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|Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine

Diphtheria/Tetanus Toxoids/Acellular Pertussis Vaccine

Trade Names:
Boostrix
- Injection 2.5 Lf units diphtheria toxoid, 5 Lf units tetanus toxoid, 2.5 mcg pertactin, 8 mcg FHA, 8 mcg inactivated pertussis toxins per 0.5 mL

Trade Names:
Daptacel
- Injection 15 Lf units diphtheria toxoid, 5 Lf units tetanus toxoid, 10 mcg pertussis toxoid, 5 mcg FHA, 3 mcg pertactin, 5 mcg fimbriae types 2 and 3 per 0.5 mL

Trade Names:
Infanrix
- Injection 25 Lf units diphtheria, 10 Lf units tetanus toxoid, 25 mcg pertussis toxin, 25 mcg FHA, 8 mcg pertactin per 0.5 mL

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

Mechanism of Action

Pharmacology

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

Indications and Usage

Active booster immunization against diphtheria, tetanus, and pertussis as a single dose in individuals 10 through 18 yr of age.

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

Contraindications

Adults and children 7 yr and older; encephalopathy within 7 days of previous administration of DTP or DTaP that is not attributable to another cause; progressive neurologic disorders (eg, infantile spasms, uncontrolled epilepsy, progressive encephalopathy) in addition, pertussis vaccine should not be administered to individuals with these conditions until a treatment regimen has been established and condition has stabilized; 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.

Adults and children 7 yr of age and older; if contraindication to pertussis vaccine component occurs, substitute diphtheria and tetanus toxoids for pediatric use (DT) for each remaining dose; defer elective immunization procedures during outbreak of poliomyelitis because of risk of provoking paralysis.

Dosage and Administration

It is recommended that the same brand of DTaP be given for all doses in the immunization series because no data exist on the interchangeability of DTaP vaccines.

IM 0.5 mL.

IM Immunization is 4 doses of 0.5 mL at 2, 4, and 6 mo of age, at intervals of 6 to 8 wk and at 17 to 20 mo of age. The interval between the third and fourth dose should be at least 6 mo.

IM Primary immunization series is 3 doses of 0.5 mL at 4- to 8-wk intervals (preferably 8 wk). Customarily, the first dose is 2 mo of age (but may be given at 6 wk of age). A fourth dose (booster immunization) is recommended at 15 to 20 mo of age (interval between third and fourth dose at least 6 mo). A fifth dose is recommended at 4 to 6 yr of age in those who received all 4 doses by the fourth birthday. If the fourth dose is given after the fourth birthday, a fifth dose prior to school entry is not necessary.

IM Primary immunization series is 3 doses of 0.5 mL at 4- to 8-wk intervals. A fourth dose is recommended at 15 to 20 mo of age (interval between third and fourth dose at least 6 mo). A fifth dose is recommended at 4 to 6 yr of age, preferably prior to school entry. If the fourth dose is 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 the series.
• 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. No not use if particulate matter or discoloration are noted or if vaccine cannot be resuspended.
• Rotate vial or syringe in palm to bring contents to room temperature before administering and administer immediately.
• Discard any vaccine remaining in the vial after withdrawing dose.
• Administer IM in anterolateral thigh in infants (younger than 1 yr of age) or the deltoid muscle of the upper arm (for older children). Avoid injection into gluteal area or areas where there may be a major nerve trunk or blood vessel.
• May administer vaccine in conjunction with injectable polio, Haemophilus influenza type b, hepatitis B, Varicella, and measles, mumps, pneumococcal conjugate, and rubella virus vaccines using separate syringes and different sites for administration.
• Tripedia may be used to reconstitute ActHIB vaccine for administration of fourth dose to children 15 to 18 mo of age.
• 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 (36° to 46°F). Do not freeze. Discard if vaccine has been frozen.

Drug Interactions

Give DTaP with caution to patients on anticoagulant therapy.

May reduce vaccine"s effectiveness.

