Vyzulta 0.024% Ophthalmic 2.5ml

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LATANOPROSTENE BUNOD SOLUTION - OPHTHALMIC

(la-TAN-oh-PROS-teen BUE-nod)

COMMON BRAND NAME(S): Vyzulta

USES: Latanoprostene bunod is used to treat high pressure inside the eye due to glaucoma (open-angle type) or other eye diseases (such as ocular hypertension). Lowering high pressure inside the eye can help prevent blindness. This medication works by controlling the flow of fluid within the eye to maintain a normal pressure.

HOW TO USE: Use this medication in the affected eye(s) as directed by your doctor, usually once daily in the evening. Do not increase your dose or use this medication more often than prescribed. Doing so may make this medication work less well. To apply eye drops, wash hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface. If you are wearing contact lenses, remove them before using eye drops. Wait at least 15 minutes before replacing your contact lenses. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward, gently close your eyes, and place one finger at the corner of your eye (near the nose). Apply gentle pressure for 1 to 2 minutes before opening your eyes. This will prevent the medication from draining out. Try not to blink or rub your eye. If directed to use this medication in both eyes, repeat these steps for your other eye. Do not rinse the dropper. Replace the dropper cap after each use. If you are using another kind of eye medication (such as drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye. Wait several minutes for your vision to clear before driving or operating machinery. Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day. It is important to continue using latanoprostene bunod even if you feel well. Most people with glaucoma or high pressure in the eye do not have symptoms.

SIDE EFFECTS: Eye discomfort/irritation/redness or temporary blurred vision may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. This medication may slowly (over months to years) cause the colored portion of the eye (iris) to turn brown. If you are using latanoprostene bunod in only one eye, only that iris may change color. An increase in eyelash number/length/thickness and darkening of the eyelashes/eyelids may also occur in the treated eye. These changes may be permanent, but the long-term effects are uncertain. Tell your doctor if this occurs and schedule regular eye exams to monitor it. 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. Tell your doctor right away if you have any serious side effects, including: vision changes, eye pain/swelling, swelling/redness of the eyelids. A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using latanoprostene bunod, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems (such as macular edema, iritis, uveitis, lens extraction/aphakia). After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug are: eyelash treatments (such as topically applied bimatoprost).

OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Lab and/or medical tests (such as eye exams) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, use it as soon as you remember if it is on the same day. If you do not remember until the next day, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store the unopened bottles in the refrigerator. Protect the bottle from freezing or from light. Once a bottle is opened for use, it may be stored at room temperature for 8 weeks. Discard any opened, unused bottles after this time period. Read the product package carefully. If you have any questions about storage, ask your pharmacist. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised December 2017. Copyright(c) 2017 First Databank, Inc.