openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS Endophthalmitis and Retinal Detachments ( 5.1 ) Retinal Vasculitis and/or Retinal Vascular Occlusion ( 5.2 ) Neovascular AMD ( 5.3 ) Intraocular inflammation ( 5.4 ) Increased Intraocular Pressure ( 5.5 ) 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections, including those with SYFOVRE, may be associated with endophthalmitis and retinal detachments [see Adverse Reactions (6.1) ] . Proper aseptic injection technique must always be used when administering SYFOVRE in order to minimize the risk of endophthalmitis [see Dosage and Administration (2.4) ] . Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay and should be managed appropriately. 5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of SYFOVRE [see Adverse Reactions (6.2) ] . Cases may occur with the first dose of SYFOVRE and may result in severe vision loss. Discontinue treatment with SYFOVRE in patients who develop these events. Patients should be instructed to report any change in vision without delay. 5.3 Neovascular AMD In clinical trials, use of SYFOVRE was associated with increased rates of neovascular (wet) AMD or choroidal neovascularization (12% when administered monthly, 7% when administered every other month and 3% in the control group) by Month 24. Patients receiving SYFOVRE should be monitored for signs of neovascular AMD. In case anti-Vascular Endothelial Growth Factor (anti-VEGF) is required, it should be given separately from SYFOVRE administration. 5.4 Intraocular Inflammation In clinical trials, use of SYFOVRE was associated with episodes of intraocular inflammation including: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, and anterior chamber flare. After inflammation resolves patients may resume treatment with SYFOVRE. 5.5 Increased Intraocular Pressure Acute increase in IOP may occur within minutes of any intravitreal injection, including with SYFOVRE. Perfusion of the optic nerve head should be monitored following the injection and managed as needed [see Dosage and Administration (2.4) ] .
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Ocular and periocular infections [see Contraindications (4.1) ] Active intraocular inflammation [see Contraindications (4.2) ] Hypersensitivity [see Contraindications (4.3) ] Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.2) ] Neovascular AMD [see Warnings and Precautions (5.3) ] Intraocular inflammation [see Warnings and Precautions (5.4) ] Increased intraocular pressure [see Warnings and Precautions (5.5) ] Most common adverse reactions (incidence ≥5%) are ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, and conjunctival hemorrhage. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apellis Pharmaceuticals, Inc. at 1-833-866-3346 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. A total of 839 patients with GA in two Phase 3 studies (OAKS and DERBY) were treated with intravitreal SYFOVRE, 15 mg (0.1 mL of 150 mg/mL solution). Four hundred nineteen (419) of these patients were treated in the affected eye monthly and 420 were treated in the affected eye every other month. Four hundred seventeen (417) patients were assigned to sham. The most common adverse reactions (≥5%) reported in patients receiving SYFOVRE were ocular discomfort, neovascular age-related macular degeneration, vitreous floaters, and conjunctival hemorrhage. Table 1: Adverse Reactions in Study Eye Reported in ≥2% of Patients Treated with SYFOVRE Through Month 24 in Studies OAKS and DERBY Adverse Reactions PM (N = 419) % PEOM (N = 420) % Sham Pooled (N = 417) % PM: SYFOVRE monthly; PEOM: SYFOVRE every other month Ocular discomfort The following reported terms were combined: Ocular discomfort included: eye pain, eye irritation, foreign body sensation in eyes, ocular discomfort, abnormal sensation in eye Neovascular age-related macular degeneration included: exudative age-related macular degeneration, choroidal neovascularization Punctate keratitis included: punctate keratitis, keratitis Intraocular inflammation included: vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber cells, iritis, anterior chamber flare 13 10 11 Neovascular age-related macular degeneration 12 7 3 Vitreous floaters 10 7 1 Conjunctival hemorrhage 8 8 4 Vitreous detachment 4 6 3 Retinal hemorrhage 4 5 3 Punctate keratitis 5 3 <1 Posterior capsule opacification 4 4 3 Intraocular inflammation 4 2 <1 Intraocular pressure increased 2 3 <1 Endophthalmitis, retinal detachment, hyphema and retinal tears were reported in less than 1% of patients. Optic ischemic neuropathy was reported in 1.7% of patients treated monthly, 0.2% of patients treated every other month and 0.0% of patients assigned to sham. Deaths were reported in 6.7% of patients treated monthly, 3.6% of patients treated every other month and 3.8% of patients assigned to sham. The rates and causes of death were consistent with the elderly study population. 6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of SYFOVRE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Eye disorders : retinal vasculitis with or without retinal vascular occlusion. Systemic reactions: anaphylaxis, rash, and urticaria.