brolucizumab

brolucizumab is used for: Macular Degeneration

Macular Degeneration Indicated for treatment of neovascular (wet) age-related macular degeneration (AMD) 6 mg (0.05 mL of 120 mg/mL solution) by intravitreal injection monthly (~q25-31 days) x3 doses, THEN 6 mg q8-12weeks Hepatic impairment Effect of severe renal impairment or any degree of hepatic impairment on the pharmacokinetics of brolucizumab is unknown Significant increases in serum brolucizumab exposures are not expected with intravitreal route of administration; no dosage adjustment is needed based on hepatic impairment status

Renal impairment Effect of severe renal impairment or any degree of hepatic impairment on the pharmacokinetics of brolucizumab is unknown Significant increases in serum brolucizumab exposures are not expected with intravitreal route of administration; no dosage adjustment is needed based on renal impairment status

Intravitreal Preparation Before use, unopened glass vial may be kept at room temperature (20-25ºC [68-77ºF]) for up to 24 hr After vial is opened, proceed under aseptic conditions Inspect visually before administration; do not use if particulates, cloudiness, or discoloration are visible Kit includes sterile glass vial and filter needle which are for single use only Do not use if packaging, vial and/or filter needle are damaged or expired See prescribing information with diagrams for precise steps to aseptically prepare dose Intravitreal Administration Administer immediately after dose preparation Intravitreal injection procedure must 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), and the availability of sterile paracentesis equipment (if required) Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid, and ocular surface should be administered beforehand Inject slowly until the rubber stopper reaches the end of the syringe to deliver the volume of 0.05 mL; confirm delivery of the full dose by checking that the rubber stopper has reached the end of the syringe barrel Immediately following the intravitreal injection, monitor for elevated IOP; check for perfusion of the optic nerve head or tonometry; if required, a sterile paracentesis needle should be available Following injection, instruct patient to report any symptoms suggestive of endophthalmitis or retinal detachment (eg, eye pain, redness of the eye, photophobia, blurring of vision) without delay Vial is for treatment of a single eye; if the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before brolucizumab is administered to the other eye Dispose of unused medicinal product or waste material according to local regulations

Hypersensitivity Ocular or periocular infections Active intraocular inflammation

Intravitreal injections are associated with endophthalmitis and retinal detachments; instruct patients to immediately report any symptoms suggestive of endophthalmitis or retinal detachment Acute increases in intraocular pressure (IOP) have been seen within 30 minutes of intravitreal injection; sustained IOP increases have also been reported; both IOP and perfusion of the optic nerve head must be monitored and managed appropriately A low rate of arterial thromboembolic events observed during clinical trials following intravitreal use of vascular endothelial growth factor (VEGF) inhibitors

Pregnancy There are no adequate and well-controlled studies in pregnant women Based on anti-VEGF mechanism of action, treatment may pose risk to human embryofetal development Use during pregnancy only if the potential benefit outweighs the potential fetal risk Animal data VEGF inhibition has been shown to cause malformations, embryofetal resorption, and decreased fetal weight VEGF inhibition has also been shown to affect follicular development, corpus luteum function, and fertility Contraception Females of reproductive potential should use highly effective contraception (methods that result in <1% pregnancy rates) during treatment and for at least 1 month after the last dose following brolucizumab discontinuation Infertility No studies have been conducted and it is not known whether brolucizumab can affect reproductive capacity Based on its anti-VEGF mechanism of action, treatment may pose a risk to reproductive capacity Lactation No data are available regarding the presence of brolucizumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion Because many drugs are transferred in human milk and because of the potential for absorption and adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for at least 1 month after the last dose following discontinuation

Side effects of brolucizumab : 1-10% Blurred vision (10%) Cataract (7%) Conjunctival hemorrhage (6%) Vitreous floaters (5%) Eye pain (5%) Intraocular inflammation (4%) Intraocular pressure increased (4%) Retinal hemorrhage (4%) Vitreous detachment (4%) Conjunctivitis (3%) Retinal pigment epithelial tear (3%) Corneal abrasion (2%) Hypersensitivity (2%) Punctate keratitis (1%) Retinal tear (1%) Endophthalmitis (1%) Blindness (1%) Retinal artery occlusion (1%) Retinal detachment (1%) Conjunctival hyperemia (1%) Lacrimation increased (1%) Abnormal sensation in eye (1%) Detachment of retinal pigment epithelium (1%)

Human VEGF inhibitor; binds to the 3 major VEGF-A isoforms (eg, VEGF110, VEGF121, VEGF165), thereby preventing interaction with receptors VEGFR-1 and VEGFR-2 By inhibiting VEGF-A, brolucizumab suppresses endothelial cell proliferation, neovascularization, and vascular permeability