Brolucizumab (Pagenax®): Risk of Intraocular Inflammation, Including Retinal Vasculitis and/or Retinal Vascular Occlusion (Updated Recommendations to Minimise the Known Risks)

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Product Overview

Brolucizumab (Pagenax®) is a humanised monoclonal antibody indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD) in adults.

At present, there is one (1) brolucizumab-containing product registered with the Drug Control Authority (DCA) in Malaysia.

 

Background of the Safety Issue

Intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion, are known adverse drug reactions associated with brolucizumab. However, a few recent studies have generated new information pertaining to these known adverse reactions, including possible mechanisms and risk factors.

According to the MERLIN study, the incidence of intraocular inflammation with 4-weekly dosing of brolucizumab (9.3%) was higher as compared to a dosing interval of every 8 weeks/12 weeks (4.4%). In light of these findings, the dosing interval of brolucizumab for maintenance phase has been restricted to every 8 weeks or longer.

In terms of possible mechanisms, new data from the mechanistic study BASICHR0049 elucidated that retinal vasculitis and/or retinal vascular occlusion are immune-mediated events. As evidenced by this study, more intraocular inflammation events were seen among patients who developed anti-brolucizumab antibodies during treatment.

On top of that, the findings of two non-interventional retrospective real-world evidence studies (NCT05082415 and NCT05111743) have suggested that patients with a medical history of intraocular inflammation or retinal vascular occlusion in the year before treatment with brolucizumab are more likely to present with similar events after brolucizumab injection, as compared with patients with no history of these events. Females and Japanese ancestry have also been identified as additional risk factors for intraocular inflammation.

 

Advice for Healthcare Professionals:

  • Be aware that intraocular inflammation events may occur at any time during treatment with brolucizumab, and occur more frequently during early treatment.
  • Use brolucizumab with caution and closely monitor:
    • female patients
    • patients with Japanese ancestry
    • patients with medical history of intraocular inflammation and/or retinal vascular occlusion in the year prior to treatment with brolucizumab
  • Do not administer the maintenance doses of brolucizumab (after the first 3 doses) at intervals of less than 8 weeks.
  • Educate patients on how to recognise early signs and symptoms of intraocular inflammation, including a decrease or change in vision, eye pain, worsening eye redness, or sensitivity to light. Advise patients to seek medical attention without delay if these side effects are suspected. 
  • Discontinue treatment with brolucizumab in patients developing intraocular inflammation and promptly manage these events.

The local packet insert for Pagenax® (brolucizumab) has been updated to include new recommendations to minimise the known risk of intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion.

On 29th June 2022, the NPRA has approved a Direct Healthcare Professional Communication (DHPC) letter to be distributed by Novartis Corporation (M) Sdn. Bhd. to highlight these new recommendations to minimise intraocular inflammation risk. For further information, please contact your local sales person for a copy of the DHPC.

 

Reference:

Direct Healthcare Professional Communication (DHPC). Pagenax® (brolucizumab): Updated recommendations to minimise the known risk of intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion. Novartis Corporation (M) Sdn Bhd; 2022 Jun 29.

 

DISCLAIMER

This publication is aimed at health professionals. The information is meant to provide updates on medication safety issues, and not as a substitute for clinical judgement. While reasonable care has been taken to verify the accuracy of the information at the time of publication, the NPRA shall not be held liable for any loss whatsoever arising from the use of or reliance on this publication.

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Profesor Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

 

 

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