Prescribing information

 

Safety profile with Beovu in clinical trials.

Beovu treated patients exhibited an overall well-tolerated safety profile in HAWK & HARRIER1

>1,000 patients were treated with Beovu in two Phase III trials.1*

  • Uncommon adverse reactions (<1%) included endophthalmitis, blindness, retinal artery occlusion, retinal detachment, conjunctival hyperaemia, lacrimation increased and vitreous haemorrhage2
  • Most serious adverse reactions included blindness (0.8%), endophthalmitis (0.7%), retinal artery occlusion (0.8%) and retinal detachment (0.7%)2
  • The proportion of eyes with ≥15-letter loss at Week 48 was balanced across both treatments.1  

Percentage of patients with common (≥1%) adverse drug reactions in clinical trials2,3

Table showing the percentage of patients with common (≥1%) adverse drug reactions with Beovu and aflibercept in clinical trials

Additional safety information

Post-marketing: retinal vasculitis and/or retinal vascular occlusion have been observed, typically in the presence of intraocular inflammation. The frequency of these events is not known.2

Beovu® is contraindicated in patients with2:

  • Active or suspected ocular or periocular infections
  • Active intraocular inflammation
  • Known hypersensitivty to Beovu or any of the excipients (4) in Beovu

Following injection with Beovu, tell your patients to contact you immediately if they2:

  • Develop redness of the eye, eye pain, increased discomfort, worsening eye redness, blurred or decreased visdion, an increased number of small particles in their vision, or an increased sensitivity to light
  • Develop sudden vision loss, which could be a sign of retinal vascular occlusion

In patients who develop retinal vasculitis and.or retinal vascular occlusion, treatment with Beovu should be discontinued and the events should be promptly managed.2

The primary efficacy endpoint in both studies was non-inferiority in mean BCVA change from baseline to Week 48 as measured by ETDRS. The primary endpoint was met in both studies.1
*Beovu arms in HAWK: 3 mg (n=358), 6 mg (n=360); in HARRIER: 6 mg (n=370).1
In a clinical trial (HAWK), the incidence was 2/60 (3.3%) in Japanese patients on Beovu and 6/300 (2.0%) in all other patients.2
In a clinical trial (HAWK), the incidence was 4/60 (6.7%) in Japanese patients on Beovu and 5/300 (1.7%) in all other patients.2
§Including urticaria, rash, pruritus and erythema.2

BCVA, best corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study.

References

  1. Dugel PU et al. Ophthalmology. 2020; 127: 72–84.
  2. Beovu Summary of Product Characteristics, 2020.
  3. Novartis data on file. BRODOF20-001 Core Data Sheet: 2019
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BEO20-C039m(1) November 2020.
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]