Riboflavin 5-phosphate (Ophthalmic)

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

This medicine should only be given by your doctor or under their supervision.

Your doctor will monitor your progress closely while you are using this medicine. This will help your doctor see if the medicine is working well and to look for any side effects.

Call your doctor immediately if you experience severe eye pain or if you 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 reducing exposure to bright light may help reduce discomfort.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits. For this medicine, keep the following in mind:

Allergies

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

Pediatric

Appropriate studies have not been done on the effects of Photrexa® or Photrexa® Viscous in children younger than 14 years. Safety and effectiveness have not been established.

Geriatric

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

Breast Feeding

Studies in women indicate that this medication poses minimal risk to infants when used during breastfeeding.

Interactions with Medicines

Some medicines should never be used together. In other cases, two different medicines may be used together despite potential interactions. In these situations, your doctor may 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

Certain medicines should not be taken around mealtimes or with specific types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems can affect the use of this medicine. Be sure to inform 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. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor or nurse right away 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, redness, or inflammation
• feeling like there is 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have 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.