Photrexa Viscous (Ophthalmic)

Riboflavin 5-Phosphate eye drops is a photoenhancer used together with the KXL® System in corneal collagen cross-linking to treat progressive keratoconus and corneal ectasia after refractive surgery. Keratoconus is an eye disease that leads to ongoing thinning and distortion of the cornea.

This medicine is to be given only by or under the supervision of your doctor.

Your doctor will monitor your progress closely while you take this medicine. This helps your doctor determine if the medicine is working correctly and to look for any side effects.

Contact your doctor immediately if you experience severe eye pain or notice any sudden changes in your vision after using this medicine.

This medicine may make your eyes more sensitive to light than usual. Wearing sunglasses and limiting exposure to bright light may help reduce discomfort.

In deciding to use this medicine, you and your doctor need to think about the risks compared to the benefits. Here are some things to consider:

Allergies

Let your doctor know if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on the effects of Photrexa® or Photrexa® Viscous in children younger than 14 years of age. Safety and effectiveness have not been proven in this age group.

Geriatric

There is no information available about the effects of Photrexa® or Photrexa® Viscous in older patients.

Breast Feeding

Studies suggest that this medication poses minimal risk to infants when used during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if an interaction might happen. In these cases, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used during meals or around certain foods due to possible interactions. Using alcohol or tobacco with some medicines can also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Eye or corneal problems (e.g., keratitis)—Use with caution. This may worsen these conditions.

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.

In the U.S.

• Photrexa
• Photrexa Viscous

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Riboflavin

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.