ABRYSVO™ Highlights

(Respiratory Syncytial Virus Vaccine)

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.

ABRYSVOTM (Respiratory Syncytial Virus Vaccine) solution for intramuscular injection
Initial U.S. Approval: 2023

RECENT MAJOR CHANGES

Indications and Usage (1.1)

8/2023

Warnings and Precautions (5.1)

8/2023

INDICATIONS AND USAGE

ABRYSVO is a vaccine indicated for

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 respiratory syncytial virus (RSV) in individuals 60 years of age and older. (1.2)

DOSAGE AND ADMINISTRATION

For intramuscular use only. (2)
Administer ABRYSVO as a single approximately 0.5 mL dose. (2.3)

DOSAGE FORMS AND STRENGTHS

Solution for injection. A single dose after reconstitution is approximately 0.5 mL. (3)

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

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)

ADVERSE REACTIONS

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 (15.5%), headache (12.8%), pain at the injection site (10.5%), and muscle pain (10.1%). (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: 8/2023

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Highlights

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.

ABRYSVOTM (Respiratory Syncytial Virus Vaccine) solution for intramuscular injection
Initial U.S. Approval: 2023

RECENT MAJOR CHANGES

Indications and Usage (1.1)

8/2023

Warnings and Precautions (5.1)

8/2023

INDICATIONS AND USAGE

ABRYSVO is a vaccine indicated for

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 respiratory syncytial virus (RSV) in individuals 60 years of age and older. (1.2)

DOSAGE AND ADMINISTRATION

For intramuscular use only. (2)
Administer ABRYSVO as a single approximately 0.5 mL dose. (2.3)

DOSAGE FORMS AND STRENGTHS

Solution for injection. A single dose after reconstitution is approximately 0.5 mL. (3)

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

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)

ADVERSE REACTIONS

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 (15.5%), headache (12.8%), pain at the injection site (10.5%), and muscle pain (10.1%). (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: 8/2023

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FDA Medwatch

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