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Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine

Medically reviewed by Drugs.com. Last updated on Sep 30, 2020.

Pronunciation

(dif THEER ee a & TET a nus TOKS oyds, & ay CEL yoo lar per TUS sis vak SEEN)

Index Terms

  • Acellular Pertussis
  • Diphth/Tetanus/Acel. Pertussis
  • Diphtheria
  • DTaP
  • Pertussis
  • Tdap
  • Tetanus
  • Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis, Adsorbed
  • Tripedia

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]

Brand Names: U.S.

  • Adacel
  • Boostrix
  • Daptacel
  • Infanrix

Pharmacologic Category

  • Vaccine
  • Vaccine, Inactivated (Bacterial)

Pharmacology

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 in patients from 6 weeks through 6 years of age (prior to seventh birthday); wound management for the prevention of tetanus.

Adacel, Boostrix (Tdap): Active booster immunization against diphtheria, tetanus, and pertussis in persons ≥10 years of age (Boostrix) or persons 10 to 64 years of age (Adacel); wound management for the prevention of tetanus.

The Advisory Committee on Immunization Practices (ACIP) recommends vaccination for the following (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]):

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

• Routine: Primary immunization against diphtheria, tetanus and pertussis.

• Wound management: To prevent tetanus in patients with unknown or <3 doses of previous tetanus vaccination. Tetanus immune globulin is also recommended for some wounds; refer to full Centers for Disease Control and Prevention (CDC)/Advisory Committee on Immunization Practices (ACIP) recommendations for details.

Children 7 to 10 years of age (Tdap):

• Catch-up: Children not fully immunized with DTaP vaccine should receive a single dose of Tdap, preferably as the first dose in the catch-up series. Children never vaccinated against diphtheria, tetanus, or pertussis, or whose vaccination status is not known, should receive a series of 3 vaccinations containing tetanus and diphtheria toxoids; at least 1 dose should be Tdap (preferably the first dose).

• Wound management: To prevent tetanus in patients with unknown or <3 doses of previous tetanus vaccine, or who have not received a tetanus-containing vaccine recently (ie, 10 years for clean and minor wounds; 5 years for all other wounds). Tetanus immune globulin is also recommended for some wounds; refer to full CDC/ACIP recommendations for details. Patients not fully immunized presenting for wound management may need additional catch-up doses as above.

Children ≥11 years of age and adolescents (Tdap):

• Routine: A single dose of Tdap as a routine booster dose in individuals who have completed the recommended or catch-up childhood DTaP vaccination series prior to 10 years of age (preferred age of administration is 11 to 12 years).

• Catch-up: 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; at least 1 dose should be Tdap (preferably the first dose).

• Wound management: To prevent tetanus in patients with unknown or <3 doses of previous tetanus vaccine or who have not received a tetanus-containing vaccine recently (ie, 10 years for clean and minor wounds; 5 years for all other wounds) Tdap or Td may be used, regardless of time since last Tdap dose. Tetanus immune globulin is also recommended for some wounds; refer to full CDC/ACIP recommendations for details.

Pregnant patients (Tdap):

• Routine: Pregnant females should receive a single dose of Tdap with each pregnancy, regardless of previous vaccination status, preferably during the early part of 27 to 36 weeks' gestation.

• Catch-up: If the patient has never received a dose of Tdap AND did not receive a dose during pregnancy, a dose should be administered immediately postpartum.

• Wound management: Tdap is recommended as the preferred tetanus wound management in pregnant women.

Adults ≥19 years of age (including adults ≥65 years of age) (Tdap):

• Routine: 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, either Tdap or Td vaccine can be used for routine boosters administered every 10 years.

• Catch-up: Patients never vaccinated against diphtheria, tetanus, or pertussis, or whose vaccination status is not known, should receive a series of 3 vaccinations containing tetanus and diphtheria toxoids; all 3 doses may be, and at least 1 of the doses should be, Tdap (preferably the first dose). 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.

- Health care providers with direct patient contact.

• Wound management: To prevent tetanus in patients with unknown or <3 doses of previous tetanus vaccine or who have not received a tetanus-containing vaccine recently (ie, 10 years for clean and minor wounds; 5 years for all other wounds) Tdap or Td may be used, regardless of time since last Tdap dose. Tetanus immune globulin is also recommended for some wounds; refer to full CDC/ACIP recommendations for details.

All 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.

