Approved Uses and Important Safety Information for PENMENVY, BEXSERO, and MENVEO
What are PENMENVY, BEXSERO, and MENVEO?
Important Safety Information About PENMENVY, BEXSERO, and MENVEO
What are PENMENVY, BEXSERO, and MENVEO?
PENMENVY is an FDA-approved vaccine to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age.
BEXSERO is an FDA-approved vaccine to prevent invasive disease caused by N. meningitidis serogroup B. BEXSERO is approved for use in individuals aged 10 through 25 years.
MENVEO is an FDA-approved vaccine to prevent invasive disease caused by N. meningitidis serogroups A, C, W, and Y. MENVEO does not prevent disease caused by serogroup B infections. MENVEO is approved for use in individuals 2 months through 55 years of age.
Important Safety Information About PENMENVY, BEXSERO, and MENVEO
- Anyone who had a severe allergic reaction to a previous dose of PENMENVY, to one of its ingredients, or to any other diphtheria toxoid-containing vaccine should not receive PENMENVY
- Anyone who had a severe allergic reaction to a previous dose of MENVEO, to one of its ingredients, or to any other diphtheria toxoid-containing vaccine should not receive MENVEO
- Anyone who is allergic to the ingredients of BEXSERO or who had a severe allergic reaction after a previous dose should not receive BEXSERO
- For BEXSERO, the tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions
- Fainting can happen after getting PENMENVY, BEXSERO, or MENVEO. Precautions should be taken to avoid injury due to fainting
- PENMENVY, BEXSERO, or MENVEO may not protect all vaccine recipients
- Some individuals with weakened immune systems, including those receiving immunosuppressive treatment, may have reduced immune responses to PENMENVY, BEXSERO, or MENVEO
- Individuals with certain complement deficiencies and individuals receiving treatment that inhibits complement function are at increased risk for invasive disease caused by N. meningitidis, including disease caused by groups A, B, C, W, and Y, even after being vaccinated with PENMENVY, BEXSERO, or MENVEO
- Guillain-Barré syndrome (GBS) has been reported following administration of another US-licensed meningococcal vaccine for groups A, C, W, and Y. Ask your healthcare provider about the risks and benefits of PENMENVY or MENVEO if you have a history of GBS
- For PENMENVY, the most common side effects are pain, redness, and swelling at the injection site; fatigue; headache; muscle pain; and nausea
- For BEXSERO, the most common side effects are pain, redness or swelling at the injection site; fatigue; headache; nausea; and muscle pain
- For MENVEO, the most common side effects among adolescents and adults aged 11 through 55 years who received a single dose of MENVEO were pain at the injection site; headache; muscle pain; malaise; and nausea. Across all age groups, some events were severe. Similar side effects among adolescents and adults occurred following a single booster dose
- Tell your healthcare provider if you are pregnant, plan to become pregnant, or are breast-feeding
- Ask your healthcare provider about the risks and benefits of PENMENVY, BEXSERO, and MENVEO. Only a healthcare provider can decide if PENMENVY, BEXSERO, and MENVEO are right for you or your child
Prescribing Information for PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine)
Prescribing Information for BEXSERO (Meningococcal Group B Vaccine)
