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Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine

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; 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) [preservative free; contains aluminum]

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 and polysorbate 80]

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 and polysorbate 80; prefilled syringes contain natural rubber/natural latex] [DSC]

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 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:

Infants and Children 6 weeks to <7 years (DTaP):

• For primary immunization against diphtheria, tetanus and pertussis (Use of diphtheria toxoid [ACIP] 2000)

• 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]).

Children 7 to 10 years (Tdap):

• Children who did not complete a fully primary DTaP series should receive a single dose of Tdap (if no contraindications exist) (CDC/ACIP 60[1] 2011)

• 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 60[1] 2011)

Adolescents 11 to 18 years (Tdap):

• A single dose of Tdap as a booster dose in adolescents who have completed the recommended childhood DTaP vaccination series (preferred age of administration is 11 to 12 years) (CDC/ACIP 60[1] 2011)

Adolescents ≥11 years and adults (Tdap):

• 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])

Pregnant patients: (Tdap): Pregnant females should receive a single dose with each pregnancy, preferably between 27-36 weeks gestation (CDC/ACIP 62[7] 2013)

Adults ≥19 years (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 (ACIP [Kim 2016]). 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 60[41] 2011; CDC/ACIP [Kretsinger 2006]).

• Health care providers with direct patient contact (CDC/ACIP [Kretsinger 2006])

Note: Tdap is currently recommended for a single dose only (all age groups) (CDC/ACIP 60[1] 2011; CDC/ACIP 61[25] 2012), except pregnant females (CDC/ACIP 62[7] 2013)

Contraindications

Hypersensitivity to diphtheria, tetanus toxoids, pertussis, or any component of the formulation; progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy or progressive epilepsy (postpone until condition stabilized); encephalopathy occurring within 7 days of administration and not attributable to another cause

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 (CDC/ACIP 60[1] 2011; CDC/ACIP 61[25] 2012), except pregnant females who should receive a Tdap dose during each pregnancy (preferably between 27 and 36 weeks’ gestation) (CDCACIP 62[7] 2013).

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 (CDC [Kretsinger 2006]). Tdap should be administered regardless of interval since last tetanus- or diphtheria-containing vaccine (CDC/ACIP 61[25] 2012).

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

Wound management (CDC/ACIP [Broder 2006]): 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.

Tetanus Prophylaxis in Wound Management

History of Tetanus Immunization Doses

Clean, Minor Wounds

All Other Wounds1

Tetanus Toxoid2

TIG

Tetanus Toxoid2

TIG

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 of age, DTaP (DT, if pertussis vaccine contraindicated) is preferred to tetanus toxoid alone. For children ≥7 years, adolescents, and adults, Td preferred to tetanus toxoid alone; Tdap may be preferred if the patient has not previously been vaccinated with Tdap.

3Yes, if ≥10 years since last dose.

4Yes, if ≥5 years since last dose.

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

Uncertain or <3 doses

Yes

No

Yes

Yes

3 or more doses

No3

No

No4

No

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 61[25] 2012).

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

Primary immunization: IM:

Infants and Children 6 weeks to <7 years: Note: Whenever possible, the same product should be used for all doses. Interruption of recommended schedule does not require starting the series over; a delay between doses should not interfere with final immunity.

Daptacel, Infanrix: 0.5 mL per dose, total of 5 doses administered as follows:

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 20 months of age, but at least 6 months after third dose. The fourth dose may be given as early as 12 months of age.

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

For children who start primary immunization series ≥4 months of age, refer to current ACIP "Catch-up Immunization Schedule".

Booster immunization: ACIP recommendations: 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 (CDC/ACIP 60[1] 2011), except pregnant females who should receive a Tdap dose during each pregnancy (preferably between 27 and 36 weeks’ gestation) (CDCACIP 62[7] 2013).

Children ≥10 years and Adolescents to 18 years: IM: 0.5 mL per dose. Tdap should be given as a single booster dose at age 11 or 12 years in adolescents who have completed a childhood DTaP vaccination series, followed by booster doses of Td every 10 years. Adolescents 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 (ACIP [Robinson 2016]; CDC [Broder 2006]; CDC/ACIP 60[1] 2011).

Booster immunization: Manufacturer's labeling: IM:

Children ≥10 years and Adolescents (Adacel, 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: Refer to adult dosing.

