Description
Revakinagene taroretcel-lwey intravitreal implant is used to treat idiopathic macular telangiectasia type 2 (MacTel).
This medicine is to be given only by or under the direct supervision of your doctor.
This product is available in the following dosage forms:
- Implant
Before Using
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 revakinagene taroretcel-lwey intravitreal 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 revakinagene taroretcel-lwey intravitreal implant in the elderly.
Breastfeeding
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.
Drug Interactions
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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
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:
- Bleeding problems or
- Other eye or vision problems—Use with caution. May make these conditions worse.
- Eye infections, active or suspected—Should not be used in patients with this condition.
Proper Use
Your eye doctor (ophthalmologist) will give you this medicine in a hospital or clinic. This medicine is an implant that is inserted through the white part of the eye (sclera).
Your doctor will ask you to avoid heavy lifting and keep water out of your eyes for one week after surgery. You will also need to use eyeglasses or protective eyewear during the day and an eye shield at night for one week after the surgery.
Your doctor will ask you to use eye drops (eg, steroid medicine) and topical antibiotic solution starting the day after the surgery for 7 days.
This medicine should come with a patient information. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Precautions
Your eye doctor will want to check your progress at regular visits, especially during the first few days after you receive this medicine, to make sure this medicine is working properly and to check for unwanted effects.
Serious eye or vision problems (eg, eye infection or bleeding, cataracts, implant extrusion, loss of vision, retinal detachment or tear, or suture-related problems) may occur with this medicine. Check with your doctor right away if your eye becomes blurry, red, painful, tearing, or if you are seeing flashes or sparks of light, seeing floating spots before the eyes, or a veil or curtain appearing across part of vision, or a change or loss of vision after you receive this medicine.
This medicine may cause delayed dark adaptation (ability of the eye to adjust from bright lighting to dark lighting conditions). Drive with caution when moving from bright to dark areas. Use flashlights or night lights at home. Wear sunglasses or tinted lenses in bright areas.
Do not drive or do anything else that could be dangerous until your eye shield can be removed and you can see.
Tell your doctor that you have this medicine implanted in your eye before you have an MRI.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
- Bloody eye
- blurred vision
- change in vision not present before treatment
- constricted, pinpoint, or small pupils (black part of the eye)
- dry eye
- eye pain or irritation
- headache
- redness of the eye
- redness of the white part of the eyes or inside of eyelids
- seeing floaters, veil, or curtain appearing across part of vision
Less common
- Drainage from eyes
- tearing
Incidence not known
- Blindness
- seeing flashes or sparks of light
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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