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Dosing and administration for MENVEO
MENVEO is approved in two presentations: a 1-vial presentation for use in individuals 10 through 55 years of age and a 2-vial presentation for use in individuals 2 months through 55 years of age. Differences between the 1-vial and 2-vial presentations are summarized in this Dear Healthcare Provider Letter
MENVEO can help protect your younger and older adolescent patients
| MENVEO Dosing for Younger and Older Adolescents1 | |
| Primary Vaccination | Booster Vaccination |
| Single dose in adolescents and adults aged 10 through 55 years | Single booster dose may be administered to individuals 15 through 55 years of age who are at continued risk of meningococcal disease, at least 4 years after a prior dose of a MenACWY vaccine |
Consider MENVEO 2-vial presentation for your at-risk patients as young as 2 months of age
| MENVEO 2-Vial Presentation Dosing for Infants1 | |
| 2 Months of Age | 7 Months Through 23 Months of Age |
| 4-dose series with a single dose (0.5 mL) at 2, 4, 6, and 12 months of age | 2-dose series (0.5 mL each) with the second dose administered in the second year of life, at least 3 months after the first dose |
MENVEO 2-vial presentation is the only MenACWY vaccine approved for use in infants as young as 2 months of age.1-3
Reconstitution for MENVEO 2-vial presentation
MENVEO 2-vial presentation is a solution for intramuscular injection supplied in 2 vials, the contents of which must be combined prior to administration1:
- MenCYW-135 liquid conjugate vaccine component (Vial 1)
- MenA lyophilized conjugate vaccine component (Vial 2)
After reconstitution, a single dose of MENVEO 2-vial presentation is 0.5 mL.1
Please note that neither component should be given alone.
MENVEO 2-vial presentation can be reconstituted in 3 steps: PULL, MIX, and SHAKE1
PULL the entire contents of MenCYW-135 liquid (Vial 1) from the vial while slightly tilting.
MIX the MenCYW-135 liquid with the MenA conjugate (Vial 2).
INVERT the vial and shake well until powder is completely dissolved.
After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine. Each dose of MENVEO 2-vial presentation should be administered as a single 0.5-mL intramuscular injection.
MENVEO 1-vial presentation does not require reconstitution.
MenACWY=meningococcal serogroups A, C, W, Y.
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 in individuals 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections.
IMPORTANT SAFETY INFORMATION FOR MENVEO
- Do not administer MENVEO to individuals with a severe allergic reaction (eg, anaphylaxis) to a previous dose of MENVEO, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine
- Appropriate medical treatment must be available should an acute allergic reaction, including an anaphylactic reaction, occur following administration of MENVEO
- Syncope (fainting) has occurred in association with administration of MENVEO. Procedures should be in place to avoid injury from fainting
- Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MENVEO
- Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroups A, C, Y, and W, even if they develop antibodies following vaccination with MENVEO
- 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 individuals with a history of GBS should take into account the expected benefits and potential risks
- Apnea following intramuscular vaccination has been observed in some infants born prematurely. A decision about when to administer 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
- Common solicited adverse reactions 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; 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; at 2 through 10 years of age who received MENVEO were injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Common solicited adverse reactions among adolescents and adults aged 11 through 55 years who received a single dose of MENVEO were pain at the injection site, headache, myalgia, malaise, and nausea. Across all age groups, some events were severe. Similar rates of solicited adverse reactions among adolescents and adults were observed following a single booster dose
- In two clinical studies, there were no notable differences in frequency and severity of solicited adverse reactions in individuals who received MENVEO 1-vial presentation compared to individuals who received the 2-vial presentation
- Vaccination with MENVEO may not result in protection in all vaccine recipients
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