Generic name: CLOSTRIDIUM TETANI TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2.0[Lf] in 0.5mL, CORYNEBACTERIUM DIPHTHERIAE TOXOID ANTIGEN (FORMALDEHYDE INACTIVATED) 2.0[Lf] in 0.5mL
Dosage form: intramuscular injection
Drug class: Vaccine combinations
Medically reviewed by Drugs.com. Last updated on May 15, 2023.
MassBiologics' TDVAX may be used in persons 7 years of age and older who have not been previously immunized against tetanus and diphtheria, as a primary immunization series consisting of three 0.5 mL doses. The first two doses are administered 4-8 weeks apart and the third dose is administered 6-12 months after the second dose.
MassBiologics' TDVAX may be used to complete the primary immunization series for tetanus and diphtheria, following one or two 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) vaccine. However, the safety and efficacy of MassBiologics' TDVAX in such regimens have not been evaluated.
ROUTINE BOOSTER IMMUNIZATION
MassBiologics' TDVAX may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older who have completed primary immunization against tetanus and diphtheria. Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter.10
The Advisory Committee on Immunization Practices (ACIP) has specific recommendations on booster immunization against tetanus and diphtheria for adolescents and adults.10, 13, 14
TETANUS PROPHYLAXIS IN WOUND MANAGEMENT
For active tetanus immunization in wound management of patients 7 years of age and older, a preparation containing tetanus and diphtheria toxoids is preferred instead of single-antigen tetanus toxoid to enhance diphtheria protection.15 MassBiologics' TDVAX is approved for wound management of patients 7 years of age and older.
The need for active immunization with a tetanus toxoid-containing preparation, with or without Tetanus Immune Globulin (TIG) (Human) depends on both the condition of the wound and the patient's vaccination history (Table 1).
When indicated, TIG (Human) should be administered using a separate needle and syringe at a different anatomic site, according to the manufacturer's package insert. If a contraindication to using a tetanus toxoid-containing vaccine exists in a person who has not completed tetanus primary immunization and other than a clean, minor wound is sustained, only passive immunization with TIG (Human) should be given.15
TABLE 1 GUIDE TO TETANUS PROPHYLAXIS IN ROUTINE WOUND MANAGEMENT IN PERSONS AGED 7 YEARS AND OLDER13, 14, 15
|History of Adsorbed Tetanus Toxoid (Doses)||Clean, Minor Wounds||All Other Wounds*|
|Unknown or < 3||Yes||No||Yes||Yes|
|≥ 3 ‡||No§||No||No¶||No|
* Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns and frostbite.
† The ACIP has specific recommendations on use of Td or Tetanus Toxoid, Reduced Diphtheria Toxoids and Acellular Pertussis Vaccine Adsorbed (Tdap) in adolescents and adults.13,14
‡ If only three doses of fluid tetanus toxoid have been received, then a fourth dose of toxoid, preferably an adsorbed toxoid, should be given.
§ Yes, if > 10 years since the last tetanus toxoid-containing vaccine dose.
¶ Yes, if > 5 years since the last tetanus toxoid-containing vaccine dose. (More frequent boosters are not needed and can accentuate side effects.)
DIPHTHERIA PROPHYLAXIS FOR CASE CONTACTS
MassBiologics' TDVAX may be used for post-exposure diphtheria prophylaxis in persons 7 years of age and older who have not completed primary vaccination, whose vaccination status is unknown, or who have not been vaccinated with diphtheria toxoid within the previous 5 years. Consult ACIP recommendations for additional interventions for post-exposure diphtheria prophylaxis.15
Shake the vial well to resuspend the vaccine before withdrawing the dose. After shaking, MassBiologics' TDVAX is a homogenous milky white suspension. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, MassBiologics' TDVAX should not be administered.
Inject 0.5 mL of MassBiologics' TDVAX intramuscularly. The preferred site is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.
Do not administer this vaccine intravenously, subcutaneously, or intradermally.
MassBiologics' TDVAX should not be combined through reconstitution or mixed with any other vaccine.
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