Ozurdex

What is Ozurdex used for?

Ozurdex is a prescription medicine that is used to treat eye swelling. It is used to treat eye irritation.

Description

OZURDEX® is an intravitreal implant containing 0.7 mg (700 mcg) dexamethasone in the NOVADUR® solid polymer sustained-release drug delivery system. OZURDEX® is preloaded into a single-use, DDS® applicator to facilitate injection of the rod-shaped implant directly into the vitreous. The NOVADUR® system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix without a preservative. The chemical name for dexamethasone is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-. Its structural formula is:

• MW 392.47;
• molecular formula: C22H29FO5

Dexamethasone occurs as a white to cream-colored crystalline powder having not more than a slight odor, and is practically insoluble in water and very soluble in alcohol.

The PLGA matrix slowly degrades to lactic acid and glycolic acid.

  Mechanism of Action

Dexamethasone, a corticosteroid, has been shown to suppress inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage and migration of inflammatory cells.

Before taking Ozurdex, tell your doctor:

• If you are allergic to Ozurdex; 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 any of these health problems: A fungal, TB (tuberculosis), or viral infection of the eye.
• If you have any kind of eye infection.
• If you have glaucoma.
• If you have ever had a herpes infection of the eye.
• If you have a type of eye problem called torn or ruptured posterior lens capsule.

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 Ozurdex 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 Ozurdex?

• Tell all of your health care providers that you take Ozurdex. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use Ozurdex for longer than you were told by your doctor.
• 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.
• This medicine may cause blurred eyesight after it is put in your eye. Avoid driving and doing other tasks or actions that call for clear eyesight until this goes away.
• Some eye problems like raised eye pressure, cataracts, and glaucoma have happened with Ozurdex. If you have questions, talk with the doctor.
• Have an eye exam as you have been told by your doctor.

How is Ozurdex best taken?

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

• This medicine is given into the eye by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Ozurdex 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 redness.
• If bright lights bother your eyes.
• Seeing floaters.

What are some other side effects of Ozurdex?

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:

• Irritation where Ozurdex is used.
• Blurred eyesight.
• Feeling that something is in the eye.
• Dry eyes.
• Blurred eyesight after the shot.

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 Ozurdex?

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

Label

PRINCIPAL DISPLAY PANEL