Prevnar 13

Prevnar 13 Special Precautions

vaccine, pneumococcal




Zuellig Pharma
Full Prescribing Info
Special Precautions
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 Prevnar 13 (see Adverse Reactions).
The administration of Prevnar 13 should be postponed in patients suffering from acute severe febrile illness.
As with any IM 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 only protect against Streptococcus pneumoniae serotypes included in the vaccine, and will not protect against other microorganisms that cause invasive disease, pneumonia, or as with any vaccine, Prevnar 13 may not protect all individuals receiving the vaccine from pneumococcal disease.
Children with impaired immune responsiveness, whether due to the use of immunosuppressive therapy, a genetic defect, HIV infection or other causes, may have reduced antibody response to active immunization.
Safety and immunogenicity data on Prevnar 13 are not available for individuals in immunocompromised groups (eg, individuals with malignancy or nephrotic syndrome) and vaccination should be considered on an individual basis.
Infants and Children 6 Weeks to 5 Years: Limited data have demonstrated that pneumococcal 7-valent conjugate vaccine (3-dose primary series) induces an acceptable immune response in infants with sickle cell disease with a safety profile similar to that observed in non-high-risk groups (see Pharmacology: Pharmacodynamics under Actions).
The use of pneumococcal conjugate vaccine does not replace the use of PPSV23 in children ≥24 months with sickle cell disease, asplenia, HIV infection, chronic illness or those who are otherwise immunocompromised. Data on sequential vaccination with Prevnar 13 followed by PPSV23 are not available; data on sequential vaccination with pneumococcal 7-valent conjugate 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 hrs 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.
When Prevnar 13 is administered concomitantly with Infanrix hexa (DTaP-HBV-IPV/Hib), the rates of febrile reactions are similar to those seen with concomitant administration of Pneumococcal 7-valent conjugate vaccine and Infanrix hexa (see Adverse Reactions).
Use in Pregnancy & Lactation: Information on the safety of Prevnar 13 when used during pregnancy and lactation is not available.
It is not known whether vaccine antigens or antibodies are excreted in human milk.
Use in Children: The safety and effectiveness of Prevnar 13 in children <6 weeks have not been established.
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