HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYATM (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023 INDICATIONS AND USAGEPENBRAYA 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. (1) DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSPENBRAYA is a suspension for injection. A single dose after reconstitution is approximately 0.5 mL. (3) CONTRAINDICATIONSSevere allergic reaction (e.g., anaphylaxis) to any component of PENBRAYA. (4) ADVERSE REACTIONSThe 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%). (6) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. See 17 for PATIENT COUNSELING INFORMATION. Revised: 6/2024 |
HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use PENBRAYA safely and effectively. See full prescribing information for PENBRAYA. PENBRAYATM (Meningococcal Groups A, B, C, W, and Y Vaccine), suspension for intramuscular injection Initial U.S. Approval: 2023 INDICATIONS AND USAGEPENBRAYA 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. (1) DOSAGE AND ADMINISTRATIONDOSAGE FORMS AND STRENGTHSPENBRAYA is a suspension for injection. A single dose after reconstitution is approximately 0.5 mL. (3) CONTRAINDICATIONSSevere allergic reaction (e.g., anaphylaxis) to any component of PENBRAYA. (4) ADVERSE REACTIONSThe 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%). (6) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or http://vaers.hhs.gov. See 17 for PATIENT COUNSELING INFORMATION. Revised: 6/2024 |
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