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Diphtheria / Tetanus Toxoids / Acellular Pertussis Vaccine

( DTaP/Tdap )

Pronunciation: dif-THEER-ee-a/TET-a-nus/aye-SELL-yoo-ler per-TUS-is
Class: Vaccine, combination

Trade Names

Adacel
- Injection, suspension diphtheria toxoid 2 Lf units, tetanus toxoid 5 Lf units, acellular pertussis antigens (pertactin 3 mcg, filamentous hemagglutinin [FHA] 5 mcg, detoxified pertussis toxins 2.5 mcg, fimbriae types two and three 5 mcg) per 0.5 mL

Boostrix
- Injection, suspension diphtheria toxoid 2.5 Lf units, tetanus toxoid 5 Lf units, acellular pertussis antigens (pertactin 2.5 mcg, FHA 8 mcg, inactivated pertussis toxins 8 mcg) per 0.5 mL

Daptacel
- Injection, suspension diphtheria toxoid 15 Lf units, tetanus toxoid 5 Lf units, acellular pertussis antigens (pertussis toxoid 10 mcg, FHA 5 mcg, pertactin 3 mcg, fimbriae types two and three 5 mcg) per 0.5 mL

Infanrix
- Injection, suspension diphtheria 25 Lf units, tetanus toxoid 10 Lf units, acellular pertussis antigens (inactivated pertussis toxin 25 mcg, FHA 25 mcg, pertactin 8 mcg) per 0.5 mL

Tripedia
- Injection, suspension diphtheria toxoid 6.7 Lf units, tetanus toxoid 5 Lf units, pertussis antigens 46.8 mcg (approximately 23.4 mcg each of inactivated pertussis toxin and FHA) per 0.5 mL

Pharmacology

Diphtheria and tetanus toxoids induce antibodies against toxins made by Corynebacterium diphtheriae and Clostridium tetani . Pertussis vaccine protects against Bordetella pertussis .

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Indications and Usage

Per CDC, Tdap is for use in adults and children 10 to 64 yr of age, and DTaP is for use in infants and children younger than 7 yr of age.

Adacel (Tdap)

Active booster immunization against diphtheria, tetanus, and pertussis in persons 11 to 64 yr of age.

Boostrix (Tdap)

Active booster immunization against diphtheria, tetanus, and pertussis in persons 10 to 64 yr of age.

Daptacel , Infanrix , Tripedia (DTaP)

Active immunization against diphtheria, tetanus, and pertussis in infants and children 6 wk up to 7 yr of age (prior to seventh birthday).

Contraindications

Encephalopathy within 7 days of previous administration of any pertussis-containing vaccine that is not attributable to another cause; hypersensitivity to any component of the vaccine; history of serious allergic reaction temporarily associated with a previous dose of vaccine or any component of the vaccine.

Daptacel , Infanrix , Tripedia

Progressive neurologic disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy) until a treatment regimen has been established and condition has stabilized; if contraindication to pertussis vaccine component occurs, substitute diphtheria and tetanus toxoids adsorbed for pediatric use (DT) for each remaining dose.

Dosage and Administration

Adacel (Tdap)
Adults and Children 11 yr of age and older

IM 0.5 mL as a single dose.

Boostrix (Tdap)
Adults and Children 10 to 64 yr of age

IM 0.5 mL as a single dose.

Daptacel (DTaP)
Infants and Children 6 wk up to 7 yr of age (prior to seventh birthday)

IM Immunization is a 5-dose series of 0.5 mL at 2, 4, and 6 mo of age (at intervals of 6 to 8 wk); at 15 to 20 mo of age; and at 4 to 6 yr of age.

Infanrix (DTaP)
Infants and Children 6 wk up to 7 yr of age (prior to seventh birthday)

IM Immunization is a 5-dose series of 0.5 mL at 2, 4, and 6 mo of age; at 15 to 20 mo of age; and at 4 to 6 yr of age. The first dose may be given as early as 6 wk of age. The recommended interval between the first 3 doses is 4 to 8 wk.

