tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine (Rx)

Brand and Other Names:Adacel, Boostrix, more...Tdap
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Lf = limits of flocculation

pertussis/diphtheria/tetanus

injection for suspension

  • (15.5mcg/2Lf/5Lf)/0.5mL (Adacel)
  • (18.5mcg/2.5Lf/5Lf)/0.5mL (Boostrix)

Immunization

Indicated for active booster immunization against tetanus, diphtheria, and pertussis as a single dose; substitute 1-time dose of Tdap for Td booster, then boost with Td every 10 yr

Boostrix: 0.5 mL IM once; approved for individuals aged ≥10 yr

Adacel

  • 0.5 mL IM once; approved for individuals aged 10-64 yr
  • Routine booster vaccination
    • First dose: Administer ≥5 yr after the last dose of diphtheria and tetanus toxoids and acellular pertussis (DTaP) series or after a dose of tetanus and diphtheria toxoids adsorbed (Td)
    • May administer a second dose ≥8 yr after the first dose of Tdap
  • Wound management
    • May administer for tetanus prophylaxis for wound management
    • Booster dose may be administered if >5 yr have elapsed since previous receipt of a tetanus toxoid containing vaccine

CDC ACIP Recommendations

  • CDC recommends that all adults aged ≥65 yr who have not previously received Tdap should receive 1 Tdap booster dose in place of Td (ACIP; February 2012)
  • Indicated for adults (including those aged ≥65 yr) who have not previously received Tdap and who have or who anticipate having close contact with infants <12 months (eg, parents, grandparents, childcare providers, healthcare workers); from ACIP revised recommendations MMWR January 14, 2011 / 60(01);13-15
  • Also indicated for healthcare personnel, regardless of age, in hospitals or ambulatory care settings who have direct patient contact and have not previously received Tdap; ACIP revised recommendations for healthcare personnel February 23, 2011 (Fall 2011 scheduled publication in MMWR)

Immunization During Pregnancy

Administer Tdap vaccine to pregnant women to reduce morbidity and mortality associated with pertussis in infants <2 months

The CDC's Advisory Committee on Immunization Practices (ACIP) recommends all pregnant women receive 1 dose of Tdap during each pregnancy ideally between 27 and 36 weeks of gestation regardless of vaccination history and time since prior Td or Tdap

Dosage Forms & Strengths

Lf = limits of flocculation

pertussis/diphtheria/tetanus

injection for suspension

  • (15.5mcg/2Lf/5Lf)/0.5mL (Adacel)
  • (18.5mcg/2.5Lf/5Lf)/0.5mL (Boostrix)

Routine Vaccination

Indicated as active booster immunization for prevention of tetanus, diphtheria (not indicated for primary immunization series)

Boostrix: 0.5 mL IM once; approved for individuals aged ≥10 yr

Adacel

  • 0.5 mL IM once; approved for individuals aged ≥10 yr
  • Routine booster vaccination
    • First dose: Administer ≥5 yr after the last dose of diphtheria and tetanus toxoids and acellular pertussis (DTaP) series or after a dose of tetanus and diphtheria toxoids adsorbed (Td)
    • May administer a second dose ≥8 yr after the first dose of Tdap
  • Wound management
    • May administer for tetanus prophylaxis for wound management
    • Booster dose may be administered if >5 yr have elapsed since previous receipt of a tetanus toxoid containing vaccine

Catch-up Vaccination

≥7 years who are not fully immunized with DTaP vaccine: Administer a single-dose Tdap vaccine (preferably the first) dose in the catch-up series; if additional doses are needed, use Td vaccine

Children 7-10 years who receive a dose of Tdap as part of the catch-up series: Administer an adolescent Tdap vaccine dose at age 11-12 years

11-18 years: Administer booster of Td every 10 years

≥19 years who did previously receive dose of Tdap: Administer 1 dose in place of the decennial Td booster dose

Immunization During Pregnancy

Administer Tdap vaccine to pregnant adolescents to reduce morbidity and mortality associated with pertussis in infants <2 months

The CDC's Advisory Committee on Immunization Practices (ACIP) recommends all pregnant females receive 1 dose of Tdap during each pregnancy ideally between 27 and 36 weeks of gestation regardless of vaccination history and time since prior Td or Tdap

