber/natural latex in prefilled syringe]

Injection, suspension [DTaP, active immunization formulation]:

Daptacel: Diphtheria 15 Lf units, tetanus 5 Lf units, and acellular pertussis antigens [detoxified pertussis toxin 10 mcg, filamentous hemagglutinin 5 mcg, pertactin 3 mcg, fimbriae (types 2 and 3) 5 mcg] per 0.5 mL (0.5 mL) [contains aluminum, formaldehyde]

Infanrix: Diphtheria 25 Lf units, tetanus 10 Lf units, and acellular pertussis antigens [inactivated pertussis toxin 25 mcg, filamentous hemagglutinin 25 mcg, pertactin 8 mcg] per 0.5 mL (0.5 mL) [preservative free; contains aluminum, formaldehyde, polysorbate 80; prefilled syringes contain natural rubber/natural latex]

Pharmacology

Mechanism of Action

Promotes active immunity to diphtheria, tetanus, and pertussis by inducing production of specific antibodies.

Use: Labeled Indications

Diphtheria, tetanus, and pertussis disease prevention:

Daptacel, Infanrix (DTaP): Active immunization against diphtheria, tetanus, and pertussis from age 6 weeks through 6 years of age (prior to seventh birthday)

Adacel, Boostrix (Tdap): Active booster immunization against diphtheria, tetanus, and pertussis in persons 10 years and older (Boostrix) or persons 10 to 64 years of age (Adacel)

The Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination for the following:

Pediatric patients:

6 weeks to <7 years of age (DTaP):

• For primary immunization against diphtheria, tetanus and pertussis (CDC/ACIP [Liang 2018])
• Pediatric patients who are wounded in bombings or similar mass casualty events and who have penetrating injuries or nonintact skin exposure, and have an uncertain vaccination history should receive a tetanus booster with DTaP (if no contraindications exist) (CDC [Chapman 2008]).

7 to 10 years of age (Tdap):

• Children who did not complete a full primary DTaP series should receive a single dose of Tdap (if no contraindications exist) (CDC/ACIP [Liang 2018])
• Children never vaccinated against diphtheria, tetanus, or pertussis, or whose vaccination status is not known should receive a series of three vaccinations containing tetanus and diphtheria toxoids and the first dose should be with Tdap (CDC/ACIP [Liang 2018])

11 to 18 years of age (Tdap):

• A single dose of Tdap as a booster dose in individuals who have completed the recommended childhood DTaP vaccination series (preferred age of administration is 11 to 12 years) (CDC/ACIP [Liang 2018])
• Individuals never vaccinated against diphtheria, tetanus, or pertussis, or whose vaccination status is not known should receive a series of three vaccinations containing tetanus and diphtheria toxoids and the first dose should be with Tdap (CDC/ACIP [Liang 2018])
• Persons wounded in bombings or similar mass casualty events and who cannot confirm receipt of a tetanus booster within the previous 5 years and who have penetrating injuries or nonintact skin exposure should receive a single dose of Tdap (CDC [Chapman 2008])

Pregnant patients: (Tdap): Pregnant females should receive a single dose with each pregnancy, preferably during the early part of 27 to 36 weeks gestation (ACIP [Kroger 2017]; CDC/ACIP [Liang 2018])

Adult patients wounded in bombings or similar mass casualty events:

• Persons wounded in bombings or similar mass casualty events and who cannot confirm receipt of a tetanus booster within the previous 5 years and who have penetrating injuries or nonintact skin exposure should receive a single dose of Tdap (CDC/ACIP 61[25] 2012; CDC [Chapman 2008])

Adults ≥19 years of age (including adults ≥65 years) (Tdap): A single dose of Tdap should be given to all patients who have not previously received Tdap or for whom their vaccine status is unknown. Following administration of Tdap, Td vaccine should be used for routine boosters (CDC/ACIP [Liang 2018]). The following patients, who have not yet received Tdap or for whom vaccine status is not known, should receive a single dose of Tdap as soon as feasible:

• Close contacts of children <12 months of age; Tdap should ideally be administered at least 2 weeks prior to beginning close contact (CDC/ACIP [Liang 2018]).
• Health care providers with direct patient contact (CDC/ACIP [Liang 2018])

Patients who have recovered from tetanus or diphtheria infection:

• Because tetanus or diphtheria infection does not confer life-long immunity, active vaccination should be initiated at the time of recovery from the illness (according to the schedule). If the primary tetanus vaccination series has been completed, then a booster dose should be administered as soon as feasible during convalescence. Persons with unknown or uncertain previous tetanus vaccination histories should begin the 3-dose tetanus and diphtheria toxoids vaccination series (CDC/ACIP [Liang 2018]).

