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Beovu is a brand name for Brolucizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Beovu is indicated in adults for the treatment of • neovascular (wet) age-related macular degeneration (AMD) (see section 5.1), • visual impairment due to diabetic macular oedema (DME) (see section 5.1). 3
Verbatim from this product's EMA label. Tap a section to expand.
Beovu must be administered by a qualified ophthalmologist experienced in intravitreal injections. 05 ml solution), administered by intravitreal injection every 4 weeks (monthly) for the first 3 doses. A disease activity assessment is suggested 16 weeks (4 months) after treatment start.
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.
Maintenance treatment After the last loading dose, the physician may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. In patients without disease activity, treatment every 12 weeks (3 months) should be considered.
In patients with disease activity, treatment every 8 weeks (2 months) should be considered. If patients are being treated according to a treat-and- extend regimen and there are no signs of disease activity, the treatment intervals could be extended stepwise until signs of disease activity recur.
1). There are limited data on treatment intervals longer than 20 weeks (5 months). 4). If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued. 05 ml solution) administered by intravitreal injection every 6 weeks for the first 5 doses.
Thereafter, the physician may individualise treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. In patients without disease activity, treatment every 12 weeks (3 months) should be considered.
In patients with disease activity, treatment every 8 weeks (2 months) should be considered. 1). If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued. 2). 2).
Hepatic impairment Brolucizumab has not been studied in patients with hepatic impairment. 2). 4 Paediatric population The safety and efficacy of brolucizumab in children and adolescents below 18 years of age have not been established.
No data are available. Method of administration Beovu is for intravitreal use only. 6). The intravitreal injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent).
Summary of the safety profile Wet AMD For wet AMD, a total of 1 088 patients treated with brolucizumab constituted the safety population in two Phase III studies. Of these, 730 patients were treated with the recommended dose of 6 mg.
1%). 7%). DME For DME, a total of 558 patients treated with brolucizumab constituted the safety population in two Phase III studies. Of these, 368 patients were treated with the recommended dose of 6 mg. 4%). 5%). Tabulated list of adverse reactions The adverse reactions experienced following administration of Beovu in clinical studies are summarised in Table 1 below.
Adverse reactions (Table 1) are listed according to the MedDRA system organ class. Within each system organ class, the adverse reactions are ranked by frequency, with the most frequent reactions first. Frequency categories for each adverse reaction are based on the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Table 1 Frequencies of adverse reactions in clinical studies MedDRA System organ class Frequency category* Immune system disorders Hypersensitivity (including urticaria, rash, pruritus, erythema) Common Eye disorders Visual acuity reduced Common Retinal haemorrhage Common Uveitis Common Iridocyclitis Common Iritis Common Retinal vascular occlusion Common Vitreous haemorrhage Common Vitreous detachment Common Retinal tear Common Cataract Common Conjunctival haemorrhage Common Vitreous floaters Common Eye pain Common 9 Intraocular pressure increase Common Conjunctivitis Common Retinal pigment epithelial tear Common Vision blurred Common Corneal abrasion Common Punctate keratitis Common Blindness Uncommon Endophthalmitis Uncommon Retinal detachment Uncommon Conjunctival hyperaemia Uncommon Lacrimation increased Uncommon Abnormal sensation in eye Uncommon Detachment of retinal pigment epithelium Uncommon Vitritis Uncommon Anterior chamber inflammation Uncommon Anterior chamber flare Uncommon Corneal oedema Uncommon Retinal vasculitis Uncommon Scleritis** Uncommon *The frequency category for each adverse reaction is based on the most conservative incidence rate from either pooled nAMD or pooled DME Phase III pivotal studies.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 8). Proper aseptic injection techniques must always be used when administering Beovu.
Patients should be instructed to report any symptoms suggestive of the above-mentioned events without delay. 8). A higher number of intraocular inflammation events were observed among patients with treatment-emergent antibodies. After investigation, retinal vasculitis and/or retinal vascular occlusion were found to be immune-mediated events.
Intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion, may occur following the first intravitreal injection and at any time of treatment. These events were observed more frequently at the beginning of the treatment.
g. 3% females vs. 2% males in HAWK and HARRIER) and in Japanese patients. In patients developing these events, treatment with Beovu should be discontinued and the events should be promptly managed. Patients treated with Beovu with a medical history of intraocular inflammation and/or retinal vascular occlusion (within 12 months prior to the first brolucizumab injection) should be closely monitored, since they are at increased risk of developing retinal vasculitis and/or retinal vascular occlusion.
