Ilevro

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Ilevro is a prescription medication used to relieve eye pain and swelling caused by cataract surgery. Ilevro belongs to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) which help to stop the release of substances that cause allergy symptoms and inflammation.

This medication comes in the form of eye drops. One drop of Ilevro should be applied to the affected eye(s) one time daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks after surgery. Remove contact lenses before instilling Ilevro drops.

Common side effects include sticky sensation and decrease in the sharpness of vision.

• Alcon Laboratories, Inc.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Ilevro has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Ilevro, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Your eye doctor will check your or your child's eyes at regular visits to make sure it is working properly and is not causing unwanted effects.

If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.

Slow or delayed healing may occur while you or your child are using this medicine. Ask your doctor before using this medicine together with a topical corticosteroid (eg, betamethasone, hydrocortisone).

Using this medicine may increase risk of having corneal (front part of the eye) problems, including keratitis. Check with your eye doctor right away if you or your child have blurred vision, changes in vision, or eye redness, irritation, or pain while using this medicine.

Make sure your doctor knows if you are pregnant. Do not use this medicine during the later part of a pregnancy, unless your doctor tells you to.

If you hurt your eye or develop an eye infection, talk with your doctor right away. You may need to change your medicine or stop using it.

Do not use other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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 immediately if any of the following side effects occur:

• Blurred vision
• change in vision
• decrease in vision
• loss of vision

• Eye pain
• itching of the eye
• swelling and/or redness of the eye and lining of the eyelid

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:

• Feeling of having something in the eye
• sticky sensation of the eyelids

• Change in color vision
• cough
• crusting in the corner of the eye
• difficulty seeing at night
• dizziness
• dry eyes
• fever
• headache
• increased sensitivity of the eyes to sunlight
• nausea or vomiting
• nervousness
• pounding in the ears
• seeing flashes or sparks of light
• seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• slow or fast heartbeat
• stuffy or runny nose
• tenderness around the eyes and cheekbones
• tightness of the chest or wheezing
• troubled breathing

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.

• If you have an allergy to nepafenac or any other part of Ilevro (nepafenac).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are more than 24 weeks pregnant.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Serious and Otherwise Important Adverse Reactions

The following adverse reactions are discussed in greater detail in other sections of labeling.

• Increased Bleeding Time (Warnings and Precautions 5.1)
• Delayed Healing (Warnings and Precautions 5.2)
• Corneal Effects (Warnings and Precautions 5.3)

Ocular Adverse Reactions

The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These reactions occurred in approximately 5 to 10% of patients.

Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment.

Some of these reactions may be the consequence of the cataract surgical procedure.

Non-Ocular Adverse Reactions

Non-ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis.

Slow or Delayed Healing

Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

Avoiding Contamination of the Product

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections.  Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

Contact Lens Wear

Ilevro* (nepafenac ophthalmic suspension), 0.3% should not be administered while wearing contact lens.

Intercurrent Ocular Conditions

Patients should be advised that if they develop an intercurrent ocular condition (e.g., trauma, or infection) or have ocular surgery, they should immediately seek their physician’s advice concerning the continued use of the multi-dose container.

Concomitant Topical Ocular Therapy

If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

Shake Well Before Use

Patients should be instructed to shake well before each use.

U.S. Patent Nos. 5,475,034; 6,403,609; and 7,169,767

*a Trademark of Novartis

ALCON®
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
© 2014 Novartis

9010719-0514

Use is not recommended. US FDA pregnancy category: C Comments: -This drug should not be used by women of child bearing potential not using contraception. -Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (premature closure of ductus arteriosus), the use of this drug during late pregnancy should be avoided.

Animal studies have shown reproductive toxicity. There are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.