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HomeCDC RecommendationAbout RSVAbout ABRYSVO

About ABRYSVO

Efficacy ProfileImmunobridgingSafety ProfileDosing, Storage, & ReconstitutionPatient ProfilesOrder ABRYSVO

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Prescribing InformationIndicationsPatient SiteMaternal
Administered with Pfizer’s convenient needle-free* reconstitution preparation options*Needle required for intramuscular injection is not included.
ABRYSVO® IS THE ONLY RSV VACCINE WITH NEEDLE-FREE PREPARATION OPTIONS THAT ARE NEVER FROZEN OR THAWED1
Two preparation options to fit your practice

ABRYSVO® ACT-O-VIAL®

ABRYSVO® Reconstitution Kit

Tab Number 3

ACT-O-VIAL® Instructions for Use Video

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

See the 2-step process: press and swirl for reconstitution, then prep for administration1

ACT-O-VIAL: single-dose administration

  • Administered as a single-dose intramuscular injection1
  • 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 mL1

Needle-free* reconstitution

  • ACT-O-VIAL is a dual-compartment vial system that allows reconstitution of ABRYSVO by combining the diluent and lyophilized antigen all in 1 vial1
*Needle required for intramuscular injection is not included.1

Storage and handling

  • Storage before reconstitution: ABRYSVO should be stored refrigerated at 2°C to 8°C (36°F to 46°F)1
DO NOT FREEZE. Discard if the carton has been frozen1
  • 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 hours1
DO NOT FREEZE RECONSTITUTED VACCINE1

preF=prefusion F; RSV=respiratory syncytial virus.

Click, Mix, Prep Highlights

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 started

Reconstitution Kit

  • Administered as an intramuscular injection1
  • 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 mL1

Needle-free* reconstitution

  • ABRYSVO is reconstituted with a reconstitution kit that eliminates needles during the reconstitution process1∗
*Needle required for intramuscular injection is not included.1

Storage and handling

  • Storage before reconstitution: ABRYSVO should be stored refrigerated at 2°C to 8°C (36°F to 46°F)1
DO NOT FREEZE. Discard if the carton has been frozen1
  • 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 hours1
DO NOT FREEZE RECONSTITUTED VACCINE1

preF=prefusion F; RSV=respiratory syncytial virus.

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Reference:ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; January 2025.

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.

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PP-A1G-USA-1986
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
  • 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
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
  • The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with 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 adults aged 60+, the most commonly reported (≥10%) adverse reactions
were fatigue (15.7%), headache (12.9%), pain at the injection site (10.7%), and muscle pain (10.2%)
  • In clinical trials with adults aged 18-59, the most commonly reported (≥10%) adverse reactions were pain at the injection site (35.3%), muscle pain (24.4%), joint pain (12.4%), and nausea (11.8%)
  • 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
     
  • 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
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