Data from FDA - Curated by Toby Galbraith - Last updated 17 April 2017

Licensing authority

FDA (Food and Drug Administration, USA)


• TENIVAC is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older. (1)

Full Prescribing information

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Advisory information

• Severe allergic reaction (e.g., anaphylaxis) to a previous dose of TENIVAC, or any other tetanus or diphtheria toxoid-containing vaccine, or any component of this vaccine. (4.1)
Special warnings and precautions
• The tip caps of the prefilled syringes may contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. (5.2)
• More frequent administration of TENIVAC than described in Dosage and Administration (2.1, 2.2, 2.3, 2.4) may be associated with increased incidence and severity of adverse reactions. (5.3)
• Persons who experienced an Arthus-type hypersensitivity reaction following 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. (5.4)
• Carefully consider benefits and risks before administering TENIVAC to persons with a history of Guillain-Barré syndrome within 6 weeks of a previous tetanus toxoid-containing vaccine. (5.5)
Adverse reactions
• The most frequent solicited injection site reaction within 0-3 days following TENIVAC was pain, reported in 78.3% of study participants 11-59 years of age and 35.3% of participants ≥60 years of age. (6.1)
• The most frequent solicited systemic reaction within 0-3 days following TENIVAC was headache, reported in 17.9% of participants, overall. (6.1)
• Other common (≥10%) solicited adverse reactions within 0-3 days following TENIVAC were injection site redness, injection site swelling, malaise, muscle weakness and pain in joints. (6.1)

Usage information

Dosing and administration
• Each 0.5 mL dose should be administered intramuscularly. (2.5)
• Primary immunization with TENIVAC consists of 3 doses. The first 2 doses are administered 2 months apart and the third dose is administered 6-8 months after the second dose. (2.1)
• TENIVAC may be used for booster immunization against tetanus and diphtheria. Routine booster immunization against tetanus and diphtheria is recommended at 11-12 years of age and every 10 years thereafter. (2.2)
• For post-exposure diphtheria prophylaxis and for management of a tetanus prone wound, a booster dose of TENIVAC may be administered if at least 5 years have elapsed since previous receipt of a diphtheria toxoid and tetanus toxoid containing vaccine. (2.3) (2.4)
Use in special populations
Pre- and post-vaccination tetanus and diphtheria seroprotection rates were lower in study participants ≥65 years of age compared to younger participants. In general, rates of solicited adverse reactions were not higher in participants ≥65 years of age compared to younger participants. (8.5)


• No safety and immunogenicity data are available on the concomitant administration of TENIVAC with other US licensed vaccines. (7.1)
• If passive protection against tetanus is required, Tetanus Immune Globulin (TIG) (Human) may be administered concomitantly at a separate site with a separate needle and syringe. (7.2)
• Immunosuppressive therapies may reduce the immune response to TENIVAC. (7.3)

More information

Category Value
Authorisation number BLA103171
Orphan designation No
Product NDC 49281-215
Date First Approved 08-12-2010
Marketing authorisation holder Sanofi Pasteur Inc.

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