LUCENTIS SIDE EFFECTS
- Generic Name: ranibizumab injection
- Brand Name: Lucentis
- Drug Class: Macular Degeneration Agents, Ophthalmics, VEGF Inhibitors
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the label:
- Endophthalmitis and Retinal Detachments
- Increases in Intraocular Pressure
- Thromboembolic Events
- Fatal Events in patients with DME and DR at baseline
Injection Procedure
Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.
Clinical Studies 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 below reflect exposure to 0.5 mg LUCENTIS in 440 patients with neovascular AMD in Studies AMD-1, AMD-2, and AMD-3; in 259 patients with macular edema following RVO. The data also reflect exposure to 0.3 mg LUCENTIS in 250 patients with DME and DR at baseline.
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 LUCENTIS-treated patients compared with the control group.
Table 1 – Ocular Reactions in the DME and DR, AMD, and RVO Studies
| Adverse Reaction | DME and DR 2-year |
AMD 2-year |
AMD 1-year |
RVO 6-month |
||||
| LUCENTIS 0.3 mg n=250 |
Control n=250 |
LUCENTIS 0.5 mg n=379 |
Control n=379 |
LUCENTIS 0.5 mg n=440 |
Control n=441 |
LUCENTIS 0.5 mg n=259 |
Control n=260 |
|
| Conjunctival hemorrhage | 47% | 32% | 74% | 60% | 64% | 50% | 48% | 37% |
| Eye pain | 17% | 13% | 35% | 30% | 26% | 20% | 17% | 12% |
| Vitreous floaters | 10% | 4% | 27% | 8% | 19% | 5% | 7% | 2% |
| Intraocular pressure increased | 18% | 7% | 24% | 7% | 17% | 5% | 7% | 2% |
| Vitreous detachment | 11% | 15% | 21% | 19% | 15% | 15% | 4% | 2% |
| Intraocular inflammation | 4% | 3% | 18% | 8% | 13% | 7% | 1% | 3% |
| Cataract | 28% | 32% | 17% | 14% | 11% | 9% | 2% | 2% |
| Foreign body sensation in eyes | 10% | 5% | 16% | 14% | 13% | 10% | 7% | 5% |
| Eye irritation | 8% | 5% | 15% | 15% | 13% | 12% | 7% | 6% |
| Lacrimation increased | 5% | 4% | 14% | 12% | 8% | 8% | 2% | 3% |
| Blepharitis | 3% | 2% | 12% | 8% | 8% | 5% | 0% | 1% |
| Dry eye | 5% | 3% | 12% | 7% | 7% | 7% | 3% | 3% |
| Visual disturbance or vision blurred | 8% | 4% | 18% | 15% | 13% | 10% | 5% | 3% |
| Eye pruritis | 4% | 4% | 12% | 11% | 9% | 7% | 1% | 2% |
| Ocular hyperemia | 9% | 9% | 11% | 8% | 7% | 4% | 5% | 3% |
| Retinal disorder | 2% | 2% | 10% | 7% | 8% | 4% | 2% | 1% |
| Maculopathy | 5% | 7% | 9% | 9% | 6% | 6% | 11% | 7% |
| Retinal degeneration | 1% | 0% | 8% | 6% | 5% | 3% | 1% | 0% |
| Ocular discomfort | 2% | 1% | 7% | 4% | 5% | 2% | 2% | 2% |
| Conjunctival hyperemia | 1% | 2% | 7% | 6% | 5% | 4% | 0% | 0% |
| Posterior capsule opacification | 4% | 3% | 7% | 4% | 2% | 2% | 0% | 1% |
| Injection site hemorrhage | 1% | 0% | 5% | 2% | 3% | 1% | 0% | 0% |
Non-Ocular Reactions
Non-ocular adverse reactions with an incidence of ≥ 5% in patients receiving LUCENTIS for DR, DME, AMD, and/or RVO and which occurred at a ≥ 1% higher frequency in patients treated with LUCENTIS 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 DME and DR, AMD, and RVO Studies
| Adverse Reactions | DME and DR 2-year |
AMD 2-year |
AMD 1-year |
RVO 6-month |
||||
| LUCENTIS 0.3 mg n=250 |
Control n=250 |
LUCENTIS 0.5 mg n=379 |
Control n=379 |
LUCENTIS 0.5 mg n=440 |
Control n=441 |
LUCENTIS 0.5 mg n=259 |
Control n=260 |
|
| Nasopharyngitis | 12% | 6% | 16% | 13% | 8% | 9% | 5% | 4% |
| Anemia | 11% | 10% | 8% | 7% | 4% | 3% | 1% | 1% |
| Nausea | 10% | 9% | 9% | 6% | 5% | 5% | 1% | 2% |
| Cough | 9% | 4% | 9% | 8% | 5% | 4% | 1% | 2% |
| Constipation | 8% | 4% | 5% | 7% | 3% | 4% | 0% | 1% |
| Seasonal allergy | 8% | 4% | 4% | 4% | 2% | 2% | 0% | 2% |
| Hypercholesterolemia | 7% | 5% | 5% | 5% | 3% | 2% | 1% | 1% |
| Influenza | 7% | 3% | 7% | 5% | 3% | 2% | 3% | 2% |
| Renal failure | 7% | 6% | 1% | 1% | 0% | 0% | 0% | 0% |
| Upper respiratory tract infection | 7% | 7% | 9% | 8% | 5% | 5% | 2% | 2% |
| Gastroesophageal reflux disease | 6% | 4% | 4% | 6% | 3% | 4% | 1% | 0% |
| Headache | 6% | 8% | 12% | 9% | 6% | 5% | 3% | 3% |
| Edema peripheral | 6% | 4% | 3% | 5% | 2% | 3% | 0% | 1% |
| Renal failure chronic | 6% | 2% | 0% | 1% | 0% | 0% | 0% | 0% |
| Neuropathy peripheral | 5% | 3% | 1% | 1% | 1% | 0% | 0% | 0% |
| Sinusitis | 5% | 8% | 8% | 7% | 5% | 5% | 3% | 2% |
| Bronchitis | 4% | 4% | 11% | 9% | 6% | 5% | 0% | 2% |
| Atrial fibrillation | 3% | 3% | 5% | 4% | 2% | 2% | 1% | 0% |
| Arthralgia | 3% | 3% | 11% | 9% | 5% | 5% | 2% | 1% |
| Chronic obstructive pulmonary disease | 1% | 1% | 6% | 3% | 3% | 1% | 0% | 0% |
| Wound healing complications | 1% | 0% | 1% | 1% | 1% | 0% | 0% | 0% |
Immunogenicity
As with all therapeutic proteins, there is the potential for an immune response in patients treated with LUCENTIS. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to LUCENTIS in immunoassays and are highly dependent on the sensitivity and specificity of the assays.
The pre-treatment incidence of immunoreactivity to LUCENTIS was 0%-5% across treatment groups. After monthly dosing with LUCENTIS for 6 to 24 months, antibodies to LUCENTIS were detected in approximately 1%-9% of patients.
The clinical significance of immunoreactivity to LUCENTIS is unclear at this time. Among neovascular AMD patients with the highest levels of immunoreactivity, some were noted to have iritis or vitritis. Intraocular inflammation was not observed in patients with DME and DR at baseline, or RVO patients with the highest levels of immunoreactivity.
Postmarketing Experience
The following adverse reaction has been identified during post-approval use of LUCENTIS. Because this reaction was reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
- Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD.
SRC: NLM .