BEOVU DATA

Safety

Clinical Safety Profile

Common adverse drug reactions (≥1%) in HAWK and HARRIER (pooled data) through Week 961*

Some common Adverse Drug Reactions and Events for BEOVU include blurred vision, cataract, vitreous floaters, and eye pain Some common Adverse Drug Reactions and Events for BEOVU include blurred vision, cataract, vitreous floaters, and eye pain

*Data for BEOVU 6 mg. BEOVU 6 mg is the only dose available for commercial use.

†Including vision blurred, visual acuity reduced, visual acuity reduced transiently, and visual impairment.1

‡Including anterior chamber cell, anterior chamber flare, anterior chamber inflammation, chorioretinitis, eye inflammation, iridocyclitis, iritis, retinal vasculitis, retinal vascular occlusion, uveitis, vitreous haze, vitritis.1

§Including urticaria, rash, pruritus, erythema.1

||Including blindness, blindness transient, amaurosis, and amaurosis fugax.1

  • In HAWK, 3.1% of patients in the BEOVU arm discontinued due to ocular adverse events
    vs 3.3% for aflibercept2

  • In HARRIER, 3.5% of patients in the BEOVU arm discontinued due to ocular adverse events
    vs 1.6% for aflibercept3

Patient monitoring and counseling

BEOVU is contraindicated in1:

  • Patients with ocular or periocular infections

  • Patients with active intraocular inflammation

  • Patients with known hypersensitivity to brolucizumab or any of the excipients in BEOVU

    • Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation

Guidance1:

  • Advise patients there is a risk of developing endophthalmitis, retinal detachment, retinal vasculitis, and/or retinal vascular occlusion in the days following BEOVU administration

  • Reports of retinal vasculitis and/or retinal vascular occlusion typically occurred in the presence of intraocular inflammation

  • Patients should be monitored for increased intraocular pressure immediately following the intravitreal injection. Monitoring may include checking for perfusion of the optic nerve head or tonometry

  • These immune mediated adverse events may occur following the first intravitreal injection. Discontinue treatment with BEOVU in patients who develop these events. Patients treated with BEOVU who experience intraocular inflammation may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored.

Patients should be instructed to seek immediate care from their ophthalmologist if they experience any of the following symptoms or any change in vision1:

  • Increased light sensitivity

  • Floaters

  • Pain in their eye

  • Decrease in vision

  • Redness on the white
    part of
    the eye

This is a subset of information from the Prescribing Information. As always, please review the full Prescribing Information.

The Vision Monitoring Guide was developed to help your patients monitor their vision at home and know what to do if they experience changes in vision.

Vision Monitoring Guide
Vision Monitoring Guide

IOI=intraocular inflammation.

References: 1. BEOVU [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; March 2022. 2. Data on file. RTH258-C001 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2018. 3. Data on file. RTH258-C002 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2018. 4. ASRS Member Update: Novartis-Appointed Safety Review Committee Reports Initial Brolucizumab Findings. Preliminary report available June 4, 2020. https://www.asrs.org/clinical/clinical-updates. Accessed on November 18th, 2020.

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INDICATIONS AND USAGE

IMPORTANT SAFETY INFORMATION

COLLAPSE

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IMPORTANT SAFETY INFORMATION

BEOVU® (brolucizumab-dbll) injection is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME).

CONTRAINDICATIONS

BEOVU is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to brolucizumab or any of the excipients in BEOVU. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.

WARNINGS AND PRECAUTIONS

Endophthalmitis and Retinal Detachment

Intravitreal injections, including those with BEOVU, have been associated with endophthalmitis and retinal detachment. Proper aseptic injection techniques must always be used when administering BEOVU. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately.

Retinal Vasculitis and/or Retinal Vascular Occlusion

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU. These immune-mediated adverse events may occur following the first intravitreal injection. Discontinue treatment with BEOVU in patients who develop these events. Patients treated with BEOVU who experience intraocular inflammation may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored. Patients should be instructed to report any change in vision without delay.

Increase in Intraocular Pressure

Acute increases in intraocular pressure (IOP) have been seen within 30 minutes of intravitreal injection, including with BEOVU. Sustained IOP increases have also been reported. Both IOP and perfusion of the optic nerve head must be monitored and managed appropriately.

Thromboembolic Events

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the BEOVU clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. Arterial thromboembolic events are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The ATE rate in the two controlled 96-week neovascular AMD (nAMD) studies (HAWK and HARRIER) during the first 96-weeks was 4.5% (33 of 730) in the pooled brolucizumab arms compared with 4.7% (34 of 729) in the pooled aflibercept arms.

ADVERSE REACTIONS

Serious adverse reactions, including endophthalmitis, retinal detachment, retinal vasculitis and/or retinal vascular occlusion, increases in intraocular pressure, and arterial thromboembolic events, have occurred following intravitreal injections with BEOVU.

The most common adverse events (≥5% of patients) reported in nAMD clinical studies (HAWK and HARRIER) in patients who received BEOVU were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters, and eye pain. The most common adverse event (≥5% of patients) reported in DME clinical studies (KITE and KESTREL) in patients who received BEOVU was conjunctival hemorrhage.

In a clinical study (MERLIN), patients with nAMD who received BEOVU every 4-week maintenance dosing experienced a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion than patients who received BEOVU every 8- or 12-week maintenance dosing in the clinical studies (HAWK and HARRIER). The interval between 2 BEOVU doses during maintenance treatment should not be less than 8 weeks.

As with all therapeutic proteins, there is a potential for an immune response in patients treated with BEOVU. Anti-brolucizumab antibodies were detected in the pre-treatment sample of 36% to 64% of treatment-naive patients. After initiation of dosing, anti-brolucizumab antibodies were detected in at least one serum sample in 53% to 76% of patients treated with BEOVU. Intraocular inflammation was observed in 6% of patients with anti-brolucizumab antibodies detected during dosing with BEOVU in clinical trials. Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, are immune-mediated adverse events related to exposure to BEOVU. This treatment-emergent antibody response may develop following the first intravitreal injection. Anti-brolucizumab antibodies were not associated with an impact on clinical efficacy.

INDICATIONS AND USAGE

BEOVU® (brolucizumab-dbll) injection is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME).

Please see full Prescribing Information for BEOVU.