Tripedia (DTaP)
Infants and Children 6 wk up to 7 yr of age (prior to the seventh birthday)

IM Immunization is a 5-dose series of 0.5 mL at 2, 4, and 6 mo of age; at 15 to 18 mo of age; and at 4 to 6 yr of age. The first dose may be given as early as 6 wk. The recommended interval between the first 3 doses is 4 to 8 wk. The recommended interval between the third and fourth dose is 6 to 12 mo. The fifth dose is recommended before entry into kindergarten or elementary school. If the fourth dose was given after the fourth birthday, a fifth dose prior to school entry is not necessary.

General Advice

  • For IM administration only. Not for intradermal, subcutaneous, IV, or intra-arterial administration.
  • Have epinephrine injection and other appropriate agents and equipment immediately available should an acute anaphylactic reaction occur.
  • Attempt to use the same brand of vaccine for the entire series; however, when this is not possible, use any DTaP vaccine to continue or complete series.
  • Tdap vaccines ( Adacel , Boostrix ) are not interchangeable with DTaP vaccines.
  • Interruption of recommended schedule with a delay between doses does not interfere with development of final immunity. There is no need to start the series over again.
  • Use vaccine as supplied; no dilution or reconstitution is necessary. Do not mix with any other vaccine in the same vial or syringe.
  • Shake vial or syringe vigorously immediately prior to use to obtain a uniform suspension. Suspension should be homogeneous and white. Do not use if particulate matter or discoloration is noted or if vaccine cannot be resuspended.
  • Rotate vial or syringe in palm to bring contents to room temperature before administering; administer immediately.
  • Discard any vaccine remaining in vial after withdrawing dose.
  • Administer IM in anterolateral thigh in infants (younger than 1 yr of age) or deltoid muscle of upper arm (for older children and adults). Avoid injection into gluteal area or areas where there may be a major nerve trunk or blood vessel.
  • May administer DTaP vaccine in conjunction with injectable polio (IPV), Haemophilus influenza type b (Hib), hepatitis B, hepatitis A, varicella, MMR, pneumococcal conjugate, and seasonal influenza vaccines using separate syringes and different sites for administration.
  • Tripedia may be used to reconstitute Haemophilus b conjugate vaccine for administration of fourth dose to children 15 to 18 mo of age.
  • Tdap : 5 yr should have elapsed since the person's last dose of tetanus toxoid, diphtheria, and/or pertussis-containing vaccine.
  • Always record manufacturer's name and vaccine lot number in patient's permanent medical record file, along with date of administration and name and title of person administering vaccine.

Storage/Stability

Store vials and syringes in refrigerator (35° to 46°F). Do not freeze. Discard if vaccine has been frozen.

Drug Interactions

Anticoagulants

Administer DTaP/Tdap with caution to patients on anticoagulant therapy.

Immunosuppressants (eg, alkylating agents, antimetabolites, corticosteroids [in greater than physiologic doses], cytotoxic agents, irradiation)

May reduce efficacy of the vaccine.

Adverse Reactions

Cardiovascular

Adacel

Myocarditis (postmarketing).

Boostrix

Myocarditis (postmarketing).

Daptacel

Cyanosis (postmarketing).

Infanrix

Cyanosis (postmarketing).

CNS

Adacel

Headache (44%); tiredness (30%); convulsions, hypesthesia, facial palsy, paresthesia, syncope (postmarketing).

Boostrix

Headache (43%); fatigue (37%); convulsion, encephalitis, facial palsy, paresthesia (postmarketing).

Daptacel

Fussiness (76%); fretfulness (40%); drowsiness (33%); convulsions, febrile convulsion, grand mal convulsion, hypotonia, hypotonic-hyporesponsive episode, partial seizures, screaming, somnolence (postmarketing).

Infanrix

Irritability (54%); drowsiness (36%); anorexia (25%); encephalopathy, hypotonia (postmarketing).

