TETANUS AND DIPHTHERIA TOXOIDS ADSORBED- clostridium tetani toxoid antigen (formaldehyde inactivated) and corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) injection
Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine usually have high serum tetanus antitoxin levels and should not receive MassBiologics' Td more frequently than every 10 years, even for tetanus prophylaxis as part of wound management. (See DOSAGE AND ADMINISTRATION).
A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and Guillain-Barré Syndrome.9 If Guillain-Barré Syndrome occurred within 6 weeks after receipt of a previous dose of tetanus toxoid-containing vaccine, the decision to give subsequent doses of MassBiologics' Td or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.10
DATA FROM CLINICAL TRIALS
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect the rates observed in practice. However, the adverse reaction information from clinical trials provides a basis for identifying adverse events that appear to be related to vaccine use and for approximating rates. Data on adverse reactions following fluid and adsorbed preparations of MassBiologics' Td with various doses of the diphtheria and tetanus components have been reported in a series of studies.5,7,8,11,12
The following adverse events have been identified during post-approval use of MassBiologics' Td. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequencies or to establish a causal relationship to vaccination. The following adverse events were included because of seriousness or frequency of reporting:
General Disorders and Administration Site Conditions: Injection site reactions, including pain, tenderness, erythema, induration, pruritis, swelling and warmth; peripheral oedema, pyrexia, malaise
Nervous System Disorders: Dizziness, headache, convulsions
Musculoskeletal and Connective Tissue Disorders: Myalgia, musculoskeletal stiffness or pain, arthralgia
Skin and Subcutaneous Tissue Disorders: Rash
Gastrointestinal Disorders: Nausea
Infections and Infestations: Cellulitis
REPORTING OF SUSPECTED ADVERSE REACTIONS
To report SUSPECTED ADVERSE REACTIONS, contact MassBiologics at 1-800-457-4626 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
MassBiologics' Td 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' Td in such regimens have not been evaluated.
ROUTINE BOOSTER IMMUNIZATION
MassBiologics' Td 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' Td 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 OLDER 13,14,15
|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' Td 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' Td 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' Td should not be administered.
Inject 0.5 ml of MassBiologics' Td 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' Td should not be combined through reconstitution or mixed with any other vaccine.
The stopper of the vial is latex free.
MassBiologics’ Td is supplied in single-dose (0.5 ml) vials.
NDC No. 17478-131-01 – Package of 10 single dose vials.
1. Latham WC, Bent DF, and Levine L. Tetanus toxin production in the absence of protein. Appl. Microbiol. 10(2): March 1962;146-152.
2. Mueller JH and Miller PA. Production of diphtheric toxin of high potency (100 Lf) on a reproducible medium. J. Immunol. 40: 1941;21-32.
3. Food and Drug Administration. Department of Health and Human Services (DHHS). Biological Products; bacterial vaccines and toxoids; implementation of efficacy review; proposed rule. Fed Reg 1985;50(240): 51002-117.
4. Wassilak SGF, et al. Tetanus toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008. p. 805-839.
5. Ipsen J. Jr. Immunization of adults against diphtheria and tetanus. NEJM. 1954; 251:459-466
6. Vitek CR and Wharton M. Diphtheria toxoid. In: Plotkin SA, Orenstein WA, Offit PA, editors. Vaccines. 5th ed. Philadelphia, PA: WB Saunders Company; 2008. p. 139-156.
7. Edsall G, Altman JS, and Gaspar AJ. Combined tetanus-diphtheria immunization of adults: Use of small doses of diphtheria toxoid. Am J Public Health Nations Health. 1954 Dec;44(12):1537-1545.
8. Levine L, Ipsen J, and McComb JA. Adult immunization: preparation and evaluation of combined fluid tetanus and diphtheria toxoids for adult use. Am. J. Hyg. 1961;73:20-35.
9. Institute of Medicine. Stratton KR, et al, eds. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Casuality. Washington D.C.: National Academy Press. 1994:67-117.
10. Centers for Disease Control and Prevention. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(No. RR-15):1-48.
11. McComb JA and Levine L. Adult immunization II. Dosage reduction as a solution to increasing reactions to tetanus toxoid. NEJM. 1961;256:1152-1158.
12. Levine L and Edsall G. Tetanus toxoid: What determines reaction proneness? J. Infect. Dis. 1981;144:376.
13. Centers for Disease Control and Prevention. Preventing tetanus, diphtheria and pertussis among adolescents: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(No. RR-3):1-43.
14. Centers for Disease Control and Prevention. Preventing tetanus, diphtheria and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel. MMWR 2006;55(No. RR-17):1-37.
15. Centers for Disease Control and Prevention. Recommendations of the Immunization Practices Advisory Committee (ACIP). Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures. MMWR 1991;40(No. RR-10):1-35.
University of Massachusetts Medical School
Boston, MA 02130
US Government License No. 1779
Lake Forest, IL 60045
Product information as of August 2012
|TETANUS AND DIPHTHERIA TOXOIDS ADSORBED
tetanus and diphtheria toxoids adsorbed injection
|Labeler - Akorn, Inc. (062649876)|
|Registrant - MassBiologics (019081961)|