Lucentis Side Effects

Please note - some side effects for Lucentis may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Lucentis - for the Consumer

Lucentis

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lucentis:

Dry eye; eye discomfort; feeling of something in the eye; headache; increased tears; nausea; nose or throat irritation; seeing floaters or spots.

Seek medical attention right away if any of these SEVERE side effects occur when using Lucentis:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest, jaw, or left arm pain; decreased vision or other vision changes; eye or eyelid swelling; eye pain, pressure, redness, bleeding, or discharge; sensitivity to light; symptoms of infection (eg, fever, chills, persistent sore throat); symptoms of a stroke (eg, one-sided weakness, slurred speech, confusion).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Lucentis Side Effects - for the Professional

Lucentis

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 (5.1)], rhegmatogenous retinal detachments, and iatrogenic traumatic cataracts.

Clinical Studies Experience

The data below reflect exposure to 0.5 mg Lucentis in 440 patients with neovascular AMD in three double-masked, controlled studies (AMD-1, AMD-2, and AMD-3) [see Clinical Studies (14.1)] as well as exposure to 0.5 mg Lucentis in 259 patients with macular edema following RVO in two double-masked, controlled studies (RVO-1 and RVO-2) [see Clinical Studies (14.2)].

Ocular Reactions

Table 1 shows frequently reported ocular adverse reactions in Lucentis treated patients compared with the control group.

Table 1: Ocular Reactions in AMD and RVO Studies

Adverse Reaction	AMD 2-year		AMD 1-year		RVO 6-month
	Lucentis	Control	Lucentis	Control	Lucentis	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

Table 2 shows frequently reported non-ocular adverse reactions in Lucentis 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		RVO 6-month
	Lucentis	Control	Lucentis	Control	Lucentis	Control
	n=379	n=379	n=440	n=441	n=259	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. 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%-8% 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 the RVO patients with the highest levels of immunoreactivity.

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Side Effects by Body System - for Healthcare Professionals

Ocular

Ocular side effects including endophthalmitis, rhegmatogenous retinal detachments, and iatrogenic traumatic cataracts are serious adverse events related to the injection procedure that have occurred in < 0.1% of intravitreal injections.

Conjunctival hemorrhage (43% to 77%), eye pain (17% to 37%), vitreous floaters (3% to 32%), retinal hemorrhage (15% to 26%), increased intraocular pressure (8% to 24%), vitreous detachment (7% to 22%), intraocular inflammation (5% to 18%), eye irritation (4% to 19%), cataract (5% to 16%), foreign body sensation in eyes (6% to 19%), increased lacrimation (3% to 17%), eye pruritus (0% to 13%), visual disturbance (0% to 14%), blepharitis (3% to 13%), subretinal fibrosis (0% to 13%), ocular hyperemia (5% to 10%), maculopathy (3% to 10%), visual acuity blurred/decreased (4% to 17%), detachment of the retinal pigment epithelium (1% to 11%), dry eye (3% to 10%), ocular discomfort (0% to 8%), conjunctival hyperemia (0% to 9%), posterior capsule opacification (0% to 8%), and retinal exudates (1% to 9%) have also been reported.

Cardiovascular

Cardiovascular side effects including hypertension/elevated blood pressure (5% to 23%) have been reported.

The rate of arterial thromboembolic events in the three studies in the first year was 2.1% of patients. In the second year of Study 1, the rate of arterial thromboembolic events was 3.0% of patients.

The results of one study showed that patients receiving the intravitreal ranibizumab 0.5 mg dose had a significantly higher incidence of strokes than those given the 0.3 mg dose (1.2% vs 0.3%).

Respiratory

Respiratory side effects including nasopharyngitis (5% to 16%), bronchitis (3% to 10%), cough (3% to 10%), sinusitis (2% to 8%), and upper respiratory tract infection (2% to 15%) have been reported.

Nervous system

Nervous system side effects including headache (2% to 15%) and dizziness (2% to 8%) have been reported.

Musculoskeletal

Musculoskeletal side effects including arthralgia (3% to 11%), back pain (1% to 10%), and arthritis (0% to 8%) have been reported.

General

General side effects including influenza (2% to 10%) have been reported.

Renal

Renal side effects including urinary tract infection (4% to 9%) have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (2% to 9%) and constipation (3% to 7%) have been reported.

Hematologic

Hematologic side effects including anemia (3% to 8%) have been reported.

Immunologic

Immunologic side effects including immunogenicity have been reported.

The pretreatment incidence of immunoreactivity to ranibizumab was up to 3% across treatment groups. After monthly dosing with ranibizumab for 12 to 24 months, low titers of antibodies to ranibizumab were detected in approximately 1% to 6% of patients. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to ranibizumab in an electrochemiluminescence assay and are highly dependent on the sensitivity and specificity of the assay. The clinical significance of immunoreactivity to ranibizumab is unclear at this time, although some patients with the highest levels of immunoreactivity were noted to have iritis or vitritis.

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