(Respiratory Syncytial Virus Vaccine)

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ABRYSVO safely and effectively. See full prescribing information for ABRYSVO.

ABRYSVO® (Respiratory Syncytial Virus Vaccine) for injection, for intramuscular use
Initial U.S. Approval: 2023

RECENT MAJOR CHANGES

Indications and Usage (1.3)

10/2024

Dosage and Administration (2.2)

7/2024

Warnings and Precautions, Guillain‑Barré Syndrome (5.1)

1/2025

INDICATIONS AND USAGE

ABRYSVO is a vaccine indicated for

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Active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. (1.1)
•
Active immunization for the prevention of LRTD caused by RSV in individuals 60 years of age and older. (1.2)
•
Active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. (1.3)

DOSAGE AND ADMINISTRATION

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For intramuscular use. (2)
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After reconstitution, a single dose of ABRYSVO is either 0.5 mL (Act-O-Vial presentation and vial and vial presentation) or approximately 0.5 mL (vial and prefilled syringe presentation). (2.1)

DOSAGE FORMS AND STRENGTHS

For injection.

•
For the Act-O-Vial presentation, a single dose after reconstitution is 0.5 mL. (3)
•
For the vial and prefilled syringe presentation, a single dose after reconstitution is approximately 0.5 mL. (3)
•
For the vial and vial presentation, a single dose after reconstitution is 0.5 mL. (3)

CONTRAINDICATIONS

History of severe allergic reaction (e.g., anaphylaxis) to any component of ABRYSVO. (4)

WARNINGS AND PRECAUTIONS

•
Guillain‑Barré Syndrome. The results of a postmarketing observational study suggest an increased risk of Guillain‑Barré syndrome during the 42 days following vaccination with ABRYSVO. (5.1, 6.2)
•
Potential risk of preterm birth. To avoid the potential risk of preterm birth with use of ABRYSVO before 32 weeks of gestation, administer ABRYSVO as indicated in pregnant individuals at 32 through 36 weeks gestational age. (5.2)

ADVERSE REACTIONS

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The most commonly reported solicited local and systemic adverse reactions in pregnant individuals (≥10%) were pain at the injection site (40.6%), headache (31.0%), muscle pain (26.5%), and nausea (20.0%). (6.1)
•
The most commonly reported solicited local and systemic adverse reactions in individuals 60 years of age and older (≥10%) were fatigue (15.7%), headache (12.9%), pain at the injection site (10.6%), and muscle pain (10.2%). (6.1)
•
The most commonly reported solicited local and systemic adverse reactions in individuals 18 through 59 years of age (≥10%) were pain at the injection site (35.3%), muscle pain (24.4%), joint pain (12.4%), and nausea (11.8%). (6.1)

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: 6/2025

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