Indication & Important Safety Info
Indication
Important Safety Information
Indication
AREXVY 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;
- individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.
Limitations of Use
AREXVY is not for use in pregnant individuals.
Important Safety Information
- AREXVY is contraindicated in anyone with a history of a severe allergic reaction (eg, anaphylaxis) to any component of AREXVY
- The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY
- Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY
- Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting
- Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY
- In adults 60 years of age and older, the most commonly reported adverse reactions (≥10%) were injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%), headache (27.2%), and arthralgia (18.1%)
- In adults 50 through 59 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (75.8%), fatigue (39.8%), myalgia (35.6%), headache (31.7%), arthralgia (23.4%), erythema (13.2%), and swelling (10.4%)
- In adults 18 through 49 years of age, the most commonly reported adverse reactions (≥10%) were injection site pain (76.0%), myalgia (59.9%), fatigue (59.6%), headache (43.6%), and arthralgia (28.3%)
- Vaccination with AREXVY may not result in protection of all vaccine recipients
Please see full Prescribing Information.