Lucentis
SIDE EFFECTS
Injection Procedure
Serious adverse events related to the injection procedure have occurred in <0.1% of intravitreal injections, including endophthalmitis [see WARNINGS AND PRECAUTIONS ], rhegmatogenous retinal detachments, and iatrogenic traumatic cataracts.
Clinical Trials Experience Ocular Events
Other serious ocular adverse events observed among LUCENTIS-treated patients occurring in <2% of patients included intraocular inflammation and increased intraocular pressure [see WARNINGS AND PRECAUTIONS].
The available safety data include exposure to LUCENTIS in 874 patients with neovascular age-related macular degeneration in three double-masked, controlled studies with dosage regimens of 0.3 mg (375 patients) or 0.5 mg (379 patients) administered monthly by intravitreal injection (Studies 1 and 2) [see CLINICAL STUDIES ] and dosage regimens of 0.3 mg (59 patients) or 0.5 mg (61 patients) administered once a month for 3 consecutive doses followed by a dose administered once every 3 months (Study 3) [see CLINICAL STUDIES ].
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.
Table 1 shows the most frequently reported ocular adverse events that were reported with LUCENTIS treatment. The ranges represent the maximum and minimum rates across all three studies for control, and across all three studies and both dose groups for LUCENTIS.
| Table 1 | ||
| LUCENTIS | Control | |
| Conjunctival hemorrhage | 77%-43% | 66%-29% |
| Eye pain | 37%-17% | 33%-11% |
| Vitreous floaters | 32%-3% | 10%-3% |
| Retinal hemorrhage | 26%-15% | 56%-37% |
| Intraocular pressure increased | 24%-8% | 7%-3% |
| Vitreous detachment | 22%-7% | 18%-13% |
| Intraocular inflammation | 18%-5% | 11%-3% |
| Eye irritation | 19%-4% | 20%-6% |
| Cataract | 16%-5% | 16%-6% |
| Foreign body sensation in eyes | 19%-6% | 14%-6% |
| Lacrimation increased | 17%-3% | 16%-0% |
| Eye pruritis | 13%-0% | 12%-3% |
| Visual disturbance | 14%-0% | 9%-2% |
| Blepharitis | 13%-3% | 9%-4% |
| Subretinal fibrosis | 13%-0% | 19%-10% |
| Ocular hyperemia | 10%-5% | 10%-1% |
| Maculopathy | 10%-3% | 11%-3% |
| Visual acuity blurred/decreased | 17%-4% | 24%-10% |
| Detachment of the retinal pigment epithelium | 11%-1% | 15%-3% |
| Dry eye | 10%-3% | 8%-5% |
| Ocular discomfort | 8%-0% | 5%-0% |
| Conjunctival hyperemia | 9%-0% | 7%-0% |
| Posterior capsule opacification | 8%-0% | 5%-0% |
| Retinal exudates | 9%-1% | 11%-3% |
Clinical Trials Experience Non-Ocular Events
Table 2 shows the most frequently reported non-ocular adverse events with LUCENTIS treatment. The ranges represent the maximum and minimum rates across all three studies for control, and across all three studies and both dose groups for LUCENTIS.
| Table 2 | ||
| Adverse Event | LUCENTIS | Control |
| Hypertension/elevated blood pressure | 23%-5% | 23%-8% |
| Nasopharyngitis | 16%-5% | 13%-5% |
| Arthralgia | 11%-3% | 9%-0% |
| Headache | 15%-2% | 10%-3% |
| Bronchitis | 10%-3% | 8%-2% |
| Cough | 10%-3% | 7%-2% |
| Anemia | 8%-3% | 8%-0% |
| Nausea | 9%-2% | 6%-4% |
| Sinusitis | 8%-2% | 6%-4% |
| Upper respiratory tract infection | 15%-2% | 10%-4% |
| Back pain | 10%-1% | 9%-0% |
| Urinary tract infection | 9%-4% | 8%-5% |
| Influenza | 10%-2% | 5%-1% |
| Arthritis | 8%-0% | 8%-2% |
| Dizziness | 8%-2% | 10%-2% |
| Constipation | 7%-3% | 8%-2% |
The rate of arterial thromboembolic events in the three studies in the first year was 2.1% of patients (18 out of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS compared with 1.1% of patients (5 out of 441) in the control arms of the studies. In the second year of Study 1, the rate of arterial thromboembolic events was 3.0% of patients (14 out of 466) in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS compared with 3.2% of patients (7 out of 216) in the control arm [see WARNINGS AND PRECAUTIONS].
Immunogenicity
The pre-treatment incidence of immunoreactivity to LUCENTIS was 0%-3% across treatment groups. After monthly dosing with LUCENTIS for 12 to 24 months, low titers of antibodies to LUCENTIS were detected in approximately 1%-6% of patients. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to LUCENTIS in an electrochemiluminescence assay and are highly dependent on the sensitivity and specificity of the assay. The clinical significance of immunoreactivity to LUCENTIS is unclear at this time, although some patients with the highest levels of immunoreactivity were noted to have iritis or vitritis.
DRUG INTERACTIONS
Drug interaction studies have not been conducted with LUCENTIS.
LUCENTIS intravitreal injection has been used adjunctively with verteporfin photodynamic therapy (PDT). Twelve of 105 (11%) patients developed serious intraocular inflammation; in 10 of the 12 patients, this occurred when LUCENTIS was administered 7 days (±2 days) after verteporfin PDT.
Generic Name: Ranibizumab Injection
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