Retisert - Consumer Medicine Information
|Manufacture:||Bausch and Lomb|
|Condition:||Inflammatory Conditions, Macular Edema, Uveitis|
|Ingredients:||fluocinolone acetonide, magnesium stearate, microcrystalline cellulose, polyvinyl alcohol, silicone elastomer, silicone, adhesive|
About this medication
What the medication is used for:
RETISERT™ is used to treat a rare inflammatory disease called non-infectious posterior uveitis that affects the back section of the eye.
What it does:
RETISERT™ is a brand name for a drug that belongs to a group of medicines called corticosteroids which are used to reduce inflammation. It is believed that RETISERT™ reduces inflammation in your eye by blocking the production of substances that cause inflammation.
When it should not be used:
RETISERT™ should not be used if you:
- Have a bacterial infection in your eye
- Have a viral infection in your eye
- Have a fungal disease in your eye
- Are allergic or have a known or suspected hypersensitivity to any of the ingredients in RETISERT™ or other corticosteroids (see what the nonmedicinal ingredients are).
What the medicinal ingredient is:
RETISERT™ is a small, sterile implant that contains the active ingredient fluocinolone acetonide. Fluocinolone acetonide belongs to a group of medicines called corticosteroids. Corticosteroids are known to reduce inflammation.
What the important nonmedicinal ingredients are:
- Magnesium Stearate
- Microcrystalline Cellulose
- Polyvinyl Alcohol
- Silicone Elastomer
- Silicone Adhesive
What dosage forms it comes in:
0.59 mg intravitreal implant
Warning and precautions
BEFORE you are implanted with RETISERT™ talk to your doctor or pharmacist if:
- You have a mycobacterial infectious disease
- You have a fungal disease of the eye
- You are pregnant or intend to become pregnant. If you become pregnant after RETISERT™ has been put into your eye, tell your doctor so that he can decide if your RETISERT™ must be removed.
- You are breast feeding or intend to breast feed. Your doctor will tell you whether to stop or continue breast feeding once RETISERT™ has been put into your eye.
- You have known or suspected hypersensitivity to any of the ingredients in RETISERT™ or other corticosteroids.
- You have had recent eye surgery or further eye surgery is planned.
Tell your doctor if you are taking or have recently taken any other medicines, especially other corticosteroids, including medicines obtained without a prescription. These medicines may affect how you feel during surgery. Your doctor will prescribe eye drops for you to use after the operation. All eye care products must be discussed with your doctor beforeuse.
Your doctor will tell you about eating and drinking at the time of the operation to implant RETISERT™. Once the operation is over, you will be able to eat and drink as normal.
After the operation you are likely to have blurred vision for up to four weeks. Do not drive or operate machinery until you can see clearly again. If you have any concerns about how well you can see, talk to your doctor to have your eyes tested. Always tell your doctor that you have RETISERT™ in your eye because it will be visible during the examination.
Contact your doctor if an eye infection develops or your eye condition worsens.
Interactions whith medication
Drug interactions were not studied with this product and are not expected.
Proper use of this medication
A doctor in a hospital will implant RETISERT™ into the eye by making a small incision (cut) in the sclera (white part of the eye).
Each RETISERT™ implant contains 0.59 mg of fluocinolone acetonide. You will not be able to feel RETISERT™ after it has been implanted in your eye. The active substance is slowly released from the implant into your eye over approximately 3 years. Your doctor will decide if you need another RETISERT™ implanted after approximately 3 years. It will take about one month before you get the benefits from RETISERT™.
Given the nature of the product (i.e., surgical implantation by physician), it is unlikely that overdose could occur.
Side effects and what to do about them
Like all medicines, RETISERT™ can cause side effects, although not everybody gets them. As with any surgical procedure there is risk involved. If any side effects get serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.
If you get any of the following side effects you must contact your doctor. More than 1 in 10 patients may experience the following side effects from RETISERT™ treatment:
- A rise in the pressure inside your eye with or without glaucoma – you will not be able to tell if this is happening and it is therefore important that you have your eyeschecked regularly by your doctor
- Blurred vision from the operation.
- Cataract (clouding of the lens of your eye). Your doctor must check your eyes regularly to see if a cataract is forming. Cataract requires surgery.
- Blurred vision due to cataract formation
- Eye pain from the operation.
- Appearance of Floaters in the eye.
Other side effects that may affect more than 1 in 10 patients include:
- Bleeding in the eye – if this happens see your doctor immediately.
- Swelling of the eye lids
- Increased tear production
- Irritation of the eye (itching, feeling there is ‘something’ in the eye)
- Photophobia (pain in the eye in strong light)
- Runny nose or cough
- Feeling of, or being sick
- Headache or dizziness
This is not a complete list of side effects. For any unexpected effects, contact your doctor or pharmacist.
How to store it
RETISERT™ is stored at the hospital until it is implanted in your eye. It is kept in its original package at a temperature of 15-25°C until surgery takes place.
|REPORTING SUSPECTED SIDE EFFECTS|
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:
By toll-free telephone: 866-234-2345
By regular mail:
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared forhealth professionals can be obtained by contacting the sponsor,Bausch and Lomb, at: