TENIVAC- clostridium tetani toxoid antigen (formaldehyde inactivated) and corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) injection, suspension
Sanofi Pasteur Inc.
1 INDICATIONS AND USAGE
TENIVAC� is a vaccine indicated for active immunization for the prevention of tetanus and diphtheria in persons 7 years of age and older.
2 DOSAGE AND ADMINISTRATION
2.1 Primary Immunization
In persons who have not been immunized previously against tetanus and diphtheria, primary immunization with TENIVAC vaccine consists of three 0.5 mL doses. The first 2 doses are administered 2 months apart and the third dose is administered 6-8 months after the second dose.
TENIVAC vaccine 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). However, the safety and efficacy of TENIVAC vaccine in such regimens have not been evaluated.
2.2 Routine Booster Immunization
TENIVAC vaccine may be used for routine booster immunization against tetanus and diphtheria in persons 7 years of age and older. Routine booster immunization against tetanus and diphtheria is recommended in children 11-12 years of age and every 10 years thereafter.
2.3 Diphtheria Prophylaxis for Case Contacts
TENIVAC 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 recommendations of the Advisory Committee on Immunization Practices for additional interventions for diphtheria prophylaxis in close contacts of diphtheria patients.
DOSAGE FORMS AND STRENGTHS
TENIVAC vaccine is a suspension for injection available in 0.5 mL single-dose vials or syringes. [See Description (11).]
4 CONTRAINDICATIONS
4.1 Hypersensitivity
A severe allergic reaction (e.g., anaphylaxis) after a previous dose of TENIVAC vaccine or any other tetanus toxoid or diphtheria toxoid-containing vaccine or any other component of this vaccine is a contraindication to administration of TENIVAC vaccine. [See Description (11).] Because of uncertainty as to which component of the vaccine may be responsible, none of the components should be administered. Alternatively, such individuals may be referred to an allergist for evaluation if further immunizations are to be considered.
5 WARNINGS AND PRECAUTIONS
5.1 Management of Acute Allergic Reactions
Epinephrine hydrochloride solution (1:1,000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.
5.2 Latex
The tip caps of the TENIVAC prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals.
5.3 Frequency of Administration
More frequent doses of TENIVAC vaccine than described in Section 2, Dosage and Administration, may be associated with increased incidence and severity of adverse reactions. [See Dosage and Administration (2.1, 2.2, 2.3, 2.4).]
5.4 Arthus Reactions
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 TENIVAC vaccine more frequently than every 10 years, even for tetanus prophylaxis as part of wound management.
5.5 Guillain-Barr� Syndrome and Brachial Neuritis
A review by the Institute of Medicine found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillian-Barr� syndrome. (2) If Guillain-Barr� syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the decision to give TENIVAC vaccine or any vaccine containing tetanus toxoid should be based on careful consideration of the potential benefits and possible risks.
5.6 Limitations of Vaccine Effectiveness
Vaccination with TENIVAC vaccine may not protect all individuals.
5.7 Altered Immunocompetence
If TENIVAC vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained.
Concomitant Vaccine Administration
No safety and immunogenicity data are available on the concomitant administration of TENIVAC vaccine with other US licensed vaccines.
7.2 Tetanus Immune Globulin (Human)
If passive protection against tetanus is required, TIG (Human) may be administered according to its prescribing information, concomitantly with TENIVAC vaccine at a separate site with a separate needle and syringe. [See Dosage and Administration (2.4).]
7.3 Immunosuppressive Treatments
Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to TENIVAC vaccine. [See Warnings and Precautions (5.7).]
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C
Animal reproduction studies have not been conducted with TENIVAC vaccine. It is also not known whether TENIVAC vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. TENIVAC vaccine should be given to a pregnant woman only if clearly needed.
DESCRIPTION
TENIVAC vaccine, Tetanus and Diphtheria Toxoids Adsorbed, is a sterile isotonic suspension of tetanus and diphtheria toxoids adsorbed on aluminum phosphate.
Each 0.5 mL dose of TENIVAC vaccine contains the following active ingredients:
Tetanus Toxoid 5 Lf
Diphtheria Toxoid 2 Lf
Other ingredients per 0.5 mL dose include 1.5 mg of aluminum phosphate (0.33 mg of aluminum) as the adjuvant and ≤5.0 mcg of residual formaldehyde.
Clostridium tetani is grown in modified Mueller-Miller casamino acid medium without beef heart infusion. (3) Tetanus toxin is detoxified with formaldehyde and purified by ammonium sulfate fractionation and diafiltration. Corynebacterium diphtheriae is grown in modified Mueller's growth medium. (4) After purification by ammonium sulfate fractionation, diphtheria toxin is detoxified with formaldehyde and diafiltered. Tetanus and diphtheria toxoids are individually adsorbed onto aluminum phosphate.
The adsorbed tetanus and diphtheria toxoids are combined with aluminum phosphate (as adjuvant), sodium chloride and water for injection. This product contains no preservative.
In the guinea pig potency test, the tetanus toxoid component induces at least 2 neutralizing units/mL of serum and the diphtheria toxoid component induces at least 0.5 neutralizing units/mL of serum.
The tip caps of the prefilled syringes may contain natural rubber latex. The vial stoppers do not contain latex.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Tetanus
Tetanus is an acute disease caused by an extremely potent neurotoxin produced by C tetani. Protection against disease is due to the development of neutralizing antibodies to tetanus toxin. A serum tetanus antitoxin level of at least 0.01 IU/mL, measured by neutralization assay is considered the minimum protective level. (5) (6) A tetanus antitoxoid level of ≥0.1 IU/mL as measured by the ELISA used in some clinical studies of TENIVAC vaccine is considered protective.
Diphtheria
Diphtheria is an acute toxin-mediated disease caused by toxigenic strains of C diphtheriae. Protection against disease is due to the development of neutralizing antibodies to diphtheria toxin. A serum diphtheria antitoxin level of 0.01 IU/mL is the lowest level giving some degree of protection. Antitoxin levels of at least 0.1 IU/mL are generally regarded as protective. (5) A level of at least of 1.0 IU/mL has been associated with long-term protection. (7)
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
TENIVAC vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.
17 PATIENT COUNSELING INFORMATION
Before administration of TENIVAC vaccine health-care providers should inform the patient, parent or guardian of the benefits and risks of the vaccine and the importance of completing the primary immunization series or receiving recommended booster doses, as appropriate, unless a contraindication to further immunization exists.
The health-care provider should inform the patient, parent or guardian about the potential for adverse reactions that have been temporally associated with TENIVAC vaccine or other vaccines containing similar components. The health-care provider should provide the Vaccine Information Statements (VISs) which are required by the National Childhood Vaccine Injury Act of 1986 to be given with each immunization. Patients, parents, or guardians should be instructed to report adverse reactions to their health-care provider.
Product information as of April 2013.
Manufactured by:
Sanofi Pasteur Limited
Toronto Ontario Canada