Tripedia

Drowsiness (42%); irritability (35%); fussiness (19%); loss of appetite (15%); encephalopathy, hypotonia, neuropathy, seizures/tonic-clonic seizures, somnolence (postmarketing).

Dermatologic

Adacel

Rash (3%); pruritus, urticaria (postmarketing).

Boostrix

Exanthem, Henoch-Schönlein purpura, rash, urticaria (postmarketing).

Infanrix

Erythema, pruritus, rash, urticaria (postmarketing).

EENT

Infanrix

Ear pain (postmarketing).

GI

Adacel

Nausea (13%); diarrhea (10%); vomiting (5%).

Boostrix

GI symptoms including abdominal pain, diarrhea, nausea, vomiting (26%).

Daptacel

Anorexia (11%); vomiting (7%); diarrhea, nausea (postmarketing).

Tripedia

Anorexia (22%); vomiting (7%); diarrhea (6%).

Hematologic-Lymphatic

Adacel

Lymph node swelling (7%).

Boostrix

Lymphadenitis, lymphadenopathy (postmarketing).

Infanrix

Lymphadenopathy, thrombocytopenia (postmarketing).

Tripedia

Idiopathic thrombocytopenic purpura (postmarketing).

Hypersensitivity

Adacel

Anaphylactic reaction; hypersensitivity reaction including angioedema, edema, hypotension, rash (postmarketing).

Daptacel

Allergic reaction; anaphylactic reaction including edema, face edema, face swelling, generalized rash and other types of rash, pruritus; hypersensitivity (postmarketing).

Infanrix

Anaphylactic reaction, hypersensitivity (postmarketing).

Tripedia

Anaphylactic reaction (postmarketing).

Local

Adacel

Pain (78%); erythema (25%); swelling (21%); extensive limb swelling, large injection-site reactions (greater than 50 mm), injection-site bruising, sterile abscess (postmarketing).

Boostrix

Pain (75%); redness (48%); swelling (39%); increase in arm circumference (28%); extensive swelling, induration, inflammation, local reaction, mass, nodule, pruritus, warmth (postmarketing).

Daptacel

Tenderness (62%); increased arm circumference (38%); redness (36%); swelling (24%); cellulitis, abscess, extensive swelling, injection-site rash, mass, nodule, pain (postmarketing).

Infanrix

Redness (50%); pain (48%); increase in mid-thigh circumference, swelling (33%); injection-site reactions (postmarketing).

Tripedia

Swelling (61%); redness (60%); tenderness (46%); pain (21%).

Musculoskeletal

Adacel

Body ache or muscle weakness (30%); sore and swollen joints (11%); muscle spasms, myelitis, myositis (postmarketing).

Boostrix

Arthralgia, back pain, myalgia (postmarketing).

Infanrix

Limb swelling (postmarketing).

Respiratory

Infanrix

Respiratory tract infection (postmarketing).

Tripedia

Apnea (postmarketing).

Miscellaneous

Adacel

Chills (15%); fever (5%).

Boostrix

Fever (14%).

Daptacel

Crying (59%); decreased activity (51%); fever (24%).

Infanrix

Fever (15%); cellulitis, crying, sudden infant death syndrome (postmarketing).

Tripedia

Fever (25%); crying (2%); autism, cellulitis, sudden infant death syndrome (postmarketing).

Precautions

Monitor

When child returns for next dose in series, question parent or guardian about serious adverse reactions with previous dose. Note any adverse reactions that would contraindicate additional pertussis vaccine; if reactions are observed, complete immunization series with diphtheria and tetanus toxoids adsorbed (DT) for pediatric use.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Adacel

Safety and efficacy not established in children younger than 11 yr of age.

Boostrix

Not indicated for use in patients younger than 10 yr of age.

Daptacel , Infanrix , Tripedia

Safety and efficacy in infants younger than 6 wk of age not established; not for use in persons 7 yr of age and older.

Elderly

Adacel , Boostrix

Safety and efficacy not established in persons 65 yr of age and older.

