Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use)

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Tetanus and diphtheria toxoids; aluminum adsorbed; susp for IM inj; preservative-free.

    Pharmacological Class

    DT vaccine.

    How Supplied

    Single-dose vials (0.5mL)—10

    Storage

    • Store at 2° to 8°C (35° to 46° F). Do not freeze. Product which has been exposed to freezing should not be used. Do not use vaccine beyond the expiration date. Discard unused portion.

    Manufacturer

    Sanofi Pasteur, Inc.

    Mechanism of Action

    Protection against diphtheria is due to the development of neutralizing antibodies to diphtheria toxin. Protection against tetanus is due to the development of neutralizing antibodies to tetanus toxin.

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Indications

    Indications

    Tetanus and diphtheria immunization in patients 6 weeks through 6 years of age (before 7th birthday) when pertussis vaccine cannot be used.

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Dosage and Administration

    Children

    <6wks and ≥7yrs: not recommended. Give IM in anterolateral thigh (for infants <1yr) or deltoid (for older children). 5-dose series: give at 2, 4, 6, 15–18 months, and 4–6 years. May give first dose as early as 6 weeks of age. 

    Administration

    • Inspect parenteral drug products visually for particulate matter and discoloration prior to administration. Do not administer the product if particulate matter and/or discoloration exist.

    • Just prior to use, shake the vial well until it's a uniform, white, cloudy suspension.

    • For infants younger than 1 year, administer into the anterolateral aspect of the thigh as it is the preferred site of injection.

    • For older children, administer into the deltoid muscle.

    • Do not inject into the gluteal area or areas where there may be a major nerve trunk.

    • Do not combine Diphtheria and Tetanus Toxoids Adsorbed vaccine through reconstitution or mix with any other vaccine.

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Contraindications

    Contraindications

    History of systemic allergic or neurologic reactions to a previous dose of DT.

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Boxed Warnings

    Not Applicable

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Warnings/Precautions

    Warnings/Precautions

    Defer in moderate or severe active respiratory or other febrile infection (may vaccinate if mild or minor illness) or during polio outbreak. Bleeding disorders. Guillain-Barre syndrome (within 6 weeks) of previous tetanus vaccination. Immunosuppressed. Have epinephrine (1:1000) available. Risk of apnea (premature infants).

    Warnings/Precautions

    Management of Acute Allergic Reactions

    • Have epinephrine injection (1:1000) and other appropriate agents and equipment immediately available in case an anaphylactic or acute hypersensitivity reaction occurs.

    Guillain-Barré Syndrome and Brachial Neuritis

    • The risk for Guillain-Barré Syndrome (GBS) may be increased following Diphtheria and Tetanus Toxoids Adsorbed vaccine if GBS occurred within 6 weeks of a previous vaccine containing tetanus toxoid.

    • Evidence has been found for a causal relation between tetanus toxoid and both GBS and brachial neuritis.

    Limitations of Vaccine Effectiveness

    • Diphtheria and Tetanus Toxoids Adsorbed vaccine may not protect all individuals.

    Altered Immunocompetence

    • Immunosuppressed persons, including those receiving immunosuppressive therapy may not obtain the expected immune response.

    Apnea in Premature Infants

    • Risk of apnea has been observed in some infants born prematurely.

    • Consider the individual infant’s medical status and the potential benefits and risks of vaccination.

    Syncope

    • Syncope may occur. Procedures should be in place to avoid injury from fainting.

    Pregnancy Considerations

    • Not approved for use in individuals 7 years of age and older.

    • No data available to assess vaccine-associated risks in pregnancy.

    Nursing Mother Considerations

    • Not approved for use in individuals 7 years of age and older.

    • No data available to assess the impact of Diphtheria and Tetanus Toxoids Adsorbed vaccine on milk production, its presence in breast milk, or its effects on the breastfed infant.

    Pediatric Considerations

    • Not indicated for infants below 6 weeks of age or children 7 years of age or older. 

    • Safety and efficacy in these age groups have not been established.

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Pharmacokinetics

    See Literature

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Interactions

    Interactions

    Concomitant vaccines: insufficient data; see full labeling. Concomitant tetanus immune globulin (human): give at a separate site using a separate needle and syringe. May get suboptimal response with immunosuppressants (eg, chemotherapy, high dose corticosteroids ≥2 weeks, radiation).

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Adverse Reactions

    Adverse Reactions

    Local reactions (eg, erythema, edema), malaise, fever, hypotension, arthralgia, nausea; syncope, rare: neurologic disorders.

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Clinical Trials

    Clinical Trials

    • A clinical study conducted in Baltimore, MD evaluated 3 lots of Diphtheria and Tetanus Toxoids Adsorbed (formulation that contained thimerosal) in infants. Patients received 0.5mL of Diphtheria and Tetanus Toxoids Adsorbed at 2, 4, and 6 months of age. Patients also received concomitant oral poliovirus vaccine (no longer licensed in the US) at 2 and 4 months of age. Levels were evaluated at 8 months of age.

    • At 8 months of age, protective levels of diphtheria antitoxin (≥0.01 IU/mL) and tetanus antitoxin (≥0.01 IU/mL) were detected in 99% and 100%, respectively, of the Diphtheria and Tetanus Toxoids Adsorbed recipients after 3 doses.

    • The geometric mean titers (GMT's) for diphtheria and tetanus antitoxin antibodies in recipients were not significantly different, ranging from 0.25 to 0.35 IU/mL for diphtheria antitoxin antibodies, and from 0.75 to 0.80 IU/mL for tetanus antibodies after the third dose. 

    • Among 75 infants who received an investigational acellular pertussis vaccine simultaneously with the Diphtheria and Tetanus Toxoids Adsorbed but at separate sites, the protective antitoxin levels for diphtheria and tetanus developed in 100% of the recipients.

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Note

    Not Applicable

    Diphtheria And Tetanus Toxoids Adsorbed (for Pediatric Use) Patient Counseling

    Patient Counseling

    Inform the parent or guardian of the following:

    • It is important to complete the immunization series for maximum protection against diphtheria and tetanus.

    • Common adverse reactions include local redness, swelling, and tenderness at the injection site, fever, crying, and loss of appetite.

    • Other adverse reactions can occur. Call your healthcare provider with any adverse reactions of concern.

    • Provide the Vaccine Information Statements (VIS), which are required by the National Childhood Vaccine Injury Act of 1986.

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