To attribute causality of adverse reactions, do not give influenza vaccine within 3 days of pertussis vaccination.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Myocarditis (postmarketing).

CNS

Drowsiness; brachial neuritis; Guillain-Barré syndrome; neurological complications (including cochlear lesions, brachial plexus neuropathies, paralysis of radial nerve, paralysis of recurrent nerve, accommodation paresis, EEG disturbances with encephalopathy); convulsions, hypotonia, hypotonic-hyporesponsive episode, irritability, somnolence (postmarketing).

Fatigue, headache; convulsions, encephalitis, facial palsy, paresthesia (postmarketing).

Dermatologic

Erythema, pruritus, rash, urticaria (postmarketing).

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

EENT

Ear pain (postmarketing).

GI

Anorexia; vomiting; diarrhea, intussusception (postmarketing).

Abdominal pain, diarrhea, nausea, vomiting.

Hematologic-Lymphatic

Idiopathic thrombocytopenic purpura, lymphadenopathy, thrombocytopenia (postmarketing).

Lymphadenitis, lymphadenopathy (postmarketing).

Hypersensitivity

Anaphylactic reactions; arthus-type hypersensitivity.

Local

Redness; swelling; pain.

Pain, redness, swelling, increase arm circumference, induration, inflammation, mass, nodule, warmth, local reaction, extensive swelling of injected limb (postmarketing).

Metabolic-Nutritional

Insulin-dependent diabetes mellitus (postmarketing).

Musculoskeletal

Arthralgia, back pain, myalgia (postmarketing).

Respiratory

Respiratory tract infection (postmarketing).

Miscellaneous

Fever; crying (for 3 hr or more); irritability; fussiness; cellulitis, cyanosis, injection site reactions, limb swelling, sudden infant death (postmarketing).

Fever.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

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

Not indicated for use in patients younger than 10 yr or older than 18 yr of age.

Special Risk Patients

If any of the following occurs in temporal relation with receipt of either whole-cell pertussis DTP or DTaP, carefully consider decision to administer subsequent doses of vaccine containing pertussis component: temperature of at least 105°F within 48 hr, not caused by another identifiable cause; collapse or shock-like state (hypotonic-hyporesponsive episode) within 48 hr; persistent inconsolable crying lasting at least 3 hr, occurring within 48 hr; or convulsions, with or without fever, occurring within 3 days. If the decision is made to withhold pertussis component, continue immunization with DT (dT if 7 yr of age or older). If Guillain-Barré syndrome occurs within 6 wk of receipt of prior vaccine containing tetanus toxoids, base decision to give subsequent doses of DTaP or any vaccine containing tetanus toxoids on potential benefits versus risks. Patients who experience serious Arthus-type hypersensitivity reactions following a prior dose of tetanus toxoids usually have high serum tetanus antitoxin levels and should not be given Td or DTaP vaccines or even emergency doses of Td more frequently than every 10 yr, even if wound is neither clean nor minor.

Bleeding disorders

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

Convulsions/CNS disorders

Family history of seizures or other CNS disorders is not a contraindication to pertussis vaccine.

Febrile illness or acute infection

Defer immunization during course of illness. Minor respiratory illness, such as mild upper respiratory tract infection, is usually not a reason to defer immunization.

Immunodeficiency

May have diminished antibody response; defer immunization, if possible, until immunocompetency is restored.

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 individuals.

Overdosage

Symptoms

None noted.

Patient Information

• Explain name, action, and potential side effects 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.
• Review immunization schedule.
• Provide parent or guardian with immunization history record and record this immunization in patient"s immunization record.
• Advise 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 hr, 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, tiredness, poor appetite, vomiting.
• Advise parent or guardian to use non-aspirin containing OTC analgesics (eg, acetaminophen, ibuprofen) for fever, pain, or discomfort at injection site.
• Instruct parent or guardian to immediately notify health care provider if: child develops fever of 105°F or more; faints or persistently cries for more than 3 hours within 48 hr of receiving vaccine; 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 occur within 7 days of receiving vaccination.