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AboutAboutAbout APEXXNARMechanism of actionClinical programmeClinical programmeAPEXXNAR clinical study overviewAPEXXNAR adverse drug reactionsAdministration
Apexxnar® adverse drug reactions1Tabulated adverse drug reactions from Phase 3 trials (4,263 participants who received APEXXNAR®) and Prevenar 13® (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) postmarketing experience1

As APEXXNAR contains the same 13 serotype-specific capsular polysaccharide conjugates and the same vaccine excipients as Prevenar 13®, the adverse reactions already identified for Prevenar 13 have been adopted for APEXXNAR.1


No new adverse reactions were identified as compared to Prevenar 13.1


Adverse experiences that have been spontaneously reported during the postmarketing use of Prevenar 13, may also occur with APEXXNAR.1 

Events reported spontaneously in Prevenar 13 postmarketing experience; therefore, the frequencies could not be estimated from the available data and are considered as not known.Not reported in the adult Phase 3 trials of APEXXNAR; therefore, the frequency is not known.Event reported in clinical trials with Prevenar 13 with very common frequency (≥ 1/10). 

Safety with concomitant vaccine administration in adults1

When APEXXNAR was administered to adults aged ≥ 65 years together with the third (booster) dose of a COVID-19 mRNA vaccine (nucleoside modified), the tolerability profile generally resembled that of the COVID-19 mRNA vaccine (nucleoside modified) administered alone. There were a few differences in the safety profile when compared to administration of APEXXNAR alone. In the phase 3 trial B7471026, pyrexia (13.0%) and chills (26.5%) were reported as 'very common' with co-administration. There was also one report of dizziness in the co-administration group.1

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 for how to report adverse reactions.References:APEXXNAR® Summary of Product Characteristics.Froes F, Roche N, Blasi F. Pneumococcal vaccination and chronic respiratory diseases. Int J Chron Obstruct Pulmon Dis. 2017;12:3457-3468.Clinical programme How does APEXXNAR work?

Conjugate vaccines like APEXXNAR are designed to deliver long-lasting  immunity.1,2

 Learn how Loading View Summary of Product Characteristics Apexxnar® Loading Prevenar 13®

Legal Category: S1A
Further information is available upon request

PP-PNR-IRL-0017 Date of Preparation: August 2022

Adverse events should be reported. Report an adverse event to your national reporting system (HPRA Pharmacovigilance)
 

Adverse events should also be reported to Pfizer Medical Information on 1800 633 363

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