Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed: patient information, prescribing information, ingredients, manufacturer, adverse reactions and side effects

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Adacel safely and effectively. See full prescribing information for Adacel.

See full insert sheet at this link at the Natural News Reference website.

Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed )

Suspension for Intramuscular Injection

Initial US Approval: 2005

INGREDIENTS AND EXCIPIENTS

Adacel vaccine is a sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis 288 antigens adsorbed on aluminum phosphate, for intramuscular injection.

Each 0.5 mL dose contains 5 Lf tetanus toxoid (T), 2 Lf diphtheria toxoid (d), and acellular pertussis antigens [2.5 mcg detoxified pertussis toxin (PT), 5 mcg filamentous hemagglutinin (FHA), 3 mcg pertactin (PRN), 5 mcg fimbriae types 2 and 3 (FIM)].Other ingredients per 0.5 mL dose include 1.5 mg aluminum phosphate (0.33 mg aluminum) as the adjuvant, ≤5 mcg residual formaldehyde, <50 ng residual glutaraldehyde and 3.3 mg (0.6% v/v) 2-phenoxyethanol (not as a preservative). The antigens are the same as those in DAPTACEL vaccine; however, Adacel vaccine is formulated with reduced quantities of diphtheria and detoxified PT.

The acellular pertussis vaccine components are produced from Bordetella pertussis cultures grown in Stainer-Scholte medium (2) modified by the addition of casamino acids and dimethyl- beta-cyclodextrin. PT, FHA and PRN are isolated separately from the supernatant culture medium. FIM are extracted and co-purified from the bacterial cells. The pertussis antigens are purified by sequential filtration, salt-precipitation, ultrafiltration and chromatography. PT is detoxified with glutaraldehyde, FHA is treated with formaldehyde, and the residual aldehydes are removed by ultrafiltration. The individual antigens are adsorbed onto aluminum phosphate. The tetanus toxin is produced from Clostridium tetani 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. The adsorbed diphtheria, tetanus and acellular pertussis components are combined with aluminum phosphate (as adjuvant), 2-phenoxyethanol (not as a preservative) and water for injection. Adacel vaccine does not contain a preservative.

In the guinea pig potency test, the tetanus component induces at least 2 neutralizing units/mL of serum and the diphtheria component induces at least 0.5 neutralizing units/mL of serum. The potency of the acellular pertussis vaccine components is evaluated by the antibody response of immunized mice to detoxified PT, FHA, PRN and FIM as measured by enzyme-linked immunosorbent assay (ELISA).

Diphtheria and tetanus toxoids are individually adsorbed onto aluminum phosphate.

INDICATIONS AND USAGE

Adacel is a vaccine indicated for active booster immunization against tetanus, diphtheria and pertussis. Adacel is approved for use as a single dose in persons 10 through 64 years of age. (1)

DOSAGE AND ADMINISTRATION

A single intramuscular injection of 0.5 mL. (2.1)

DOSAGE FORMS AND STRENGTHS

Single-dose vials and prefilled syringes containing a 0.5-mL suspension for injection. (3)

CONTRAINDICATIONS

Severe allergic reaction (eg, anaphylaxis) to any component of Adacel or any other diphtheria toxoid, tetanus toxoid and pertussis antigencontaining vaccine. (4.1)

Encephalopathy (eg, coma, decreased level of consciousness, prolonged seizures) within 7 days of administration of a previous pertussis antigen-containing vaccine. (4.2)

WARNINGS AND PRECAUTIONS

The tip caps of the Adacel prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex sensitive individuals. (5.2, 17)

If Guillain-Barré syndrome occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the risk for Guillain-Barré syndrome may be increased following a subsequent dose of Adacel vaccine. (5.3)

Progressive or unstable neurologic conditions are reasons to defer Adacel vaccination. (5.4)

Persons who experienced an Arthus-type hypersensitivity reaction following a prior dose of a tetanus toxoid-containing vaccine should not receive Adacel unless at least 10 years have elapsed since the last dose of a tetanus toxoid-containing vaccine. (5.5)

Syncope (fainting) can occur in association with administration of injectable vaccines, including Adacel. Procedures should be in place to prevent falling injury and manage syncopal reactions. (5.7)

ADVERSE REACTIONS

The most common solicited injection site reactions occurring within 0-14 days following vaccination with Adacel were:

– For Adolescents 11-17 years of age: pain (77.8%), swelling (20.9%), erythema (20.8%).

– For Adults 18-64 years of age: pain (65.7%), swelling (21.0%), erythema (24.7%) (6.1)

The most common solicited systemic reactions occurring within 0-14 days following vaccination with Adacel were:

For Adolescents 11-17 years of age: headache (43.7%), body ache or muscle weakness (30.4%), tiredness (15.1%).

For Adults 18-64 years of age: headache (33.9%), body ache or muscle weakness (21.9%) (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 at 1-800-822-2463 (1-800- VACCINE) or VAERS at 1-800-822-7967 or http://vaers.hhs.gov.

DRUG INTERACTIONS

When Adacel vaccine was administered concomitantly with trivalent inactivated influenza vaccine (TIV) to adults 19-64 years of age, a lower antibody response was observed for pertactin antigen as compared to Adacel vaccine administered alone. (7.1, 14.3)

Immunosuppressive therapies may reduce the immune response to Adacel. (7.2)

Do not mix Adacel vaccine with any other vaccine in the same syringe or vial.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with Adacel vaccine. It is also not known whether Adacel vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Adacel vaccine should be given to a pregnant woman only if clearly needed.

Animal fertility studies have not been conducted with Adacel vaccine. The effect of Adacel vaccine on embryo-fetal and pre-weaning development was evaluated in two developmental toxicity studies using pregnant rabbits. Animals were administered Adacel vaccine twice prior to gestation, during the period of organogenesis (gestation day 6) and later during pregnancy on gestation day 29, 0.5 mL/rabbit/occasion (a 17-fold increase compared to the human dose of Adacel vaccine on a body weight basis), by intramuscular injection. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no vaccine related fetal malformations or other evidence of teratogenesis noted in this study

Registry of Receipt of Adacel Vaccine During Pregnancy

Sanofi Pasteur Inc. maintains a surveillance registry to collect data on pregnancy outcomes and newborn health status outcomes following vaccination with Adacel vaccine during pregnancy. Women who receive Adacel vaccine during pregnancy are encouraged to contact directly or have their health-care professional contact Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE).

Nursing Mothers

It is not known whether Adacel vaccine is excreted in human milk. Because many drugs are 272 excreted in human milk, caution should be exercised when Adacel vaccine is given to a nursing 273 woman.

Pediatric Use

Adacel vaccine is not approved for individuals less than 10 years of age. Safety and effectiveness 277 of Adacel vaccine in persons less than 10 years of age have not been established.

Geriatric Use

Adacel vaccine is not approved for use in individuals 65 years of age and older. In a clinical study, individuals 65 years of age and older received a single dose of Adacel vaccine. Based on pre-specified criteria, persons 65 years of age and older who received a dose of Adacel vaccine had lower geometric mean concentrations of antibodies to PT, PRN and FIM when compared to infants who had received a primary series of DAPTACEL® 283 , Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP). [See Section 14 for description of DAPTACEL vaccine.]

Revised: [XX/201X]

https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142764.pdf

http://naturalnewsreference.com/vaccine-insert-sheets/Adacel.pdf