Note: Tdap is currently recommended for a single dose only, except pregnant females (CDC/ACIP [Liang 2018])

Contraindications

Hypersensitivity to diphtheria toxoid-, tetanus toxoid-, or pertussis-containing vaccine, or any component of the formulation; progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, or progressive encephalopathy (postpone until condition stabilized) (Infanrix only); encephalopathy occurring within 7 days of a previous dose of a pertussis-containing vaccine and not attributable to another cause; administration to children and adults ≥7 years of age (Daptacel only)

Dosage and Administration

Dosing: Adult

Note: Tdap can be administered regardless of the interval between the last tetanus or diphtheria toxoid containing vaccine. Tdap is currently recommended for a single dose only, except pregnant females who should receive a Tdap dose during each pregnancy (preferably during the early part of 27 and 36 weeks’ gestation) (CDC/ACIP [Liang 2018]).

Booster immunization: ACIP recommendations: IM: Adults ≥19 years: 0.5 mL per dose. A single dose of Tdap should be given to replace a single dose of the 10 year Td booster in patients who have not previously received Tdap or for whom vaccine status is not known. A single dose of Tdap is recommended for health care personnel who have not previously received Tdap and who have direct patient contact. Tdap should be administered regardless of interval since last tetanus- or diphtheria-containing vaccine (CDC/ACIP [Liang 2018]).

Booster immunization: Manufacturer's labeling: IM: Adults (Adacel [≤64 years], Boostrix): 0.5 mL as a single dose, administered ≥5 years after last dose of tetanus toxoid, diphtheria toxoid, and/or pertussis-containing vaccine. A second dose may be administered ≥8 years after the first dose of Tdap (Adacel only).

Wound management (CDC/ACIP [Liang 2018]): IM: Adacel or Boostrix may be used as an alternative to Td vaccine when a tetanus toxoid-containing vaccine is needed for wound management, and in whom the pertussis component is also indicated. Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated, 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.

Tetanus Prophylaxis in Wound Management

History of tetanus immunization: Uncertain or <3 doses

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

Children ≤6 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.

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 ≤6 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.

History of tetanus immunization: Three or more doses

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

Children ≤6 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.

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 ≤6 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.

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

Booster Immunization: IM: Adults ≥65 years:

ACIP recommendations: Refer to adult dosing. In adults ≥65 years Boostrix should be used if feasible; however, ACIP has concluded that either Tdap vaccine (Boostrix or Adacel) may be used (CDC/ACIP [Liang 2018]).

Manufacturer's labeling: Boostrix: 0.5 mL as a single dose, administered 5 years after last dose of tetanus toxoid, diphtheria toxoid, and/or pertussis-containing vaccine.

Wound Management: IM: Refer to adult dosing.

Dosing: Pediatric

Note: Consult CDC/ACIP annual immunization schedules for additional information including specific detailed recommendations for catch-up scenarios and/or care of patients with high-risk conditions. According to ACIP, doses administered ≤4 days before minimum interval or age are considered valid; however, local or state mandates may supersede this timeframe (ACIP [Kroger 2017]).

Primary immunization: CDC (ACIP) Recommendations: Infants and Children 6 weeks to <7 years: Note: Whenever possible, the same product should be used for all doses. Preterm infants should be vaccinated according to their chronological age from birth. DTaP (Daptacel, Infanrix): IM: 0.5 mL per dose for a total of 5 doses administered as follows (CDC/ACIP [Liang 2018]):

Three doses, usually given at 2, 4, and 6 months of age; may be given as early as 6 weeks of age and repeated every 4 to 8 weeks

Fourth dose: Given at ~15 to 18 months of age but at least 6 months after third dose. The fourth dose may be given as early as 12 months of age. Note: If the fourth dose is inadvertently administered early (≥4 months from the third dose instead of 6 months) and the child is ≥1 year of age, then the fourth dose does not need repeated.

Fifth dose: Given at 4 to 6 years of age, prior to starting school or kindergarten; if the fourth dose is given at ≥4 years of age, the fifth dose may be omitted

Catch-up immunization: CDC (ACIP) Recommendations (CDC/ACIP [Liang 2018]): Note: Do not restart the series. If doses have been given, begin the below schedule at the applicable dose number.

Infants and children who start primary immunization series ≥4 months of age through 6 years (prior to 7th birthday): DTaP (Daptacel, Infanrix): IM: 0.5 mL per dose for a total of 4 to 5 doses depending on number of previous doses and age.

