Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 16 April 2018

Indication(s)

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. (1)

Full Prescribing information

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Advisory information

contraindications

Severe allergic reaction (e.g., 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. (4)

Special warnings and precautions

• Appropriate medical treatment must be available should an acute allergic reaction, including an anaphylactic reaction, occur following administration of MENVEO. (5.1)
• Syncope, sometimes resulting in falling injury, has been reported following vaccination with MENVEO. Vaccinees should be observed for at least 15 minutes after vaccine administration. (5.2)
• 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. (5.5)

Adverse reactions

• Common solicited adverse reactions (> 10%) among children initiating vaccination at 2 months of age and receiving the four-dose series were tenderness (24-41%) and erythema at injection site (11-15%), irritability (42-57%), sleepiness (29-50%), persistent crying (21-41%), change in eating habits (17-23%), vomiting (5-11%) and diarrhea (8-16%). (6.1)
• Common solicited adverse reactions (≥ 10%) among children initiating vaccination at 7 months through 23 months of age and receiving the two-dose series were tenderness (10-16%) and erythema at injection site (12-15%), irritability (27-40%), sleepiness (17-29%), persistent crying (12-21%), change in eating habits (12-20%) and diarrhea (10-16%). (6.1)
• Common solicited adverse reactions (> 10%) among children 2 years through 10 years of age who received MENVEO were injection site pain (31%), erythema (23%), irritability (18%), induration (16%), sleepiness (14%), malaise (12%), and headache (11%). (6.1)
• Common solicited adverse reactions (> 10%) among adolescents and adults who received MENVEO were pain at the injection site (41%), headache (30%), myalgia (18%), malaise (16%) and nausea (10%). (6.1)

Usage information

Dosing and administration

• For intramuscular injection only (0.5 mL).
• MENVEO is supplied in two vials that must be combined prior to administration: reconstitute the MenA lyophilized conjugate vaccine component with the MenCYW-135 liquid conjugate vaccine component immediately before administration. (2.1)
• In children initiating vaccination at 2 months of age, MENVEO is to be administered as a four-dose series at 2, 4, 6, and 12 months of age. (2.3)
• In children initiating vaccination at 7 months through 23 months of age, MENVEO is to be administered as a two-dose series with the second dose administered in the second year of life and at least three months after the first dose. (2.3)
• In individuals 2 years through 55 years of age Menveo is to be administered as a single dose. (2.3)

Use in special populations

Pregnancy: Safety and effectiveness have not been established in pregnant women. Pregnancy registry available at +1 877-413-4759. (8.1)

Interactions

Do not mix MENVEO or any of its components with any other vaccine or diluent in the same syringe or vial. (7.1)

More information

Category Value
Authorisation number BLA125300
Orphan designation No
Product NDC 46028-208
Date First Approved 19-02-2010
Marketing authorisation holder Novartis Vaccines and Diagnostics, Inc.