SAFETY AND TOLERABILITY
The Safety Profile of VAXNEUVANCE Was Assessed in Trials of >7000 Patients
These studies included assessments of VAXNEUVANCE:
- In healthy adults
- In adults with underlying medical conditions or behavioral risk factors that increase the risk of pneumococcal disease
- In immunocompromised adults living with HIV
- In adults at increased risk due to advancing age
- When given concomitantly with seasonal inactivated influenza vaccine
The most commonly reported solicited adverse reactions in individuals 18 through 49 years of age were: injection-site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection-site swelling (21.7%), injection-site erythema (15.1%), and arthralgia (12.7%).
The most commonly reported solicited adverse reactions in individuals 50 years of age and older were: injection-site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection-site swelling (15.4%), injection-site erythema (10.9%), and arthralgia (7.7%).
The safety profile of VAXNEUVANCE was similar compared with PCV13 in adults with HIV.
No clinically meaningful differences in the safety profile of VAXNEUVANCE were observed in older individuals (65 to 74 years and 75 years of age and older) compared to younger individuals.
The safety profile was similar when VAXNEUVANCE was administered with or without seasonal inactivated influenza vaccine.
HIV, human immunodeficiency virus; PCV13, 13-valent pneumococcal conjugate vaccine.
Indication for VAXNEUVANCE
VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) is indicated for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older.
Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.
Do not administer VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) to individuals with a severe allergic reaction (eg, anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.
Some individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.
The most commonly reported solicited adverse reactions in individuals 18 through 49 years of age were: injection-site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection-site swelling (21.7%), injection-site erythema (15.1%), and arthralgia (12.7%).
The most commonly reported solicited adverse reactions in individuals 50 years of age and older were: injection-site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection-site swelling (15.4%), injection-site erythema (10.9%), and arthralgia (7.7%).
Vaccination with VAXNEUVANCE may not protect all vaccine recipients.
Before administering VAXNEUVANCE, please read the accompanying Prescribing Information. The Patient Information also is available.