Children ≥7 years and Adolescents not fully vaccinated against pertussis, or whose vaccination status is not known: IM: 0.5 mL single dose as part of the catch-up series; any additional doses needed would be Td.

Booster immunization (Adacel, Boostrix): Children ≥10 years and Adolescents: Note: Tdap can be administered regardless of the interval between the last tetanus or diphtheria toxoid-containing vaccine. Tdap is currently recommended for a single dose only, except pregnant females who should receive a Tdap dose during each pregnancy (preferably between 27 and 36 weeks' gestation) (CDC/ACIP [Liang 2018]). Note: If Tdap was received as part of a catch-up series, Tdap should not be administered as the booster dose; use Td instead.

Children ≥10 years and Adolescents: Tdap (Adacel, Boostrix): IM: 0.5 mL per dose as a single dose administered ≥5 years after last dose of tetanus toxoid, diphtheria toxoid, and/or pertussis-containing vaccine; in patients ≥18 years, a second booster may be administered ≥8 years after the first Tdap dose (Adacel only) (Manufacturer labeling). CDC/ACIP recommends booster dosing at the following ages: Tdap should be given as a single booster dose at age 11 or 12 years in children who have completed a childhood vaccination series, followed by booster doses of Td every 10 years (CDC/ACIP [Liang 2018]).

Note: If Tdap was given as part of catch-up dosing at 7 to 10 years of age, the 11- to 12-year booster is not needed. Regular Td booster immunizations should begin 10 years after the last dose of the primary series. Children who have not received Tdap at age 11 or 12 should receive a single dose of Tdap in place of a single Td booster dose (CDC/ACIP [Liang 2018]).

Tetanus prophylaxis in wound management (CDC/ACIP [Liang 2018]): Children ≥7 years and Adolescents: Tdap (Adacel, Boostrix): IM: 0.5 mL as a single dose may be used as an alternative to Td vaccine when a tetanus toxoid-containing vaccine is needed for wound management, and in whom the pertussis component is also indicated. Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated, 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 ≤6 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 ≤6 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 ≤6 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 ≤6 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.

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; 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

Administration

IM: Administer IM. Shake suspension well. Do not mix with other vaccines or injections; separate needles and syringes should be used for each injection. To prevent syncope related injuries, patients should be vaccinated while seated or lying down (ACIP [Kroger 2017]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, and the administering person's name, title, and address be entered into the patient's permanent medical record.

Adacel, Boostrix: Administer IM preferably into deltoid muscle of upper arm.

For patients at risk of hemorrhage following intramuscular injection, the vaccine 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 (ACIP [Kroger 2017]).

Storage

Refrigerate at 2°C to 8°C (35°F to 46°F); do not freeze; discard if frozen. Extended storage information at room temperature may be available; contact product manufacturer to obtain current recommendations.

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 (Groups A / C / Y and W-135) Diphtheria Conjugate Vaccine: Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine may diminish the therapeutic effect of Meningococcal (Groups A / C / Y and W-135) Diphtheria Conjugate Vaccine. More specifically, prior administration of the diphtheria and tetanus toxoids, and acellular pertussis vaccine may diminish antibody response to the meningococcal (groups A / C / Y / and W-135) diphtheria conjugate vaccine in some patients. Management: Administer the meningococcal (groups A / C / Y and W-135) diphtheria conjugate vaccine (Menactra brand) before or concurrently with the diphtheria and tetanus toxoids, and acellular pertussis vaccine (Daptacel brand) in children 4 to 6 years of age. Monitor therapy

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

DTaP (ages <7 years). Adverse reactions may be reported with use of other concomitant vaccines. Adverse reactions occurred with infants and children unless otherwise specified.

>10%:

Central nervous system: Irritability (children: ≤76%; infants: 32% to 62%), excessive crying (children: 7% to 59%; infants: ≤3%), drowsiness (infants: 19% to 54%; children: 18% to 36%), lethargy (children: ≤51%)

Endocrine & metabolic: Increased arm circumference (children: 1% to 38%)

Gastrointestinal: Anorexia (8% to 28%)

Local: Tenderness at injection site (children: 38% to 62%; infants: 8% to 11%), pain at injection site (children: 45% to 53%; infants: 30% to 32%), erythema at injection site (children: 6% to 50%; infants: ≤39%), swelling at injection site (≤33%)

Miscellaneous: Fussiness (children: ≤76%; infants: 57% to 62%), fever (infants: ≤30%; children: 5% to 16%)

1% to 10%:

Gastrointestinal: Vomiting (infants: 4% to 7%; children: <1%)

Respiratory: Bronchiolitis (children: 2%)

Tdap (>10 years). Adverse reactions may be reported with use of other concomitant vaccines. Adverse reactions occurred with adolescents and adults unless otherwise specified.

