Safety and Dosing Profile of Prevnar 13^®

Prevnar 13^® showed a comparable adverse event profile to Prevnar^® (Pneumococcal 7-valent Conjugate Vaccine [Diphtheria CRM₁₉₇
Protein])²

• 4729 infants and toddlers received at least 1 dose of Prevnar 13^® in 13 clinical trials ²
• A total of 1907 subjects received at least 1 dose of Prevnar 13^® and 701 subjects received at least 1 dose of Prevnar^® in the 3 US studies²
  • A similar proportion of Prevnar 13^® and Prevnar^® recipients reported solicited local and systemic adverse reactions as well as unsolicited adverse events, among US study subjects
  • The most commonly reported solicited adverse reactions (≥20%) in US clinical trials were redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep
• As shown in clinical trials, Prevnar 13^® can be administered concomitantly with routine pediatric vaccines ²
  • Responses to diphtheria toxoid, tetanus toxoid, pertussis, polio types 1, 2, and 3, hepatitis B, PRP-T, PRP-OMP, measles, and varicella antigens in Prevnar 13^® recipients were similar to those in Prevnar^® recipients. Based on limited data, responses to mumps and rubella antigens in Prevnar 13^® recipients were similar to those in Prevnar^® recipients

Prevnar 13^® dosing schedule is similar to Prevnar^{® 2}

*May be given as early as 6 weeks of age.
†The recommended dosing interval is 4 to 8 weeks.
‡The fourth dose should be administered at approximately 12-15 months of age and
at least 2 months after the third dose.

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.