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)

Dosing: Adult

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should NOT be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, outpatient visits solely for vaccination should be delayed in persons in quarantine due to close contact with COVID-19 or persons who have suspected or confirmed COVID-19 infection (regardless of symptoms); refer to the CDC's "Interim Guidance for Immunization Services During the COVID-19 Pandemic" for current recommendations (https://www.cdc.gov/vaccines/pandemic-guidance/index.html). Additional information is available from the American Academy of Pediatrics and the Immunization Action Coalition.

Note: Tdap can be administered regardless of the interval between the last tetanus or diphtheria toxoid-containing vaccine. Tdap or Td can be used for most adults when tetanus vaccination is recommended. Pregnant females should receive a single dose of Tdap dose during each pregnancy (preferably during the early part of 27 to 36 weeks’ gestation) regardless of previous vaccination status (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]).

Catch-up immunization (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]): IM: 0.5 mL as a 3-dose series at 0, ≥4 weeks, and 6 to 12 months later. At least 1 dose should be Tdap; preferably dose 1, with either Td or Tdap appropriate for doses 2 and 3. Note: For persons who have never received a pertussis-, tetanus-, or diphtheria-containing vaccine.

Booster immunization (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]): IM: 0.5 mL per dose. Any patient who has not previously received a dose of Tdap should receive a dose of Tdap, regardless of interval since last tetanus- or diphtheria-containing vaccine. A booster dose of either Td or Tdap should be administered every 10 years throughout life.

Tetanus prophylaxis in wound management (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]): 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, including time from last tetanus-containing vaccine. Wound management includes use of tetanus toxoid and/or tetanus immune globulin (TIG) where appropriate, 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 in Wound Management

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 ≤6 years of age, DTaP (DT, if pertussis vaccine contraindicated) is recommended. For children 7 to 10 years of age 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.

cYes, if ≥10 years since last dose.

dYes, if ≥5 years since last dose.

eFor 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 ≤6 years of age); DTaP = Diphtheria and tetanus toxoids, and acellular pertussis (formulation for ≤6 years of age; Daptacel, Infanrix); Td = Diphtheria and tetanus toxoids (formulation for ≥7 years of age; Decavac, Tenivac); Tdap = Diphtheria and tetanus Toxoids, and acellular pertussis (Adacel or Boostrix [formulations for ≥7 years of age]); TIG = Tetanus immune globulin.

Uncertain or <3 doses

Yes

No

Yes

Yes

≥3 doses

Noc

No

Nod

Noe

Dosing: Geriatric

Booster immunization: IM: Adults ≥65 years of age:

The Advisory Committee on Immunization Practices (ACIP) recommendations: Refer to adult dosing. In adults ≥65 years of age Boostrix should be used if feasible; however, ACIP has concluded that either Tdap vaccine (Boostrix or Adacel) may be used (CDC/ACIP [Havers 2020]; 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 if received.

Wound management: IM: Refer to adult dosing.

Dosing: Pediatric

Note: Immunization during coronavirus disease 2019 (COVID-19) pandemic: Routine vaccination should NOT be delayed because of the COVID-19 pandemic (CDC 2020; WHO 2020). In general, simultaneous administration of all vaccines for which a patient is eligible (according to current immunization schedules/guidelines) is recommended (ACIP [Ezeanolue 2020]). However, outpatient visits solely for vaccination should be delayed in persons in quarantine due to close contact with COVID-19 or persons who have suspected or confirmed COVID-19 infection (regardless of symptoms); refer to the CDC's "Interim Guidance for Immunization Services During the COVID-19 Pandemic" for current recommendations (https://www.cdc.gov/vaccines/pandemic-guidance/index.html). Additional information is available from the American Academy of Pediatrics and the Immunization Action Coalition.

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 [Ezeanolue 2020]).

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 (primary series): 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 (first booster): 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 (second booster): 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 [Havers 2020]; 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: Tdap: IM: 0.5 mL as first dose of the catch-up series; if additional doses are needed per catch-up schedule, either Tdap or Td may be used (CDC/ACIP [Havers 2020]).

Note: If DTaP was inadvertently given as catch-up dose to a undervaccinated child 7 to 9 years of age, it should count as a Tdap dose in the catch-up series (CDC/ACIP [Havers 2020]).

Booster immunization (Adacel, Boostrix): Children ≥10 years and Adolescents: Note: Tdap can be administered regardless of the interval between the last acellular pertussis, tetanus, or diphtheria toxoid-containing vaccine.