>10%:

Cardiovascular: Hypoactivity (children: ≤51%)

Central nervous system: Headache (30% to 44%; older adults: 12%), fatigue (24% to 37%; older adults: 13%), malaise (33%), body pain (≤30%), myasthenia (≤30%), chills (8% to 15%)

Endocrine & metabolic: Increased arm circumference (adolescents: 28%; adults: <1%)

Gastrointestinal: Gastrointestinal symptoms (adolescents: 26%; adults: 8% to 16%), nausea (9% to 13%)

Local: Pain at injection site (61% to 87%; older adults: 22%), erythema at injection site (6% to 25%; older adults: 11%), swelling at injection site (7% to 21%; older adults: 8%)

Neuromuscular & skeletal: Myalgia (58%), arthralgia (≤15%), joint swelling (≤15%)

Miscellaneous: Fever (≤14%; older adults: 2%)

1% to 10%:

Dermatologic: Skin rash (2% to 3%)

Gastrointestinal: Diarrhea (10%), vomiting (3% to 5%)

Hematologic & oncologic: Benign lymph node hyperplasia (7%)

<1%, postmarketing, and/or case reports: Abscess at injection site, anaphylactoid shock, anaphylaxis, angioedema, apnea, asthma, back pain, bronchitis, bronchospasm, bruising at injection site, cellulitis, cellulitis at injection site, cough, cyanosis, diarrhea, encephalitis, encephalopathy, erythema, erythematous rash, facial edema, facial nerve paralysis, fatigue, febrile seizures, Guillain-Barre syndrome, headache, Henoch-Schonlein purpura, hypersensitivity reaction, hypoesthesia, hypotension, hypotonia, hypotonic/hyporesponsive episode, hypoxia, immune thrombocytopenia, induration at injection site, infantile spasm, inflammation at injection site, injection site nodule, injection site pruritus, injection site reaction, localized warm feeling, loss of consciousness, lymphadenitis, lymphadenopathy, macular eruption, maculopapular rash, meningitis, migraine, muscle spasm, myelitis, myocarditis, myositis, nausea, nerve compression, neuritis (brachial), otalgia, paresthesia, pneumonia, pruritus, rash at injection site, residual mass at injection site, respiratory tract infection, screaming, seizure, sepsis, sterile abscess, sudden infant death syndrome, syncope, thrombocytopenia, unresponsive to stimuli, urticaria

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 vaccine use (ACIP [Kroger 2017]).
• Arthus-type hypersensitivity: Patients with a history of severe local reaction (Arthus-type) following a previous diphtheria toxoid or tetanus toxoid-containing vaccine dose should not be given further routine or emergency doses of Td unless ≥10 years since most recent dose, even if using for wound management with wounds that are not clean or minor; these patients generally have high serum antitoxin levels (CDC/ACIP [Liang 2018]).
• Reactions from previous dose: Carefully consider use in patients with history of any of the following effects from previous administration of any pertussis-containing vaccine: Fever ≥105°F (40.5°C) within 48 hours of unknown cause; seizures with or without fever occurring within 3 days; persistent, inconsolable crying episodes lasting ≥3 hours and occurring within 48 hours; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hours (CDC/ACIP [Liang 2018]).
• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2017]).

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. Defer administration in patients with moderate or severe acute illness (with or without fever); vaccination should not be delayed for patients with mild acute illness (with or without fever) (ACIP [Kroger 2017]).
• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding/hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2017]).
• Guillain-Barré syndrome: Use with caution if Guillain-Barré syndrome occurred within 6 weeks of prior tetanus toxoid-containing vaccine (CDC/ACIP 67[2] 2018).
• Neurologic disorders: Use with caution in patients with progressive neurologic disease including infantile spasms, uncontrolled seizure, or a progressive encephalopathy, or conditions predisposing to seizures; ACIP guidelines recommend deferring immunization until health status can be assessed and condition stabilized (CDC/ACIP [Liang 2018]).

Concurrent drug therapy issues:

• Anticoagulant therapy: Use with caution in patients receiving anticoagulant therapy; bleeding/hematoma may occur from IM administration (ACIP [Kroger 2017]).
• Vaccines: In order to maximize vaccination rates, the ACIP recommends simultaneous administration (ie, >1 vaccine on the same day at different anatomic sites) 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. The ACIP prefers each dose of a specific vaccine in a series come from the same manufacturer when possible; however, vaccination should not be deferred because a specific brand name is unavailable (ACIP [Kroger 2017]). Administration of Menactra (meningococcal MenACWY-D conjugate vaccine) one month after Daptacel has been shown to have reduced meningococcal antibody responses in children 4 to 6 years; these vaccines should be administered simultaneously or Menactra should be administered prior to Daptacel.

