HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Menactra® (Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine) safely and effectively. See full prescribing information for Menactra vaccine.
Menactra® (Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine)
For Intramuscular Injection
Initial U.S. Approval: 2005
RECENT MAJOR CHANGES
Indications and Usage (1) [6/2010]
Dosage and Administration (2) [6/2010]
Warnings and Precautions (5) [5/2011]

INDICATIONS AND USAGE
Menactra is indicated for active immunization to prevent invasive meningococcal disease caused by N meningitidis serogroups A, C, Y and W-135. Menactra is approved for use in individuals 9 months through 55 years of age. (1)

DOSAGE AND ADMINISTRATION
A 0.5 mL dose for intramuscular injection. (2)

Children 9 through 23 months of age:
Two doses, three months apart.

Individuals 2 through 55 years of age:
A single dose.

DOSAGE FORMS AND STRENGTHS
Liquid solution supplied in 0.5 mL single-dose vials (3)

CONTRAINDICATIONS
Severe allergic reaction (eg, anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid- or CRM197-containing vaccine, or to any component of Menactra vaccine. (4.1)
Known history of Guillain-Barré syndrome. (4.2)

WARNINGS AND PRECAUTIONS
Persons previously diagnosed with Guillain-Barré syndrome (GBS) should not receive Menactra vaccine. (5.1)

ADVERSE REACTIONS
Common (≥10%) solicited adverse events in infants and toddlers 9 and 12 months of age were injection site tenderness, erythema, and swelling; irritability, abnormal crying, drowsiness, appetite loss, vomiting, and fever. (6)
Common (≥10%) solicited adverse events in individuals 2 through 55 years of age were injection site pain, redness, induration, and swelling; anorexia and diarrhea. Other common solicited adverse events were irritability and drowsiness (2-10 years of age), headache, fatigue, malaise, and arthralgia (11-55 years of age). (6)

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

DRUG INTERACTIONS
Pneumococcal antibody responses to some serotypes in Prevnar (PCV7) were decreased following co-administration of Menactra vaccine and PCV7. (7.1)

USE IN SPECIFIC POPULATIONS
Safety and effectiveness of Menactra vaccine have not been established in children younger than 9 months of age, pregnant women, nursing mothers, and adults older than 55 years of age. (8.1, 8.3, 8.4, 8.5)
A Pregnancy Registry is available. Contact Sanofi Pasteur Inc. at 1-800-822-2463. (8.1)

See 17 for PATIENT COUNSELING INFORMATION 

Revised: 07/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 
1.INDICATIONS AND USAGE
2.DOSAGE AND ADMINISTRATION
2.1. Preparation for Administration
2.2. Dose and Schedule
2.3. Revaccination
3.DOSAGE FORMS AND STRENGTHS
4.CONTRAINDICATIONS
4.1. Hypersensitivity
4.2. Guillain-B