Lucentis

Last updated on RxList: 1/11/2021
Lucentis Side Effects Center

What Is Lucentis?

Lucentis (ranibizumab) Injection is a monoclonal antibody that works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels used to treat the wet form of age-related macular degeneration.

What Are Side Effects of Lucentis?

Common side effects of Lucentis include:

  • discomfort and increased tears in the affected eye(s),
  • itchy or watery eyes,
  • dry eyes,
  • swelling of the eyelids,
  • blurred vision,
  • sinus pain,
  • sore throat,
  • cough, or
  • joint pain.

Lucentis may infrequently increase your risk for developing a certain serious eye condition (endophthalmitis), especially during the first week after receiving a dose. Tell your doctor if you notice symptoms in the affected eye(s) such as pain, redness, sensitivity to light, or a sudden change in vision.

Dosage for Lucentis

Lucentis is administered as an injection into the eye, with local anesthetic. It is done under physician supervision. Dose is 0.5 mg (0.05 mL) and is administered once a month.

What Drugs, Substances, or Supplements Interact with Lucentis?

Other drugs may interact with Lucentis. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Lucentis During Pregnancy and Breastfeeding

During pregnancy, Lucentis should be used only when prescribed. It is unknown if this drug passes into breast milk. However, this medication is unlikely to pass into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Lucentis (ranibizumab) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Pink Eye (Conjunctivitis) Symptoms, Causes, Treatments See Slideshow
Lucentis Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • eye pain or redness, swelling around your eyes;
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights;
  • increased sensitivity to light;
  • discharge or bleeding from the eye;
  • seeing flashes of light or "floaters" in your vision;
  • sudden numbness or weakness (especially on one side of the body); or
  • sudden severe headache, problems with speech or balance.

Common side effects may include:

  • eye pain or irritation;
  • feeling like something is in your eye;
  • itchy or watery eyes;
  • dry eyes, puffy eyelids;
  • blurred vision;
  • sinus pain, sore throat, cough; or
  • nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lucentis (Ranibizumab Injection)

QUESTION

What causes dry eyes? See Answer
Lucentis Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the label:

  • Endophthalmitis and Retinal Detachments [see WARNINGS AND PRECAUTIONS]
  • Increases in Intraocular Pressure [see WARNINGS AND PRECAUTIONS]
  • Thromboembolic Events [see WARNINGS AND PRECAUTIONS]
  • Fatal Events in patients with DME and DR at baseline [see WARNINGS AND PRECAUTIONS]

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 detachment, and iatrogenic traumatic cataract.

Clinical Studies Experience

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.

The data below reflect exposure to 0.5 mg LUCENTIS in 440 patients with neovascular AMD in Studies AMD-1, AMD-2, and AMD-3; in 259 patients with macular edema following RVO. The data also reflect exposure to 0.3 mg LUCENTIS in 250 patients with DME and DR at baseline [see Clinical Studies].

Safety data observed in 224 patients with mCNV, as well as Studies AMD-4 and D-3, were consistent with these results. On average, the rates and types of adverse reactions in patients were not significantly affected by dosing regimen.

Ocular Reactions

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

Table 1 - Ocular Reactions in the DME and DR, AMD, and RVO Studies

Adverse ReactionDME and DR
2-year
AMD
2-year
AMD
1-year
RVO
6-month
LUCENTIS
0.3 mg
n=250
Control
n=250
LUCENTIS
0.5 mg
n=379
Control
n=379
LUCENTIS
0.5 mg
n=440
Control
n=441
LUCENTIS
0.5 mg
n=259
Control
n=260
Conjunctival hemorrhage47%32%74%60%64%50%48%37%
Eye pain17%13%35%30%26%20%17%12%
Vitreous floaters10%4%27%8%19%5%7%2%
Intraocular pressure increased18%7%24%7%17%5%7%2%
Vitreous detachment11%15%21%19%15%15%4%2%
Intraocular inflammation4%3%18%8%13%7%1%3%
Cataract28%32%17%14%11%9%2%2%
Foreign body sensation in eyes10%5%16%14%13%10%7%5%
Eye irritation8%5%15%15%13%12%7%6%
Lacrimation increased5%4%14%12%8%8%2%3%
Blepharitis3%2%12%8%8%5%0%1%
Dry eye5%3%12%7%7%7%3%3%
Visual disturbance or vision blurred8%4%18%15%13%10%5%3%
Eye pruritis4%4%12%11%9%7%1%2%
Ocular hyperemia9%9%11%8%7%4%5%3%
Retinal disorder2%2%10%7%8%4%2%1%
Maculopathy5%7%9%9%6%6%11%7%
Retinal degeneration1%0%8%6%5%3%1%0%
Ocular discomfort2%1%7%4%5%2%2%2%
Conjunctival hyperemia1%2%7%6%5%4%0%0%
Posterior capsule opacification4%3%7%4%2%2%0%1%
Injection site hemorrhage1%0%5%2%3%1%0%0%

Non-Ocular Reactions

Non-ocular adverse reactions with an incidence of ≥ 5% in patients receiving LUCENTIS for DR, DME, AMD, and/or RVO and which occurred at a ≥ 1% higher frequency in patients treated with LUCENTIS compared to control are shown in Table 2. Though less common, wound healing complications were also observed in some studies.

Table 2 Non-Ocular Reactions in the DME and DR, AMD, and RVO Studies

Adverse ReactionsDME and DR
2-year
AMD
2-year
AMD
1-year
RVO
6-month
LUCENTIS
0.3 mg
n=250
Control
n=250
LUCENTIS
0.5 mg
n=379
Control
n=379
LUCENTIS
0.5 mg
n=440
Control
n=441
LUCENTIS
0.5 mg
n=259
Control
n=260
Nasopharyngitis12%6%16%13%8%9%5%4%
Anemia11%10%8%7%4%3%1%1%
Nausea10%9%9%6%5%5%1%2%
Cough9%4%9%8%5%4%1%2%
Constipation8%4%5%7%3%4%0%1%
Seasonal allergy8%4%4%4%2%2%0%2%
Hypercholesterolemia7%5%5%5%3%2%1%1%
Influenza7%3%7%5%3%2%3%2%
Renal failure7%6%1%1%0%0%0%0%
Upper respiratory tract infection7%7%9%8%5%5%2%2%
Gastroesophageal reflux disease6%4%4%6%3%4%1%0%
Headache6%8%12%9%6%5%3%3%
Edema peripheral6%4%3%5%2%3%0%1%
Renal failure chronic6%2%0%1%0%0%0%0%
Neuropathy peripheral5%3%1%1%1%0%0%0%
Sinusitis5%8%8%7%5%5%3%2%
Bronchitis4%4%11%9%6%5%0%2%
Atrial fibrillation3%3%5%4%2%2%1%0%
Arthralgia3%3%11%9%5%5%2%1%
Chronic obstructive pulmonary disease1%1%6%3%3%1%0%0%
Wound healing complications1%0%1%1%1%0%0%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%-9% 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 patients with DME and DR at baseline, or RVO patients with the highest levels of immunoreactivity.

Postmarketing Experience

The following adverse reaction has been identified during post-approval use of LUCENTIS. Because this reaction was reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.

  • Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD

Read the entire FDA prescribing information for Lucentis (Ranibizumab Injection)

© Lucentis Patient Information is supplied by Cerner Multum, Inc. and Lucentis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors