Photrexa Viscous

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• eye redness or watering;
• severe eye pain; or
• sudden change in your vision.

Common side effects may include:

• feeling like something is in your eye;
• increased tearing;
• blurred vision, hazy vision;
• increased glare in your vision; or
• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid rubbing your eyes for at least 5 days after your procedure.

Your eyes may be more sensitive to light after your procedure. Wear sunglasses when you are exposed to bright light.

It is not likely that other drugs you take orally or inject will have an effect on riboflavin used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

• If you have an allergy to this medicine (Photrexa Viscous) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are pregnant or may be pregnant. Do not use this medicine (Photrexa Viscous) if you are pregnant.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

PHOTREXA® VISCOUS and PHOTREXA® are indicated for use in corneal collagen cross-linking in combination with the KXL™ System for the treatment of

Progressive keratoconus

Corneal ectasia following refractive surgery

Using topical anesthesia, debride the epithelium to a diameter of approximately 9 mm using standard aseptic technique. Post epithelial debridement, instill 1 drop of Photrexa Viscous topically on the eye every 2 minutes for 30 minutes.

At the end of the 30 minute soaking period, examine the eye under the slit lamp for the presence of a yellow flare in the anterior chamber. If the yellow flare is not detected, instill 1 drop of Photrexa Viscous every 2 minutes for an additional 2 to 3 drops and recheck for the presence of a yellow flare. This process can be repeated as necessary.

Once the yellow flare is observed, perform ultrasound pachymetry. If corneal thickness is less than 400 microns, instill 2 drops of PHOTREXA every 5 to 10 seconds until the corneal thickness increases to at least 400 microns. Irradiation should not be performed unless this 400 micron threshold is met and the yellow flare is seen.

Irradiate the eye for 30 continuous minutes at 3mW/cm2 at a wavelength of 365 nm, centered over the cornea, using the KXL System as per the instructions in the KXL manual. During irradiation, continue topical instillation of Photrexa Viscous onto the eye every 2 minutes for the 30 minute irradiation period.

For topical ophthalmic use. Do not inject.

Single use Photrexa Viscous and PHOTREXA only. Discard syringe(s) after use.

Photrexa Viscous and PHOTREXA are for use with the KXL System only.

PLEASE REFER TO THE KXL OPERATOR’S MANUAL FOR SPECIFIC DEVICE INSTRUCTIONS.

. Pregnancy

Risk Summary

Animal development and reproduction studies have not been conducted with the PHOTREXA® VISCOUS/PHOTREXA®/KXL® System. Since it is not known whether the corneal collagen cross-linking procedure can cause fetal harm or affect reproduction capacity, it should not be performed on pregnant women.

. Lactation

Risk Summary

There are no data on the presence of Photrexa Viscous or PHOTREXA in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for the PHOTREXA/KXL corneal collagen cross-linking procedure and any potential adverse effects on the breastfed child from the PHOTREXA/KXL corneal collagen cross-linking procedure or from the underlying maternal condition.

. Pediatric Use

The safety and effectiveness of corneal collagen cross-linking has not been established in pediatric patients below the age of 14 years.

. Geriatric Use

No patients enrolled in the clinical studies were 65 years of age or older.