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PREVNAR 13 (Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)) Warnings And Precautions

Warnings And Precautions

General

  • Immunocompromised individuals may have a reduced antibody response to the vaccine.
  • Safety and immunogenicity data on Prevnar 13 are not available for individuals in certain immunocompromised groups (e.g., individuals with malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis. Some safety and immunogenicity data are available in individuals with sickle cell disease (SCD), with human immunodeficiency virus (HIV) infection, or with hematopoietic stem cell transplant (see PART II, CLINICAL TRIALS).
  • As with all injectable vaccines, appropriate medical treatment and supervision must always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
  • Minor illnesses, such as mild respiratory infection, with or without low-grade fever, are not generally contraindications to vaccination. The decision to administer or delay vaccination because of a current or recent febrile illness depends largely on the severity of the symptoms and their etiology. The administration of Prevnar 13 should be postponed in subjects suffering from acute severe febrile illness.
  • As with any intramuscular injection, Prevnar 13 should be given with caution to infants, children or adults with thrombocytopenia or any coagulation disorder, or to those receiving anticoagulant therapy.
  • Prevnar 13 will not protect against Streptococcus pneumoniae serotypes not included in the vaccine. Prevnar 13 will not protect against other microorganisms that cause invasive disease, pneumonia or otitis media. This vaccine is not intended to be used for treatment of active infection.
  • As with any vaccine, Prevnar 13 may not protect all individuals receiving the vaccine from pneumococcal disease.

Infants and Children Aged 6 Weeks to 5 Years

  • The use of pneumococcal conjugate vaccine does not replace the use of 23-valent pneumococcal polysaccharide vaccine (PPSV23) in children ≥ 24 months of age with sickle cell disease, asplenia, HIV infection, chronic illness, or who are otherwise immunocompromised. Data on sequential vaccination with Prevnar 13 followed by PPSV23 are not available; data on sequential vaccination with Prevnar (7-valent) vaccine followed by PPSV23 are limited.
  • As with all injectable pediatric vaccines, the potential risk of apnea should be considered when administering the primary immunization series to premature infants. The need for monitoring for at least 48 hours after vaccination should be considered for very premature infants (born ≤ 30 weeks of gestation) who remain hospitalized at the time of the recommended administration. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
  • Immunization with Prevnar 13 does not substitute for routine diphtheria immunization.
  • When Prevnar 13 is administered concomitantly with Infanrix hexa (DTaP-HBV-IPV/Hib), there are no data that would suggest that the rates of febrile reactions would be different to those seen with concomitant administration of pneumococcal 7-valent conjugate vaccine and Infanrix hexa. A higher incidence of fever (≥ 38.0°C to ≤ 39.0°C) was reported in infants receiving Infanrix hexa and pneumococcal 7-valent conjugate vaccine compared to infants receiving the hexavalent vaccine alone. Increased reporting rates of convulsions (with or without fever) and hypotonic-hyporesponsive episode (HHE) were observed with concomitant administration of Prevnar 13 and Infanrix hexa (see ADVERSE REACTIONS section).

Special Populations

Pregnant Women:

A reproduction study has been performed in female rabbits at doses equal to the human dose and has revealed no evidence of impaired fertility or harm to the fetus due to Prevnar 13. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this vaccine should be used during pregnancy only if clearly needed.

Nursing Women:

Safety during lactation has not been established.
It is not known whether vaccine antigens or antibodies are excreted in human milk.

Pediatrics:

The safety and immunogenicity of Prevnar 13 in children below the age of 6 weeks have not been established.

Geriatrics:

Prevnar 13 has been studied in the geriatric population (see PART II, CLINICAL TRIALS section).

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