Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine

• If you have an allergy to any part of diphtheria and tetanus toxoids, and acellular pertussis vaccine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have seizures or any other brain or nervous system problem.
• If you have had a brain problem like coma, lowered level of awareness, or seizures from an unknown cause within 7 days of a previous vaccine that has pertussis.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take diphtheria and tetanus toxoids, and acellular pertussis vaccine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take diphtheria and tetanus toxoids, and acellular pertussis vaccine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to diphtheria and tetanus toxoids, and acellular pertussis vaccine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

• Acellular Pertussis
• Diphth/Tetanus/Acel. Pertussis
• Diphtheria
• DTaP
• Pertussis
• Tdap
• Tetanus
• Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis, Adsorbed
• Tripedia

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)

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.

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

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).

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 (Groups A / C / Y and W-135) Diphtheria Conjugate Vaccine: Diphtheria and Tetanus Toxoids, and Acellular Pertussis Vaccine may diminish the therapeutic effect of Meningococcal (Groups A / C / Y and W-135) Diphtheria Conjugate Vaccine. More specifically, prior administration of the diphtheria and tetanus toxoids, and acellular pertussis vaccine may diminish antibody response to the meningococcal (groups A / C / Y / and W-135) diphtheria conjugate vaccine in some patients. Management: Administer the meningococcal (groups A / C / Y and W-135) diphtheria conjugate vaccine (Menactra brand) before or concurrently with the diphtheria and tetanus toxoids, and acellular pertussis vaccine (Daptacel brand) in children 4 to 6 years of age. Monitor therapy

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

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.

Applies to diphtheria and tetanus toxoids / pertussis, acellular: intramuscular suspension

Local

Local side effects have included erythema, swelling, tenderness, and pain.[Ref]

Hypersensitivity

Hypersensitivity side effects have included rare reports of anaphylactic reactions (ie, hives, swelling of the mouth, difficulty breathing, hypotension, or shock). Arthus-type hypersensitivity reactions, characterized by severe local reactions (generally starting 2 to 8 hours after an injection), may follow receipt of tetanus toxoid.[Ref]

General

General side effects have included fever greater than 101 degrees F (rectal), high-pitched cry, persistent cry, and irritability.[Ref]

Gastrointestinal

Gastrointestinal side effects have included anorexia and vomiting.[Ref]

Nervous system

Nervous system side effects have included drowsiness. A review by the Institute of Medicine (IOM) found evidence for a causal relationship between tetanus toxoid and both brachial neuritis and Guillain-Barre syndrome.[Ref]

Some side effects of diphtheria and tetanus toxoids / pertussis, acellular may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.