arré Syndrome
5.WARNINGS AND PRECAUTIONS
5.1. Guillain-Barré Syndrome
5.2. Preventing and Managing Allergic Vaccine Reactions
5.3. Altered Immunocompetence
5.4. Limitations of Vaccine Effectiveness
6.ADVERSE REACTIONS
6.1. Clinical Trial Experience
6.2. Post-Marketing Reports
7.DRUG INTERACTIONS
7.1. Concomitant Administration with Other Vaccines
7.2. Immunosuppressive Therapies
8.USE IN SPECIFIC POPULATIONS
8.1. Pregnancy
8.3.Nursing Mothers
8.4.Pediatric Use
8.5.Geriatric Use
11.DESCRIPTION
12.CLINICAL PHARMACOLOGY
12.1.Mechanism of Action
13. NON-CLINICAL TOXICOLOGY
13.1.Carcinogenesis, Mutagenesis, Impairment of Fertility
14.CLINICAL STUDIES
14.1. Efficacy
14.2.Immunogenicity
14.3.Concomitant Vaccine Administration
15.REFERENCES
16.HOW SUPPLIED/STORAGE AND HANDLING
16.1.How Supplied
16.2.Storage and Handling
17.PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
1.INDICATIONS AND USAGE
Menactra®, Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, 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.
Menactra vaccine does not prevent N meningitidis serogroup B disease.
2.DOSAGE AND ADMINISTRATION
2.1. Preparation for Administration
Menactra vaccine is a clear to slightly turbid solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exist, the vaccine should not be administered.
2.2. Dose and Schedule
Menactra vaccine is administered as a 0.5 mL dose by intramuscular injection.
In children 9 through 23 months of age, Menactra is given as a 2-dose series three months apart.
Individuals 2 through 55 years of age receive a single dose.
Do not administer this product intravenously or subcutaneously.
2.3. Revaccination
The need for a booster dose of Menactra vaccine has not yet been determined.
3.DOSAGE FORMS AND STRENGTHS
Menactra vaccine is a liquid solution supplied in 0.5 mL single-dose vials. [See Description (11) for a complete listing of ingredients.]
4.CONTRAINDICATIONS
4.1. Hypersensitivity
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 [see Description (11)].
4.2. Guillain-Barré Syndrome
Known history of Guillain-Barré syndrome (GBS) [see Warnings and Precautions (5)] is a contraindication to vaccine administration.
5.WARNINGS AND PRECAUTIONS
5.1. Guillain-Barré Syndrome
GBS has been reported in temporal relationship following administration of Menactra vaccine. An eva luation of post-marketing adverse events suggests a potential for an increased risk of GBS following Menactra vaccination (1) [see Contraindications (4.2), Adverse Reactions (6), Post-Marketing Reports (6.2)]. Persons previously diagnosed with GBS should not receive Menactra vaccine.
5.2. P
