Vyzulta

What is Vyzulta used for?

Vyzulta is a prescription medicine that is used to treat glaucoma.

Description

VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is a prostaglandin analog formulated as a sterile topical ophthalmic solution. VYZULTA contains the active ingredient latanoprostene bunod 0.24 mg/mL, the preservative benzalkonium chloride 0.2 mg/mL, and the following inactive ingredients: polysorbate 80, glycerin, EDTA, and water. The formulation is buffered to pH 5.5 with citric acid/sodium citrate.

Its chemical name is 4-(Nitrooxy)butyl (5Z)-7-{(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl}hept-5-enoate. Its molecular formula is C27H41NO8. Molecular weight: 507.62.

Its chemical structure is:

Latanoprostene bunod is a colorless to yellow oil.

• Mechanism of Action

  Latanoprostene bunod is thought to lower intraocular pressure by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Intraocular pressure is a major modifiable risk factor for glaucoma progression. Reduction of intraocular pressure reduces risk of glaucomatous visual field loss.

• It is used to lower high eye pressure.

Description

Before taking Vyzulta, tell your doctor:

For all patients taking Vyzulta:

• If you are allergic to Vyzulta; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have an eye infection or swelling in the eye.

Children:

• If the patient is a child. Do not give Vyzulta to a child.

This is not a list of all drugs or health problems that interact with this medicine.

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 Vyzulta with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Vyzulta?

• Tell all of your health care providers that you take Vyzulta. This includes your doctors, nurses, pharmacists, and dentists.
• Have your eye pressure and eyesight checked as you have been told by the doctor.
• Tell your doctor if you have an eye infection, eye injury, or will be having eye surgery.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Vyzulta best taken?

Use Vyzulta as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For the eye only.
• Use in the evening.
• Wash hands before and after use.
• Take out contact lenses before using Vyzulta. Lenses may be put back in 15 minutes after Vyzulta is given. Do not put contacts back in if your eyes are irritated or infected.
• Do not touch the container tip to the eye, lid, or other skin.
• Tilt your head back and drop drug into the eye.
• Blot extra solution from the eyelid.
• If more than 1 drug is being used in the same eye, use each drug at least 5 minutes apart.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are the side effects of Vyzulta that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Eye color may change to a brown color. This change may be long-lasting. Eye color changes may happen a few months to years after starting Vyzulta. If eye color changes, call the doctor.

What are some other side effects of Vyzulta?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Eye irritation.
• Change in color of eyelid skin to a darker color.
• Eyelash growth.
• This medicine may cause eyelash changes like dark eyelashes, thickness, or more eyelashes. Most of the time, these changes go back to normal after Vyzulta is stopped.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Vyzulta?

• Store unopened bottles in the refrigerator. Do not freeze.
• Store opened bottles in the refrigerator or at room temperature. Throw away any part not used after 8 weeks.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• NDC 24208-504-05
• VYZULTA®(latanoprostene bunod ophthalmic solution) 0.024%
• Sterile
• FOR TOPICAL OPHTHALMIC USE
• Rx only
• 5 mL

PACKAGE/LABEL DISPLAY PANEL