Important Notice

This site is intended for US Healthcare Professionals only.

 

 

The person depicted is a model used for illustrative purposes only.

Watch the Implementing MENVEO Into Your Practice Video

MENVEO is a solution for intramuscular injection supplied in 2 vials the contents of which must be combined prior to administration1:

  • MenA lyophilized conjugate vaccine component
  • MenCYW-135 liquid conjugate vaccine component

After reconstitution, a single dose of MENVEO is 0.5 mL1

Please note that neither component should be given alone.

MENVEO can be reconstituted in 3 steps: PULL, MIX, and SHAKE1

PULL the MenCYW-135 liquid from the vial

MIX the MenCYW-135 liquid with the MenA conjugate

SHAKE the vial upside down until the vaccine is dissolved

 

Watch the MENVEO Preparation Video

INDICATION

MENVEO is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135. MENVEO is approved for use in persons 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections.

IMPORTANT SAFETY INFORMATION FOR MENVEO

  • 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 result in protection in all vaccine recipients

Please see full Prescribing Information for MENVEO.

825823R0 October 2017

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