Prevnar 13™ Pneumococcal 13-valent conjugate vaccine Manufacturer: Wyerth FDA Approval Date: 12/2011

Prevnar 13™ - Pneumococcal 13-valent conjugate Clinical Application Indications: Immunization of infants and children against Strep pneumoniae caused by included serotypes Immunization of infants and children against otitis media caused by Strep pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F Immunization of adults ≥50 years against pneumococcal pneumonia and invasive disease caused by included Strep pneumoniae serotypes

Prevnar 13™ - Pneumococcal 13-valent conjugate Clinical Application Place in therapy: Vaccination used to immunize patients as young as 6 weeks against various strains of Strep pneumoniae

Prevnar 13™ - Pneumococcal 13-valent conjugate Clinical Application Contraindications: Hypersensitivity Warnings: Apnea and Acute Illness Precautions: Use in pts w/ altered immunocompetence Use in Elderly (>65yoa)

Prevnar 13™ - Pneumococcal 13-valent conjugate Clinical Application Pregnancy: B Lactation: Excretion in breast milk unknown/use caution

Prevnar 13™ - Pneumococcal 13-valent conjugate Drug Facts Pharmacology Administered as a series of 4 injections given at 2, 4, 6, and 15-18 months of age Full efficacy w/in 1 month of the final vaccination

Prevnar 13™ - Pneumococcal 13-valent conjugate Drug Interactions Drug Interactions – Precipitant Drugs Belimumab: May the therapeutic effect of this Vaccine (inactivate) Fingolimod: May the therapeutic effect of this Vaccine (inactivate)

Prevnar 13™ - Pneumococcal 13-valent conjugate Adverse Effects Common Adverse Effects: (>10%) Central nervous system: Chills, drowsiness, fatigue, fever, headache, insomnia, irritability Dermatologic: Rash Gastrointestinal: Appetite decreased Local: Erythema, limitation of arm motion, pain, swelling, tenderness Neuromuscular & skeletal: Arthralgia, myalgia

Prevnar 13™ - Pneumococcal 13-valent conjugate Monitoring Parameters Efficacy Monitoring None Toxicity Monitoring

Cost: Estimated $430 for complete series Prevnar 13™ - Pneumococcal 13-valent conjugate Prescription Information Dosing: Infants and Children 6 weeks-59 months: 0.5 mL/dose X 4 doses: The first dose may be given as young as 6 weeks - 2 months. The 3 remaining doses are usually given at 4, 6, and 12-15 months The recommended dosing interval is 4-8 weeks The minimum interval between doses in children <1 year of age is 1 month The minimum interval between the third and fourth dose is 2 months Cost: Estimated $430 for complete series

Prevnar 13™ - Pneumococcal 13-valent conjugate vaccine Summary Prevnar 13™ is the successor to the previously-marketed Prevnar® and is used in patients as young as 6 weeks. Prevnar 13™ contains an additional 6 serotypes of Streptococcus pneumoniae, compared to the 7 serotypes provided in the original Prevnar® formulation. The CDC has announced that young children appear to be at increased risk of febrile seizures when given the pneumococcal conjugate vaccine (PCV 13) at the same time as the inactivated influenza virus vaccine (TIV). The risk appears to be greatest from ages 12-23 months. Because febrile seizures are typically benign and occur in 2% to 5% of all young children, the ACIP does not recommend a delay in administration of either vaccine or altering the vaccine schedule in any manner due to the potential risk of infection.

Prevnar 13™ - Pneumococcal 13-valent conjugate References Prenvar-13 package insert. Wyerth Pharmaceuticals. Jan. 2012. http://labeling.pfizer.com/showlabeling.aspx?id=501 Pubmed. MMWR Recomm Rep. 2010 Dec 10;59(RR-11):1-18. Accessed 01/12. http://www.ncbi.nlm.nih.gov/pubmed/21150868