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Decavac

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Decavac

Decavac

INDICATIONS

DECAVAC vaccine is indicated for active immunization for the prevention of tetanus and diphtheria. DECAVAC vaccine is approved for use in persons 7 years of age and older.

DOSAGE AND ADMINISTRATION

Primary Immunization

DECAVAC vaccine may be used in persons 7 years of age and older who have not been immunized previously against tetanus and diphtheria, as a primary immunization series 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.

DECAVAC vaccine may be used to complete the primary immunization series for tetanus and diphtheria in persons 7 years of age or older who have received 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). However, the safety and efficacy of DECAVAC vaccine in such regimens have not been evaluated.

Routine Booster Immunization

DECAVAC vaccine 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.7 The Advisory Committee on Immunization Practices (ACIP) has specific recommendations on booster immunization against tetanus and diphtheria for adolescents and adults.7,10,11

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.12 DECAVAC vaccine 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.12

Table 1: Summary Guide to Tetanus Prophylaxis in Routine Wound Management for Persons 7 Years of Age and Older10,11,12

History of Adsorbed Tetanus Toxoid (doses) Clean, Minor Wounds All Other Wounds*
Td† TIG Td† TIG
Unknown or < three 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 Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap) in adolescents and adults.10,11
‡ 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

DECAVAC vaccine 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.12

Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions exist, DECAVAC vaccine should not be administered.

DECAVAC vaccine, after shaking, is a turbid liquid, whitish-gray in color.

For DECAVAC vaccine supplied in vials, shake the vial well before withdrawing the dose. Discard vial if DECAVAC vaccine cannot be resuspended.

For DECAVAC vaccine supplied in syringes, shake the syringe well before administering the dose. Discard syringe if DECAVAC vaccine cannot be resuspended.

Inject 0.5 mL intramuscularly. The preferred site is the deltoid muscle. DECAVAC vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer DECAVAC vaccine intravenously or subcutaneously.

DECAVAC vaccine should not be combined through reconstitution or mixed with any other vaccine.

HOW SUPPLIED

Vial (latex-free), 1 Dose (10 per package) – NDC 49281-291-83

Syringe (latex-free), 1 Dose (10 per package, without needle) – NDC 49281-291-10

Storage

Store at 2°to 8°C (35°to 46°F). Do not freeze.

Do not use vaccine after expiration date.

REFERENCES

7. CDC. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006;55(RR-15):1-48.

10. 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.

11. 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.

12. .CDC. Diphtheria, tetanus, and pertussis: recommendations for vaccine use and other preventive measures: recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991:40(No. RR-10):1-28.

Manufactured by: Sanofi Pasteur Inc., Swiftwater, PA 18370 USA. Product Information as of December 2008.

Last reviewed on RxList: 10/29/2009
This monograph has been modified to include the generic and brand name in many instances.

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