Ozurdex

• Allergan, Inc.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ozurdex falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

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

It is not known if Ozurdex crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Ozurdex.

Use Ozurdex exactly as prescribed.

This medication is available in an intravitreal eye implant form for implantation into the eye by a healthcare professional. Your physician will monitor you after implantation of Ozurdex.

If your eyes become red, sensitive to light, painful, or develop a change in vision, seek immediate care from your ophthalmologist.

You should not receive this implant if you are allergic to dexamethasone, or if you have:

• an eye infection;

• advanced glaucoma;

• an artificial lens implanted in your eye; or

• a history of eye ulcer, surgery, or wound that has injured or removed the lens in your eye.

To make sure dexamethasone intravitreal is safe for you, tell your doctor if you have ever had herpes infection of the eyes.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Dexamethasone can pass into breast milk and may harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

It is not likely that other drugs you take orally or inject will have an effect on dexamethasone used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of dexamethasone implant in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dexamethasone implant in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Artemether
• Desmopressin
• Praziquantel
• Rilpivirine
• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Aldesleukin
• Amtolmetin Guacil
• Bemiparin
• Boceprevir
• Bosutinib
• Bromfenac
• Bufexamac
• Bupropion
• Celecoxib
• Ceritinib
• Choline Salicylate
• Clarithromycin
• Clonixin
• Cobicistat
• Conivaptan
• Daclatasvir
• Darunavir
• Dasatinib
• Desogestrel
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dienogest
• Diflunisal
• Dipyrone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Drospirenone
• Droxicam
• Efavirenz
• Elvitegravir
• Enzalutamide
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etodolac
• Etofenamate
• Etonogestrel
• Etoricoxib
• Etravirine
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Fosamprenavir
• Gestodene
• Ibuprofen
• Idelalisib
• Indomethacin
• Ixabepilone
• Ketoprofen
• Ketorolac
• Lapatinib
• Levonorgestrel
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Mestranol
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nepafenac
• Nevirapine
• Nifedipine
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nimodipine
• Norethindrone
• Norgestimate
• Norgestrel
• Olaparib
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piperaquine
• Piroxicam
• Pixantrone
• Pranoprofen
• Proglumetacin
• Propyphenazone
• Proquazone
• Ritonavir
• Rofecoxib
• Romidepsin
• Salicylic Acid
• Salsalate
• Saquinavir
• Sodium Salicylate
• Sulindac
• Sunitinib
• Tacrolimus
• Telaprevir
• Tenoxicam
• Thalidomide
• Tiaprofenic Acid
• Ticagrelor
• Tolfenamic Acid
• Tolmetin
• Ulipristal
• Valdecoxib
• Vincristine Sulfate Liposome
• Vortioxetine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium
• Aminoglutethimide
• Aprepitant
• Aspirin
• Atracurium
• Caspofungin
• Fluindione
• Fosaprepitant
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Netupitant
• Ospemifene
• Pancuronium
• Phenobarbital
• Phenytoin
• Rifampin
• Rifapentine
• Saiboku-To
• Vecuronium
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Detached retina (eye disorder) or
• Endophthalmitis (inflammation of the eye) or
• Glaucoma (increased pressure in the eye) or
• Herpes infection of the eye, history of—Use with caution. May make these conditions worse.

• Eye infection caused by a virus, fungus, or bacteria or
• Eye lens problems (non-intact posterior lens capsule) or
• Glaucoma, advanced—Should not be used in patients with these conditions.

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.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Ozurdex, please talk with your doctor, nurse, pharmacist, or other health care provider.
• 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.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ozurdex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Ozurdex.

Review Date: October 4, 2017

Intravitreal Injection-related Effects

Intravitreal injections, including those with Ozurdex®, have been associated with endophthalmitis, eye inflammation, increased intraocular pressure, and retinal detachments. Patients should be monitored regularly following the injection [see Patient Counseling Information (17)].

Steroid-related Effects

Use of corticosteroids including Ozurdex® may produce posterior subcapsular cataracts, increased intraocular pressure, and glaucoma. Use of corticosteroids may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses [see Adverse Reactions (6.1)].

Corticosteroids are not recommended to be used in patients with a history of ocular herpes simplex because of the potential for reactivation of the viral infection.

You should not receive Ozurdex if you are allergic to dexamethasone, or if you have:

• an eye infection;

• advanced glaucoma;

• certain types of artificial lens implanted in your eye; or

• a history of eye ulcer, surgery, or wound that has injured or removed the lens in your eye.

To make sure Ozurdex is safe for you, tell your doctor if you have ever had herpes infection of the eyes.

FDA pregnancy category C. It is not known whether Ozurdex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether dexamethasone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.