PENBRAYA™ Highlights

(meningococcal groups A, B, C, W, and Y vaccine)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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 USAGE

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. (1)

DOSAGE AND ADMINISTRATION

For intramuscular use only. (2)
Administer 2 doses (approximately 0.5 mL each) of PENBRAYA 6 months apart. (2.1)
To prepare PENBRAYA, reconstitute the Lyophilized MenACWY Component with the MenB Component. (2.2)

DOSAGE FORMS AND STRENGTHS

PENBRAYA is a suspension for injection. A single dose after reconstitution is approximately 0.5 mL. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) to any component of PENBRAYA. (4)

ADVERSE REACTIONS

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%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 10/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These 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 USAGE

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. (1)

DOSAGE AND ADMINISTRATION

For intramuscular use only. (2)
Administer 2 doses (approximately 0.5 mL each) of PENBRAYA 6 months apart. (2.1)
To prepare PENBRAYA, reconstitute the Lyophilized MenACWY Component with the MenB Component. (2.2)

DOSAGE FORMS AND STRENGTHS

PENBRAYA is a suspension for injection. A single dose after reconstitution is approximately 0.5 mL. (3)

CONTRAINDICATIONS

Severe allergic reaction (e.g., anaphylaxis) to any component of PENBRAYA. (4)

ADVERSE REACTIONS

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%). (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 10/2023

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