WARNINGS
Prevnar 20® should not be given to anyone who has had a severe allergic reaction to any component of Prevnar 20 or to diphtheria toxoid.
Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups.
A temporary pause in breathing after getting the vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your healthcare provider about the infant's medical status when deciding to get vaccinated with Prevnar 20.
In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite, injection site redness, injection site swelling, and fever.
In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue, muscle pain, decreased appetite, injection site swelling, injection site redness, headache, and fever.
In individuals 18 years and older, the most common side effects reported at a rate of >10% were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Also, injection site swelling was common in individuals 18 years through 59 years of age.
Ask your healthcare provider about the risks and benefits of Prevnar 20. Only a healthcare provider can decide if Prevnar 20 is right for you or your child.
1. Management of Acute Allergic Reactions
Appropriate medical treatment and supervision used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration of Prevnar 20.
2. Altered Immunocompetence
Safety and immunogenicity data on Prevnar 20 are not available for individuals in immunocompromised groups and vaccination should be considered on an individual basis.
Based on experience with pneumococcal vaccines, individuals with altered immunocompetence may have reduced immune responses to Prevnar 20.
3. Apnea in Premature Infants
Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer Prevnar 20 to infants born prematurely should be based on consideration of the individual infant’s medical status and the potential benefits and possible risks of vaccination.
USES
Prevnar 20® is a vaccine indicated for
active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 6 weeks of age and older.
active immunization for the prevention of otitis media caused by S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F in individuals 6 weeks through 5 years of age.
active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older.
The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
HOW TO USE
Please call your healthcare provider for more information.
For adults, the most common side effects reported in clinical trials were:
Pain at the injection site
Muscle pain
Fatigue
Headache
Joint pain
For adults under 60 years of age, swelling at the injection site was also common.
If you have any questions about the safety information, or want more details, talk to your doctor or pharmacist.
None.
OVERDOSE
Please call your healthcare provider for more information.
MISSED DOSE
Please call your healthcare provider for more information.
STORAGE
Upon receipt, store refrigerated at 2-degrees C to 8-degrees C (36-degrees F to 46-degrees F).
Syringes should be stored in the refrigerator horizontally to minimize the resuspension time
NOTES
Medication Guide: revision date N/A
Prescribing Information: revision date 04/2023
1.) Prior Vaccination With PNEUMOVAX 23
In adults, receipt of PPSV23 1 to 5 years prior to Prevnar 20 resulted in diminished OPA geometric mean titers (GMTs) to Prevnar 20 compared to OPA GMTs in recipients who received Prevnar 13 at least 6 months prior to Prevnar 20, and compared to OPA GMTs in recipients who received Prevnar 13 followed by PPSV23, with the last dose of PPSV23 given at least 1 year prior to Prevnar 20.
2.) Immunosuppressive Therapies
Individuals with impaired immune responsiveness due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents) may not respond optimally to Prevnar 20.
See WARNINGS above.