Dosing Considerations

Inadvertent doses of Tdap vaccine

  • Age 2 months–6 years
    • If Tdap is administered inadvertently instead of DTaP as any one of the first 3 doses of the tetanus-diphtheria-pertussis vaccination series, do not count Tdap dose and administer replacement dose of DTaP
    • If Tdap is administered inadvertently as fourth or fifth dose in tetanus-diphtheria-pertussis vaccination series, count Tdap dose as valid and do not replace; administer adolescent Tdap dose as recommended when this child is aged 11–12 years
  • Age 7-10 years
    • Children aged 7–10 years who are fully vaccinated: If Tdap is administered inadvertently, do not count Tdap dose as valid
    • Administer adolescent Tdap dose as recommended when child is 11–12 years
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Interactions

Interaction Checker

and tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine

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            Adverse Effects

            >10% (Boostrix)

            Pain (21.5%)

            Fatigue (12.5%)

            Headache (11.5%)

            Redness (10.8%)

            Swelling (7.5%)

            >10% (Adacel)

            Any injection site pain (65.7-77.8%)

            Malaise (30.8-33.3%)

            Headache (33.9-43.7%)

            Body ache or muscle weakness (21.9-30.4%)

            Tiredness (24.3-30.2%)

            Any injection site erythema (20.8-24.7%)

            Any injection site swelling (20.9-21%)

            Moderate injection site pain (15.1-18%)

            Chills (8.1-15.1%)

            Nausea (9.2-13.3%)

            Sore and swollen joints (9.1-11.3%)

            Diarrhea (10.3%)

            1-10% (Boostrix)

            Gastrointestinal symptoms (7.6%)

            Swelling (7.5%)

            Fever (≥99.5°F [37.5°C])

            1-10% (Adacel)

            Body aches/muscle weakness (1.2-8.5%)

            Injection site erythema (2.7-8.4%)

            Lymph node swelling (6.5-6.6%)

            Injection site swelling (2.8-6.4%)

            Fever (1.4-5%)

            Vomiting (3-4.6%)

            Chills, moderate (1.3-3.2%)

            Nausea (1-3.2%)

            Rash (2-2.7%)

            Joint pain, moderate (2.5%)

            Severe injection site reactions (1.1-1.5%)

            Lymphadenopathy (1%)

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            Warnings

            Contraindications

            Hypersensitivity

            Encephalopathy with 7 days of previously administered pertussis antigen

            History of Arthus reaction to prior tetanus vaccination (unless 10 yr have elapsed)

            Cautions

            Epinephrine and other emergency equipment should be available to respond to hypersensitivity reactions

            Not indicated for primary vaccination series; for children aged 6 months-7 yr, see DTaP

            Caution if Guillain-Barré syndrome and brachial neuritis has occurred with previously administered tetanus toxoid

            Caution with neurologic disorders (eg, epilepsy, CVA, encephalopathic condition)

            Defer vaccine if moderate or severe illness present

            Syncope has been associated with administration of injectable vaccine

            Attenuated immune response may occur with immunosuppressed conditions (eg, high-dose corticosteroids, use of antineoplastic agents, immunosuppressive illness)

            Prefilled syringes contain natural latex rubber

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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies of administration in pregnant women

            Available data suggest the rates of major birth defects and miscarriage in women who receive Tdap within 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates

            Animal studies

            • Adacel: Two developmental toxicity studies were performed in female rabbits given 0.5 mL (a single human dose) of Adacel twice prior and during gestation
            • Boostrix: Developmental toxicity studies were performed in female rats and New Zealand White rabbits did not observe fetal abnormalities following vaccine administration before mating and during gestation

            Pregnancy registries

            • Clinicians are encouraged to call and register women in the following pregnancy exposure registries
            • Adacel: 1-800-822- 2463 (1-800-VACCINE)
            • Boostrix: 1-888-452-9622

            Lactation

            Unknown if distributed in human breast milk

            Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Active immunization resulting in development of neutralizing antibodies to tetanus, diphtheria, and pertussis toxins

            These products convey active immunity via stimulation of production of endogenously produced antibodies

            Pharmacokinetics

            The onset of protection from disease is relatively slow, but duration is long lasting (years)

            Duration: Variable, possibly >10 yr; Tdap maternal pertussis antibodies appear to wane greatly between subsequent pregnancies

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            Administration

            IM Preparation

            Shake vigorously to obtain a homogeneous, turbid, white suspension before administration; do not use if resuspension does not occur with vigorous shaking

            Visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit

            Adacel or Boostrix vial: Withdraw 0.5 mL dose from vial using a sterile needle and syringe

            IM Administration

            IM administration only

            Do not administer IV, intradermally, or SC

            Storage

            All formulations: Refrigerate between 2-8°C (36-46°F); do not freeze

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.