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

Administration

Shake suspension well. To prevent syncope related injuries, adolescents and adults should be vaccinated while seated or lying down (NCIRD/ACIP 2011). 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 only IM in deltoid muscle of upper arm.

Daptacel, Infanrix: Administer only IM in anterolateral aspect of thigh or deltoid muscle of upper arm.

If feasible, the same brand of DTaP should be used for all doses in the series (NCIRD/ACIP 2011).

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 (NCIRD/ACIP 2011).

Compatibility

Do not mix with other vaccines or injections. Separate needles and syringes should be used for each injection.

Storage

Refrigerate at 2°C to 8°C (35°F to 46°F); do not freeze; discard if frozen. The following stability information has also been reported for Infanrix: May be stored at room temperature for up to 72 hours (Cohen 2007).

Drug Interactions

Belimumab: May diminish the therapeutic effect of Vaccines (Inactivated). Management: Patients should receive inactivated vaccines prior to initiation of belimumab therapy whenever possible, due to the risk for an impaired response to the vaccine during belimumab therapy. Consider therapy modification

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

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

Adverse Reactions

All serious adverse reactions must be reported to the U.S. Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS) 1-800-822-7967 or online at https://vaers.hhs.gov/esub/index. In Canada, adverse reactions may be reported to local provincial/territorial health agencies or to the Vaccine Safety Section at Public Health Agency of Canada (1-866-844-0018).

Daptacel, Infanrix (incidence of erythema, swelling, and fever increases with successive doses): Frequency not defined:

Central nervous system: Drowsiness, irritability, lethargy

Gastrointestinal: Decreased appetite, vomiting

Local: Erythema at injection site, local pain, localized edema, tenderness at injection site

Miscellaneous: Crying (prolonged or persistent), fever, fussiness

<1% (Limited to important or life-threatening): Anaphylaxis, angioedema, apnea, brain disease, bronchitis, cellulitis, cough, cyanosis, diarrhea, erythema, fatigue, headache, hypersensitivity reaction, hypotonia, hypotonic/hyporesponsive episode, immune thrombocytopenia, infantile spasm, injection site reaction (abscess, cellulitis, induration, mass, nodule, rash), lymphadenopathy, nausea, otalgia, peripheral edema, pruritus, respiratory tract infection, screaming, seizure, skin rash, sudden infant death syndrome, thrombocytopenia, urticaria

Adacel, Boostrix: Note: Ranges presented, actual percent varies by product and age group

>10%:

Central nervous system: Headache (adolescents 43% to 44%; adults 30% to 34%; older adults 12%), fatigue (adolescents 37%; adults 28%; older adults 13%), chills (8% to 15%; severe <1%)

Endocrine & metabolic: Increased arm circumference (children 30% to 38%; adolescents 28%)

Gastrointestinal: Gastrointestinal symptoms (includes abdominal pain, diarrhea, nausea, and/or vomiting; adolescents 26%; adults 16%; older adults 8%)

Local: Pain at injection site (adolescents 62% to 80%; adults 61% to 66%; older adults 22%), erythema at injection site (21% to 48%; adults 21% to 25%; older adults 11%), swelling at injection site (adolescents 21% to 39%; adults 18% to 21%; older adults 8%)

Neuromuscular & skeletal: Myalgia (22% to 30%; severe: 1%), arthralgia (9% to 11%; severe: <1%)

1% to 10%:

Dermatologic: Skin rash (2% to 3%)

Miscellaneous: Fever (≥38°C [≥100.4°F]: adolescents 5% to 14%; adults 1% to 6%; older adults 2%)

Adacel, Boostrix

<1% (Limited to important or life-threatening): Anaphylaxis, back pain, diabetes mellitus, encephalitis, facial paralysis, Guillain-Barre syndrome, hypersensitivity reaction, hypoesthesia, IgA vasculitis, injection site reaction (bruising, induration, inflammation, mass, nodule, pruritus, sterile abscess, warmth), lymphadenitis, lymphadenopathy, myalgia, myocarditis, myositis, nerve compression, paresthesia, peripheral edema (extensive), pruritus, seizure, syncope, urticaria

