Lucentis Side Effects

Generic name: ranibizumab ophthalmic

Note: This document contains side effect information about ranibizumab ophthalmic. Some of the dosage forms listed on this page may not apply to the brand name Lucentis.

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

For the Consumer

Applies to ranibizumab ophthalmic: intraocular solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking ranibizumab ophthalmic (the active ingredient contained in Lucentis) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• eye pain or redness, swelling around your eyes;

• sudden vision problems;

• discharge or bleeding from the eye;

• eyes being more sensitive to light;

• seeing flashes of light or "floaters" in your vision;

• feeling like something is in your eye;

• sudden numbness or weakness, especially on one side of the body;

• sudden severe headache, confusion, problems with speech or balance; or

• pain or burning when you urinate.

Less serious side effects of ranibizumab ophthalmic may include:

• itchy or watery eyes;

• dry eyes, swelling of the eyelids;

• blurred vision;

• sinus pain, sore throat, cough; or

• joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ranibizumab ophthalmic: intraocular solution

Cardiovascular

Cardiovascular side effects including peripheral edema (up to 6%) and atrial fibrillation (up to 5%).

Although a low rate of arterial thromboembolic events were observed in clinical trials, there is a potential risk of ATE's (nonfatal stroke, nonfatal myocardial infarction, or vascular death) following intravitreal use of VEGF inhibitors.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 10%), constipation (up to 8%), and gastroesophageal reflux disease (up to 6%) have been reported.

General

General side effects including wound healing complications (up to 1%) have been reported.

Hematologic

Hematologic side effects including anemia (up to 11%) have been reported.

Immunologic

The pretreatment incidence of immunoreactivity to ranibizumab was 0% to 5% across treatment groups. After monthly dosing with ranibizumab for 6 to 24 months, antibodies to ranibizumab were detected in approximately 1% to 8% of patients. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to ranibizumab in immunoassays 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.

Immunologic side effects including seasonal allergies (up to 8%) and immunogenicity have been reported.

Metabolic

Metabolic side effects include hypercholesterolemia (up to 7%).

Musculoskeletal

Musculoskeletal side effects including arthralgia (up to 11%) have been reported.

Nervous system

Nervous system side effects including headache (up to 12%) and peripheral neuropathy (up to 5%) have been reported.

Ocular

Conjunctival hemorrhage (up to 74%), eye pain (up to 35%), vitreous floaters (up to 27%), increased intraocular pressure (up to 24%), vitreous detachment (up to 21%), intraocular inflammation (up to 18%), cataract (up to 28%), foreign body sensation in the eye (up to 16%), eye irritation (up to 15%), increased lacrimation (up to 14%), blepharitis (up to 12%), dry eye (up to 12%), visual disturbance or blurred vision (up to 18%), eye pruritus (up to 12%), ocular hyperemia (up to 11%), retinal disorder (up to 10%), maculopathy (up to 11%), retinal degeneration (up to 8%), ocular discomfort (up to 7%), conjunctival hyperemia (up to 7%), posterior capsule opacification (up to 7%), and injection site hemorrhage (up to 5%) have also been reported.

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 less than 0.1% of intravitreal injections.

Tear of the retinal pigment epithelium among neovascular AMD patients has been identified postmarketing.

Renal

Renal side effects including renal failure (up to 7%) and chronic renal failure (up to 6%) have been reported.

Respiratory

Respiratory side effects including nasopharyngitis (up to 16%), bronchitis (up to 11%), cough (up to 9%), upper respiratory tract infection (up to 9%), sinusitis (up to 8%), influenza (up to 7%), and chronic obstructive pulmonary disease (up to 6%) have been reported.

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