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warnings and cautions
5 WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection ( 5.1 ). Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection ( 5.2 ). There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ( 5.3 ). 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering BYOOVIZ. In addition, patients should be monitored following the injection to permit early treatment should an infection occur [ see Dosage and Administration (2.5 , 2.6) and Patient Counseling Information (17) ]. 5.2 Increases in Intraocular Pressure Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with BYOOVIZ and manage appropriately [ see Dosage and Administration (2.6) ]. 5.3 Thromboembolic Events Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. Arterial thromboembolic events are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). Neovascular (Wet) Age-Related Macular Degeneration The ATE rate in the three controlled neovascular AMD studies (AMD-1, AMD-2, AMD-3) during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab compared with 1.1% (5 of 441) in patients from the control arms [ see Clinical Studies (14.1) ]. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of ranibizumab-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the 0.5 mg arms during the first and second year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3. In a pooled analysis of 2-year controlled studies [AMD-1, AMD-2, and a study of ranibizumab used adjunctive...
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adverse reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: 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) ] The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP ( 6.2 ). To report SUSPECTED ADVERSE REACTIONS, contact Biogen Inc. at 1-877-422-8360 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Injection Procedure Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections, including endophthalmitis [ see Warnings and Precautions (5.1) ], rhegmatogenous retinal detachment, and iatrogenic traumatic cataract. 6.2 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice. The data below reflect exposure to 0.5 mg ranibizumab in 440 patients with neovascular AMD in Studies AMD-1, AMD-2, and AMD-3; in 259 patients with macular edema following RVO. Safety data observed in 224 patients with mCNV, as well as Studies AMD-4 and D-3, were consistent with these results. On average, the rates and types of adverse reactions in patients were not significantly affected by dosing regimen. Ocular Reactions Table 1 shows frequently reported ocular adverse reactions in ranibizumab-treated patients compared with the control group. Table 1 Ocular Reactions in the AMD, and RVO Studies Adverse Reaction AMD 2-year AMD 1-year RVO 6-month Ranibizumab 0.5 mg Control Ranibizumab 0.5 mg Control Ranibizumab 0.5 mg Control n=379 n=379 n=440 n=441 n=259 n=260 Conjunctival hemorrhage 74% 60% 64% 50% 48% 37% Eye pain 35% 30% 26% 20% 17% 12% Vitreous floaters 27% 8% 19% 5% 7% 2% Intraocular pressure increased 24% 7% 17% 5% 7% 2% Vitreous detachment 21% 19% 15% 15% 4% 2% Intraocular inflammation 18% 8% 13% 7% 1% 3% Cataract 17% 14% 11% 9% 2% 2% Foreign body sensation in eyes 16% 14% 13% 10% 7% 5% Eye irritation 15% 15% 13% 12% 7% 6% Lacrimatio...
adverse reactions table
Table 1 Ocular Reactions in the AMD, and RVO StudiesAdverse ReactionAMD 2-year AMD 1-year RVO 6-month Ranibizumab 0.5 mg ControlRanibizumab 0.5 mg ControlRanibizumab 0.5 mg Controln=379n=379n=440n=441n=259n=260Conjunctival hemorrhage74%60%64%50%48%37%Eye pain35%30%26%20%17%12%Vitreous floaters27%8%19%5%7%2%Intraocular pressure increased24%7%17%5%7%2%Vitreous detachment21%19%15%15%4%2%Intraocular inflammation18%8%13%7%1%3%Cataract17%14%11%9%2%2%Foreign body sensation in eyes16%14%13%10%7%5%Eye irritation15%15%13%12%7%6%Lacrimation increased14%12%8%8%2%3%Blepharitis12%8%8%5%0%1%Dry eye12%7%7%7%3%3%Visual disturbance or vision blurred18%15%13%10%5%3%Eye pruritis12%11%9%7%1%2%Ocular hyperemia11%8%7%4%5%3%Retinal disorder10%7%8%4%2%1%Maculopathy9%9%6%6%11%7%Retinal degeneration8%6%5%3%1%0%Ocular discomfort7%4%5%2%2%2%Conjunctival hyperemia7%6%5%4%0%0%Posterior capsule opacification7%4%2%2%0%1%Injection site hemorrhage5%2%3%1%0%0%