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Guidance for treating physicians

Reports from clinicians of events that have occurred during marketed use so far suggest that these events can occur as early as the first or second injection of Beovu, with patients reporting changes in vision, such as significant increase in floaters or blurry vision, within one to two weeks of treatment.

Before injecting, physicians are encouraged to look for signs of intraocular inflammation, which may include examination by slit lamp or posterior segment imaging. If active intraocular inflammation is present, you must not perform an intraocular injection with Beovu and should treat the intraocular inflammation according to medical practice. Please instruct your patients to contact you immediately if they notice any changes in visual acuity or any signs of inflammation, such as eye pain, floaters, discomfort or ocular hyperemia.

As a reminder, Beovu is contraindicated in patients with ocular or periocular infections, active intraocular inflammation or known hypersensitivity to brolucizumab or any of the excipients.

Physicians, other healthcare providers and patients are encouraged to report any observed or suspected adverse events according to local country requirements. You can make a report to Novartis at https://www.report.novartis.com.

Prescribing information and label updates

Adverse events as reported by study investigators were included in the Beovu US label as intraocular inflammation (4%) and retinal artery occlusion (1%). The EMA Summary of Product Characteristics (SmPC) also reports the specific type of intraocular inflammation observed and describes the occurrence of these individual events as either common or uncommon.

The US Food and Drug Administration (FDA) approved an update to the Beovu prescribing information (PI) on June 9, 2020. The update includes characterization of the adverse events, retinal vasculitis and retinal vascular occlusion, as part of the spectrum of intraocular inflammation noted in the original PI. The update to the US label includes the addition of a sub-section dedicated to retinal vasculitis and/or retinal vascular occlusion under ‘Warnings and Precautions’ (Section 5). It also specifies that these adverse reactions are part of a spectrum of intraocular inflammation rates from the Phase III HAWK & HARRIER trials (Table 1).

The EMA, based on a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) has approved an update to the Beovu SmPC on September 3, 2020. The update to the EU label includes the addition of retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation under “Special warnings and precautions for use” (Section 4.4) and “Undesirable effect” (Section 4.8). The label notes that patients developing these events should discontinue treatment and the events should be promptly managed.

The Swiss Health Authority (Swissmedic) approved an update of the Beovu SmPC on June 12, 2020. The Swiss SmPC has been updated to state that retinal vasculitis and/or retinal vascular occlusion have been reported with the use of Beovu. In most cases intraocular inflammation was also present.

The Australian Health Authority (TGA) approved an update of the Beovu PI on June 25, 2020. The Australian PI has been updated to state that retinal vasculitis and/or retinal vascular occlusion have been reported with the use of Beovu. Concomitant intraocular inflammation was reported, but not in all cases. Prior treatment was not reported for all cases, however, some patients had previous intravitreal VEGF inhibitor therapy. 

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approved an update of the Beovu product information on July 13, 2020. The approved amendment to the product information reflects the implementation of a safety labeling change for ‘retinal vasculitis’ and 'retinal vascular occlusion’ which have been reported with the use of Beovu.

Health Canada approved an update of the Beovu product information on September 30, 2020. The approved amendment includes ‘retinal vasculitis’ and/or ‘retinal vascular occlusion’, typically in the presence of intraocular inflammation, which have been reported with the use of Beovu.

To request the prescribing information for your country, click here