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warnings and cautions
5 WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management ( 5.1 ). Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection ( 5.2 ). There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition ( 5.3 ). 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection occur [ see Dosage and Administration ( 2.3 ) and Patient Counseling Information ( 17 )]. 5.2 Increases in Intraocular Pressure Increases in intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal injection with LYTENAVA and manage appropriately [ see Dosage and Administration ( 2.4 )]. 5.3 Thromboembolic Events Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity [see Contraindications ( 4 )] Endophthalmitis and Retinal Detachments [see Warnings and Precautions ( 5.1 )] Increases in Intraocular Pressure [see Warnings and Precautions ( 5.2 )] Thromboembolic Events [see Warnings and Precautions ( 5.3 )] Most common adverse reaction (≥ 4%) reported in patients receiving LYTENAVA was conjunctival hemorrhage (4%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Outlook Therapeutics Inc. at 1-833-999-OTLK (6855) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice. The data described below reflect exposure to LYTENAVA in 601 patients, in five clinical trials [ see Clinical Studies ( 14 )]. Table 1 shows the most common ocular adverse reactions in LYTENAVA treated patients compared with ranibizumab 0.5 mg. Table 1. Common Adverse Reactions (≥ 1%) Adverse Reactions LYTENAVA 1.25 mg (N = 601) Ranibizumab 0.5 mg (N = 345) Conjunctival hemorrhage 4% 3% Eye pain 2% 1% Vitreous floaters 2% 1% Less common ocular adverse reactions reported in the study eye in <1% of patients treated with LYTENAVA were corneal abrasion, dry eye, eye irritation, and intraocular pressure increased.