Indication and Important Safety Information
Menveo is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitides serogroups A, C, Y and W-125. Menveo is approved for use in persons 2 months through 55 years of age. Menveo does not prevent N. meningitides serogroup B inflections.
Severe allergic reaction (eg, anaphylaxis) after a previous dose of Menveo, any component of this vaccine, or any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine is a contraindication to administration of Menveo. Appropriate medical treatment must be available should an acute allergic reaction, including an anaphylactic reaction, occur following administration of Menveo.
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.
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 (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision to administer Menveo to subjects with a known history of GBS should take into account the potential benefits and risks.
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.
In clinical trials, common solicited adverse reactions with Menveo among children initiating vaccination at 2 months of age and receiving the four-dose series were tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea. Common solicited adverse reactions among children initiating vaccination at 7 months through 23 months of age and receiving the two-dose series were tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea. Common solicited adverse reactions among children 2 years through 10 years of age were injection-site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Common solicited adverse reactions among adolescents and adults were pain at the injection site, headache, myalgia, malaise, and nausea. Some events were severe. Safety has not been established in pregnant women. Vaccination with Menveo may not protect all individuals.
Before administering Menveo, please see full Prescribing Information.
Novartis has created a pregnancy registry to collect health information on women who may have received Menveo while pregnant. To enroll in the registry or for further information, please call 1-877-311-8972 or click here. Enrollment in the registry is limited to women who currently reside in the US or Canada.