Byooviz (Page 2 of 6)
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) ]
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.
Adverse Reaction | AMD2-year | AMD1-year | RVO6-month | |||
---|---|---|---|---|---|---|
Ranibizumab0.5 mg | Control | Ranibizumab0.5 mg | Control | Ranibizumab0.5 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% |
Lacrimation increased | 14% | 12% | 8% | 8% | 2% | 3% |
Blepharitis | 12% | 8% | 8% | 5% | 0% | 1% |
Dry eye | 12% | 7% | 7% | 7% | 3% | 3% |
Visual disturbance or vision blurred | 18% | 15% | 13% | 10% | 5% | 3% |
Eye pruritis | 12% | 11% | 9% | 7% | 1% | 2% |
Ocular hyperemia | 11% | 8% | 7% | 4% | 5% | 3% |
Retinal disorder | 10% | 7% | 8% | 4% | 2% | 1% |
Maculopathy | 9% | 9% | 6% | 6% | 11% | 7% |
Retinal degeneration | 8% | 6% | 5% | 3% | 1% | 0% |
Ocular discomfort | 7% | 4% | 5% | 2% | 2% | 2% |
Conjunctival hyperemia | 7% | 6% | 5% | 4% | 0% | 0% |
Posterior capsule opacification | 7% | 4% | 2% | 2% | 0% | 1% |
Injection site hemorrhage | 5% | 2% | 3% | 1% | 0% | 0% |
Non-Ocular Reactions
Non-ocular adverse reactions with an incidence of ≥ 5% in patients receiving ranibizumab for AMD, and/or RVO and which occurred at a ≥ 1% higher frequency in patients treated with ranibizumab compared to control are shown in Table 2. Though less common, wound healing complications were also observed in some studies.
Adverse Reaction | AMD2-year | AMD1-year | RVO6-month | |||
---|---|---|---|---|---|---|
Ranibizumab0.5 mg | Control | Ranibizumab0.5 mg | Control | Ranibizumab0.5 mg | Control | |
n=379 | n=379 | n=440 | n=441 | n=259 | n=260 | |
Nasopharyngitis | 16% | 13% | 8% | 9% | 5% | 4% |
Anemia | 8% | 7% | 4% | 3% | 1% | 1% |
Nausea | 9% | 6% | 5% | 5% | 1% | 2% |
Cough | 9% | 8% | 5% | 4% | 1% | 2% |
Constipation | 5% | 7% | 3% | 4% | 0% | 1% |
Seasonal allergy | 4% | 4% | 2% | 2% | 0% | 2% |
Hypercholesterolemia | 5% | 5% | 3% | 2% | 1% | 1% |
Influenza | 7% | 5% | 3% | 2% | 3% | 2% |
Renal failure | 1% | 1% | 0% | 0% | 0% | 0% |
Upper respiratory tract infection | 9% | 8% | 5% | 5% | 2% | 2% |
Gastroesophageal reflux disease | 4% | 6% | 3% | 4% | 1% | 0% |
Headache | 12% | 9% | 6% | 5% | 3% | 3% |
Edema peripheral | 3% | 5% | 2% | 3% | 0% | 1% |
Renal failure chronic | 0% | 1% | 0% | 0% | 0% | 0% |
Neuropathy peripheral | 1% | 1% | 1% | 0% | 0% | 0% |
Sinusitis | 8% | 7% | 5% | 5% | 3% | 2% |
Bronchitis | 11% | 9% | 6% | 5% | 0% | 2% |
Atrial fibrillation | 5% | 4% | 2% | 2% | 1% | 0% |
Arthralgia | 11% | 9% | 5% | 5% | 2% | 1% |
Chronic obstructive pulmonary disease | 6% | 3% | 3% | 1% | 0% | 0% |
Wound healing complications | 1% | 1% | 1% | 0% | 0% | 0% |
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