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Guillain-Barre Syndrome: Persons previously diagnosed with Guillain-Barré syndrome (GBS) may be at increased risk of GBS following receipt of Menactra. The decision to give Menactra should take into account the potential benefits and risks.
GBS has been reported in temporal relationship following administration of Menactra. The risk of GBS following Menactra vaccination was evaluated in a post-marketing retrospective cohort study [see Post-Marketing Experience under Adverse Reactions].
Preventing and Managing Allergic Vaccine Reactions: Prior to administration, the healthcare provider should review the immunization history for possible vaccine sensitivity and previous vaccination-related adverse reactions to allow an assessment of benefits and risks. Epinephrine and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.
Altered Immunocompetence: Reduced Immune Response: Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to Menactra.
Complement Deficiency: Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N meningitidis, including invasive disease caused by serogroups A, C, Y and W-135, even if they develop antibodies following vaccination with Menactra. [See Pharmacology under Actions.]
Limitations of Vaccine Effectiveness: Menactra may not protect all recipients.
Syncope: Syncope (fainting) has been reported following vaccination with Menactra. Procedures should be in place to prevent falling injury and manage syncopal reactions.
Use in Children: Menactra is not approved for use in infants under 9 months of age. Available data show that infants administered three doses of Menactra (at 2, 4, and 6 months of age) had diminished responses to each meningococcal vaccine serogroup compared to older children given two doses at 9 and 12 months of age.
Use in Elderly: Safety and effectiveness of Menactra in adults older than 55 years of age have not been established.
