PREVNAR 13
PREVNAR 13- streptococcus pneumoniae type 1 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 3 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 4 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 5 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 6a capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 6b capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 7f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 9v capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 14 capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 18c capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 23f capsular polysaccharide diphtheria crm197 protein conjugate antigen, streptococcus pneumoniae type 19a capsular polysaccharide diphtheria crm197 protein conjugate antigen and streptococcus pneumoniae type 19f capsular polysaccharide diphtheria crm197 protein conjugate antigen injection, suspension
Wyeth Pharmaceutical Division of Wyeth Holdings Corporation, a subsidiary of Pfizer Inc.
INDICATIONS AND USAGE
1.1 Children 6 Weeks Through 5 Years of Age
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 s erotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
active immunization for the prevention of otitis media caused by S. 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.
1.2 Children 6 Years Through 17 Years of Age
In children 6 years through 17 years of age (prior to the 18th birthday), Prevnar 13 is indicated for:
active immunization for the prevention of invasive disease caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
1.3 Adults 50 Years of Age and Older
In adults 50 years of age and older, Prevnar 13 is indicated for:
active immunization for the prevention of pneumonia and invasive disease caused by S. pneumoniaeserotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
1.4 Limitations of Prevnar 13 Use and Effectiveness
Prevnar 13 does not protect against disease caused by S. pneumoniae serotypes that are not in the vaccine.
2 DOSAGE AND ADMINISTRATION
2.1 Preparation for Administration
Since this product is a suspension containing an adjuvant, shake vigorously immediately prior to use to obtain a homogenous, white suspension in the vaccine container. Do not use the vaccine if it cannot be resuspended. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration [see Description (11)]. This product should not be used if particulate matter or discoloration is found.
Do not mix Prevnar 13 with other vaccines/products in the same syringe.
2.2 Administration Information
For intramuscular injection only.
Each 0.5 mL dose is to be injected intramuscularly using a sterile needle attached to the supplied prefilled syringe. The preferred sites for injection are the anterolateral aspect of the thigh in infants and the deltoid muscle of the upper arm in toddlers, children and adults. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.
2.3 Vaccination Schedule for Infants and Toddlers
Prevnar 13 is to be administered as a four-dose series at 2, 4, 6, and 12�15 months of age.
DOSAGE FORMS AND STRENGTHS
Prevnar 13 is a suspension for intramuscular injection available in 0.5 mL single-dose prefilled syringes.
DESCRIPTION
Prevnar 13, Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) is a sterile suspension of saccharides of the capsular antigens of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually linked to non-toxic diphtheria CRM197 protein. Each serotype is grown in soy peptone broth. The individual polysaccharides are purified through centrifugation, precipitation, ultrafiltration, and column chromatography. The polysaccharides are chemically activated to make saccharides, which are directly conjugated by reductive amination to the protein carrier CRM197 , to form the glycoconjugate. CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium. CRM197 is purified through ultrafiltration, ammonium sulfate precipitation, and ion-exchange chromatography. The individual glycoconjugates are purified by ultrafiltration and column chromatography and analyzed for saccharide to protein ratios, molecular size, free saccharide, and free protein.
CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Prevnar 13, comprised of pneumococcal polysaccharides conjugated to a carrier protein (CRM197 ), elicits a T-cell dependent immune response. Protein carrier-specific T-cells provide the signals needed for maturation of the B-cell response.
Nonclinical and clinical data support opsonophagocytic activity, as measured by opsonophagocytic activity (OPA) antibody assay, as a contributor to protection against pneumococcal disease. The OPA antibody assay provides an in vitro measurement of the ability of serum antibodies to eliminate pneumococci by promoting complement-mediated phagocytosis and is believed to reflect relevant in vivo mechanisms of protection against pneumococcal disease. OPA antibody titers are expressed as the reciprocal of the highest serum dilution that reduces survival of the pneumococci by at least 50%.
OW SUPPLIED/STORAGE AND HANDLING
Prefilled Syringe, 1 Dose (10 per package) � NDC 0005-1971-02.
Prefilled Syringe, 1 Dose (1 per package) � NDC 0005-1971-04 (Pfizer Helpful Answers Program).
Prefilled Syringe, 1 Dose (1 per package) � NDC 0005-1971-05.
After shipping, Prevnar 13 may arrive at temperatures between 2�C to 25�C (36�F to 77�F).
Upon receipt, store refrigerated at 2�C to 8�C (36�F to 46�F).
Do not freeze. Discard if the vaccine has been frozen.
The tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.