The interval between two Beovu doses during maintenance treatment should not be less than 8 weeks considering that a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion was reported in patients with nAMD who received Beovu every 4 week maintenance dosing in a clinical study compared to patients who received Beovu every 8 or 12 week maintenance dosing in the pivotal Phase III clinical studies.
8). Special precaution is needed in patients with poorly controlled glaucoma (do not inject Beovu while the intraocular pressure is ≥30 mmHg). Both intraocular pressure and perfusion of the optic nerve head must be monitored and managed appropriately.
1. Patients with active or suspected ocular or periocular infections. Patients with active intraocular inflammation.
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Sterile paracentesis equipment should be available as a precautionary measure. 3). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. 05 ml is then delivered slowly; a different scleral site should be used for subsequent injections. Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure.
Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, sterile equipment for paracentesis should be available. g. eye pain, redness of the eye, photophobia, blurring of vision) without delay.
Pre-filled syringe The pre-filled syringe is for single use only. Each pre-filled syringe should only be used for the treatment of a single eye. 05 ml), a portion of the volume contained in the pre-filled syringe must be discarded prior to administration.
Injecting the entire volume of the pre-filled syringe could result in overdose. e. 6 mg brolucizumab). Vial The vial is for single use only. Each vial should only be used for the treatment of a single eye. 05 ml), a portion of the volume contained in the vial must be discarded prior to administration.
Injecting the entire volume of the vial could result in overdose. e. 6 mg brolucizumab). 6. 5
**including episcleritis Description of selected adverse reactions Immunogenicity There is a potential for an immune response in patients treated with Beovu. Wet AMD After dosing with Beovu for 88 weeks, treatment-emergent anti-brolucizumab antibodies were detected in 23–25% of patients.
DME After dosing with Beovu for 96 weeks, treatment-emergent anti-brolucizumab antibodies were detected in 16-23% of patients. Among AMD and DME patients with treatment-emergent antibodies, a higher number of intraocular inflammation adverse reactions were observed.
4). Anti-brolucizumab antibodies were not associated with an impact on clinical efficacy. Product-class-related adverse reactions There is a theoretical risk of arterial thromboembolic events, including stroke and myocardial infarction, following intravitreal use of VEGF inhibitors.
A low incidence rate of arterial thromboembolic events was observed in the brolucizumab clinical studies in patients with AMD and DME. There were no major notable differences between the groups treated with brolucizumab and comparator.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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6 Bilateral treatment The safety and efficacy of brolucizumab administered in both eyes concurrently have not been studied. 8). 8). Concomitant use of other anti-VEGF There are no data available on the concomitant use of Beovu with other anti-VEGF medicinal products in the same eye.
5). Withholding treatment In intravitreal anti-VEGF treatments, the dose should be withheld and treatment should not be resumed earlier than the next scheduled treatment in the event of: • a decrease in best-corrected visual acuity (BCVA) of ≥30 letters compared with the last assessment of visual acuity; • a retinal break; • a subretinal haemorrhage involving the centre of the fovea, or, if the size of the haemorrhage is ≥50% of the total lesion area; • performed or planned intraocular surgery within the previous or next 28 days.
Retinal pigment epithelial tear Risk factors associated with the development of a retinal pigment epithelial tear after anti-VEGF therapy for wet AMD include a large and/or high pigment epithelial retinal detachment. When initiating brolucizumab therapy, caution should be used in patients with these risk factors for retinal pigment epithelial tears.
Rhegmatogenous retinal detachment or macular holes Treatment should be discontinued in subjects with rhegmatogenous retinal detachment or stage 3 or 4 macular holes. Systemic effects following intravitreal use Systemic adverse events, including non-ocular haemorrhages and arterial thromboembolic events, have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk that these may relate to VEGF inhibition.
There are limited data on safety in the treatment of patients with AMD and DME with a history of stroke, transient ischaemic attacks or myocardial infarction within the last 3 months. Caution should be exercised when treating such patients.
Populations with limited data There is limited experience with Beovu treatment in diabetic patients with HbA1c greater than 10% or with proliferative diabetic retinopathy. There is also no experience of treatment with Beovu in diabetic patients with uncontrolled hypertension.
This lack of information should be considered by the physician when treating such patients. 7 Sodium content This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”. 05 ml). […]