Children ≥10 years and Adolescents: Tdap (Adacel, Boostrix): IM: 0.5 mL as a single routine booster dose at age 11 or 12 years in children who have completed a childhood vaccination series, followed by additional booster doses of either Td or Tdap every 10 years (CDC/ACIP [Havers 2020]).

Note: If Tdap was given either inadvertently or used as part of catch-up dosing at 7 to 9 years of age, it should not be counted as the adolescent booster dose and the child should still receive a Tdap booster between ages 11 to 12 years. At age ≥ 10 years, Tdap doses given as part of catch-up series or DTaP doses given inadvertently may count as the adolescent Tdap dose (CDC/ACIP [Havers 2020]).

Tetanus prophylaxis in wound management (CDC/ACIP [Havers 2020]; CDC/ACIP [Liang 2018]):

Infants ≥6 weeks and Children ≤6 years: DTaP (Daptacel, Infanrix): Administration of dose should be determined based on patient's current immunization status with the primary immunization or catch-up dosing series to ensure appropriate minimum dosing intervals maintained; should count as the next dose in the series.

Children ≥7 years and Adolescents: Tdap (Adacel, Boostrix): IM: 0.5 mL as a single dose.

Tetanus prophylaxis in patients with wounds should be based on if the wound is clean or contaminated and the immunization status of the patient, including time from last tetanus-containing vaccine. Wound management includes use of tetanus toxoid and/or tetanus immune globulin (TIG) where indicated, 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 ≤6 years old, 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.

3Yes, if ≥10 years since last dose.

4Yes, if ≥ 5 years since last dose.

5For 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 2

TIG

Tetanus toxoid 2

TIG

Uncertain or <3 doses

Yes

No

Yes

Yes

3 or more doses

No3

No

No4

No5

Administration

IM: Administer IM. Shake suspension well to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur. 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 [Ezeanolue 2020]). US law requires that the date of administration, the vaccine manufacturer, lot number of vaccine, vaccine information statement (VIS) edition date and date it was provided, and the administering person's name, title, and address be recorded.

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

For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM 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, IM 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 [Ezeanolue 2020]).

Storage

Store refrigerated 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: Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated less than 2 weeks before starting or during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification

Meningococcal (Groups A / C / Y and W-135) Conjugate Vaccine: Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine may diminish the therapeutic effect of Meningococcal (Groups A / C / Y and W-135) 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) 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. 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

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

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 [Ezeanolue 2020]).

• 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]).

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis or tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• 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 [Ezeanolue 2020]).

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 [Ezeanolue 2020]).

• 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 [Ezeanolue 2020]).

• Brachial neuritis: Has occurred following tetanus toxoid-containing vaccines; use with caution (CDC/ACIP [Liang 2018]).

• Guillain-Barré syndrome: Use with caution if Guillain-Barré syndrome occurred within 6 weeks of prior tetanus toxoid-containing vaccine (CDC/ACIP [Liang 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; the Advisory Committee on Immunization Practices (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; vaccinations should be administered prior to initiation of anticoagulation therapy if possible (ACIP [Ezeanolue 2020]).

• 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 [Ezeanolue 2020]). 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 [Ezeanolue 2020]; 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 (AAP [Saari 2003]; ACIP [Ezeanolue 2020]).

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 [Ezeanolue 2020]). 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 [Ezeanolue 2020]).

Monitoring Parameters

Monitor for anaphylaxis and syncope for 15 minutes following administration (ACIP [Ezeanolue 2020]). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Considerations

In general, maternal use of inactivated vaccines is not associated with increased risks to the fetus (ACIP [Ezeanolue 2020]). In addition, an increased risk of adverse maternal or fetal outcomes, including miscarriage or major birth defects, has not been observed following maternal use of the Tdap vaccine (CDC [Havers 2020]; Moro 2016; Zheteyeva 2012).

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 [Ezeanolue 2020]; 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 is preferred over Td, 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 718 2017; CDC/ACIP [Havers 2020]).

Data collection to monitor pregnancy and infant outcomes following exposure to Tdap vaccine is ongoing. 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.

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:

• Injection site pain, redness, or swelling

• 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)

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:

• Confusion

• Severe dizziness

• Passing out

• Vision changes

• Seizures

• Burning or numbness feeling

• Muscle weakness

• High fever

• Persistent crying (children)

• 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.