Abrysvo Special Precautions

Guillain-Barré Syndrome: The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome (GBS) during the 42 days following vaccination with ABRYSVO [see Postmarketing Experience under Adverse Reactions].
Potential Risk of Preterm Birth: A numerical imbalance in preterm births in ABRYSVO recipients was observed compared to placebo recipients in two clinical studies [see Clinical Trials Experience under Adverse Reactions]. Available data are insufficient to establish or exclude a causal relationship between preterm birth and ABRYSVO. 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. Pregnant individuals who were at increased risk of preterm birth were generally excluded from clinical studies of ABRYSVO.
Management of Acute Allergic Reactions: Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an anaphylactic reaction occurs following administration of ABRYSVO.
Syncope: Syncope (fainting) may occur in association with administration of injectable vaccines, including ABRYSVO. Procedures should be in place to avoid injury from fainting.
Altered Immunocompetence: Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to ABRYSVO.
Limitations of Vaccine Effectiveness: Vaccination with ABRYSVO may not protect all vaccine recipients.
Use in Children: The safety and effectiveness of ABRYSVO to prevent RSV-associated lower respiratory tract disease (RSV-LRTD) and severe RSV-LRTD in infants born to individuals vaccinated at younger than 10 years of age have not been established.
The safety and effectiveness of ABRYSVO to prevent RSV-LRTD in non-pregnant individuals younger than 18 years of age via active immunization have not been established.
Use in the Elderly: ABRYSVO is approved for use in individuals 60 years of age and older. In Study 3, of the 18,574 recipients who received ABRYSVO 63% (n=11,619) were aged 60-69 years of age, 32% (n=5,928) were 70-79 years of age and 5% (n=1,026) were ≥80 years of age [see Clinical Trials Experience under Adverse Reactions and Pharmacology: Pharmacodynamics: Clinical Studies: Efficacy in Individuals 60 Years of Age and Older under Actions].