Special Risk Patients

If any of the following occurs in temporal relation with receipt of a pertussis-containing vaccine, carefully consider decision to administer subsequent doses of vaccine containing pertussis component: temperature of at least 105°F within 48 h not caused by another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 h; persistent inconsolable crying lasting at least 3 h and occurring within 48 h; or convulsions, with or without fever, occurring within 3 days. If the decision is made to withhold pertussis component, continue immunization with DT for pediatric use (tetanus and diphtheria toxoids for adult use [Td] if 7 yr of age and older).

Adacel

Generally defer vaccination in the following situations: in adolescents with progressive neurologic disorder, including progressive encephalopathy or uncontrolled epilepsy, until the condition has stabilized; in adults with unstable neurologic conditions (eg, cerebrovascular events and acute encephalopathic conditions) until the condition has resolved or stabilized.

Arthus-type hypersensitivity

Persons who experience an Arthus-type hypersensitivity reaction following prior administration of a tetanus toxoid–containing vaccine usually have a high serum tetanus antitoxin level and should not receive a tetanus toxoid–containing vaccine unless at least 10 yrs have elapsed since the last dose of a tetanus-containing vaccine.

Bleeding disorders

Use with caution in patients with bleeding disorders (eg, hemophilia, thrombocytopenia) or who are receiving anticoagulant therapy.

Convulsions/CNS disorders

Family history of seizures or other CNS disorders is not a contraindication to pertussis vaccine. For children at higher risk of seizures, an antipyretic may be given at the time of vaccination and for the following 24 h to reduce the possibility of postvaccination fever.

Febrile illness or acute infection

Defer immunization during course of moderate or severe illness with or without fever. Minor respiratory illness, such as mild upper respiratory tract infection, is usually not a reason to defer immunization.

Guillain-Barré syndrome and brachial neuritis

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, base the decision to give subsequent doses of any tetanus toxoid–containing vaccine on careful consideration of the potential benefits and possible risks. There is a causal relationship between administration of tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome.

Immunodeficiency

May have diminished antibody response.

Latex sensitivity

Stoppers for Daptacel and Tripedia vials, and tip cap and rubber plunger of Infanrix and Boostrix needleless prefilled syringes contain dry natural latex rubber that may cause allergic reactions in latex-sensitive persons.

Neurologic disorders

Progressive neurologic disorder, uncontrolled epilepsy, progressive encephalopathy, or unstable neurological conditions are considered reasons to defer DTaP or Tdap vaccination.

Overdosage

Symptoms

None well documented.

Patient Information

  • Explain name, action, and potential adverse reactions of vaccine. Review benefits and risks of the vaccine and importance of completing the immunization series.
  • Provide and review the Vaccine Information Statements prior to immunization. These materials are available at the CDC Web site ( http://www.cdc.gov/vaccines/ ).
  • Review immunization schedule.
  • Provide parent or guardian with immunization history record and record this immunization in patient's immunization record.
  • Advise patient, or parent or guardian of child with history of seizures or family member with seizure disorder that controlling fever after vaccination is very important. Advise parent or guardian to give the child an aspirin-free pain reliever (eg, acetaminophen, ibuprofen) when the shot is given and for the next 24 h, following package instructions.
  • Advise parent or guardian that the following problems occur frequently within 1 to 3 days after vaccination but are generally mild: fussiness, poor appetite, tiredness, vomiting.
  • Advise patient, parent, or guardian to use nonaspirin-containing OTC analgesics (eg, acetaminophen, ibuprofen) for fever, pain, or discomfort at injection site.
  • Advise patient, parent, or guardian to immediately notify health care provider if vaccine recipient develops fever of 105°F or more, faints, persistently cries for more than 3 h within 48 h of receiving vaccine, or has a seizure with or without fever within 7 days of receiving vaccine.
  • Instruct parent or guardian to immediately notify health care provider if change in mental alertness or unresponsiveness occurs within 7 days of receiving vaccination.

Copyright © 2009 Wolters Kluwer Health.

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