Photrexa

Name: Photrexa

How is Photrexa (riboflavin ophthalmic)used?

A surgeon or other healthcare provider will give you this medicine as part of your corneal collagen crosslinking procedure.

You will be given numbing eyedrops to prepare you for the procedure. You may also be given a sedative or anesthesia to help you relax. Although you will most likely be awake during the procedure, you should feel little or no discomfort. A special device will be placed around your eyelids to keep them open during the procedure.

Your eye surgeon will place riboflavin ophthalmic drops into your eyes about every 2 minutes during the procedure.

After the procedure, the surgeon will place a contact lens on the treated eye to protect it for a short time.

Call your doctor right away if the contact lens falls out or feels like it is out of place inside your eye.

You may also need to use antibiotic or steroid eyedrops to prevent infection and reduce swelling after your procedure. Carefully follow all after-care instructions and do not miss any follow-up appointments.

What happens if I miss a dose?

Because riboflavin ophthalmic is given as part of a medical procedure, this medicine has no daily dosing schedule.

What should I avoid after being treated with Photrexa (riboflavin ophthalmic)?

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.

Proper Use of riboflavin 5-phosphate

This section provides information on the proper use of a number of products that contain riboflavin 5-phosphate. It may not be specific to Photrexa. Please read with care.

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 Photrexa

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.

For Healthcare Professionals

Applies to riboflavin ophthalmic: ophthalmic solution

General

The most commonly reported side effects include corneal opacity, punctate keratitis, corneal striae and corneal epithelium defect.[Ref]

Ocular

Very common (10% or more): Corneal opacity/haze (up to 71%), corneal epithelium defect (up to 28%), eye pain (up to 26%), punctate keratitis (up to 25%), corneal striae (up to 24%), photophobia (up to 19%), blurred vision (up to 17%), foreign body sensation in eyes (up to 15%), dry eye (up to 14%), ocular hyperemia (up to 14%), reduced visual acuity (up to 11%)
Common (1% to 10%): Anterior chamber cell, anterior chamber flare, corneal disorder, asthenopia, corneal edema, diplopia, eye discharge, eye edema, eye pruritus, eyelid edema, glare, halo vision, keratitis, increased lacrimation, Meibomian gland dysfunction, ocular discomfort, visual impairment, vitreous detachment
Frequency not reported: Blepharitis, corneal thinning[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Other

Common (1% to 10%): Eye complication associated with device[Ref]

Some side effects of Photrexa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Renal Dose Adjustments

Data not available

Riboflavin ophthalmic Pregnancy Warnings

Animal development and reproductive studies have not been conducted. There are no controlled data in human pregnancy. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

Use should be avoided. US FDA pregnancy category: Not formally assigned to a pregnancy category. Risk Summary: There are no data available on use of this drug in pregnant women to inform of a drug-related risk.

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