Beovu 120 mg/ml solution for injection in pre-filled syringe

• Removal of the black triangle for additional monitoring
• Section 2 updated to include polysorbate 80 as an ‘excipient with known effect.
• Section 4.4 updated to include sections for the ‘Sodium content’ and ‘Polysorbate 80 content’

Addition of following sentence: Beovu should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child.

Addition of new section: 'Beovu contains polysorbates'

Removal of black triangle for additional reporting

New side effect added 'inflammation of the white outer coating of the eye (scleritis)'

Addition of 'scleritis' as uncommon ADR

Updated to remove UK(NI) from the sections on reporting side effects and local contacts

Improve readability of figures in dosing section

Alternative dosing/maintenance regimen for DME and wAMD

Change in frequency of some side effects

nAMD label update based on Modelling & Simulation, alternative posology:

·      Section 4.2: Updated the posology for wAMD to include the following alternative loading regimen: ‘Alternatively, 6 mg brolucizumab (0.05 ml solution) may be administered every 6 weeks for the first 2 doses. A disease activity assessment is suggested 12 weeks (3 months) after treatment start. A third dose may be administered based on disease activity as assessed by visual acuity and/or anatomical parameters at week 12.’

·      Section 5.1: Updated to include the results of the PK/PD model simulation study

DME posology & 100-week KESTREL/KITE variation:

• Section 4.2: Updated the posology for DME based on the KITE study to include 16 week or 4 months extension during maintenance phase for the DME dosing: ‘. After 12 months of treatment, in patients without disease activity, treatment intervals up to 16 weeks (4 months) could be considered’
• Section 4.8: Two sentences were added above the ADR Table 1 regarding iridocyclitis, retinal vascular occlusion and vitreous haemorrhage since these were observed at a higher frequency (category of common) in the pooled DME Phase III studies. The immunogenicity sub-section for DME was updated with the KESTREL and KITE 2-year data.
• Section 5.1: Updated to provide the updated (Week 100) safety and efficacy data from the KESTREL and KITE DME studies

First upload to medicines.ie

Updated due to new DME indication

New DME indication

Information on (limited) experience in diabetic patients added to Section 4.4 'Special warnings and precautions for use' 

Results from study in pregnant cynomolgus monkeys added to Section 4.6 'Fertility, pregnancy & lactation' and Section 5.3 'Preclinical safety data'

Last sentence in the "Commonly asked Q&A section" was omitted in error

Update Section 4.2 to remove "The physician may further individualise treatment intervals based on disease activity" from the posology

Update Section 4.4 warning on intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion and instructions that the interval between two Beovu doses during maintenance treatment should not be less than 8 weeks.

Update adverse drug reactions in Section 4.8 to remove "retinal artery occlusion" and to include "retinal vasculitis" and "retinal vascular occlusion" with frequency "unknown"

Figure 5 changed to a clearer picture