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HomeCDC RecommendationAbout RSVAbout ABRYSVOHeading

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Efficacy ProfileSafety ProfileDosing, Storage, ReconstitutionOrder ABRYSVOResourcesResourcesMaternal RSV Vaccine PlannerHealth Plan CoverageRequest A RepEventsMaterialsVideos
Prescribing InformationIndications Older AdultPatient Site
Administer with Pfizer’s needle-free* reconstitution optionsReferences

*Needle required for intramuscular injection is not included.

ABRYSVO® offers two options to fit your practice

ABRYSVO® Reconstitution Kit

ABRYSVO® ACT-O-VIAL®

Tab Number 3

Reconstitution Kit Instructions for Use Video

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View the video above or see full Prescribing Information for complete instructions on reconstituting and storing ABRYSVO.

See how to just click, mix, and prep to get started1Reconstitution Kit: single-dose administration
  • Administered as an intramuscular injection (at 32-36 weeks gestational age)
  • Contains no adjuvant or preservatives
  • After reconstitution, each dose of ABRYSVO is approximately 0.5 mL. The vaccine is formulated to contain 120 mcg of RSV-stabilized PreF proteins per 0.5 mL†
Needle-free* reconstitution
  • ABRYSVO is reconstituted with a vial adapter that eliminates needles during the reconstitution process*
Needle required for intramuscular injection is not included.

ACT-O-VIAL® Instructions for Use Video

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View the video above or see full Prescribing Information for complete instructions on reconstituting and storing ABRYSVO.

See the two-step process: press and swirl for reconstitution, then prep for administration1

ACT-O-VIAL®: single-dose administration
  • Administered as an intramuscular injection (at 32-36 weeks gestational age)
  • Contains no adjuvant or preservatives
  • After reconstitution, each dose of ABRYSVO is 0.5 mL. The vaccine is formulated to contain 120 mcg of RSV-stabilized PreF proteins per 0.5 mL†
All-in-one solution for reconstitution
  • ACT-O-VIAL is a dual-compartment vial system that allows reconstitution of ABRYSVO by  combining the diluent and lyophilized antigen all in one vial
Storage and handling
  • Storage before reconstitution: ABRYSVO should be stored refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton

DO NOT FREEZE. Discard if the carton has been frozen.

  • Storage after reconstitution: Administer ABRYSVO immediately or store at room temperature between 15°C and 30°C (59°F and 86°F) and use within 4 hours

DO NOT FREEZE RECONSTITUTED VACCINE.

60 mcg RSV PreF A and 60 mcg RSV PreF B.1

PreF=prefusion F; RSV=respiratory syncytial virus About ABRYSVO

Explore the efficacy and safety profiles of this maternal RSV vaccine.

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Learn more about coverage for this RSV vaccine for eligible pregnant patients.

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Discover helpful ABRYSVO resources and patient materials.

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Reference:

ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; August 2024.

To report an adverse event, please call 1-800-438-1985

Pfizer for Professionals 1-800-505-4426

This site is intended only for U.S. healthcare professionals. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only.

© 2024 Pfizer Inc. All rights reserved.

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IndicationsABRYSVO is a vaccine indicated for:
 
  • active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older
  • active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age

Please click here for full Prescribing Information.
Important Safety Information
  • Do not administer ABRYSVO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of ABRYSVO
  • A numerical imbalance in preterm births was observed compared to placebo in 2 clinical studies. Data are insufficient to establish or exclude a causal relationship between preterm birth and ABRYSVO. To avoid potential risk of preterm birth with use of ABRYSVO before 32 weeks of gestation, administer to pregnant individuals at 32 through 36 weeks gestational age
  • Appropriate medical treatment must be available in case of an anaphylactic reaction
  • Syncope (fainting) may occur in association with administration of injectable vaccines, including ABRYSVO. Procedures should be in place to avoid injury from fainting
  • Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to ABRYSVO
  • Vaccination with ABRYSVO may not protect all vaccine recipients
  • In clinical trials with older adults, the most commonly reported (≥10%) adverse reactions were fatigue (15.5%), headache (12.8%), pain at the injection site (10.5%), and muscle pain (10.1%)
  • In clinical trials with pregnant individuals, the most commonly reported (≥10%) adverse reactions were pain at the injection site (40.6%), headache (31.0%), muscle pain (26.5%), and nausea (20.0%)
  • In clinical trials with infants born to pregnant individuals, low birth weight (5.1% ABRYSVO versus 4.4% placebo) and neonatal jaundice (7.2% ABRYSVO versus 6.7% placebo) were observed.

Individuals who received ABRYSVO during pregnancy are encouraged to contact 1-800-616-3791 to enroll in a Pregnancy Exposure Registry.

Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

Please see full Prescribing Information for ABRYSVO. IndicationsABRYSVO is a vaccine indicated for:
  • active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older
  • active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age