Active Ingredient: Brolucizumab
Brolucizumab is indicated in adults for the treatment of neovascular (wet) age-related macular degeneration (AMD).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravitreal, 6 milligrams brolucizumab, once every 4 weeks, 3 doses in total, over the duration of 16 weeks. Afterwards, in case that there is very good treatment response, intravitreal, 6 milligrams brolucizumab, once every 12 weeks.
Regimen B: Intravitreal, 6 milligrams brolucizumab, once every 4 weeks, 3 doses in total, over the duration of 16 weeks. Afterwards, in case that there is absent response to treatment, intravitreal, 6 milligrams brolucizumab, once every 8 weeks.
Regimen C: Intravitreal, 6 milligrams brolucizumab, once every 6 weeks, 2 doses in total, over the duration of 12 weeks. Afterwards, in case that there is very good treatment response, intravitreal, 6 milligrams brolucizumab, once every 12 weeks.
Regimen D: Intravitreal, 6 milligrams brolucizumab, once every 6 weeks, 2 doses in total, over the duration of 12 weeks. Afterwards, in case that there is absent response to treatment, intravitreal, 6 milligrams brolucizumab, once every 8 weeks.
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.
If visual and anatomical outcomes indicate that the patient is not benefiting from continued treatment, Beovu should be discontinued.
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. 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.
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