Meningitis vaccine warnings and precautions

Meningitis vaccine
MENVEO® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Warnings And Precautions

Management of Acute Allergic Reactions

Appropriate medical treatment must be available should an acute allergic reaction, including an anaphylactic reaction, occur following administration of MENVEO.

Syncope

Syncope, sometimes resulting in falling injury associated with seizure-like movements has been reported following vaccination with MENVEO. Vaccinees should be observed for at least 15 minutes after vaccine administration to prevent and manage syncopal reactions.

Altered Immunocompetence

Safety and effectiveness of MENVEO have not been evaluated in immunocompromised persons. If MENVEO is administered to immunocompromised persons, including those receiving immunosuppressive therapy, the expected immune response may not be obtained.

Guillain-Barré Syndrome

Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to administer MENVEO to subjects with a known history of Guillain-Barré Syndrome should take into account the potential benefits and risks.

Apnea in Premature Infants

Apnea following intramuscular vaccination has been observed in some infants born prematurely. The decision about when to administer an intramuscular vaccine, including MENVEO, to an infant born prematurely should be based on consideration of the individual infant's medical status, and the potential benefits and possible risks of vaccination.

References

Adapted from the FDA Package Insert.