Prevnar 13 Dosage

Generic name: pneumococcal 13-valent conjugate vaccine
Dosage form: injection, suspension

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For intramuscular injection only.

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.

Administration Information

Do not inject intravenously, intradermally, or subcutaneously.

Each 0.5 mL dose is to be injected intramuscularly. The preferred sites for injection are the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in toddlers and young children. The vaccine should not be injected in the gluteal area or areas where there may be a major nerve trunk and/or blood vessel.

Vaccine 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.

Table 1: Vaccination Schedule for Infants and Toddlers
Dose Dose 1* Dose 2 Dose 3 Dose 4
* Dose 1 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.

Age at Dose 2 months 4 months 6 months 12-15 months

Vaccine Schedule for Unvaccinated Children ≥7 Months of Age

For children who are beyond the age of the routine infant schedule and have not received Prevnar or Prevnar 13, the following catch-up schedule applies:

Table 2: Vaccine Schedule for Unvaccinated Children ≥7 Months of Age
* The first 2 doses at least 4 weeks apart; third dose after the one-year birthday, separated from the second dose by at least 2 months.

Two doses at least 2 months apart.

Age at First Dose Total Number of 0.5 mL Doses
7-11 months of age 3*
12-23 months of age 2
24 months through 5 years of age (prior to the 6th birthday) 1

The immune responses induced by this catch-up schedule may result in lower antibody concentrations for some serotypes, compared to antibody concentrations following 4 doses of Prevnar 13 (given at 2, 4, 6, and 12 to 15 months). In children 24 months through 5 years of age, the catch-up schedule may result in lower antibody concentrations for some serotypes, compared to antibody concentrations following 3 doses of Prevnar 13 (given at 2, 4, and 6 months). The clinical relevance of these lower antibody responses is not known.

Prevnar 13 Vaccine Schedule for Children Previously Vaccinated With Prevnar (Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F)

Children who have received one or more doses of Prevnar may complete the 4-dose immunization series with Prevnar 13. Children 15 months through 5 years of age who have received 4 doses of Prevnar may receive one dose of Prevnar 13 to elicit immune responses to the six additional serotypes. This catch-up dose of Prevnar 13 should be administered with an interval of at least 8 weeks after the fourth dose of Prevnar. The immune responses induced by this Prevnar 13 transition 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 (given at 2, 4, 6, and 12 to 15 months). The clinical relevance of these lower antibody responses is not known.

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