MENVEO- meningococcal (groups a, c, y and w-135) oligosaccharide diphtheria crm197 conjugate vaccine
MENVEO- neisseria meningitidis group a capsular oligosaccharide diphtheria crm197 protein conjugate antigen, neisseria meningitidis group c capsular oligosaccharide diphtheria crm197 protein conjugate antigen, neisseria meningitidis group w-135 capsular oligosaccharide diphtheria crm197 protein conjugate antigen and neisseria meningitidis group y capsular oligosaccharide diphtheria crm197 protein conjugate antigen injection, solution
GlaxoSmithKline Biologicals SA
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.
For intramuscular injection only.
MENVEO is supplied in two presentations, a two-vial presentation and a one-vial presentation.
The two-vial presentation includes a vial with a gray cap containing the MenCYW-135 liquid conjugate component and a vial with an orange cap containing the MenA lyophilized conjugate component. The contents of the vials must be combined to form MENVEO prior to administration. This presentation is for use in individuals 2 months through 55 years of age.
The one-vial presentation contains MENVEO in a single vial with a pink cap and does not require reconstitution before use. This presentation is for use in individuals 10 through 55 years of age.
Reconstitution Instructions for MENVEO Two-Vial Presentation
Use the MenCYW-135 liquid conjugate component (Vial 1, gray cap) to reconstitute the MenA lyophilized conjugate component (Vial 2, orange cap) to form MENVEO. Invert Vial 2 and shake well until the lyophilized conjugate component is dissolved. After reconstitution, withdraw 0.5 mL from the vial containing the reconstituted vaccine. See Figures 1 through 4.
Administer MENVEO immediately or store between 36°F and 77°F (2°C and 25°C) for up to 8 hours. Shake well before using. Discard reconstituted vaccine if it has been frozen or not used within 8 hours.
Instructions for MENVEO One-Vial Presentation
The MENVEO presentation that is supplied in a single vial with a pink cap does NOT require reconstitution. Withdraw 0.5 mL from the vial.
MENVEO is a clear, colorless solution, free from visible foreign particles. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If any of these conditions exist, MENVEO should not be administered.
Administer a single 0.5-mL dose by intramuscular injection.
The dosing schedule is as follows:
Table 1. Dosing Schedule for MENVEO Primary Vaccination
| MENVEO Two-Vial Presentation|
Infants Aged 2 Months
4-dose series at 2, 4, 6, and 12 months of age
Children Aged 7 through 23 Months
2-dose series with the second dose administered in the second year of life and at least 3 months after the first dose
Children Aged 2 through 10 Years
A single dose
For children aged 2 through 5 years at continued high risk of meningococcal disease, a second dose may be administered 2 months after the first dose.
Adolescents and Adults Aged 11 through 55 Years
A single dose
MENVEO One-Vial Presentation
Adolescents and Adults Aged 10 through 55 Years
A single dose
Adolescents and Adults Aged 15 through 55 Years: A single booster dose of MENVEO using either the two-vial presentation or the one-vial presentation 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 meningococcal (serogroups A, C, Y, W-135) conjugate vaccine.
MENVEO is a solution for intramuscular injection. A single dose is 0.5 mL.
Do not administer MENVEO to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of MENVEO, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine. [See Description (11).]
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.
Reduced Immune Response
Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MENVEO.
Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N. meningitidis, including invasive disease caused by serogroups A, C, Y, and W, even if they develop antibodies following vaccination with MENVEO. [See Clinical Pharmacology (12.1).]
Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer MENVEO to persons with a history of GBS should take into account the expected benefits and potential risks.
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