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PREVNAR® 13 (pneumococcal 13-valent conjugate vaccine - diphtheria CRM197 protein) Drug Interactions

7 DRUG INTERACTIONS

7.1 Concomitant Immunizations

In clinical trials with infants and toddlers, Prevnar 13 was administered concomitantly with the following US-licensed vaccines: Pediarix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined] (DTaP-HBV-IPV) and ActHIB [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] (PRP-T) for the first three doses and with PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] (PRP-OMP), M-M-R II [Measles, Mumps, Rubella Virus Vaccine Live] (MMR) and Varivax [Varicella Virus Vaccine Live], or ProQuad [Measles, Mumps, Rubella and Varicella Virus Vaccine Live] (MMRV) and VAQTA [Hepatitis A vaccine, Inactivated] (HepA) for dose 4 [see Clinical Studies (14.2) and Adverse Reactions (6.1)].

In children and adolescents, data are insufficient to assess the concomitant administration of Prevnar 13 with Human Papillomavirus Vaccine (HPV), Meningococcal Conjugate Vaccine (MCV4) and Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (Tdap).

In adults, Prevnar 13 was administered concomitantly with US-licensed inactivated influenza vaccines, trivalent and quadrivalent (Studies 10, 11 and 13)[see Clinical Studies (14.4) and Adverse Reactions (6.2)]. There are no data on the concomitant administration of Prevnar 13 with diphtheria toxoid-containing vaccines and other vaccines licensed for use in adults 50 years of age and older.

When Prevnar 13 is administered at the same time as another injectable vaccine(s), the vaccines should always be administered with different syringes and given at different injection sites.

Do not mix Prevnar 13 with other vaccines/products in the same syringe.

7.2 Immunosuppressive Therapies

Individuals with impaired immune responsiveness due to the use of immunosuppressive therapy (including irradiation, corticosteroids, antimetabolites, alkylating agents, and cytotoxic agents) may not respond optimally to active immunization.

7.3 Antipyretics

A post-marketing clinical study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. The data show that 3 doses of acetaminophen (the first dose administered at the time of each vaccination and the subsequent doses at 6 to 8 hour intervals) reduced the antibody response to some serotypes following the third dose of Prevnar 13, compared with responses among infants who received antipyretics only as needed for treatment. Reduced antibody responses were not observed after the fourth dose of Prevnar 13 when acetaminophen was administered prophylactically.

7.4 Prior Vaccination with PPSV23

Prior receipt of PPSV23 within 1 year results in diminished immune responses to Prevnar 13 compared to PPSV23 naïve individuals [see Clinical Studies (14.3)].

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