Important Safety Information & Use

IMPORTANT SAFETY INFORMATION

• Do not administer PENBRAYA or TRUMENBA to individuals with a history of severe allergic reaction (eg, anaphylaxis) to any component of PENBRAYA or TRUMENBA. Appropriate medical treatment used to manage allergic reactions must be available in the event an anaphylactic reaction occurs immediately following administration of PENBRAYA or TRUMENBA
• Syncope (fainting) may occur in association with administration of injectable vaccines, including PENBRAYA or TRUMENBA. Procedures should be in place to avoid injury from fainting
• Some individuals with altered immunocompetence may have reduced immune responses to PENBRAYA or TRUMENBA
• Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis groups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENBRAYA
• Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis group B, even if they develop antibodies following vaccination with TRUMENBA
• Vaccination with PENBRAYA or TRUMENBA may not protect all vaccine recipients
• Vaccination with PENBRAYA does not substitute for vaccination with a tetanus toxoid–containing vaccine to prevent tetanus
• Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer PENBRAYA to individuals with a history of GBS should take into account the expected benefits and potential risks
• For PENBRAYA, the most commonly reported (≥15%) solicited adverse reactions after Dose 1 and Dose 2, respectively, were pain at the injection site (89% and 84%), fatigue (52% and 48%), headache (47% and 40%), muscle pain (26% and 23%), injection site redness (26% and 23%), injection site swelling (25% and 24%), joint pain (20% and 18%), and chills (20% and 16%)
• For TRUMENBA, the most common solicited adverse reactions in adolescents and young adults were pain at injection site (≥85%), fatigue (≥60%), headache (≥55%), and muscle pain (≥35%)
• Data are not available on the safety and effectiveness of using TRUMENBA and other meningococcal group B vaccines interchangeably to complete the vaccination series
• The safety and effectiveness of PENBRAYA or TRUMENBA have not been established in pregnant individuals

Indications

• PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age
• TRUMENBA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. TRUMENBA is approved for use in individuals 10 through 25 years of age