Lucentis

Name: Lucentis

What side effects can this medication cause?

Ranibizumab injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache
  • dry or itchy eyes
  • teary eyes
  • feeling that something is in your eye
  • nausea

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

  • eye redness
  • eye sensitivity to light
  • eye pain
  • decrease or changes in vision
  • bleeding in or around the eye
  • swelling of the eye or eyelid
  • seeing ''floaters'' or small specks
  • seeing flashing lights
  • chest pain
  • shortness of breath
  • slow or difficult speech
  • weakness or numbness of an arm or leg

Ranibizumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Side Effects of Lucentis

Serious side effects have occurred with Lucentis injections. See "Lucentis Precautions" section.

The most common eye-related side effects are:

  • increased redness in the white of the eye
  • eye pain
  • small specks in vision
  • increased eye pressure

The most common non–eye-related side effects are:

  • nose and throat infections
  • headache
  • lung/airway infections 
  • and nausea

This is not a complete list of  Lucentis side effects. Ask your doctor or pharmacist for more information.

Lucentis Precautions

Serious side effects have occurred with Lucentis injections including:

  • serious infections inside the eye
  • detached retinas
  • cataracts
  • inflammation inside the eye 
  • increased eye pressure
  • uncommonly, some patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes

If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your eye doctor right away.

After receiving a Lucentis injection you may experience temporary vision problems. Do not drive or operate machinery until your vision has returned to normal.

Lucentis Overdose

Lucentis is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

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 Study AMD-4 and in 224 patients with mCNV 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 Reaction DME and DR 2-year AMD 2-year AMD 1-year RVO 6-month
LUCENTIS 0.3m² Control LUCENTIS 0.5m² Control LUCENTIS 0.5m² Control LUCENTIS 0.5m² Control
n=250 n=250 n=379 n=379 n=440 n=441 n=25 9 n=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 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 Reaction DME and DR 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 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)

Read More »

Lucentis Pharmacokinetics

Absorption

Bioavailability

Following monthly intravitreal injection, peak serum concentrations attained were substantially below that necessary to inhibit the biologic activity of VEGF-A by 50%.1 Serum concentrations predicted to be approximately 90,000 times lower than vitreal concentrations.1

Peak serum concentrations predicted to be reached approximately 1 day after monthly intravitreal administration of 0.5 mg per eye.1

Elimination

Half-Life

Estimated average vitreous half-life: Approximately 9 days.1

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ranibizumab (Recombinant)

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Injection, for intravitreal use only

6 mg/mL (0.3 mg/0.05 mL)

Lucentis (available as single-dose vial with filter and injection needles)

Genentech

10 mg/mL (0.5 mg/0.05 mL)

Lucentis (available as single-dose vial with filter and injection needles)

Genentech

Precautions While Using Lucentis

Your eye doctor will want to check your progress at regular visits, especially during the first few days after you receive this medicine.

Serious eye problems may occur with this medicine. Check with your eye doctor right away if your eye becomes red, sensitive to light, or painful, or if you have a change in vision several days after you receive this medicine. Also, tell your eye doctor if you feel increased pressure in your eye.

This medicine may increase your risk of blood clots, heart attack, or stroke. Check with your doctor right away if you are having pain in your chest, groin, or legs, especially the calves, difficulty with breathing, a severe, sudden headache, slurred speech, sudden, unexplained shortness of breath, sudden loss of coordination, sudden, severe weakness or numbness in your arm or leg, or vision changes.

Lucentis Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Blindness
  • bloody eye
  • blurred vision or loss of vision
  • decreased vision or other changes in vision
  • disturbed color perception
  • dizziness
  • double vision
  • dry eye
  • eye pain
  • fainting
  • feeling of having something in the eye
  • halos around lights
  • headache
  • night blindness
  • overbright appearance of lights
  • pain or tenderness around the eyes and cheekbones
  • red, sore eyes
  • redness of the white part of the eyes or inside of the eyelids
  • redness, swelling, or itching of the eyelid
  • seeing flashes or sparks of light
  • seeing floating spots before the eyes, or a veil or curtain appearing across a part of vision
  • sensitivity of the eye to light
  • tearing of the eyes
  • tunnel vision
  • watering of the eyes
Less common
  • Body aches or pain
  • chest pain
  • chills
  • cough
  • difficulty with breathing
  • dry mouth
  • fainting
  • fast, slow, or irregular heartbeat
  • general feeling of discomfort or illness
  • head congestion
  • hoarseness, loss of voice, or other voice changes
  • loss of consciousness
  • muscle aches and pains
  • nasal congestion
  • pain in the chest, groin, or legs, especially the calves
  • painful blisters on the trunk of the body
  • pale skin
  • runny nose
  • severe, sudden headache
  • shivering
  • slow wound healing
  • slurred speech
  • sneezing
  • sore throat
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • sudden, unexplained shortness of breath
  • sweating
  • tightness in the chest
  • trouble sleeping
  • unexplained weight loss
  • unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • muscle stiffness
  • swelling or redness in the joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

How do I store and/or throw out Lucentis?

  • If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Lucentis Description

Lucentis® (ranibizumab injection) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product.

Lucentis is a sterile, colorless to pale yellow solution in a single-use prefilled syringe or a single-use glass vial. Lucentis is supplied as a preservative-free, sterile solution in a single-use container designed to deliver 0.05 mL of 10 mg/mL Lucentis (0.5 mg dose prefilled syringe or vial) or 6 mg/mL Lucentis (0.3 mg dose vial) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been conducted to determine the carcinogenic potential of ranibizumab. Based on the anti-VEGF mechanism of action of ranibizumab, treatment with Lucentis may pose a risk to reproductive capacity [see Females and Males of Reproductive Potential (8.3)].

How Supplied/Storage and Handling

  • Each Lucentis 0.5 mg carton (NDC 50242-080-03) contains a single-use, prefilled syringe designed to deliver 0.05 mL of 10 mg/mL ranibizumab solution. The prefilled syringe has a non-retractable plunger stopper and a syringe cap consisting of a tamper-evident rigid seal with a rubber tip cap including a Luer lock adapter. The prefilled syringe has a plunger rod and a CLEAR finger grip. The prefilled syringe is sterile and is packed in a sealed tray.
  • Each Lucentis 0.5 mg carton (NDC 50242-080-02) contains a single-use, 2-mL glass vial with a BLUE CAP designed to deliver 0.05 mL of 10 mg/mL ranibizumab solution.
  • Each Lucentis 0.3 mg carton (NDC 50242-082-02) contains a single-use, 2-mL glass vial with a WHITE CAP designed to deliver 0.05 mL of 6 mg/mL ranibizumab solution.

EACH CARTON IS FOR SINGLE-EYE USE ONLY.

Lucentis should be refrigerated at 2°-8°C (36°-46°F). DO NOT FREEZE. Do not use beyond the date stamped on the label. Protect Lucentis prefilled syringe and vials from light and store in the original carton until time of use. Do not open Lucentis prefilled syringe sealed tray until time of use.

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