Transitioning from Prevnar^® to Prevnar 13^®

• The immune response induced by the above Prevnar 13^® schedule may result in lower antibody concentrations for the 6 additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared to antibody concentrations following 4 doses of Prevnar 13^®. The clinical relevance of these lower antibody responses is not known²

• One dose of Prevnar 13^® may be administered after completing the 4-dose series of Prevnar^® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM₁₉₇ Protein]) to elicit immune responses to the 6 additional serotypes²
• The immune response induced by the above Prevnar 13^® schedule may result in lower antibody concentrations for the 6 additional serotypes (types 1, 3, 5, 6A, 7F, and 19A), compared to antibody concentrations following 4 doses of Prevnar 13^®. The clinical relevance of these lower antibody responses is not known²

INDICATION FOR PREVNAR 13^®

• Prevnar 13^® is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the 6th birthday)
• Prevnar 13^® 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, and 23F
• Prevnar 13^® is also indicated for the prevention of otitis media caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F. No otitis media efficacy data are available for serotypes 1, 3, 5, 6A, 7F, and 19A

IMPORTANT SAFETY INFORMATION FOR PREVNAR 13^®

• Severe allergic reaction (eg, anaphylaxis) to any component of Prevnar 13^®, Prevnar^®, or any diphtheria vaccine is a contraindication to the use of Prevnar 13^®
• Prevnar 13^® does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes. Protection against otitis media is expected to be substantially lower than protection against invasive disease
• Immunocompromised children or children with impaired immune responsiveness due to the use of immunosuppressive therapy may have reduced antibody response to active immunization
• Apnea following intramuscular vaccination has been observed in some infants born prematurely. Decisions about when to administer an intramuscular vaccine, including Prevnar13^®, 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
• The most commonly reported serious adverse events were bronchiolitis (0.9%, 1.1%), gastroenteritis (0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevnar 13^® and Prevnar^®, respectively
• The most commonly reported solicited adverse reactions (≥20%) in US clinical trials with Prevnar 13^® were redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep

Please see full Prescribing Information for PREVNAR 13^®

INDICATION FOR PREVNAR^®

• Prevnar^® is indicated for active immunization of infants and toddlers against invasive disease caused by Streptococcus pneumoniae due to capsular serotypes included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F). The routine schedule is 2, 4, 6, and 12 to 15 months of age
• The decision to administer Prevnar^® should be based primarily on its efficacy in preventing invasive pneumococcal disease. As with any vaccine, Prevnar^® may not protect all individuals receiving the vaccine from invasive pneumococcal disease
• Prevnar^® is also indicated for active immunization of infants and toddlers against otitis media caused by serotypes included in the vaccine. However, for vaccine serotypes, protection against otitis media is expected to be substantially lower than protection against invasive disease. Additionally, because otitis media is caused by many organisms other than serotypes of Streptococcus pneumoniae represented in the vaccine, protection against all causes of otitis media is expected to be low
• This vaccine is not intended to be used for treatment of active infection

IMPORTANT SAFETY INFORMATION FOR PREVNAR^®

• In clinical trials (n=18,168), the most frequently reported adverse events included injection site reactions, fever (≥38°C/100.4°F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash
• Risks are associated with all vaccines, including Prevnar^®. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar^® does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes

Please see full Prescribing Information for PREVNAR^®

These documents are in PDF (portable document format).
PDF files require Adobe Reader; click here to download this free program.