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 dose of Tdap for Td booster; ensure continued protection against tetanus and diphtheria, booster doses of either Td or Tdap should be administered every 10 yr throughout life

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

Adacel

  • 0.5 mL IM; 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

Regardless of the interval since their last tetanus or diphtheria toxoid-containing vaccine, persons aged ≥19 yr who have never received a dose of Tdap should receive 1 dose of Tdap

To ensure continued protection against tetanus and diphtheria, booster doses of either Td or Tdap should be administered every 10 yr throughout life (MMWR January 24, 2020 / 69(3);77-83)

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; approved for individuals aged ≥10 yr

Adacel

  • 0.5 mL IM; 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

CDC ACIP general recommendations

  • 11-18 years: A single dose of Tdap, preferably at a preventive care visit at age 11-12 years
  • To ensure continued protection against tetanus and diphtheria, 1 booster dose of either Td or Tdap should be administered every 10 yr throughout life (MMWR January 24, 2020 / 69(3);77-83)

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 either Td or Tdap 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 or Tdap every 10 years

≥19 years who did previously receive dose of Tdap: Administer 1 dose of Tdap; to ensure continued protection against tetanus and diphtheria, booster doses of either Td or Tdap should be administered every 10 yr throughout life

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 to 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; however, if Tdap is administered at age 10 years, the Tdap dose may count as the adolescent Tdap dose
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Interactions

Interaction Checker

and tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • ixekizumab

                ixekizumab decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating ixekizumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with ixekizumab may not elicit an immune response sufficient to prevent disease.

              • secukinumab

                secukinumab decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Prior to initiating secukinumab, complete all age appropriate immunizations; non-live vaccinations received during treatment with secukinumab may not elicit an immune response sufficient to prevent disease.

              • siponimod

                siponimod decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Pause vaccinations beginning 1 week before initiating siponimod and for 4 weeks after stopping treatment. Coadministration with live attenuated vaccines may increase infection risk.

              Monitor Closely (4)

              • certolizumab pegol

                certolizumab pegol decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Use Caution/Monitor.

              • ifosfamide

                ifosfamide decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              • melphalan

                melphalan decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by pharmacodynamic antagonism. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              • oxaliplatin

                oxaliplatin decreases effects of tetanus & reduced diphtheria toxoids/ acellular pertussis vaccine by passive renal tubular reabsorption due to increased pH. Modify Therapy/Monitor Closely. Coadministration with immunosuppressant therapy reduced efficacy of the vaccine may occur. If possible, complete all age-appropriate vaccinations at least 2 weeks prior to initiation of immunosuppressant therapy. Patients vaccinated <14 days before initiation or during immunosuppressive therapy should be revaccinated at least 3 months after therapy is discontinued. .

              Minor (0)

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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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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                Adacel (Tdap Adolescent/Adult)(PF) intramuscular
                -
                2 Lf-(2.5-5-3-5 mcg)-5Lf/0.5 mL solution
                Adacel (Tdap Adolescent/Adult)(PF) intramuscular
                -
                2 Lf-(2.5-5-3-5 mcg)-5Lf/0.5 mL solution
                Adacel (Tdap Adolescent/Adult)(PF) intramuscular
                -
                2 Lf-(2.5-5-3-5 mcg)-5Lf/0.5 mL vial

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                diphtheria,pertussis(acel)tetanus vaccine (PF) intramuscular

                DIPHTHERIA/TETANUS/ACELLULAR PERTUSSIS VACCINE - INJECTION

                (dip-THEER-ee-uh/TET-un-us/per-TUSS-iss)

                COMMON BRAND NAME(S): Adacel, Boostrix

                USES: This vaccine is used to keep up protection (immunity) against diphtheria, tetanus (lockjaw) and pertussis (whooping cough) in children and adults who have been vaccinated for these diseases in the past. Vaccination is the best way to protect against these life-threatening diseases. Vaccines work by causing the body to produce its own protection (antibodies). Booster doses are needed to keep up immunity because antibody levels may become too low over time to provide the needed protection.

                HOW TO USE: Read all vaccine information available from your health care professional before receiving the vaccine. If you have any questions, ask your health care professional.This medication is given by injection into a muscle by a health care professional. It is usually given in the upper arm.This vaccine may be given at the same time as other vaccines (such as hepatitis B) using a separate needle and injection site.

                SIDE EFFECTS: Pain, swelling, or redness at the injection site may occur. Headache, tiredness, body aches, nausea, diarrhea, fever, chills, vomiting, or sore/swollen joints may also occur. Acetaminophen or ibuprofen (non-aspirin) may be used to reduce soreness. If any of these effects persist or worsen, tell your health care professional promptly.Rarely, some people have symptoms such as fainting, dizziness, vision changes, or ringing in the ears just after getting a vaccine injection. Tell your health care professional right away if you have any of these symptoms. Sitting or lying down may help, since these symptoms usually don't last long.Remember that your health care professional has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your health care professional right away if you have any serious side effects, including: high fever (higher than 104 degrees F/40 degrees C), seizures, numbness/tingling, muscle weakness, difficulty breathing.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your health care professional.Contact the health care professional for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call the Vaccine Safety Section at Public Health Agency of Canada at 1-866-844-0018.

                PRECAUTIONS: Before receiving this vaccination, tell your health care professional if you are allergic to it; or to any other vaccines; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your health care professional for more details.Before receiving this vaccine, tell your health care professional your medical history, especially of: nervous system disorders (e.g., seizures, encephalopathy, Guillain-Barre syndrome), current illness/infection, immune system disorders (such as due to HIV infection, certain cancers such as leukemia/lymphoma, cancer or radiation treatment), vaccination history including previous reactions to any vaccines.During pregnancy, this vaccine is usually recommended. Discuss the risks and benefits with your health care professional.It is unknown if this vaccine passes into breast milk. Consult your health care professional before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your health care professional. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this vaccine include: drugs that weaken the immune system (including cyclosporine, tacrolimus, cancer chemotherapy, corticosteroids such as prednisone), other vaccines (e.g., diphtheria/tetanus toxoids).

                OVERDOSE: Not applicable.

                NOTES: There are various combinations of vaccines available. Based on your age, vaccination history, and previous reaction to vaccines, your health care professional will determine the most appropriate one for you. Discuss the risks and benefits of vaccination with your health care professional.History of infection with tetanus or diphtheria does not always protect against future infections with these bacteria. You should still receive this vaccine if your health care professional orders it for you.

                MISSED DOSE: It is important to receive each vaccination as scheduled. Be sure to make a note of when the vaccination was last given for your medical record.

                STORAGE: Store in the refrigerator. Do not freeze. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised March 2020. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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