Data from FDA (Food and Drug Administration, USA) - Curated by Marshall Pearce - Last updated 17 April 2017

Indication(s)

• 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)

Full Prescribing information

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Hypogonadism

Hypogonadism

Epidemiology, pathophysiology, diagnosis/treatment guidelines, recent publication summaries and more.

+ 1 more

Bedwetting

Bedwetting

Essential screening, diagnosis and best strategies to manage bedwetting.

+ 7 more

Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

+ 4 more

Load more

Related Content

Advisory information

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)
Special 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).

Usage information

Dosing and administration
• Single-dose vials and prefilled syringes containing a 0.5-mL suspension for injection. (3)
Use in special populations
• Safety and effectiveness of Adacel vaccine have not been established in pregnant women. (8.1)
• Pregnancy Surveillance Registry: contact Sanofi Pasteur Inc. at 1-800-822-2463 (1-800-VACCINE). (8.1)

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.

More information

Category Value
Authorisation number BLA125111
Orphan designation No
Product NDC 49281-400
Date First Approved 10-06-2005
Marketing authorisation holder Sanofi Pasteur Limited