PREVNAR 13 Drug Interactions

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

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Drug-Drug Interactions

Different injectable vaccines should always be given at different vaccination-sites.

Infants and Children Aged 6 Weeks to 5 Years

Prevnar 13 can be given, at a different vaccination-site, with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, meningococcal serogroup C, measles, mumps, rubella and varicella.

In the clinical trials, some infants and children were given rotavirus vaccine (oral administration) or hepatitis A vaccine (at a different site) with Prevnar 13. The safety profiles were comparable for these children but immunogenicity data were not available.

Prevnar 13 can also be given concomitantly with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine, administered between 12-23 months of age in children who have previously received the infant series of Prevnar 13 (see PART II, CLINICAL TRIALS section).

Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and acetaminophen) on the immune response to Prevnar 13 suggest that prophylactic administration of acetaminophen may reduce the immune response to Prevnar 13 after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown.

Children and Adolescents 6 to 17 Years of Age

In children and adolescents, data are insufficient to assess the concomitant administration of Prevnar 13 with other routinely administered vaccines in this age group, including human papillomavirus vaccine (HPV), meningococcal protein conjugate vaccine (MCV4), influenza vaccine and tetanus, diphtheria and pertussis vaccine (Tdap).

Adults 18 to 49 Years of Age

No data are currently available regarding concomitant use with other vaccines.

Adults 50 Years and Older

Concomitant administration of Prevnar 13 and a trivalent inactivated influenza vaccine (TIV) has been studied in adults 50 years and older. Concomitant administration of Prevnar 13 and quadrivalent inactivated influenza vaccine (QIV) has been studied in adults 50 years of age and older who had previously received the 23-valent pneumococcal polysaccharide vaccine (PPSV23) at least one year prior (see PART II, CLINICAL TRIALS section).

Drug-Lifestyle Interactions

Some of the effects mentioned under the ADVERSE REACTIONS section may temporarily affect the ability to drive or use machines.

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Drug Interactions

Drug-Drug Interactions

Different injectable vaccines should always be given at different vaccination-sites.

Infants and Children Aged 6 Weeks to 5 Years

Prevnar 13 can be given, at a different vaccination-site, with any of the following vaccine antigens, either as monovalent or combination vaccines: diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, hepatitis B, meningococcal serogroup C, measles, mumps, rubella and varicella.

In the clinical trials, some infants and children were given rotavirus vaccine (oral administration) or hepatitis A vaccine (at a different site) with Prevnar 13. The safety profiles were comparable for these children but immunogenicity data were not available.

Prevnar 13 can also be given concomitantly with the tetanus toxoid conjugated meningococcal polysaccharide serogroups A, C, W and Y vaccine, administered between 12-23 months of age in children who have previously received the infant series of Prevnar 13 (see PART II, CLINICAL TRIALS section).

Data from a postmarketing clinical study evaluating the impact of prophylactic use of antipyretics (ibuprofen and acetaminophen) on the immune response to Prevnar 13 suggest that prophylactic administration of acetaminophen may reduce the immune response to Prevnar 13 after the infant series. Responses to the booster dose administered at 12 months were unaffected. The clinical significance of this observation is unknown.

Children and Adolescents 6 to 17 Years of Age

In children and adolescents, data are insufficient to assess the concomitant administration of Prevnar 13 with other routinely administered vaccines in this age group, including human papillomavirus vaccine (HPV), meningococcal protein conjugate vaccine (MCV4), influenza vaccine and tetanus, diphtheria and pertussis vaccine (Tdap).

Adults 18 to 49 Years of Age

No data are currently available regarding concomitant use with other vaccines.

Adults 50 Years and Older

Concomitant administration of Prevnar 13 and a trivalent inactivated influenza vaccine (TIV) has been studied in adults 50 years and older. Concomitant administration of Prevnar 13 and quadrivalent inactivated influenza vaccine (QIV) has been studied in adults 50 years of age and older who had previously received the 23-valent pneumococcal polysaccharide vaccine (PPSV23) at least one year prior (see PART II, CLINICAL TRIALS section).

Drug-Lifestyle Interactions

Some of the effects mentioned under the ADVERSE REACTIONS section may temporarily affect the ability to drive or use machines.

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