Description
Riboflavin 5-Phosphate eye drops is a photoenhancer used in combination with the KXL® System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. Keratoconus is a degenerative eye disease that cause progressive thinning and distortion of the cornea.
This medicine is to be given only by or under the supervision of your doctor.
This product is available in the following dosage forms:
- Solution
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 Photrexa® or Photrexa® Viscous in children younger than 14 years of age. Safety and efficacy have not been established.
Geriatric
No information is available on the relationship of age to the effects of Photrexa® or Photrexa® Viscous in geriatric patients.
Breastfeeding
Studies in women suggest that this medication poses minimal risk to the infant when used during 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:
- Eye or corneal problems (eg, keratitis)—Use with caution. May make these conditions worse.
Proper Use
A nurse or other trained health professional will give you this medicine. This medicine is given as eye drops and must be used with the KXL® System only. Your doctor will perform an eye procedure after you receive this medicine.
Do not rub your eyes for the first 5 days after your eye procedure.
If the bandage contact lens that was placed on your eye falls out or becomes dislodged, do not replace it and call your doctor right away.
Precautions
Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.
Contact your doctor right away if you have severe eye pain or if you notice any sudden change in your vision after receiving this medicine.
This medicine may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.
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
- Blindness
- blurred vision
- change in color vision
- decreased vision
- difficulty seeing at night
- eye pain, irritation or redness, or inflammation
- feeling of having something in the eye
- increased sensitivity of the eyes to sunlight
- painful irritation of the clear front part of the eye
Less common
- Drainage from the eyes
- eye discomfort
- seeing flashes or sparks of light
- seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
- sensitivity of the eyes to light
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Dry eyes
- headache
Less common
- Double vision
- redness, swelling, or itching of the eyelid
- seeing double
- watering of the eyes
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.
DRG-20235484
