Dosing & Administration | MENVEO [Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM₁₉₇ Conjugate Vaccine]

DOSING AND ADMINISTRATION

MENVEO is approved in two presentations¹

1-vial presentation for use in individuals 10 through 55 years of age
2-vial presentation for use in individuals 2 months through 55 years of age

Please see the Dear Healthcare Provider Letter for a summary of the differences between the MENVEO 1-vial and 2-vial presentations.

1-VIAL PRESENTATION
2-VIAL PRESENTATION

FDA-approved MENVEO dosing for adolescents and adults

PRIMARY
VACCINATION

SINGLE DOSE (0.5 mL) in adolescents and adults aged 10 through 55 years¹

BOOSTER
VACCINATION

SINGLE BOOSTER dose (0.5 mL) in individuals 15 through 55 years of age who are at continued risk of meningococcal disease, at least 4 years after a prior dose (0.5 mL) of a meningitis ACWY (MenACWY) vaccine¹

Administering MENVEO 1-vial presentation

MENVEO 1-vial presentation is a solution for intramuscular injection supplied in a single vial with a pink cap and does NOT require reconstitution. Withdraw 0.5 mL from the vial and administer intramuscularly.¹

FDA-approved MENVEO dosing for infants, adolescents, and adults

PRIMARY
VACCINATION

SINGLE DOSE (0.5 mL) in adolescents and adults aged 10 through 55 years¹

BOOSTER
VACCINATION

MENVEO 2-vial presentation dosing for infants and young children

MENVEO 2-vial presentation is the only MenACWY vaccine approved for use in the US for infants as young as 2 months of age.^1-3

MENVEO 2-vial presentation dosing for infants and young children

MENVEO 2-vial presentation is the only MenACWY vaccine approved for use in the US for infants as young as 2 months of age.^1-3

2 MONTHS
OF AGE

4-DOSE SERIES with a single dose (0.5 mL) at 2, 4, 6, and 12 months of age¹

7 THROUGH 23
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 dose¹

2 THROUGH 10
YEARS OF AGE

A SINGLE DOSE (0.5 mL). For children aged 2 through 5 years at continued high risk of meningococcal disease, a second dose (0.5 mL) may be administered 2 months after the first dose¹

11 THROUGH 55
YEARS OF AGE

A SINGLE DOSE (0.5 mL)¹
A SINGLE BOOSTER DOSE (0.5 mL) may be administered to individuals who are at continued risk for meningococcal disease if at least 4 years have elapsed since a prior dose of a MenACWY vaccine

Safety and effectiveness of MENVEO 1-vial presentation in children aged younger than 10 years have not been established¹

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 administration.¹

MenCYW-135 liquid conjugate component (gray cap)
MenA lyophilized conjugate component (orange cap)

After reconstitution, a single dose of MENVEO is 0.5 mL.¹ Please note that neither component should be given alone.

MENVEO 2-vial presentation can be reconstituted in 3 steps¹: PULL, MIX, and SHAKE

Syringe pulling contents from tilted Vial 1

PULL the entire contents of
MenCYW-135 liquid conjugate (Vial 1)
from the vial while slightly tilting.¹

MIX the MenCYW-135 liquid with the
MenA lyophilized conjugate (Vial 2).¹

Syringe inserted into Vial 2, both upside-down

INVERT the vial and SHAKE well until the
lyophilized conjugate component is
completely dissolved.¹

Invert the vial and SHAKE well until the lyophilized conjugate component is completely dissolved.¹

After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine and administer intramuscularly.¹

SEE THE DATA

Vaccination may not protect all recipients.

INDICATION & IMPORTANT SAFETY INFO

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 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; 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

Please see full Prescribing Information for MENVEO.