5 WARNINGS AND PRECAUTIONS
5.1 Management of Allergic Reactions
Epinephrine and other appropriate agents used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Trumenba.
5.2 Altered Immunocompetence
Reduced Immune Response
Some individuals with altered immunocompetence may have reduced immune responses to Trumenba.
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 serogroup B even if they develop antibodies following vaccination with Trumenba [see Clinical Pharmacology (12.0)].
5.3 Limitation of Vaccine Effectiveness
As with any vaccine, vaccination with Trumenba may not protect all vaccine recipients against N. meningitidis serogroup B infections.