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Vaccine Information: DIPHTHERIA AND TETANUS TOXOIDS ADSORBED

DIPHTHERIA AND TETANUS TOXOIDS ADSORBED- corynebacterium diphtheriae toxoid antigen (formaldehyde inactivated) and clostridium tetani toxoid antigen (formaldehyde inactivated) injection, suspension
Sanofi Pasteur Inc.

1 INDICATIONS AND USAGE

Diphtheria and Tetanus Toxoids Adsorbed is a vaccine indicated for active immunization against diphtheria and tetanus. Diphtheria and Tetanus Toxoids Adsorbed is approved for use in children from 6 weeks through 6 years of age (prior to 7th birthday).

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine (DTaP) or a DTaP-containing vaccine is recommended for immunization of infants and children 6 weeks through 6 years of age. Diphtheria and Tetanus Toxoids Adsorbed should be used in instances where the pertussis vaccine component is contraindicated.

Diphtheria and Tetanus Toxoids Adsorbed is not to be used for treatment of diphtheria or tetanus infection.

2 DOSAGE AND ADMINISTRATION

For intramuscular use only.

2.1 Dosage and Schedule

Diphtheria and Tetanus Toxoids Adsorbed is approved for administration as a 5 dose series at 2, 4, 6, 15-18 months, and 4-6 years. The first dose of Diphtheria and Tetanus Toxoids Adsorbed may be administered as early as 6 weeks of age.

2.2 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, the product should not be administered.

After removing the “flip-off” cap, cleanse the vaccine vial stopper with a suitable germicide. Do not remove either the rubber stopper or the metal seal holding it in place. Just before use, shake the vial well until a uniform, white, cloudy suspension results.

Using a sterile needle and syringe and aseptic technique, withdraw and administer a single 0.5 mL dose of Diphtheria and Tetanus Toxoids Adsorbed intramuscularly. Use a separate sterile needle and syringe for each injection. Changing needles between withdrawing the vaccine from the vial and injecting it into a recipient is not necessary unless the needle has been damaged or contaminated. In infants younger than 1 year, the anterolateral aspect of the thigh provides the largest muscle and is the preferred site of injection. In older children, the deltoid muscle is usually large enough for injection. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Diphtheria and Tetanus Toxoids Adsorbed vaccine should not be combined through reconstitution or mixed with any other vaccine.

3 DOSAGE FORMS AND STRENGTHS

Diphtheria and Tetanus Toxoids Adsorbed is a suspension for injection in 0.5 mL single dose vials.

4 CONTRAINDICATIONS

A severe allergic reaction (e.g., anaphylaxis) after a previous dose of Diphtheria and Tetanus Toxoids Adsorbed or any other diphtheria toxoid or tetanus toxoid-containing vaccine, or any other component of this vaccine is a contraindication to administration of Diphtheria and Tetanus Toxoids Adsorbed. [See Description (11).]

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Epinephrine Injection (1:1000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction occurs.

5.2 Guillain-Barré Syndrome and Brachial Neuritis

A review by the Institute of Medicine (IOM) found evidence for a causal relation between tetanus toxoid and both brachial neuritis and Guillain-Barré syndrome. (1) If Guillain-Barré syndrome occurred within 6 weeks of receipt of prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following Diphtheria and Tetanus Toxoids Adsorbed vaccine.

5.3 Limitation of Vaccine Effectiveness

Vaccination with Diphtheria and Tetanus Toxoids Adsorbed may not protect all individuals.

5.4 Altered Immunocompetence

If Diphtheria and Tetanus Toxoids Adsorbed vaccine is administered to immunocompromised persons, including persons receiving immunosuppressive therapy, the expected immune response may not be obtained. [See Immunosuppressive Treatments (7.3).]

5.5 Apnea in Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including Diphtheria and Tetanus Toxoids Adsorbed, to an infant born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination.

5.6 Syncope

Syncope (fainting) has been reported following vaccination with Diphtheria and Tetanus Toxoids Adsorbed vaccine. Procedures should be in place to prevent falling injury and manage syncopal reactions.

6 ADVERSE REACTIONS

The most common adverse reactions (≥5%) were crying, fever, and loss of appetite.

6.1 Clinical Trials Experience

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. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to vaccine use and for approximating rates of those events.

In a clinical trial in Baltimore, 163 infants received Diphtheria and Tetanus Toxoids Adsorbed at 2, 4 and 6 months of age. The results of this trial are presented in Table 1.

Table 1: Percentage of Children Experiencing Local and Systemic Reactions at 24 Hours Following Immunization
Reaction BALTIMORE *(N=163)
Dose 1(%)(n = 155) Dose 2(%)(n = 145) Dose 3(%)(n = 136)
*
A total of 163 children received one of the three lots of Diphtheria and Tetanus Toxoids Adsorbed at 2, 4, and 6 months of age, and acellular pertussis vaccine at 3, 5, and 7 months of age. One control group (N=85) received Diphtheria and Tetanus Toxoids Adsorbed concurrently at a separate site with acellular pertussis vaccine at 2, 4 and 6 months of age (data not shown). A second control group (N=85) received commercial DTwP vaccine at 2, 4, and 6 months of age, and a placebo at 3, 5, and 7 months of age (data not shown).
Systemic Reactions
Fever ≥38°C <39°C (≥100.4°F <102.2°F) 0.7 0.8 6.6
Fever ≥39°C (≥102.2°F ) 0 0 0
Crying 13.6 15.2 13.0
Loss of Appetite 3.9 6.2 2.9
Injection Site Reactions
Redness ≥2.5 cm 0.7 0 3.6
Slight Pain 2.6 2.8 2.2
Moderate Pain 0.7 1.4 0
Hardness ≥2.5 cm 1.3 1.4 3.6

Two clinical trials were conducted in Canada. In the first clinical trial, 52 children aged 17-22 months who had previously received 3 doses of whole-cell DTP Adsorbed vaccine (not licensed in US), received Diphtheria and Tetanus Toxoids Adsorbed with either an acellular pertussis (n = 25) or a whole cell pertussis (n = 27) vaccine (neither licensed in US) given concurrently but at a separate site. The only reported local reaction was slight pain at the Diphtheria and Tetanus Toxoids Adsorbed injection site in 11% of children.

In a second clinical trial conducted in Canada, 99 children aged 4 to 6 years old who were eligible for the preschool (fifth) dose of DTP received Diphtheria and Tetanus Toxoids Adsorbed in one arm and a whole-cell Monovalent Pertussis vaccine (not licensed in US) in the other. The following local reactions at the Diphtheria and Tetanus Toxoids Adsorbed injection site were reported: redness ≥50 mm — 9%, swelling >50 mm — 51%, tenderness, moderate or severe — 17%, arm mobility “too sore to move” — 9%. (2)

Diphtheria and Tetanus Toxoids Adsorbed evaluated in clinical trials contained thimerosal.

6.2 Postmarketing Experience

The following adverse events have been spontaneously reported during the postmarketing use of a Diphtheria and Tetanus Toxoids Adsorbed vaccine manufactured by Sanofi Pasteur Limited that contained thimerosal. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

The following adverse events were included based on severity, frequency of reporting or the strength of causal association with Diphtheria and Tetanus Toxoids Adsorbed:

Blood and lymphatic system disorders

Lymphadenopathy

Gastrointestinal disorders

Nausea

General disorders and administration site conditions

Injection site inflammation
Injection site hypersensitivity
Pain

Nervous system disorders

Convulsion
Somnolence
Syncope
Headache

Skin and subcutaneous tissue disorders

Rash
Urticaria

Vascular disorders

Pallor
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