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Details for: OZURDEX

Company: ALLERGAN INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
02363445OZURDEXDEXAMETHASONE0.7 MGIMPLANTINTRAVITREAL
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Summary Reports

Regulatory Decision Summary

Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

OZURDEX® is used to treat:

  • a condition called macular edema that is caused by a blockage of veins in the eye.
  • a condition called non-infectious uveitis of the posterior segment of the eye that is not caused by an eye infection.
  • a condition called diabetic macular in patients who have had cataract surgery and intraocular lens implantation.
These conditions cause swelling in the back part of your eye, which leads to vision changes and vision loss.
What it does

OZURDEX® works by reducing swelling of the macula. This helps to lessen or prevent more damage to the macula. The macula is an area in the centre of the back part of the eye. It is responsible for clear vision.

OZURDEX® also works by reducing the inflammation in the back part of the eye.

When it should not be used

Do not use OZURDEX® if:

  • you are allergic to dexamethasone or any of the other ingredients in OZURDEX®
  • you are allergic to other medicines like OZURDEX® , called corticosteroids
  • you have an eye infection of any kind caused by bacteria, a virus or a fungus
  • you have glaucoma that is at an advanced stage
  • you have aphakic eyes (eyes without natural or artificial lens) along with a tear in the posterior lens capsule of your eye
  • you have a condition called Anterior Chamber Intraocular Lens (ACIOL) along with a tear in the posterior lens capsule of your eye
Ask your doctor if you are not sure if you have any of the conditions listed above.

The use of OZURDEX® in children and adolescents is not recommended.
What the medicinal ingredient is

dexamethasone

What the non-medicinal ingredients are

A polymer drug delivery system contains PLGA biodegradable polymer matrix (NOVADUR™): Resomer® RG 502, Poly (D,L-lactide-co-glycolide), 50:50 PLGA ester terminated; and Resomer® RG 502 H, Poly (D,L-lactide-co-glycolide),50:50 PLGA acid terminated.

What dosage form it comes in

As an intravitreal implant that contains 0.7 mg dexamethasone. Intravitreal means that this implant is placed into the eye through an injection.

Warnings and precautions

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OZURDEX® . Talk about any health conditions or problems you may have, including if:

  • you have aphakic eyes (eyes without natural or artificial lens)
  • you have a tear in the posterior lens capsule of your eye
  • you have had a herpes simplex infection in your eye before (an ulcer on the eye that has been there a long time, or sores on the eye),
  • you are taking any medication to thin the blood or any other medication
  • you are pregnant or planning to become pregnant,
  • you are breast feeding or planning to breast feed,
  • you had recent eye surgery, or plan to have one,
Other warnings you should know about:
The following may occur or get worse after OZURDEX® treatment:
  • an infection inside or around the eye
  • redness (inflammation) inside the eye
  • glaucoma and/or increased pressure in the eye
  • detachment of the layer in the back of the eye (retinal detachment), or
  • clouding of the lens (cataract
  • misplacement of implant that requires surgical intervention
It is important to identify and treat these conditions listed directly above as soon as possible. Please tell your doctor immediately if you have any concerns with your eye or experience any of the following signs:
  • Blurred or decreased vision
  • Eye pain or increased discomfort
  • Worsening eye redness
  • A feeling of spots in front of the eye (called ‘floaters’)
  • Increased sensitivity to light
In some patients the pressure in the eye may increase right after OZURDEX® is implanted into the eye. This is something you may not notice, so your doctor might monitor this after OZURDEX® is implanted.
Driving and using machines:
After OZURDEX® treatment you may experience some blurred vision for a short time. Wait until you can see clearly before driving or using machines. Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Interactions with this medication

The following medicines may interact with OZURDEX®

  • Medicines used to thin your blood called blood thinners.
  • Sedatives and sleep-inducing medicines called barbiturates.
  • Rifampin, which is a medicine used to treat tuberculosis.
  • Ketoconazole, which is a medicine used to treat fungal infections.
  • Indinavir, which is a medicine used to treat HIV infection.
  • Medicines used to treat seizures, like phenytoin or carbamazepine.
  • Erythromycin, which is an antibiotic.
Proper use of this medication

How to take OZURDEX®?

  • OZURDEX® will be given to you by a doctor, called an ophthalmologist, who has experience in giving injections into the eye.
  • It will be implanted directly into your eye through an injection.
  • It is not recommended that both of your eyes be injected with OZURDEX® at the same time.
  • After you receive the injection, your doctor will check your eye.
  • You may be given antibiotic eye drops to use before, during or after your injection to prevent eye infections.
  • You may also be given a pain medicine on the day of your injection.
  • You may hear a ‘click’ during the injection of OZURDEX® ; you should not move, as this is expected.
  • Follow all instructions given to you by your doctor.

Usual Dose

The usual dose is one OZURDEX® implant to be given by injection into your eye. Your doctor will decide if you should receive another OZURDEX injection If you need another injection, your doctor will wait 6 months to give it to you.

Overdose

If you think you have taken too much OZURDEX® , contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose

If you miss your appointment to receive OZURDEX® , contact your doctor or hospital as soon as possible to reschedule your appointment.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking OZURDEX® . If you experience any side effects not listed here, contact your healthcare professional.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor, nurse, or pharmacist only if severe Talk with your doctor, nurse, or pharmacist in all cases Stop taking drug and get immediate medical help
Very Common
Increased pressure in the eye x    
Glaucoma (serious eye disease where pressure in the eye is increased): blurred vision, eye redness, halos around lights, loss of vision, nausea, severe eye pain, vomiting.    
Cataracts (clouding of the lens of your eye): blurry vision, clouded vision, eye pain, fading or yellowing of colours, seeing halos and glare around lights, trouble seeing at night    
Bleeding on the surface of the eye*    
Common
Vitreous detachment (detachment of the jelly inside the eye from the light-sensitive layer at the back of the eye): seeing flashes and floaters    
Bleeding into the inside of the eye*: blurry or blocked vision, floaters    
Vision blurred, decreased or difficulty seeing clearly    
A feeling of spots in front of the eye (including ‘floaters’)*    
Abnormal feeling in the eye    
Eye pain*    
Inflammation and itchiness of the eyelid    
Migraine    
Seeing flashes of light    
Swelling on the surface of the eye*    
A feeling of looking through mist or fog*    
Difficulties in seeing clearly    
Redness of the white of the eye    
Rare
Tear in the retina: vision loss or difficulty seeing    
Anterior chamber flare (increased protein in the front of the eye due to inflammation): blurry vision    
Headache    
A severe inflammation at the back of the eye (usually due to viral infection): eye redness, pain in your eyeball, sensitive to light, and vision loss  
Severe infection and Inflammation inside the eye: eye pain, redness, visual loss    
Unknown Frequency
mplant migrated from the back to the front part of the eye: blurry vision    
Low eye pressure    

*Some of these side effects could have been caused by the injection procedure or the OZURDEX implant itself

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

How to store

Keep out of the reach and sight of children.

Store at room temperature between 15º C and 30º C. Protect from excessive heat.

Reporting side effects

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you want more information about OZURDEX®

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (http://hc-sc.gc.ca/index-eng.php); the manufacturer’s website: www.allergan.ca, or by calling 1-800-668-6424.
This leaflet was prepared by Allergan Inc.

Last revised: August 21, 2019

©2019 Allergan Inc., Markham, ON L6G 0B5. ®Marks owned by Allergan Inc. All rights reserved.

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