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Urgent Safety Communication: Brolucizumab (Beovu(R)/PAGENAX(R)) – Emerging safety issue of increased incidence of Intraocular Inflammation and related adverse events (28 พฤษภาคม 2564) – ศูนย์เฝ้าระวังความปลอดภัยด้านผลิตภัณฑ์สุขภาพ

Urgent Safety Communication: Brolucizumab (Beovu(R)/PAGENAX(R)) – Emerging safety issue of increased incidence of Intraocular Inflammation and related adverse events (28 พฤษภาคม 2564)

อาการไม่พึงประสงค์ของยา Brolucizumab (Beovu(R)/PAGENAX(R)) (28 พฤษภาคม 2564)

Summary

– An emerging safety issue of increased incidence of Intraocular Inflammation (IOl) and related adverse events including RV, and RO in patients with every 4 weeks (q4 week) dosing beyond the first three doses in nAMD based on first interpretable results (FIR) from the CRTH258AUS04 (MERLIN) study has been observed.

– A higher frequency of 1OI including RV, and RO was noted in brolucizumab 6 mg q4 week arm as compared to aflibercept 2mg q4 week.

– You should not dose patients with Beovu/PAGENAX 6 mg at intervals less than 8 weeks beyond the first three doses.

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