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6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label:

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 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.

Table 2 Non-Ocular Reactions in the AMD, and RVO 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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