Pronunciation:

RYE-boe-flay-vin 5 FOS-fate

Brand Names:

• Photrexa
• Photrexa Viscous

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Pharmacologic—

Riboflavin

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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.

Older adults—

No information is available on the relationship of age to the effects of Photrexa® or Photrexa® Viscous in geriatric patients.

Breast-feeding—

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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.