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Lucentis

"June 29, 2011 (San Diego) -- Lucentis, a drug used to treat people with vision problems from age-related macular degeneration, may help to restore vision among people with eye complications caused by diabetes, two studies suggest.

The"...

Lucentis

Lucentis Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Lucentis (ranibizumab) Injection is used to treat the wet form of age-related macular degeneration. It 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. Common side effects include mild discomfort and increased tears in the affected eye(s).

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Lucentis in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.

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

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Lucentis Overview - Patient Information: Side Effects

SIDE EFFECTS: Mild discomfort and increased tears may occur in the affected eye(s). If either of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication 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 immediately if you notice any of these symptoms in the affected eye(s): pain, redness, sensitivity to light, sudden change in vision.

This medication may sometimes increase the risk of serious (possibly fatal) blood clots. This may lead to stroke, heart attack, and other blood vessel problems. Get medical help right away if you develop: symptoms of stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion), symptoms of a heart attack (such as chest/jaw/left arm pain).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Lucentis (Ranibizumab Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Lucentis FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in the WARNINGS AND PRECAUTIONS (5) section of the label:

  • Endophthalmitis and Retinal Detachments
  • Increases in Intraocular Pressure
  • Thromboembolic Events
  • Fatal Events in DME Patients

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, and 259 patients with macular edema following RVO. The data also reflect exposure to 0.3 mg LUCENTIS in 250 patients with DME [see Clinical Studies].

Safety data observed in Study AMD-4 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, AMD, and RVO Studies

Adverse Reaction DME 2-year AMD 2-year AMD 1-year RVO 6-month
LUCENTIS 0.3 mg Control LUCENTIS 0.5 mg Control LUCENTIS 0.5 mg Control LUCENTIS 0.5 mg Control
n=250 n=250 n=379 n=379 n=440 n=441 n=259n =260
Conjunctival hemorrhage 47% 32% 74% 60% 64% 50% 48% 37%
Eye pain 17% 13% 35% 30% 26% 20% 17% 12%
Vitreous floaters 10% 4% 27% 8% 19% 5% 7% 2%
Intraocular pressure increased 18% 7% 24% 7% 17% 5% 7% 2%
Vitreous detachment 11% 15% 21% 19% 15% 15% 4% 2%
Intraocular inflammation 4% 3% 18% 8% 13% 7% 1% 3%
Cataract 28% 32% 17% 14% 11% 9% 2% 2%
Foreign body sensation in eyes 10% 5% 16% 14% 13% 10% 7% 5%
Eye irritation 8% 5% 15% 15% 13% 12% 7% 6%
Lacrimation increased 5% 4% 14% 12% 8% 8% 2% 3%
Blepharitis 3% 2% 12% 8% 8% 5% 0% 1%
Dry eye 5% 3% 12% 7% 7% 7% 3% 3%
Visual disturbance or vision blurred 8% 4% 18% 15% 13% 10% 5% 3%
Eye pruritis 4% 4% 12% 11% 9% 7% 1% 2%
Ocular hyperemia 9% 9% 11% 8% 7% 4% 5% 3%
Retinal disorder 2% 2% 10% 7% 8% 4% 2% 1%
Maculopathy 5% 7% 9% 9% 6% 6% 11% 7%
Retinal degeneration 1% 0% 8% 6% 5% 3% 1% 0%
Ocular discomfort 2% 1% 7% 4% 5% 2% 2% 2%
Conjunctival hyperemia 1% 2% 7% 6% 5% 4% 0% 0%
Posterior capsule opacification 4% 3% 7% 4% 2% 2% 0% 1%
Injection site hemorrhage 1% 0% 5% 2% 3% 1% 0% 0%

Non-Ocular Reactions

Non-ocular adverse reactions with an incidence of ≥ 5% in patients receiving LUCENTIS for 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, AMD and RVO Studies

Adverse Reaction DME 2-year AMD 2-year AMD 1-year RVO 6-month
LUCENTIS 0.3 mg Control LUCENTIS 0.5 mg Control LUCENTIS 0.5 mg Control LUCENTIS 0.5 mg Control
n=250 n=250 n=379 n=379 n=440 n=441 n=259 n=260
Nasopharyngitis 12% 6% 16% 13% 8% 9% 5% 4%
Anemia 11% 10% 8% 7% 4% 3% 1% 1%
Nausea 10% 9% 9% 6% 5% 5% 1% 2%
Cough 9% 4% 9% 8% 5% 4% 1% 2%
Constipation 8% 4% 5% 7% 3% 4% 0% 1%
Seasonal allergy 8% 4% 4% 4% 2% 2% 0% 2%
Hypercholesterolemia 7% 5% 5% 5% 3% 2% 1% 1%
Influenza 7% 3% 7% 5% 3% 2% 3% 2%
Renal failure 7% 6% 1% 1% 0% 0% 0% 0%
Upper respiratory tract infection 7% 7% 9% 8% 5% 5% 2% 2%
Gastroesophageal reflux disease 6% 4% 4% 6% 3% 4% 1% 0%
Headache 6% 8% 12% 9% 6% 5% 3% 3%
Edema peripheral 6% 4% 3% 5% 2% 3% 0% 1%
Renal failure chronic 6% 2% 0% 1% 0% 0% 0% 0%
Neuropathy peripheral 5% 3% 1% 1% 1% 0% 0% 0%
Sinusitis 5% 8% 8% 7% 5% 5% 3% 2%
Bronchitis 4% 4% 11% 9% 6% 5% 0% 2%
Atrial fibrillation 3% 3% 5% 4% 2% 2% 1% 0%
Arthralgia 3% 3% 11% 9% 5% 5% 2% 1%
Chronic obstructive pulmonary disease 1% 1% 6% 3% 3% 1% 0% 0%
Wound healing complications 1% 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 DME or RVO patients with the highest levels of immunoreactivity.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of LUCENTIS. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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

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Lucentis - User Reviews

Lucentis User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Lucentis sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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