Source: European Medicines Agency (EU) Revision Year: 2024 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Beovu is indicated in adults for the treatment of
Beovu must be administered by a qualified ophthalmologist experienced in intravitreal injections.
The recommended dose is 6 mg brolucizumab (0.05 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.
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.
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 (see sections 4.4 and 5.1).
If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued.
The recommended dose is 6 mg brolucizumab (0.05 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. After 12 months of treatment, in patients without disease activity, treatment intervals up to 16 weeks (4 months) could be considered (see sections 4.4 and 5.1).
If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued.
No dose adjustment is required in patients aged 65 years or above (see section 5.2).
No dose adjustment is required in patients with renal impairment (see section 5.2).
Brolucizumab has not been studied in patients with hepatic impairment. No dose adjustment is required in patients with hepatic impairment (see section 5.2).
The safety and efficacy of brolucizumab in children and adolescents below 18 years of age have not been established. No data are available.
Beovu is for intravitreal use only.
The solution for injection should be inspected visually prior to administration (see section 6.6).
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). Sterile paracentesis equipment should be available as a precautionary measure. The patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.3). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
The injection needle should be inserted 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 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.
Following intravitreal injection patients should be instructed to report any symptoms suggestive of endophthalmitis (e.g. eye pain, redness of the eye, photophobia, blurring of vision) without delay.
The pre-filled syringe is for single use only. Each pre-filled syringe should only be used for the treatment of a single eye.
Since the volume contained in the pre-filled syringe (0.165 ml) is greater than the recommended dose (0.05 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. To expel the air bubble along with excess medicinal product, the plunger should be slowly depressed until the edge below the dome of the rubber stopper is aligned with the 0.05 ml dose mark (equivalent to 50 μl, i.e. 6 mg brolucizumab).
The vial is for single use only. Each vial should only be used for the treatment of a single eye.
Since the volume contained in the vial (0.23 ml) is greater than the recommended dose (0.05 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. To expel the air bubble along with excess medicinal product, the air should be carefully expelled from the syringe and the dose adjusted to the 0.05 ml mark (equivalent to 50 μl, i.e. 6 mg brolucizumab).
For instructions on preparation of the medicinal product before administration, see section 6.6.
Overdosing with greater than recommended injection volume may increase intraocular pressure. In the event of overdose, intraocular pressure should therefore be monitored and, if deemed necessary by the treating physician, appropriate treatment should be initiated.
Pre-filled syringe: 2 years.
Vial: 2 years.
Pre-filled syringe:
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the pre-filled syringe in its sealed blister and in the outer carton in order to protect from light. Prior to use, the unopened blister may be kept at room temperature (below 25°C) for up to 24 hours.
Vial:
Store in a refrigerator (2°C-8°C).
Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Prior to use, the unopened vial may be kept at room temperature (below 25°C) for up to 24 hours.
Pre-filled syringe:
0.165 ml sterile solution in a pre-filled syringe (type I glass) with a bromobutyl rubber plunger stopper and a syringe cap consisting of a white, tamper-evident rigid seal with a grey bromobutyl rubber tip cap including a Luer lock adapter. The pre-filled syringe has a plunger rod and a purple finger grip, and is packed in a sealed blister.
Pack size of 1 pre-filled syringe.
Vial:
0.23 ml sterile solution in a 2 ml glass vial with a coated rubber stopper sealed with an aluminium cap with a purple plastic flip-off disk.
Pack size of 1 vial and 1 blunt filter needle (18G x 1½″, 1.2 mm x 40 mm, 5 μm).
Not all pack sizes may be marketed.
Pre-filled syringe:
The pre-filled syringe contains more than the recommended dose of 6 mg. The extractable volume of the pre-filled syringe (0.165 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the pre-filled syringe could result in overdose. To expel the air bubble along with the excess medicinal product, slowly push the plunger until the edge below the dome of the rubber stopper is aligned with the black dosing line on the syringe (equivalent to 0.05 ml, i.e., 6 mg brolucizumab).
The solution should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the pre-filled syringe must not be used and appropriate replacement procedures followed.
The pre-filled syringe is sterile and for single use only. Do not use if the packaging, or pre-filled syringe are damaged or expired. Detailed instructions for use are provided in the package leaflet.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Vial:
The vial contains more than the recommended dose of 6 mg. The extractable volume of the vial (0.23 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the vial could result in overdose. The injection dose must be set to the 0.05 ml dose mark, i.e. 6 mg brolucizumab.
The solution should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the vial must not be used, and appropriate replacement procedures must be followed.
The content of the vial and the filter needle are sterile and for single use only. Do not use if the packaging, vial and/or filter needle are damaged or expired. Detailed instructions for use are provided in the package leaflet.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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