Daptacel, Infanrix

<1% (Limited to important or life-threatening): Anaphylaxis, angioedema, apnea, back pain, brain disease, bronchitis, cellulitis, cough, cyanosis, diabetes mellitus, diarrhea, encephalitis, erythema, facial paralysis, fatigue, Guillain-Barre syndrome, headache, hypersensitivity reaction, hypoesthesia, hypotonia, IgA vasculitis, immune thrombocytopenia, infantile spasm, injection site reaction (abscess, bruising, cellulitis, induration, inflammation, mass, nodule, pruritus, sterile abscess, rash, warmth), lymphadenopathy, nausea, otalgia, peripheral edema, pruritus, respiratory tract infection, screaming, seizure, skin rash, sudden infant death syndrome, thrombocytopenia, 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 (NCIRD/ACIP 2011).

• Arthus-type hypersensitivity: Patients with a history of severe local reaction (Arthus-type) following a previous tetanus toxoid dose should not be given further routine or emergency doses of Td more frequently than every 10 years, even if using for wound management with wounds that are not clean or minor; these patients generally have high serum antitoxin levels (NCIRD/ACIP 2011).

• 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.

• 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 (NCIRD/ACIP 2011).

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. Consider deferring 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) (NCIRD/ACIP 2011).

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia) and patients on anticoagulant therapy; 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 (NCIRD/ACIP 2011).

• Guillain-Barré syndrome: Use with caution if Guillain-Barré syndrome occured within 6 weeks of prior tetanus toxoid-containing vaccine.

• Neurologic disorders: Use with caution in patients with history of seizure disorder, progressive neurologic disease, or conditions predisposing to seizures; ACIP guidelines recommend deferring immunization until health status can be assessed and condition stabilized (NCIRD/ACIP 2011).

Concurrent drug therapy issues:

• 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 (NCIRD/ACIP 2011).

Special populations:

• Altered immunocompetence: Use with caution in severely immunocompromised patients (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 (IDSA [Rubin 2014]; NCIRD/ACIP 2011); inactivated vaccines should be administered ≥2 weeks prior to planned immunosuppression when feasible (IDSA [Rubin 2014]).

• Pediatric: Apnea has been reported following IM vaccine administration in premature infants; consider risk versus benefit in infants born prematurely In general, preterm infants should be vaccinated at the same chronological age as full-term infants (NCIRD/ACIP 2011).

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 (NCIRD/ACIP 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).

• 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 ACIP Recommended Adult Immunization Schedule (ACIP [Kim 2016]). 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 (NCIRD/ACIP 2011).

Monitoring Parameters

Monitor for syncope for 15 minutes following administration (NCIRD/ACIP 2011). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Pregnancy Risk Factor

B/C (manufacturer specific)

Pregnancy Considerations

Animal reproduction studies have not been conducted with all products; when conducted, adverse effects to the fetus were not observed in developmental toxicity studies. Inactivated bacterial vaccines have not been shown to cause increased risks to the fetus (NCIRD/ACIP 2011). Daptacel and Infanrix are not recommended for use in a pregnant woman or any patient ≥7 years of age. Using data collected from 2005-2010 VAERS, there were not any patterns of adverse maternal, fetal, or neonatal outcomes identified following maternal use of the Tdap vaccine (Zheteyeva 2012).

All pregnant females should receive a single dose of Tdap during each pregnancy, regardless of previous vaccination status, preferably between 27-36 weeks gestation. Alternately, administration of Tdap can be given immediately postpartum to all women who have not previously been vaccinated with Tdap in order to protect the mother and infant from pertussis (CDC/ACIP 62[7] 2013). In case of an ongoing local pertussis epidemic, pregnant women should be vaccinated with Tdap for their own protection as is recommended for nonpregnant women, 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 27-36 weeks gestation in these instances, women should not receive more than 1 dose during the same pregnancy (ACOG 2013).

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

Patient Education

• Discuss specific use of vaccine 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 pain, headache, loss of strength and energy, chills, nausea, vomiting, abdominal pain, diarrhea, joint pain, joint edema, enlarged lymph nodes, irritability (children), lack of appetite (children), fatigue (children), or abnormal crying (children). Have patient report immediately to prescriber confusion, severe dizziness, passing out, vision changes, seizures, burning or numbness feeling, muscle weakness, abnormal movements, or severe injection site irritation (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 healthcare 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.

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