Lucentis (Ranibizumab Injection) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Lucentis

Macular Degeneration »

Macular degeneration facts

The macula is in the center of the retina, the light-sensitive layer of tissue at the back of the eye. The macula is responsible for central vision (straight-ahead vision). Degeneration of the macula occurs most often after the age of 60 years and is termed age-related macular generation (AMD).
AMD is a painless condition.
There are two types of AMD: dry AMD and wet AMD.
Smoking, high blood pressure, obesity, a diet high in unsaturated fats and simple carbohydrates and lack of exercise all increase the risk of AMD.
Early symptoms of dry AMD include slightly blurred vision, the need for more light for reading, and difficulty recognizing faces until very close to the person. A symptom of more advanced dry AMD is the presence of a blurred spot in the center of vision. An early symptom of wet AMD is the wavy appearance of straight lines.
Dry AMD cannot be treated...

Read the Macular Degeneration article »

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SIDE EFFECTS

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.

Injection Procedure

Serious adverse reactions 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 Studies Experience

The data below reflect exposure to 0.5 mg LUCENTIS (ranibizumab injection) in 440 patients with neovascular AMD in three double-masked, controlled studies (AMD-1, AMD-2, and AMD-3) [see Clinical Studies] as well as exposure to 0.5 mg LUCENTIS (ranibizumab injection) in 259 patients with macular edema following RVO in two double-masked, controlled studies (RVO-1 and RVO-2) [see Clinical Studies].

Ocular Reactions

Table 1 shows frequently reported ocular adverse reactions in LUCENTIS (ranibizumab injection) treated patients compared with the control group.

Table 1: Ocular Reactions in AMD and RVO Studies

Adverse Reaction	AMD 2 - Year		AMD 1 - Year		ROV 6 - Month
Adverse Reaction	LUCENTIS n= 379	Control n=379	LUCENTIS n= 440	Control n=441	LUCENTIS n= 259	Control 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%	1 3%	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

Table 2 shows frequently reported non-ocular adverse reactions in LUCENTIS (ranibizumab injection) treated patients compared with the control group.

Table 2: Non-Ocular Reactions in AMD and RVO Studies

Adverse Reaction	AMD 2 - Year		AMD 1 - Year		ROV 6 - Month
Adverse Reaction	LUCENTIS n= 379	Control n=379	LUCENTIS n= 440	Control n=441	LUCENTIS n= 259	Control n=260
Nasopharyngitis	16%	13%	8%	9%	5%	4%
Headache	12%	9%	6%	5%	3%	3%
Arthralgia	11%	9%	5%	5%	2%	1%
Bronchitis	11%	9%	6%	5%	0%	2%
Urinary tract infection	9%	9%	5%	5%	1%	2%
Cough	9%	8%	5%	4%	2%	2%
Nausea	9%	6%	5%	5%	1%	2%
Upper respiratory tract infection	9%	8%	5%	5%	2%	2%
Sinusitis	8%	7%	5%	5%	3%	2%
Anemia	8%	7%	4%	3%	1%	1%
Influenza	7%	5%	3%	2%	3%	2%
Chronic obstructive pulmonary disease	6%	3%	1%	0%	0%	0%
Hypercholesterolemia	5%	5%	3%	2%	1%	1%
Insomnia	5%	5%	3%	2%	1%	1%
Pain in extremity	5%	6%	3%	2%	1%	1%
Atrial fibrillation	5%	4%	2%	2%	1%	0%
Anxiety	4%	4%	3%	2%	1%	2%
Dyspnea	4%	3%	2%	2%	0%	0%
Gastroenteritis viral	4%	1%	3%	1%	1%	0%

Immunogenicity

As with all therapeutic proteins, there is the potential for an immune response in patients treated with LUCENTIS (ranibizumab injection) . The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to LUCENTIS (ranibizumab injection) in immunoassays and are highly dependent on the sensitivity and specificity of the assays.

The pre-treatment incidence of immunoreactivity to LUCENTIS (ranibizumab injection) was 0%-5% across treatment groups. After monthly dosing with LUCENTIS (ranibizumab injection) for 6 to 24 months, antibodies to LUCENTIS (ranibizumab injection) were detected in approximately l%-8% of patients.

The clinical significance of immunoreactivity to LUCENTIS (ranibizumab injection) 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 the RVO patients with the highest levels of immunoreactivity.

DRUG INTERACTIONS

Drug interaction studies have not been conducted with LUCENTIS (ranibizumab injection) .

LUCENTIS (ranibizumab injection) intravitreal injection has been used adjunctively with verteporfin photodynamic therapy (PDT). Twelve of 105 (11%) patients with neovascular AMD developed serious intraocular inflammation; in 10 of the 12 patients, this occurred when LUCENTIS (ranibizumab injection) was administered 7 days (±2 days) after verteporfin PDT.

Last reviewed on RxList: 7/21/2010
This monograph has been modified to include the generic and brand name in many instances.