Tenivac

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  • Vaccines
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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

    • Tenivac Generic Name & Formulations

    Legal Class

    Rx

    General Description

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

    Pharmacological Class

    Td vaccine.

    How Supplied

    Single-dose vials (0.5mL)—10
    Single-dose prefilled syringe (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.

    Manufacturer

    Sanofi Pasteur, Inc.

    Mechanism of Action

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

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

    Tenivac Indications

    Indications

    Tetanus and diphtheria immunization in patients ≥7yrs.

    Tenivac Dosage and Administration

    Adults and Children

    <7yrs: not established. ≥7yrs: Give IM in deltoid muscle. Previously unvaccinated: three 0.5mL doses, administer first two doses 2 months apart and then third dose 6–8 months after second dose. Routine booster: give at 11–12yrs of age and every 10 years thereafter. Diphtheria and tetanus prophylaxis: see full labeling.

    Adults and Children

    Primary Immunization

    • <7yrs: not established. ≥7yrs: Give IM in deltoid muscle.

    • Previously unvaccinated against tetanus and diphtheria: primary immunization consists of three 0.5 mL doses. Administer the first two doses 2 months apart and then the third dose 6–8 months after the second dose.

    • Tenivac may be used to complete the primary immmunization series for tetanus and diphtheria, following 1 or 2 doses of Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (whole-cell DTP), Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP), and/or Diphtheria and Tetanus Toxoids Adsorbed (DT). 

    Routine Booster Immunization

    • May be used for routine booster immunization in children 11–12 years of age and every 10 years thereafter.

    Diphtheria Prophylaxis for Case Contacts

    • May be used for post-exposure diphtheria prophylaxis in children ≥7yrs who have not completed primary vaccination, vaccination status is unknown, or who have not been vaccinated with diphtheria toxoid within the previous 5 years.

    • Consult ACIP recommendations for additional interventions.

    Tetanus Prophylaxis in Wound Management

    • For active tetanus immunization in wound management of patients ≥7yrs, use a preparation containing tetanus and diphtheria toxoids instead of a single-antigen tetanus toxoid.

    • Tenivac is approved for wound management of patients ≥7yrs. 

    • Active immunization with or without passive immunization with Tetanus Immune Globulin (TIG) (Human) is based on both the wound condition and vaccination history. If indicated, administer TIG (Human) at a separate site. 

    • Administer only passive immunization with TIG (Human) in individuals with a contraindication to using tetanus toxoid-containing preparations who did not receive primary immunization of tetanus toxioid and have a clean, minor wound.

    • Guide for use of Tetanus and Diphtheria Toxoids Adsorbed (Td) for Tetanus Prophylaxis in Routine Wound Management:

      • History of Adsorbed Tetanus Toxoid: Unknown or less than 3 doses

        • Clean, Minor Wounds (Td): YES; (TIG): NO

        • All Other Wounds (Td): YES; (TIG): YES

      • History of Adsorbed Tetanus Toxoid: 3 or more doses

        • Clean, Minor Wounds (Td): NO (Yes, if >10yrs since last dose); (TIG): NO

        • All Other Wounds (Td): NO (Yes, if >5yrs since last dose); (TIG): NO

    Tenivac Contraindications

    Contraindications

    Anaphylaxis associated with a previous dose.

    Tenivac Boxed Warnings

    Not Applicable

    Tenivac Warnings/Precautions

    Warnings/Precautions

    Guillain-Barre syndrome within 6 weeks of previous tetanus toxoid vaccine. Previous Arthus-type hypersensitivity reaction: not recommended until ≥10yrs after prior dose of tetanus toxoid-containing vaccine. Immunodeficiency. Have epinephrine (1:1000) available. Latex allergy (syringe tip cap). Pregnancy (Cat.C). Nursing mothers.

    Warnings/Precautions

    Management of Acute Allergic Reactions

    • Have epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment immediately available in case an anaphylactic or acute hypersensitivity reaction occurs.

    Latex

    • The tips of the Tenivac prefilled syringes may contain natural rubber latex.

    Arthus Reactions

    • Persons who previously had an Arthus-type hypersensitivity reaction after a prior dose of a tetanus toxoid-containing vaccine should not receive Tenivac more frequently than every 10 years, even for tetanus prophylaxis as part of wound management.

    Guillain-Barré Syndrome and Brachial Neuritis

    • If Guillain-Barre syndrome occurred within 6 weeks of receipt of prior tetanus toxoid vaccine, carefully consider the benefits and possible risks of administering Tenivac or any tetanus toxoid vaccine.

    Limitations of Vaccine Effectiveness

    • May not protect all individuals.

    Altered Immunocompetence

    • May not obtain the expected immune response when Tenivac is administered to immunocompromised persons, including those receiving immunosuppressive therapy.

    Syncope

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

    Pregnancy Considerations

    Risk Summary

    • No adequate and well-controlled studies of Tenivac administration in pregnant women.

    • Insufficient human data to establish the presence or absence of a vaccine-associated risk.

    Nursing Mother Considerations

    • Not known whether Tenivac is excreted in human milk.

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Tenivac and any potential adverse effects on the breastfed child from Tenivac or from the underlying maternal condition.

    Pediatric Considerations

    • Not approved for use in infants and children younger than 7 years of age.

    Tenivac Pharmacokinetics

    See Literature

    Tenivac Interactions

    Interactions

    Concomitant tetanus immune globulin (human): inject at separate site with separate needle and syringe if passive protection required. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.

    Tenivac Adverse Reactions

    Adverse Reactions

    Injection site reactions (eg, pain, redness, swelling), headache, malaise, muscle weakness, joint pain; syncope.

    Tenivac Clinical Trials

    Clinical Trials

    Primary Immunization

    • A study conducted in Canada evaluated the 3-dose primary immunization series with Tenivac in 17 patients 6 to 56 years of age. Patients received the first 2 doses administered 2 months apart, followed by a third dose at 6 to 8 months after the second dose.

    • All patients achieved a serum tetanus antitoxin level >0.1 IU/mL and a serum diphtheria antitoxin level ≥0.01 IU/mL after 4 weeks following the second dose.

    • All patients achieved a serum diphtheria antitoxin level >0.1 IU/mL after 4 weeks following the third dose.

    Booster Immunization

    • The immune response of Tenivac was evaluated in the US multicenter booster immunization study (TDC01) in a subset of participants 11 to 59 years of age, and compared to Decavac in participants ≥60 years of age who were randomly assigned to receive a dose of either Tenivac or Decavac. 

    • See full labeling for tetanus antitoxoid levels and booster response rates following a dose of Tenivac by age group.

    Tenivac Note

    Not Applicable

    Tenivac Patient Counseling

    Patient Counseling

    • Inform the patient, parent or guardian of the benefits and risks of the vaccine and the importance of completing the primary immunization series or receiving recommended booster doses, as appropriate, unless a contraindication to further immunization exists. 

    • Inform the patient, parent or guardian about the potential for adverse reactions that have been temporally associated with Tenivac or other vaccines containing similar components. 

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