Tdvax Generic Name & Formulations
Single-dose vials (0.5mL)—10
Store at 2°C - 8°C (36°F - 46°F). Do not freeze.
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.
Tetanus and diphtheria immunization in patients ≥7yrs.
Tdvax Dosage and Administration
Adults and Children
<7yrs: not established. ≥7yrs: Give IM in deltoid muscle. Previously unvaccinated: three 0.5mL doses at elected date, then 4–8 weeks after first dose, and 6–12 months after second dose. Give booster dose at 11–12yrs of age and every 10yrs thereafter. Diphtheria and tetanus prophylaxis: see full labeling.
Adults and Children
<7yrs: not established. ≥7yrs: Give IM in deltoid muscle.
Previously unvaccinated: three 0.5mL doses at elected date, then 4–8 weeks after first dose, and 6–12 months after second dose.
Routine Booster Immunization
Give booster dose at 11–12yrs of age and every 10yrs thereafter.
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.
Tdvax is approved for wound management of patients ≥7yrs.
Active immunization with or without 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
Diphtheria Prophylaxis for Case Contacts
May be used for post-exposure diphtheria prophylaxis in persons ≥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.
Anaphylaxis associated with a previous dose.
Tdvax Boxed Warnings
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. Elderly. Pregnancy: administer only if clearly needed. Nursing mothers.
It is not known whether Tdvax can cause fetal harm in pregnant women.
Administer Tdvax to a pregnant woman only if clearly needed.
Nursing Mother Considerations
It is not known whether Tdvax is excreted in human milk.
Exercise caution when Tdvax is administered to a nursing woman.
Not approved for use in infants and children younger than 7 years of age.
Concomitant vaccines: no safety and immunogenicity data are available. Immunosuppressants (eg, radiation, chemotherapy, high-dose steroids): may get suboptimal response.
Tdvax Adverse Reactions
Inj site reactions (eg, pain, erythema, tenderness, pruritis), dizziness, headache, myalgia, rash, nausea, arthralgia.
Tdvax Clinical Trials
The efficacy against tetanus of Tdvax is supported by the following:
Response to primary series. Of 20 adults with less than 0.0025 units/mL of tetanus antitoxin in preimmunization serum, 14 (70%) had antitoxin concentrations of 0.01 or greater after 2 doses of Tdvax (2 Lf tetanus toxoid dose). After 3 doses of Tdvax, 16 of 16 adults achieved 0.01 antitoxin units/mL.
Response to booster doses. Booster doses of Tdvax at doses of 1 Lf and 5 Lf of tetanus toxoid induced tetanus antitoxin levels greater than 0.01 units/mL when administered to all 36 adults who had received prior tetanus immunizations.
The efficacy against diphtheria of Tdvax is supported by the following:
Response to primary series. Of 10 adults with less than 0.001 units/mL of diphtheria antitoxin in preimmunization serum, 50% had antitoxin concentrations of 0.01 or greater after 2 doses of Tdvax (2 Lf diphtheria toxoid dose). After 3 doses of Tdvax, 6 of 6 adults achieved 0.01 antitoxin units/mL.
Response to booster doses. In clinical trials, booster doses of TDVAX formulated to contain 1 Lf and 5 Lf of diphtheria toxoid, both induced antitoxin levels greater than 0.01 units/mL when administered to adults with prior diphtheria immunity. In 140 adolescent males given a single booster dose of the 1 Lf formulation, all achieved an antitoxin titer of 0.01 units/mL or higher.
Tdvax Patient Counseling