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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).
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:
Seek medical attention right away if any of these SEVERE side effects occur when using Lucentis:Dry eye; eye discomfort; feeling of something in the eye; headache; nausea; seeing floaters or spots.
TopSevere allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased vision or other vision changes; eye or eyelid swelling; eye pain, redness, bleeding, or discharge; sensitivity to light; symptoms of infection (eg, fever, chills, persistent sore throat).
Lucentis Side Effects - for the Professional
Lucentis
The most common adverse reations (reported ≥ 6% higher in Lucentis-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure, and intraocular inflammation (6.2).
To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 and www.gene.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
See 17 for PATIENT COUNSELING INFORMATION
Revised: 06/2006
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2.1 General Dosing Information 2.3 Preparation for Administration 4.1 Ocular or Periocular Infections 5.1 Endophthalmitis and Retinal Detachments 5.2 Increases in Intraocular Pressure 6.2 Clinical Studies Experience‑ Ocular Reactions 6.3 Clinical Studies Experience‑ Non‑Ocular Reactions 8. Use in Specific Populations 8.6 Patients with Renal Impairment 8.7 Patients with Hepatic Dysfunction 13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility |
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FULL PRESCRIBING INFORMATION Top
Side Effects by Body System
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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