New Indication
FDA approves an additional indication for CAPVAXIVE in children and adolescents aged 2 through 17 at increased risk for pneumococcal disease
Before administering CAPVAXIVE, please read the accompanying
Prescribing Information. The Patient Information also is available.
Indications and Usage
CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in individuals 2 through 17 years of age who are at increased risk for pneumococcal disease.
Select Safety Information
Do not administer CAPVAXIVE® (Pneumococcal 21-valent Conjugate Vaccine) to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.
Syncope may occur with administration of injectable vaccines.
Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.
The most commonly reported (>10%) solicited adverse reactions in individuals 2 through 17 years of age who are at increased risk for pneumococcal disease were: injection-site pain (67.7%), injection-site erythema (24.3%), fatigue (20.1%), injection-site swelling (18.8%), headache (17.1%), malaise (13.3%), and irritability (11.6%).
The safety and effectiveness of CAPVAXIVE in individuals younger than 2 years of age have not been established.
Vaccination with CAPVAXIVE may not protect all vaccine recipients.
Before administering CAPVAXIVE, please read the accompanying Prescribing Information. The Patient Information also is available.