Special populations:

• Altered immunocompetence: Consider deferring immunization during periods of severe immunosuppression (eg, patients receiving chemo/radiation therapy or other immunosuppressive therapy (including high dose corticosteroids); may have a reduced response to vaccination. 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. Inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible; inactivated vaccines administered during chemotherapy should be readministered after immune competence is regained (ACIP [Kroger 2017]; IDSA [Rubin 2014]).
• Pediatric: Apnea has been reported following IM vaccine administration in premature infants; consider clinical status implications. In general, preterm infants should be vaccinated at the same chronological age as full-term infants (ACIP [Kroger 2017]).

Dosage form specific issues:

• Adacel: Formulated with the same antigens found in Daptacel, but with reduced quantities of tetanus and pertussis. Use in the primary immunization series or to complete the primary series has not been evaluated.
• Boostrix: Formulated with the same antigens found in Infanrix, but in reduced quantities. Use in the primary immunization series or to complete the primary series has not been evaluated.
• Latex: Packaging may contain natural latex rubber.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley, 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.

Other warnings/precautions:

• Antipyretics: Per the manufacturer, antipyretic prophylaxis may be considered for patients at high risk for seizures. However, antipyretics have not been shown to prevent febrile seizures. Antipyretics may be used to treat fever or discomfort following vaccination (ACIP [Kroger 2017]). 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).
• Appropriate use: Use of this vaccine for specific medical and/or other indications (eg, immunocompromising conditions, hepatic or kidney disease, diabetes) is also addressed in the annual ACIP Recommended Immunization Schedules (refer to CDC schedule for detailed information). Specific recommendations for vaccination in immunocompromised patients with asplenia, cancer, HIV infection, cerebrospinal fluid leaks, cochlear implants, hematopoietic stem cell transplant (prior to or after), sickle cell disease, solid organ transplant (prior to or after), or those receiving immunosuppressive therapy for chronic conditions as well as contacts of immunocompromised patients are available from the IDSA (Rubin 2014).
• 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 (ACIP [Kroger 2017]).

Monitoring Parameters

Monitor for syncope for 15 minutes following administration (ACIP [Kroger 2017]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy

Pregnancy Considerations

Inactivated bacterial vaccines have not been shown to cause increased risks to the fetus (ACIP [Kroger 2017]). Using data collected from 2005 to 2010 VAERS, there were not any patterns of adverse maternal, fetal, or neonatal outcomes identified following maternal use of the Tdap vaccine (Zheteyeva 2012). Additional VAERS data collected between 2011 and 2015 (after the current recommendations for use in pregnancy were in effect), also did not observe any new or unexpected maternal or newborn adverse events following maternal vaccination (Moro 2016).

All pregnant females should receive a single dose of Tdap during each pregnancy, regardless of previous vaccination status, preferably during the early part of 27 of 36 weeks gestation. Alternately, administration of Tdap can be given immediately postpartum to all females who have not previously been vaccinated with Tdap in order to protect the mother and infant from pertussis (ACIP [Kroger 2017]; CDC/ACIP [Liang 2018]). In case of an ongoing local pertussis epidemic, pregnant females should be vaccinated with Tdap for their own protection as is recommended for nonpregnant females, regardless of fetal gestational age. In addition, if a tetanus toxoid-containing vaccine is needed as standard care for wound management, Tdap may be given regardless of fetal gestational age if otherwise indicated. However, if Tdap is used prior to 27 to 36 weeks gestation in these instances, females should not receive more than 1 dose during the same pregnancy (ACOG 2017).

Pregnancy registries have been established for females who may become exposed to Boostrix (888-452-9622) or Adacel (800-822-2463) while pregnant.

Patient Education

What is this drug used for?

• It is used to prevent diphtheria, tetanus, and pertussis.

Frequently reported side effects of this drug

• Injection site pain, redness, or edema
• Headache
• Loss of strength and energy
• Chills
• Nausea
• Vomiting
• Abdominal pain
• Diarrhea
• Joint pain
• Joint swelling
• Swollen glands
• Irritability (children)
• Lack of appetite (children)
• Fatigue (children)

Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:

• Confusion
• Severe dizziness
• Passing out
• Vision changes
• Seizures
• Burning or numbness feeling
• Muscle weakness
• High fever
• Persistent crying (children)
• Signs of a significant reaction like 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. 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 brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.