Resources | ABRYSVO (Respiratory Syncytial Virus Vaccine) Safety Info

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Indications

ABRYSVO 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 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 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 (10.6%), 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 vs 4.3% placebo) and neonatal jaundice (7.3% ABRYSVO vs 6.9% 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.

Indications

ABRYSVO 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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